Sr. Regulatory Affairs Specialist · Siemens Medical Solutions USA, Inc. Ultrasound Division Diagnostic Ultrasound System 510(k)-QUS Page 1 of 26 Diagnostic Ultrasound Indications

U.S. Food & Drug Administration 10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 3 . 0 7 Silver Spring, MD 20993 www.fda.gov

Siemens Healthineers March 20, 2019 ℅ Ms. Christine Dunbar Sr. Regulatory Affairs Specialist 22010 SE 51 Street ISSAQUAH WA 98029 Re: K183575

Trade/Device Name: ACUSON S3000, S2000 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, OBJ Dated: February 17, 2019 Received: February 19, 2019

Dear Ms. Dunbar: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

K183575 – Ms. Christine Dunbar Page

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, For Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Siemens Medical Solutions USA, Inc. Ultrasound Division Diagnostic Ultrasound System

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Diagnostic Ultrasound Indications for Use Form 510 (k) Number (if known):

Device Name: ACUSON S3000, S2000 Diagnostic Ultrasound SystemsIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation

Clinical Application A B M PWD CWD Color Doppler

Amplitude Doppler

Color Velocity Imaging

Combined (Specify)

Other (Specify)

Ophthalmic

Fetal P

P P P P P BMDC Note 2,3,4,5,7,8,10,11,13

Abdominal P

P P P P P BMDC Note 2,3,4,5,6, 7,8,10,11, 13,16,17,18,20,21

Intraoperative (Note 9) P

P P P P P BMDC Note 2,3,4,5,7,8,10,11,14

Intraoperative Neurological P P P P P BMDC Note 2,3,4,5,7,8,10,11,14

Pediatric P

P P P P P BMDC Note 2,3,4,5,6, 7,8,10,11

Small Organ (Note 1) P

P P P P P BMDC Note 2,3,4,5,6, 7,8,10,

11,14,16,18,19,20

Neonatal Cephalic P

P P P P P BMDC Note 2,3,4,5,7,8,10

Adult Cephalic P

P P P P P BMDC Note 2,3,4,5,7,8,10

Cardiac P

P P P P P BMDC Note 2,3,4,5,7,8,10,15

Trans-esophageal P

P P P P P BMDC Note 4

Transrectal P P P P P BMDC Note 2,3,4,5,6, 7,8,10, 11,14

Transvaginal P P P P P BMDC Note 2,3,4,5,7,8,10,11 Transurethral Intravascular

Peripheral vessel P

P P P P P BMDC Note 2,3,4,5,7,8,10,11,14,15

Laparoscopic Musculo-skeletal Conventional P

P P P P P BMDC Note 2,3,4,5,7,8,10, 11,14

Musculo-skeletal Superficial P

P P P P P BMDC Note 2,3,4,5,7,8,10, 11,14

Other (specify) Neonatal cardiac P

P P P P P BMDC Note 3,4,10,17

N = new indication; P = previously cleared by K172162; K130739 (VTI); K131164(VTQ); K130881 (VTIQ)

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 6 Cadence contrast agent imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 9 For example: vascular, abdominal Note 10 Clarify VE technology Note 11 Advanced Sieclear spatial compounding Note 13 STIC Note 14 Note 15 AHP Note 16 Custom Tissue Imaging Note 17 eSie Fusion Note 18 VTI Note 19 VTIQ Note 20 VTQ Note 21 QUS (Quantitative Ultrasound)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

________________________________________________________________________ Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

____________________________________________ Division Sign-Off - Office of In Vitro Diagnostic Devices

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Diagnostic Ultrasound Indications for Use Form510 (k) Number (if known):

Device Name: CW2 Probe Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic Fetal P Abdominal P Intraoperative (Note 9) P

Intraoperative Neurological

Pediatric P Small Organ (Note 1) P

Neonatal Cephalic P Adult Cephalic P Cardiac P Trans-esophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel P Laparoscopic Musculo-skeletal Conventional P


Other (specify) N = new indication; P = previously cleared by FDA K172162

Additional Comments: Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 9 For example: vascular, abdominal




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Device Name: CW5 Probe Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic Fetal P Abdominal P Intraoperative (Note 9) P

