U.S. Food & Drug Administration 10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 2 . 0 3 Silver Spring, MD 20993 www.fda.gov

Toshiba Medical Systems Corporation℅ Orlando Tadeo, Jr.Manager, Regulatory AffairsToshiba America Medical Systems, Inc.2441 Michelle DriveTUSTIN CA 92780

Re: K173090Trade/Device Name: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4Regulation Number: 21 CFR 892.1550Regulation Name: Ultrasonic pulsed doppler imaging systemRegulatory Class: IIProduct Code: IYN, IYO, ITXDated: December 20, 2017Received: December 21, 2017

Dear Mr. Tadeo:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Page 2 - Orlando Tadeo, Jr. K173090

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Robert Ochs, Ph.D.DirectorDivision of Radiological HealthOffice of In Vitro Diagnostics

and Radiological HealthCenter for Devices and Radiological Health

Enclosure

FORM FDA 3881 (1/14) PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use510(k) Number (if known)

Device Name

Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4

PSI-30BX

PSI-70BT

PVI-475BT

PVI-475BX

PVT-482BT

PLI-1205BX

PLI-2002BT

PLI-2004BX

PET-512MC

PET-512MD

PEI-512VX

      

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 2441 Michelle Drive, Tustin, CA 92780 / 800.421.1968 / medical.toshiba.com

510(k) SUMMARY   1. SUBMITTER’S NAME: 

Toshiba Medical Systems Corporation 1385 Shimoishigami Otawara‐shi, Tochigi‐ken, Japan 324‐8550 

 2. OFFICIAL CORRESPONDENT 

Naofumi Watanabe  

3. ESTABLISHMENT REGISTRATION: 9614698  

4. CONTACT PERSON: Orlando Tadeo, Jr. Manager, Regulatory Affairs Toshiba America Medical Systems, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669‐7459  

5. Date Prepared: December 20, 2017  

6. TRADE NAME(S): Diagnostic Ultrasound System Aplio i900 Model TUS‐AI900 Software Version V2.4 Aplio i800 Model TUS‐AI800 Software Version V2.4 Aplio i700 Model TUS‐AI700 Software Version V2.4 Aplio i600 Model TUS‐AI600 Software Version V2.4  

7. COMMON NAME: System, Diagnostic Ultrasound  

 8. DEVICE CLASSIFICATION: 

Class II  Ultrasonic Pulsed Doppler Imaging System – Product Code: 90‐IYN [per 21 CFR 892.1550] Ultrasonic Pulsed Echo Imaging System – Product Code: 90‐IYO [per 21 CFR 892.1560] Diagnostic Ultrasonic Transducer – Product Code: 90‐ITX [per 21 CFR 892.1570]

 

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9. PREDICATE DEVICE:  

Product  Marketed by  510(k) Number  Clearance Date Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 (Main Predicate Device) 

Toshiba America Medical Systems 

K163702  

May 30, 2017 

Boris Platform Ultrasound System   Philips Ultrasound, Inc.  K030455  March 13, 2003 

Vivid E9  GE Healthcare  K131514  July 12, 2013 

GE EchoPAC  GE Healthcare  K120221  March 30, 2012 

Aplio Artida (SSH‐880CV), V3.2  Toshiba America Medical Systems 

K140729  May 23, 2014 

Voluson E8  GE Healthcare  K162269  October 3, 2016 

HD11  Philips Ultrasound, Inc.  K062247  August 18, 2006 

 10. REASON FOR SUBMISSION: 

Modification of a cleared device  11. DEVICE DESCRIPTION:   

The Aplio i900 Model TUS‐AI900, Aplio i800 Model TUS‐AI800, Aplio i700 Model TUS‐AI700 and Aplio i600 Model TUS‐AI600, V2.4 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 20 MHz.  

12. INDICATIONS FOR USE:  The Diagnostic Ultrasound Systems Aplio i900 Model TUS‐AI900, Aplio i800 Model TUS‐AI800, Aplio i700 Model TUS‐AI700 and Aplio i600 Model TUS‐AI600 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra‐operative (abdominal), pediatric, small organs, trans‐vaginal, trans‐rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo‐skeletal (both conventional and superficial) and laparoscopic.  

