(73 days)
Not Found
No
The summary describes proprietary software that calculates ideal bracket positions based on inputs, but there is no mention of AI, ML, or related concepts like training sets, testing sets, or specific algorithms typically associated with AI/ML. The description focuses on calculation and data transfer accuracy.
No
The device aids in orthodontic treatment planning and creates an indirect bonding tray; it does not directly apply therapy or treat a condition itself.
No
The device aids in orthodontic treatment planning to correct malocclusions but does not diagnose them. It uses patient data to calculate ideal bracket positions rather than identifying or characterizing a disease or condition.
Yes
The device is described as consisting of "proprietary software" that performs calculations for treatment planning. While it utilizes external inputs (dental impressions/3D models, X-rays, images) and results in an indirect bonding tray (which is a physical output), the core regulated component described is the software itself that performs the treatment planning function. The description focuses on the software's role in calculating bracket positions and the testing verifies the software's accuracy in this function and data transfer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device's intended use: The Blue Sky Bio Computerized Orthodontic Bracket System is intended for orthodontic treatment planning and the creation of an indirect bonding tray for placing brackets on teeth. This is a process performed on the patient's teeth (in vivo), not on specimens derived from the body (in vitro).
- Input: While it uses 3D models derived from scans of impressions or intra-oral scans, and images like X-rays, these are used for planning and creating a physical device (the bonding tray) for use on the patient, not for analyzing biological specimens for diagnostic information.
The device is a software system used as a tool for dental professionals to plan and execute orthodontic treatment, which is a clinical procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
Blue Sky Bio Computerized Orthodontic 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.
Product codes
DYW, NJM, ELF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
A 3D model is generated from scanned analog impressions or directly from an intra-oral scan.
A panoramic X-ray, facial and intra-oral images.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning.
The end product is an indirect bonding tray for use by the dental professional to place multiple brackets at the same time.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Blue Sky Bio % 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.
November 9, 2018
1
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 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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
| Sincerely, | |
|---|---|
| Mary S. | Digitally signed by Mary S. |
| Runner -S3 | Runner -S3 |
| Date: 2018.11.09 12:38:39 | |
| -05'00' |
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
2
Section 4 Indications for Use
3
Indications for Use
510(k) Number (if known)
Device Name
Blue Sky Bio Computerized Orthodontic Bracket System
Indications for Use (Describe)
Blue Sky Bio Computerized Orthodontic 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.
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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4
Section 5 510(k) Summary or Statement
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
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 |
Page 1 of 5
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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.
Page 2 of 5
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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.
Page 3 of 5
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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. |
| 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. |
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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.