Intraoperative Neurological P

Pediatric P Small Organ (Note 1) P

Neonatal Cephalic P Adult Cephalic P Cardiac P Trans-esophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel P Laparoscopic Musculo-skeletal Conventional P



Additional Comments:

Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 9 For example: vascular, abdominal




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Diagnostic Ultrasound Indications for Use Form

510 (k) Number (if known):

Device Name: EC9-4 Curved Array Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic Fetal P P P P P BMDC Note 2,3,4,5,7,8,10,11

Abdominal P P P P P BMDC Note 2,3,4,5,6,7,8,10,11,17

Intraoperative Intraoperative Neurological

Pediatric Small Organ (Note 1) P P P P P BMDC Note 2,3,4,5,7,8,10,11,14

Neonatal Cephalic P P P P P BMDC Note 2,3,4,5,7,8,10 Adult Cephalic Cardiac Trans-esophageal

Transrectal P P P P P BMDC Note 2,3,4,5,6,7,8,10,11,14

Transvaginal P P P P P BMDC Note 2,3,4,5,7,8,10,11 Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional

Musculo-skeletal Superficial


Additional Comments: Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 6 Cadence contrast agent imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding Note 14

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ________________________________________________________________________

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)


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Device Name: 9L4 Linear Array Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic Fetal P P P P P BMDC Note 2,3,4,5,7,8,10,11 Abdominal P P P P P BMDC Note 6,18,20 Intraoperative Intraoperative Neurological

Pediatric P P P P P BMDC Note 2,3,4,5,6, 7,8,10,11

Small Organ (Note 1) P P P P P BMDC

Note 2,3,4,5,6,7,8,10,11,14,16,18,19,20

Neonatal Cephalic P P P P P BMDC Note 2,3,4,5,7,8,10,11 Adult Cephalic P P P P P Cardiac P P P P P BMDC Note 15 Trans-esophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel P P P P P BMDC Note 2,3,4,5,7,8,10,11,14,15 Laparoscopic Musculo-skeletal Conventional P P P P P BMDC Note 2,3,4,5,7,8,10,11,14

Musculo-skeletal Superficial P P P P P BMDC Note 2,3,4,5,7,8,10,11,14



Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 6 Cadence contrast agent imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology Note 11 Advanced Sieclear Note 14 Note 15 AHP Note 16 Custom Tissue Imaging Note 18 VTI Note 19 VTIQ Note 20 VTQ




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Device Name: 14L5BV Multi-D Array Transducer for use on S2000Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic Fetal Abdominal Intraoperative Intraoperative Neurological

Pediatric


Note 2,3,4,5,7,8,10,11,14,16

Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional



Additional Comments: Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 6 Cadence contrast agent imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding Note 14 Note 16 Custom Tissue Imaging




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Device Name: 4P1 Phased Array Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic Fetal P P P P P P BMDC Note 2,3,4,5,7,8,10 Abdominal P P P P P P BMDC Note 2,3,4,5,7,8,10 Intraoperative Intraoperative Neurological

Pediatric Small Organ Neonatal Cephalic Adult Cephalic P P P P P P BMDC Note 2,3,4,5,7,8,10 Cardiac P P P P P P BMDC Note 2,3,4,5,7,8,10 Trans-esophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional



Additional Comments: Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology




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Device Name: 6C2 Curved Array Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic

Fetal P P P P P BMDC Note 2,3,4,5,7,8,10,11

Abdominal P P P P P BMDC Note 2,3,4,5,7,8,10,11,14,16,17


Pediatric P P P P P BMDC Note 2,3,4,5,7,8,10,11

Small Organ Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal Transvaginal Transurethral Intravascular

Peripheral vessel P P P P P BMDC Note 2,3,4,5,7,8,10,11

Laparoscopic Musculo-skeletal Conventional



Additional Comments: Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding Note 14 Note 16 Custom Tissue Imaging Note 17 eSie Fusion




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Device Name: 4C1 Curved Array Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic

Fetal P P P P P P BMDC Note 2,3,4,5,7,8,10,11,18,19,20

Abdominal P P P P P P BMDC Note 2,3,4,5,6,7,8,10,11,14,16,17


Pediatric P P P P P P Note 6 Small Organ P P P P P P BMDC Neonatal Cephalic Adult Cephalic Cardiac P P P P P P BMDC Trans-esophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel P P P P P P BMDC Laparoscopic Musculo-skeletal Conventional




Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 6 Cadence contrast agent imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding Note 14 Note 16 Custom Tissue Imaging Note 17 eSie Fusion Note 18 VTI Note 19 VTIQ Note 20 VTQ




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Device Name: 6C1HD Curved Array Transducer HDIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic

Fetal P P P P P P BMDC Note 2,3,4,5,7,8,10,11

Abdominal P P P P P P BMDC Note 2,3,4,5,6,7,8,10,11,14,16,17,18,19,20,21


Pediatric P P P P P P BMDC Note 6 Small Organ P P P P P P BMDC Neonatal Cephalic Adult Cephalic Cardiac P P P P P P BMDC Trans-esophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel P P P P P P BMDC Laparoscopic Musculo-skeletal Conventional



Additional Comments: Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 6 Cadence contrast agent imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding Note 14 Note 16 Custom Tissue Imaging Note 17 eSie Fusion Note 18 VTI Note 19 VTIQ Note 20 VTQ Note 21 QUS (Quantitative Ultrasound)




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Device Name: 8C3HD Curved Array Transducer for use with ACUSON S3000Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic

Fetal P P P P P BMDC Note 2,3,4,5,7,8,10,11

Abdominal P P P P P BMDC Note 2,3,4,5,7,8,10,11,14, 16


Pediatric P P P P P BMDC Note 2,3,4,5,7,8,10,11

Small Organ P P P P P BMDC Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal Transvaginal Transurethral Intravascular

Peripheral vessel P P P P P BMDC Note 2,3,4,5,7,8,10,11




Additional Comments: Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 6 Cadence contrast agent imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding Note 14 Note 16 Custom Tissue Imaging




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Device Name: 4V1 Phased Array TransducerIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic Fetal P P P P P BMDC Note 2,3,4,5,7,8,10

Abdominal P P P P P BMDC Note 2,3,4,5,7,8,10,14,16,17,18,19,20


Pediatric Small Organ Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional



Additional Comments: Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding Note 14 Note 16 Custom Tissue Imaging Note 17 eSie Fusion Note 18 VTI Note 19 VTIQ Note 20 VTQ




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Device Name: 10V4 Phased Array Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic Fetal P P P P P P BMDC Note 2,3,4,5,7,8,10 Abdominal P P P P P P BMDC Note 2,3,4,5,7,8,10 Intraoperative Intraoperative Neurological

Pediatric P P P P P P BMDC Note 2,3,4,5,7,8,10 Small Organ Neonatal Cephalic P P P P P P BMDC Note 2,3,4,5,7,8,10 Adult Cephalic Cardiac P P P P P P BMDC Note 3,4 Trans-esophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel P P P P P P BMDC Note 2,3,4,5,7,8,10 Laparoscopic Musculo-skeletal Conventional



Additional Comments: Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology




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Device Name: 14L5 SP Linear Array Transducer Indications For Use: Diagnostic imaging or fluid flow analysis of the human body as follows:

Clinical Application

Mode of Operation

A B M PWD CWD Color Doppler

Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic Fetal Abdominal Intraoperative (Note 9) P P P P P BMDC Note 2,3,4,5,7,8,10

Intraoperative Neurological P P P P P BMDC Note

2,3,4,5,7,8,10,11 Pediatric


Note 2,3,4,5,7,8,10,11,14,16

Neonatal Cephalic Adult Cephalic Cardiac P P P P P BMDC Note 15 Transesophageal Transrectal Transvaginal Transurethral Intravascular

Peripheral vessel P P P P P BMDC Note 2,3,4,5,7,8,10,11,14,15

Laparoscopic Musculo-skeletal Conventional P P P P P BMDC Note

2,3,4,5,7,8,10,11,14 Musculo-skeletal Superficial


Additional Comments: Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 15 AHP Note 2 Ensemble tissue harmonic imaging Note 16 Custom Tissue Imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 9 For example: vascular, abdominal Note 10 Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding Note 14 ty imaging / FTI




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Device Name: 7CF2 Curved array mechanical 3D transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic

Fetal P P P P P BMDC Note 2,3,4,5,7,8,10,11,13

Abdominal P P P P P BMDC Note 2,3,4,5,7,8,10,11,13


Pediatric Small Organ Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional



Additional Comments: Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding Note 13 STIC