13. SUBSTANTIAL EQUIVALENCE:  This device is substantially equivalent to the Aplio i900/i800/i700, Diagnostic Ultrasound System, V2.1, K163702, marketed by Toshiba America Medical Systems.  The Aplio i900 Model TUS‐AI900, Aplio i800 Model TUS‐AI800, Aplio i700 Model TUS‐AI700 and Aplio i600 Model TUS‐AI600, V2.4 function in a manner similar to and is intended for the same use as the predicate devices.  The subject device is a compact diagnostic ultrasound system that implements the latest technologies. 

 

 

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Device  Aplio i900/i800/ i700/i600 V2.4 

Aplio i900/i800/i700 (V2.1)

Artida V3.2 

Vivid E9/EchoPAC 

Voluson E8  

Boris Platform Ultrasound System 

HD11  Comment 

510(k) Clearance Number 

Subject Device 

K163702 (Main Predicate)

K140729 K131514/K120221 

K162269 K030455  K062247  

3D  Wall Motion Tracking  

Yes*  No  Yes  LV Analysis 

 RV Analysis 

      *LA and RV analysis are new features 

Z‐Score  Yes  No      Yes       

Mitral Valve Analysis 

Yes  No        Yes     

MPI  Yes  No          Yes   

 Improvements to previously cleared functions: Device  Aplio  

i900/i800/i700/i600V2.4 

Aplio  i900/i800/i700  (V2.1) 

Comment 

Thin Slice Imaging  Yes  Yes  Slice Thickness Control Feature Improvement(s) 

Auto Volume Measurement  Yes  Yes  Feature Improvement(s) 

CHI  Yes  Yes  High Frame Rate/4D Feature Improvement(s) 

SMI  Yes  Yes  iSMI/4D Feature Improvement(s) 

ADF  Yes  Yes  4D  Feature Improvement(s) 

Shear Wave Elastography  (ECG Sync Acquisition) 

Yes  Yes  Feature Improvement(s) 

Sensor 3D  (ECG Sync Construction) 

Yes  Yes  Feature Improvement(s) 

Smart Fusion  Yes  Yes  Feature Improvement(s) 

2D WMT  Yes  Yes  Use with 2D Array transducers Feature Improvement(s) 

Shear Wave Elastography   Yes  Yes  New clinical applications 

Shear Wave Dispersion Map  Yes  Yes  Feature Improvement(s) 

PSI‐30VX  

Yes  No  New transducer 

PSI‐40VX  

Yes  No  New transducer 

 

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Device  Aplio  i900/i800/i700/i600V2.4 

Aplio  i900/i800/i700  (V2.1) 

Comment 

PSI‐50VX  

Yes  No  New transducer 

PLI‐2002BT  

Yes  No  New transducer 

PVT‐482BT  

Yes  No  New transducer 

PVT‐675MVS  

Yes  No  New transducer 

PLI‐705BX  

Yes  No  New transducer 

PLT‐1202BT  

Yes  No  New transducer 

PEI‐512VX  

Yes  No  New transducer 

 14. SAFETY:  

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC 60601‐1, IEC 60601‐1‐2, IEC 60601‐2‐37, IEC 62304, NEMA UD 3, NEMA UD 2, and ISO 10993‐1 standards.  

15. TESTING Risk Analysis, Verification/Validation testing conducted through bench testing and clinical evaluation which are included in this submission demonstrates that the requirements for the new and improved features have been met.   Performance Testing – Assessment of 3D WMT Multiple studies were performed to confirm that the function of 3D Wall Motion Tracking on the Aplio i900/i800/i700 is substantially equivalent to the predicate devices with regard to the following:  

Left Ventricle Analysis: The subject device demonstrated equivalency in terms of volume measurement feature (EDV/ESV/EF) and strain measurement feature (Area Change Ratio, Global Longitudinal Strain, Global Circumference Strain, Global Radial Strain). Left Atrium Analysis: The subject device demonstrated equivalency in terms of volume measurement feature (EDV and ESV or Vmax and Vmin) and strain measurement feature (Global Area Change Ratio, Global Longitudinal Strain and Global Circumference Strain). Right Ventricle Analysis: The subject device demonstrated equivalency in terms of strain measurement feature (Area Change Ratio, Global Longitudinal Strain, Global Circumference Strain). Additionally, the volume measurement feature (EDV/ESV/EF) demonstrated a Correlation coefficient (r) >= 0.90 with n=11 as compared to the predicate function, Vivid E9 (K131514) with GE EchoPAC (K120221).  Representative clinical images were also obtained using the 3D WMT features LV analysis, LA analysis, RV analysis and Quad Chamber Tracking. It was concluded that the 3D WMT implemented on the subject device enables the cardiac wall trace (initial contour setting) and 

 

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the local wall motion tracking, providing wall motion information analysis and display, cardiac volume measurement, cardiac function analysis and display of the three analysis features simultaneously. 

