Inbrace Orthodontic System
Device Facts
| Record ID | K203442 |
|---|---|
| Device Name | Inbrace Orthodontic System |
| Applicant | Swift Health Systems, Inc. |
| Product Code | PNN · Dental |
| Decision Date | Feb 19, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.5470 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Inbrace Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using appliances individualized for the orthodontic patient.
Device Story
Inbrace Orthodontic System is a computer-guided treatment planning software and appliance system for correcting malocclusions. Input: 3D digital scans of patient dentition provided by orthodontist. Processing: Software generates 3D model of patient dentition; technicians determine bracket placement to achieve ideal occlusion; orthodontist reviews and approves 3D model. Output: Patient-specific metal brackets, programmed multiloop archwires, and indirect bonding (IDB) trays. Usage: Affixed to lingual side of teeth by clinician in a dental clinic. Benefit: Provides continuous gentle force to reposition teeth based on patient-specific treatment plan.
Clinical Evidence
No clinical testing was conducted. Substantial equivalence is supported by biocompatibility testing (ISO 10993-1) and software verification and validation (ISO/IEC 62304).
Technological Characteristics
Materials: Stainless steel/nickel-titanium brackets, nickel-titanium/copper-nickel-titanium archwires, clear 3D printing resin for IDB trays. Principle: 3D digital treatment planning and patient-specific appliance fabrication. Connectivity: Software-driven manufacturing. Software: ISO/IEC 62304 compliant.
Indications for Use
Indicated for orthodontic patients requiring correction of malocclusions via individualized orthodontic appliances.
Regulatory Classification
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.
Predicate Devices
- Insignia (K121524)
Submission Summary (Full Text)
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February 19, 2021
Swift Health Systems, Inc. Alicia Mszyca Director, Regulatory Affairs 111 Academy, Suite 150 Irvine, California 92617
Re: K203442
Trade/Device Name: Inbrace Orthodontic System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, EJF, DZC Dated: November 19, 2020 Received: November 23, 2020
Dear Alicia Mszyca:
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K203442
Device Name Inbrace Orthodontic System
Indications for Use (Describe)
The Inbrace Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using appliances individualized for the orthodontic patient.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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### K203442 - 510(k) SUMMARY
#### I. SUBMITTER
Swift Health Systems, Inc. (dba Inbrace) 111 Academy, Suite 150 Irvine, California 92617 Contact Person: Alicia Mszyca Telephone Number: (949) 774-2239
Date Prepared: November 19, 2020
- II. DEVICE
| Trade Name: | <b>Inbrace Orthodontic System</b> |
|----------------------|-----------------------------------------------------------------------------------------|
| Common Name: | Orthodontic Software and Appliance |
| Device Class: | II |
| Classification Name: | Orthodontic Plastic Bracket, 21 CFR § 872.5470 |
| Product Codes: | PNN (Orthodontic Software),<br>EJF (Orthodontic Metal Bracket) & DZC (Orthodontic Wire) |
#### PRIMARY PREDICATE III.
Insignia (Ormco Corporation), K121524
- DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFICATION The IV. Inbrace Orthodontic System is a treatment planning software and orthodontic appliance system designed to be affixed to the lingual side of the teeth to correct malocclusions in orthodontic patients.
The Inbrace software creates a 3-dimentional (3D) model of the patient 's dentition based on the digital scans of the patient's dentition provided by the orthodontist. The Inbrace technicians use this computer model to determine the placement of the brackets to achieve the intended repositioning of the teeth (ideal occlusion). The model is reviewed and approved by the orthodontist prior to fabrication of the actual orthodontic appliances comprising of metal brackets, patient-specific programmed multiloop arch wires, and patient-specific bracket placement trays (indirect bonding trays) used to affix the brackets in position on the patient teeth. The brackets are assembled into the indirect bonding trays and bonded with a commercially available dental adhesive.
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Image /page/4/Picture/0 description: The image shows the logo for Swift Health Systems, Inc. The word "SWIFT" is in a light blue color, and the words "Health Systems, Inc." are in a light green color. The logo is simple and modern.
#### V. INDICATIONS FOR USE
Inbrace Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using appliances individualized for the orthodontic patient.
#### COMPARISON TO PREDICATE DEVICE VI.
The Inbrace Orthodontic System is substantially equivalent to Insignia (K121524). The Inbrace Orthodontic System consists of the same components (proprietary treatment planning software and orthodontic appliances consisting of patient-specific shaped archwires, metal brackets and patient-specific indirect bonding trays to affix brackets into position), has the same technological characteristics, principles of operation, treatment sequence, mode of use, manufacturing methodology and is intended for the same use as Insignia.