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Device Name: 9EVF4 Curved Array Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic

Fetal P P P P P BMDC Note 2,3,4,5,7,8,10,11,13

Abdominal Intraoperative Intraoperative Neurological

Pediatric Small Organ

Neonatal Cephalic P P P P P BMDC Note 2,3,4,5,7,8,10,11

Adult Cephalic Cardiac Trans-esophageal Transrectal

Transvaginal P P P P P BMDC Note 2,3,4,5,7,8,10,11

Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional



Additional Comments: Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding Note 13 STIC




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Device Name: V5Ms Multiplane TEE Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)


Pediatric Small Organ Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal P P P P P P BMDC Note 4 Transrectal Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional



Additional Comments: Note 4 Tissue Equalization Technology




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Device Name: 18L6 HD Linear Array Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)


Pediatric


Note 2,3,4,5,7,8,10,11,14,16

Neonatal Cephalic Adult Cephalic Cardiac P P P P P BMDC Note 15 Trans-esophageal Transrectal Transvaginal Transurethral Intravascular



2,3,4,5,7,8,10,11,14 Musculo-skeletal Superficial P P P P P BMDC Note

2,3,4,5,7,8,10,11,14 Other (specify)

N = new indication; P = previously cleared by FDA K172162

Additional Comments: Note 1 For example: breast, testes, thyroid, penis, prostate, etc. Note 15 AHP Note 2 Ensemble tissue harmonic imaging Note 16 Custom Tissue Imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology Note 11 Advanced Sieclear spatial compounding Note 14




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Device Name: 8V3 Phased Array Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic Fetal P P P P P P BMDC Note 2,3,4,5,7,8,10 Abdominal Intraoperative Intraoperative Neurological

Pediatric P P P P P P BMDC Note 2,3,4,5,7,8,10 Small Organ Neonatal Cephalic P P P P P P BMDC Note 2,3,4,5,7,8,10 Adult Cephalic Cardiac P P P P P P BMDC Note 3,4 Trans-esophageal Transrectal Transvaginal Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional


Other (specify) Neonatal Cardiac P P P P P P BMDC Note 3,4


Additional Comments: Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology




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Device Name: 4V1c Phased Array Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic Fetal P P P P P P BMDC Note 2,3,4,5,7,8,10 Abdominal P P P P P P BMDC Note 2,3,4,5,7,8,10 Intraoperative P P P P P P BMDC Note 2,3,4,5,7,8,10 Intraoperative Neurological P P P P P P BMDC Note 2,3,4,5,7,8,10

Pediatric P P P P P P BMDC Note 2,3,4,5,7,8,10 Small Organ Neonatal Cephalic Adult Cephalic P P P P P P BMDC Note 2,3,4,5,7,8,10

Cardiac P P P P P P BMDC Note 2,3,4,5,7,8,10,15

Trans-esophageal Transrectal Transvaginal Transurethral Intravascular

Peripheral vessel P P P P P P BMDC Note 2 3 4 5 7 8 10 15



Other (specify) Neonatal Cardiac P P P P P P BMDC Note 2,3,4,5,7,8,10



Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 6 Cadence contrast agent imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology Note 15 AHP




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Device Name: EV8C4 Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic Fetal P P P P P P BMDC Note 2,3,4,5,7,8,10

Abdominal P P P P P P BMDC Note 2,3,4,5,6,7,8,10


Pediatric Small Organ Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal Transvaginal P P P P P P BMDC Note 2,3,4,5,7,8,10 Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional




Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 3-Scape real-time 3D imaging Note 6 Cadence contrast agent imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE vascular enhancement technology




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Device Name: V7M TEE Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Clinical Application

AB M PWD CWD Color

DopplerPower (Amplitude) Doppler


Combined (Specify) *

HarmonicImaging Other

(Specify)

Ophthalmic Fetal Abdominal P P P P P P P P Note 4 Intraoperative Intraoperative Neurological

Pediatric P P P P P P P P Note 4 Small Organ (specify)**

Neonatal Cephalic Adult Cephalic Cardiac P P P P P P P P Note 4 Trans-esophageal P P P P P P P P Note 4 Transrectal Transvaginal Transurethral Intravascular Peripheral Vessel Laparoscopic Musculo-skeletal (Conventional)