 Performance Testing – Assessment of Auto‐EF An assessment of workflow improvement was conducted on a group of three volunteers and it was concluded that the full‐assist function for tracing the contour line reduced operation time over that of the predicate device to obtain the EDV/ESV/EF and Global Longitudinal Strain. Additionally, a clinical evaluation of this function was conducted and it was demonstrated that Auto‐EF performed as expected in presenting appropriate clinical measurements.  Performance Testing – Assessment of 3D ACM A study conducted using a pulsating flow phantom demonstrated that flow volume measurement met performance specifications as expected.  Performance Testing – Assessment of Z‐Score Measurement A bench study was conducted using previously acquired fetal ultrasound data to demonstrate that the subject function calculate and provide the correct Z‐score for cardiac structure such as Aortic valve ,Pulmonary valve based on the pre obtained value of femur length (FL), biparietal diameter (BPD) or gestational age (GA) using fetal echocardiography.  Performance Testing – Assessment of MPI Measurement A bench study was conducted using a Doppler phantom with a water cistern and it was demonstrated that the function can (1) correctly measure velocity at an ROI to provide a graph of time variation of the velocity TIC, by using the 510(k) cleared TDI function, (2) correctly measure the time duration between two points manually indicated on TIC, and (3) calculate MPI correctly from the two time durations designated on TIC.  Performance Testing – Assessment of Mitral Valve Analysis (MVA) A side‐by‐side comparison of seventy (70) patients with varying degrees of mitral valve conditions was conducted using a double‐intubation protocol to evaluate the basic function and performance of the MVA in vivo, with regard to the visualization of the mitral valve anatomy, surrounding structures, the mitral valve spatial relationship to the aortic valve and including the annulus, anterior/ posterior leaflets, leaflet segmentation, coaptation line and commissures. Assessment included evaluation of image quality, measurement, work flow improvement and interoperator variability. Results of the study demonstrated that the subject function is substantially equivalent to the predicate device with regard to all assessment criteria.  Additionally, a cardiac phantom was scanned and analyzed by the Aplio i900/MVA software and by a Computed Tomography (CT) system. The MVA software output measurements were compared to equivalent parameters using the CT images. As a result of this study it was determined that the MVA software was able to meet the specified criteria for each of the MVA measurement items as compared to the CT image measurements.  

 

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 Performance Testing – Assessment of 4D Imaging for 2D Array transducers Bench testing was conducted using a phantom to demonstrate that the function correctly depicts the shapes and flow within the phantom. Additionally, clinical images were obtained on volunteers to demonstrate that the function performs as intended.  Additional performance testing, using phantom and volunteer studies, was conducted to assess improvements to existing features including Slice Thickness Control, Auto Volume Measurement, High Frame Rate CHI, 4D CHI, 4D ADF/SMI, iSMI, ECG Sync Acquisition (Shear Wave Elastography), ECG Sync Construction (Sensor 3D), Smart Fusion, 2D WMT (2D Array transducer use), Shear Wave Elastography and Shear Wave Dispersion Map. Results of all these studies demonstrated that the improvements met specifications and performed as intended.  

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document” issued on May 11, 2005, is also included as part of this submission.   Additionally, testing of this device was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices.    

16. CONCLUSION The Aplio i900 Model TUS‐AI900, Aplio i800 Model TUS‐AI800, Aplio i700 Model TUS‐AI700 and Aplio i600 Model TUS‐AI600, V2.4 is substantially equivalent to the predicate devices. The subject devices function in a manner similar to and is intended for the same use as the predicate devices, as described in the labeling. Based upon the bench testing, clinical evaluation, acquisition of representative clinical images, successful completion of software validation, application of risk management and design controls, it is concluded that this device is safe and effective for its intended use.