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Blue Sky Bio November 9, 2018 ℅ Dave Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041 Re: K182338
Trade/Device Name: Blue Sky Bio Computerized Orthodontic Bracket System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: DYW, NJM,ELF Dated: August 22, 2018 Received: August 28, 2018
Dear Dave Yungvirt: 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.
K182338 - Dave Yungvirt Page
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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 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 Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Mary S. Runner -S3
Digitally signed by Mary S. Runner -S3 Date: 2018.11.09 12:38:39 -05'00'
Section 4 Indications for Use
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Section 5 510(k) Summary or Statement
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Page 1 of 5
510(k) Summary
March 26, 2018
Blue Sky Bio Computerized Orthodontic Bracket System
Blue Sky Bio LLC
888 E Belvidere Rd Suite 212
Grayslake. IL 60030
718-376-0422
www.blueskybio.com
Contact Person: Albert Zickmann
General Information
Trade Name Blue Sky Bio Computerized Orthodontic Bracket System
Common Name Accessory for orthodontic bracket
Product Codes DYW (Orthodontic plastic bracket),
NJM (Orthodontic Ceramic Bracket), and
ELF (Orthodontic Metal Bracket)
Regulation No. 21CFR 872.5470 Orthodontic Plastic Brackets
Classification Class II
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Page 2 of 5
Predicate 510k: Exceed Computerized Precision Bracket Placement Solution K151702
Indications for Use:
Blue Sky Bio Computerized Bracket System is a software system intended for use as an aid in
orthodontic treatment planning to correct Malocclusions in Orthodontic Patients. For use by dental
professionals trained in orthodontic treatment, including radiographic analyses and treatment
planning. Blue Sky Bio Computerized Orthodontic Bracket System is intended for use with
commercially available brackets currently used in standard orthodontic treatment. The end product is
an indirect bonding tray for use by the Dental professional to place multiple brackets at the same
time.
This is identical to the indications for use of the predicate device.
Device Description:
The device consists of proprietary software that calculates the ideal position of the dental brackets based on the dental impressions and or 3D models supplied by the patient’s orthodontist. Commercially available brackets are used as part of the system.
This is identical to the device description for the predicate device.
Mode of Operation
The operating principle for Blue Sky Bio Computerized Orthodontic Bracket System and the Exceed Computerized Precision Bracket Placement Solution is identical. In addition Blue Sky Bio is also introducing an option to print a model that includes printed brackets. The difference between the two procedures is minor and both procedures yield the same result, a tray with the orthodontic brackets attached to it. The dentist will take the tray and apply a commercially available bonding material to the brackets. Subsequently, the tray with the brackets and the bonding material is placed onto the patient’s dentition and the brackets are bonded in the position determined by the tray. The tray is removed. The accuracy of the position of the brackets is then visually inspected in the same manner as with traditional orthodontics. In case, that the position of one or more brackets need to be corrected, the dentist can do that in a traditional manner. The orthodontic treatment is then continued in a traditional fashion.
Mechanism of Action:
The mechanism of action is similar to the predicate devices and supports a determination of
substantial equivalence. Orthodontic tooth movement occurs through forces applied to the
teeth by the appliance to the dentition as each tooth follows the programmed displacement
based on a dental health professional’s prescription.
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Page 3 of 5
Performance Testing:
Testing was conducted verifying that the treatment plan performed in the software resulted
in accurate placement of the brackets and corresponded to the treatment plan in Blue Sky
Bio software.
The accuracy of data transfer through the software was confirmed by scanning and digitizing
physical models and comparing scanned 3D models with the 3D models generated by the
treatment plan in the software. All samples met the performance criteria.
Biocompatibility Testing:
The resin used for printing indirect bonding trays is a legally marketed impression tray resin
so no testing was performed. The brackets used with the trays are all 510k exempt or 510k
cleared devices so no testing was performed. Indirect bonding trays made using pressure
forming are made from a 510k cleared or exempted resin so no testing was performed.
Software Verification and Validation Testing:
Software verification and validation testing were conducted on the Blue Sky Bio Computerized
Orthodontic Bracket System software that allows the user to locate the brackets in order to create
an indirect bonding tray and export either the bonding tray or a model to form a bonding tray over.
Documentation was provided as recommended by FDA’s Guidance for Industry and FDA staff,
“Guidance for the Content of Premarket Submission for Software Contained in Medical Devices.”
The software for this device was considered as a “moderate” level of concern.
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Page 4 of 5
Predicate Device Comparison Table
Blue Sky Bio Computerized Orthodontic Bracket System
Exceed Computerized Precision Bracket Placement Solution
Indications
for Use
Blue Sky Bio Computerized Bracket
System is a software system intended for
use as an aid in orthodontic treatment
planning to correct Malocclusions in
Orthodontic Patients. For use by dental
professionals trained in orthodontic
treatment, including radiographic
analyses and treatment planning. Blue
Sky Bio Computerized Orthodontic
Bracket System is intended for use with
commercially available brackets currently
used in standard orthodontic treatment.
The end product is an indirect bonding
tray for use by the Dental professional to
place multiple brackets at the same time.
eXceed Computerized Precision
Bracket Placement Solution is a
software system intended for use as
an aid in orthodontic treatment
planning to correct Malocclusions in
Orthodontic Patients. For use by
dental professionals trained in
orthodontic treatment, including
radiographic analyses and treatment
planning. eXceed Computerized
Precision Bracket Placement
Solution is intended for use with
commercially available brackets
currently used in standard
orthodontic treatment. The end
product is an indirect bonding tray
for use by the Dental professional to
place multiple brackets at the same
time.
Key Records A 3D model is generated from scanned
analog impressions or directly from an
intra‐oral scan
A 3D model is generated from scanned
analog impressions or directly from an
intra‐oral scan
Additional
Records
A panoramic X‐ray, facial and intra‐ oral images.
A panoramic X‐ray, facial and intra‐oral images
Treatment Plan
A detailed treatment plan is provided
by the clinician as part of case
submission.
A detailed treatment plan is
provided by the clinician as part
of case submission.
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Page 5 of 5
Virtual
Bracket
Placement
Plan
Using the submitted records and the
prescribed treatment plan, a suggested
placement plan is generated and sent for
review by the clinician. The Clinician
utilizes the Blue Sky Bio software to
adjust the plan and later have it
approved.
Using the submitted records and the
prescribed treatment plan, a
suggested placement plan is
generated and sent for review by
the clinician. The Clinician utilizes
the eXceed software to adjust the
plan and later have it approved.
Manufacturing
A working pre‐treatment model, which
includes tooth and bracket‐specific
landmarks depicting the position of the
brackets based on the approved plan, is
printed. Brackets are bonded by a
technician within the landmarks.
Alternatively, the indirect bonding tray is
printed.
A working pre‐treatment model,
which includes tooth and bracket‐
specific landmarks depicting the
position of the brackets based on
the approved plan, is printed.
Brackets are bonded by a technician
within the landmarks.
Finished
Product
Vacuum forming then follows to
produce patient‐ specific indirect
bonding trays.
Alternatively, the indirect bonding tray
is printed.
Vacuum forming then follows to
produce patient‐ specific indirect
bonding trays.
Conclusion:
Blue Sky Bio Computerized Orthodontic Bracket System is as safe, as effective, and is substantially
equivalent to the predicate device in regards to indications for use, design, technological
characteristics, mechanism of action, performance, materials and biocompatibility.
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