Musculo-skeletal (Superficial)


Additional Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler,

B+M+POWER DOPPLER, B+PWD+POWER DOPPLER, B+CWD+POWER DOPPLER, B+CLARIFY VE

Note 2 Ensemble tissue harmonic imaging Note 4 Tissue Equalization Technology Note 10 Clarify VE vascular enhancement technology




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Device Name: AcuNav 8F Ultrasound Catheter Intended Use: ouCatheter is intended for intra-cardiac and intraluminal visualization of

cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

Mode of Operation


Power (Amplitude)

Doppler



Other:HarmonicImaging

Ophtalmic Fetal Abdominal Intraoperative Intraoperative (Neurological)

Pediatric P P P P P P P Small Organ (Specify)**

Neonatal Cephalic Adult Cephalic Cardiac P P P P P P P Trans-esophageal Transrectal Transvaginal Transurethral Intra-Luminal P P P P P P P Peripheral Vessel Laparoscopic Musculo-skeletal Conventional


Other (Intra-Cardiac) P P P P P P P P=Previously cleared by the FDA K172162





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Device Name: AcuNav 10F Ultrasound Catheter Intended Use: ouCatheter is intended for intra-cardiac and intraluminal visualization of

cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients.

Mode of Operation


Power (Amplitude)

Doppler



Other:HarmonicImaging

Ophtalmic Fetal Abdominal Intraoperative Intraoperative (Neurological)

Pediatric P P P P P P P Small Organ (Specify)**

Neonatal Cephalic Adult Cephalic Cardiac P P P P P P P Trans-esophageal Transrectal Transvaginal Transurethral Intra-Luminal P P P P P P P Peripheral Vessel Laparoscopic Musculo-skeletal Conventional


Other (Intra-Cardiac) P P P P P P P P=Previously cleared by the FDA K172162





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510 (k) Number (if known): ______________________ Device Name: MC9-4 TransducerIntended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)

Ophthalmic Fetal P P P P P BMDC Note 2,3,4,5,7,8,10,11 Abdominal P P P P P BMDC Note 2,3,4,5,7,8,10,11 Intraoperative Intraoperative Neurological

Pediatric Small Organ (note 1) P P P P P BMDC Note

2,3,4,5,7,8,10,11,14 Neonatal Cephalic P P P P P BMDC Note 2,3,4,5,7,8,10 Adult Cephalic Cardiac Trans-esophageal

Transrectal P P P P P BMDC Note 2,3,4,5,7,8,10,11,14

Transvaginal P P P P P BMDC Note 2,3,4,5,7,8,10,11 Transurethral Intravascular Peripheral vessel Laparoscopic Musculo-skeletal Conventional


Other (specify) N = new indication; P = previously cleared by FDA K172162 Additional Comments: Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc. Note 2 Ensemble tissue harmonic imaging Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 Siescape real-time 3D imaging Note 6 Cadence contrast agent imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE Vascular enhancement technology Note 11 Advanced Sieclear spatial compounding Note 14 eSie Touch elasticity imaging/FTI



____________________________________________ Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)____________________

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510 (k) Number (if known): ____________________ Device Name: 14L5 Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation


Amplitude Doppler


Combined (Specify)

Other (Specify)


Pediatric

Small Organ (note 1) P P P P P BMDC

Note 2,3,4,5,7,8,10,11,14,16

Neonatal Cephalic Adult Cephalic Cardiac Trans-esophageal Transrectal Transvaginal Transurethral Intravascular



2,3,4,5,7,8,10,11,14 Musculo-skeletal Superficial

Other (specify) N = new indication; P = previously cleared by FDA K172162 Additional Comments: Note 1 i.e.: breast, testes, thyroid, penis, prostate, etc. Note 2 For example: vascular, abdominal Note 3 SieClear multi-view spatial compounding Note 4 Tissue Equalization Technology Note 5 Siescape real-time 3D imaging Note 6 Cadence contrast agent imaging Note 7 B&W SieScape panoramic imaging Note 8 Power SieScape panoramic imaging Note 10 Clarify VE Vascular enhancement technology Note 11 Advanced Sieclear spatial compounding Note 14 eSie Touch elasticity imaging/FTI Note 16 Custom Tissue Imaging



____________________________________________ Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)____________________

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Siemens Medical Solutions USA, Inc. ACUSON S3000, S2000 Ultrasound Division Diagnostic Ultrasound System

510(k)-QUS

Page 1

510(k) Summary Prepared December 16, 2018 Updated February 17, 2019

1. Sponsor: Siemens Medical Solutions USA, Inc.,

Ultrasound Division

685 East Middlefield Road

Mountain View, California 94043

Contact Person: Christine Dunbar

Tel: (925) 374-2045

2. Device Name: ACUSON Diagnostic Ultrasound System

Common Name: Diagnostic Ultrasound System with Accessories

Classification: Regulatory Class: II

Review Category: Tier II

Classification Panel: 90, Radiology

Ultrasonic Pulsed Doppler Imaging System 892.1550 90-IYN

Ultrasonic Pulsed Echo Imaging System 892.1560 90-IYO

Diagnostic Ultrasound Transducer 892.1570 90-ITX

Diagnostic Intravascular Catheter 892.1200 90-OBJ

3. Legally Marketed Predicate Devices

The modified ACUSON S3000, S2000 Diagnostic Ultrasound Systems are substantially ACUSON S3000, S2000 and S1000 system cleared under

K172162, which is the primary predicate device.

The second predicate is the Siemens Virtual Touch Quantification (VTQ) feature, as currently cleared under K131164. The VTQ software under modification includes the new Quantitative Ultrasound (QUS) feature.

The Echosens Fibroscan system with Controlled Attenuation Parameter (CAP) for measurements of the ultrasound coefficient of attenuation serves as a reference predicate system, specifically for QUS measurements of the Attenuation Coefficient (AC).

The second reference predicate is the GE IDEAL Software for magnetic resonance imaging proton density fat fraction (MRI-PDFF). The Ultrasonically-derived Fat Fraction (UDFF)

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K183575


510(k)-QUS

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index provides a clinical utility similar to that of MRI-PDFF as an aid for managing patients with hepatic steatosis.

4. Device Description The ACUSON S2000, S3000 Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display.

All of the transducers and the catheter based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a) and remain unchanged from the currently cleared ACUSON S-Family systems (K172162).

5. Intended Use The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular systStatement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for

The AcuNav Catheter is intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The Quantitative Ultrasound (QUS) software provides the ability to measure the attenuation coefficient in dB/cm-MHz at 3 MHz and the backscatter coefficient in dB/cm-str at 3 MHz in a 3-cm by 3-cm region of interest in the liver. Quantitative Ultrasound also includes the Ultrasonically-Derived Fat Fraction (UDFF) software which provides a 3-cm by 3-cm region

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of interest measurement tool to report an index that can be useful as an aid to the physician in managing adult patients with hepatic steatosis.

6. Summary of Technological Characteristics The ACUSON S2000 and S3000 Diagnostic Ultrasound Systems with software version VE11A are multi-purpose diagnostic ultrasound systems with accessories and proprietary

s, the ACUSON S1000, 2000 and S3000 VE10A (K172162) and the ACUSON S2000 and S3000 (K131164 with VTQ feature) with regard to both intended use and technological characteristics.

The subject ultrasound systems and the currently cleared primary predicate ultrasound systems function in the same manner and with the same list of transducers including cardiac catheters.

Only the VTQ application has been modified, all other hardware and software features of the Diagnostic Ultrasound device remain unchanged. Only the ACUSON S2000 and S3000 systems will be updated with the software update to VE11A upon customer purchase of the Quantitative Ultrasound (QUS) application, which will be license controlled. The S1000 system does not support the VTQ application, therefore, will not be configured to support the QUS application.

The ACUSON S2000 and S3000 with software version VE11A are substantially equivalent to the predicate devices with regard to both intended use, indications for use and technological characteristics. The table below compares the technological characteristics between the submission device and the predicated devices.

Table 1: Comparison of Technological Characteristics

Feature / Characteristic SubmissionDevice

PrimaryPredicateK172162

SecondaryPredicateK131164(VTQ)

ReferencePredicateFibroscanK181547

ReferencePredicateGE MR IDEAL K103411

Indications for Use

Fetal - -

Abdominal - Intraoperative abdominal

and vascular- -

Intraoperative neurological - - - - - Pediatric -

Small Organ - -

Neonatal cephalic - -

Adult Cephalic - -

Cardiac - -

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Trans-esophageal - -

Transrectal - -

Transvaginal - -

Peripheral vessel - - Laparoscopic - - -- - - Musculo-skeletal

(conventional)- -

Musculo-skeletal (superficial) - -

Center Frequencies Supported

2.0 MHz - - 2.5 MHz - - 3.0 MHz - -

3.2 MHz - -

3.3 MHz - -

3.5 MHz - - - -

4.2 MHz - -

4.4 MHz - -

4.8 MHz - -

5.0 MHz - -

5.2 MHz - -

6.0 MHz - -

6.5 MHz - -

6.9 MHz - -

9.5 MHz - -

10.0 MHz - -

Modes

B - - Parallel processing in B

mode - -

M - -

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PWD (Pulsed Wave Doppler) - -

CWD (Continuous Wave Doppler) - -

D (Color Doppler) - -

Amplitude Doppler -

Combined (BMDC) - -

Features

Quad processing in color - -

imaging- -

imaging

- -

panoramic imaging - -

3- -time 3D imaging - -

technology - -

technology

- -

Cardiac Imagingphysiological signal display

- -

syngo ® Auto OB measurements

- -

spatial compounding - -

STIC (Fetal Heart Imaging) - -

Amnioscopic rendering - - Cadence contrast agent

imaging - -

Contrast Dynamics - -

enhancement technology- -

elasticity imaging

- -

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syngo ® Auto Left heart Tested to ISO 10993-1

Tested to ISO 10993-1

- -

syngo ® Velocity Vector Imaging - -

Semi Auto-segmentation (eSie Calc) - -

Custom Tissue Imaging / Speed of Sound - -

Virtual Touch Imaging (VTI) (S2000, S3000)

- - -

Virtual Touch Quantification (VTQ)(S2000, S3000)

Shear wave Speed

-

Virtual Touch Imaging Quantification (VTIQ)(S2000, S3000)

- - -

Quantitative Ultrasound (QUS)

New - - -

ACAC at

3.0 MHz-

-CAP at

3.5 MHz-

BSCBSC

at 3.0 MHz- - - -

UDFF Index

Index based on acoustic

physical tissue

properties

- - -

MRI Proton Density

Fat Fraction(MRI-PDFF)

AHP - -

- -

eSie Fusion - - - Output Display Standard(Track 3)

-

Patient Contact Materials Tested to ISO 10993-1

Tested to ISO 10993-1

Tested to ISO 10993-1 - -

UL 60601-1 Certified - -

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7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety and have been found to conform to applicable medical device safety standards.

Cleared patient contact materials, electrical and mechanical safety are unchanged. Testing was performed to verify the software release.

The ACUSON S2000 and S3000 Ultrasound systems comply with the following standards:

UL 60601-1:2006, Medical electrical equipment, Part 1: General requirements for safety IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements For Basic

Safety And Essential Performance (IEC 60601-1:2005, (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012)

IEC 60601-1-2: 2007(Third Edition), Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

IEC 60601-2-37:2007+A1:2015, Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasound medical diagnostic and monitoring equipment. IEC 60601-2-18 Medical electrical equipment part 2-18: particular requirements for basic safety and essential performance of endoscopic equipment.

AIUM/NEMA UD-3:2004, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.

AIUM/NEMA UD-2:2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.

ISO 10993-1:2009, Biological evaluation of Medical Devices IEC 62366:2014, Medical Devices Application of Usability IEC 62359:2010, Ultrasonics Field characterization Test Methods for the

determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields.

8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.

Phantom Study: The accuracy and precision of the device was obtained based on tests performed on phantoms with known attenuation and backscatter coefficients. The overall range of values of AC and BSC are within +/-20% of the nominal values of the phantoms.

Clinical Study: Acoustic property measurements including the AC and BSC were obtained from the liver of one hundred and one (101) participants in an external clinical study. The UDFF index is based on a least squares fit (estimation) between the acoustic property measurements and the corresponding MRI Proton Density Fat Fraction (PDFF %) measurements.

Table 2 summarizes baseline demographic information from the clinical study including sex, age, BMI, race, and ethnicity. There were no adverse effects or complications in the

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acquisition of the ultrasound clinical data. The QUS software has identical safety considerations as compared to conventional ultrasound B-mode imaging.

Table 2:Participant Characteristics

Characteristic ValueSex

Male 39 of 101 (39)Female 62 of 101 (61)

Agemean ± SD 52.02±13.5Range 19-74

BMImean ± SD 30.6±5.1Range 17.6-43.3

Racial CategoryWhite 50 of 101 (49)Black 2 of 101 (2.0)Asian 12 of 101 (12)American Indian 1 of 101 (1.0)Hawaiian or Pacific Islander 1 of 101 (1.0)Unknown 35 of 101 (35)

Ethnic CategoryHispanic/Latino 39 of 101 (39)Non-Hispanic 60 of 101 (59)Other 2 of 101 (2)

Steatosis Grade0; <5% hepatocytes 6 of 90 (7)1: 5%-33% hepatocytes 39 of 90 (43)2; 33%-66% hepatocytes 33 of 90 (36)3; >66% hepatocytes 12 of 90 (13)

MRI-PDFF (%)mean ± SD 13.8 ±8.9Range 0.6-40.6

Note: Numbers in parentheses are percentages.

The results of the clinical study indicate that BMI does not have a statistically significant effect on measurements of the AC and BSC. Patients with lower steatosis grade had lower values of UDFF and MRI-PDFF, and patients with higher steatosis grade had larger values of UDFF and MRI-PDFF.

The trends for patients with less than 5% MRI-PDFF scores (steatosis grade S0) and with more than 30% MRI-PDFF scores (steatosis grade S3) were not clear given the small number of samples in these ranges.

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Reference Studies: In addition to the phantom and external clinical studies, peer-reviewed journal articles in studies utilizing Siemens ACUSON S3000 Diagnostic Ultrasound Systems were used to support the claim for the safety and effectiveness of quantitative ultrasound for assessing hepatic steatosis. The references below offer further reading on the performance of quantitative ultrasound.

9. Summary Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms to 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance.

The S2000 and S3000 Diagnostic ultrasound systems have accumulated a long history of safe and effective performance. The software modification of the S2000 / S3000 Diagnostic Ultrasound VTQ feature raises no new issues of safety and effectiveness.

Therefore, it is the opinion of Siemens Medical Solutions USA, Inc. that the ACUSON S2000 and S3000 systems including the new Quantitative Ultrasound (QUS) feature is substantially equivalent with respect to safety and effectiveness to the currently cleared predicate devices for the U.S. market.

10. References

[1] S. C. Lin, E. Heba, T. Wolfson, B. Ang, A. Gamst, A. Han, J. W. Erdman, W. D. diagnosis of nonalcoholic

fatty liver disease and quantification of liver fat using a new quantitative ultrasound technique," Clinical Gastroenterology and Hepatology, vol. 13, pp. 1337-1345, 2015.

[2] J. S. Paige, G. S. Bernstein, E. Heba, E. A. C. Costa, M. Fereirra, T. Wolfson, A. C. Gamst, M. A. Valasek, G. Y. Lin, A. Han and others, "A Pilot Comparative Study of Quantitative Ultrasound, Conventional Ultrasound, and MRI for Predicting Histology-Determined Steatosis Grade in Adult Nonalcoholic Fatty Liver Disease," American Journal of Roentgenology, vol. 208, pp. W168--W177, 2017.

[3] "Repeatability and Reproducibility of a Clinically Based QUS Phantom Study and Methodologies," IEEE transactions on ultrasonics, ferroelectrics, and frequency control, vol. 64, pp. 218-231, 2017.

[4] A. Han, Y. Labyed, M. P. Andre, J. W. Erdman, R. Loomba, C. B. Sirlin and W. D. -sonographer Reproducibility of Quantitative Ultrasound Outcomes and

Shear Wave Speed Measured in the Right Lobe of the Liver in Adults with Known or Suspected Nonalcoholic Fatty Liver Disease," Accepted for publication in European Radiology, 2018.

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Documents

Sr. Regulatory Affairs Specialist · Siemens Medical Solutions USA, Inc. Ultrasound Division Diagnostic Ultrasound System 510(k)-QUS Page 1 of 26 Diagnostic Ultrasound Indications