The comparison table below demonstrates system similarities used for the determination of substantial equivalence between the subject and predicate device.
| Features | Inbrace Orthodontic<br>System- subject device | Insignia - K121524 | Comparison |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Inbrace Orthodontic<br>System is a computer-<br>guided system intended for<br>use as an aid in<br>orthodontic treatment<br>planning for use by dental<br>orthodontic professionals<br>trained in orthodontic<br>treatment including<br>radiographic analyses and<br>treatment planning.<br>Inbrace contains patient-<br>specific individually<br>designed arch wires and<br>wire-specific brackets that<br>apply continuous gentle<br>force to reposition the<br>teeth. It also uses patient-<br>specific indirect bonding<br>trays to affix the brackets<br>in position | Insignia is a computer -<br>guided system intended for<br>use as an aid in orthodontic<br>treatment planning for use<br>by dental orthodontic<br>professionals trained in<br>orthodontic treatment<br>including radiographic<br>analyses and treatment<br>planning.<br>Insignia is intended for use<br>with commercially<br>available and /or<br>individually modified<br>brackets and wires that<br>apply continuous gentle<br>force to reposition the<br>teeth. It uses patient<br>specific foam placement<br>jigs to affix the brackets in<br>position | Intended for<br>same purpose<br>– movement of<br>teeth, thus<br>substantially<br>equivalent |
| Indication for<br>use statement | Inbrace Orthodontic<br>System is a treatment<br>planning software and<br>orthodontic appliance<br>system used to correct<br>malocclusions in<br>orthodontic patients using<br>appliances individualized<br>for the orthodontic patient. | Insignia Orthodontic<br>System is a treatment<br>planning software and<br>orthodontic appliance<br>system used to correct<br>malocclusions in<br>orthodontic patients using<br>appliances individualized<br>for the orthodontic patient. | Same |
| Principles of<br>operation | • A 3D digital scan of<br>patient's dentition is<br>provided by the<br>orthodontist<br>• A 3D end-of-treatment<br>outcome model is<br>generated<br>• The 3D model is sent to<br>the orthodontist for<br>review and approval<br>• Bracket placement trays<br>(indirect bonding (IDB)<br>trays) are manufactured to<br>position the brackets on<br>the patient's teeth as<br>prescribed by the<br>orthodontist<br>• Patient-specific archwires<br>are fabricated based on<br>the 3D model<br>• Brackets are adhered to<br>the patient's teeth with a<br>commercially available<br>adhesive | • A 3D digital model is<br>created on a stone model<br>or a patient's dental<br>impression<br>• A 3D end-of-treatment<br>outcome model is<br>generated<br>• The 3D model is sent to<br>the orthodontist for review<br>• Bracket placement jigs are<br>manufactured to position<br>the brackets on the<br>patient's teeth as<br>prescribed by the<br>orthodontist<br>• Patient-specific arch wires<br>are provided<br>• Brackets are adhered to<br>the patient's teeth with a<br>commercially available<br>adhesive | Same.<br>Both consist of<br>1) treatment<br>using a 3D<br>digital scan,<br>2) 3D model is<br>sent to<br>orthodontist<br>for review and<br>approval,<br>3) bracket<br>placement<br>using either an<br>IDB tray<br>(Inbrace) or<br>placement jigs<br>(Insignia).<br>The difference<br>in placement<br>does not affect<br>performance<br>thus,<br>substantially<br>equivalent. |
| | | | |
| Mode of Use | Inbrace brackets are<br>fabricated and fixed to the<br>patient's teeth using<br>patient-specific indirect<br>bonding trays.<br>Patient-specific archwires<br>of traditional metallurgy<br>are fabricated and<br>provided.<br>The appliances are fixed<br>to the teeth with the<br>commercially available<br>adhesives. | Either patient-specific<br>(individually modified) or<br>standard appliances are<br>fixed to the patient's teeth<br>using patient specific<br>foam placement trays.<br>Patient specific archwires<br>of traditional metallurgy<br>are provided.<br>The appliances are fixed<br>to the teeth with<br>commercially available<br>adhesives. | Same |
| Bracket<br>material | Stainless steel /nickel-<br>titanium | Stainless steel /ceramic/<br>plastic | Same for metal<br>brackets.<br>Inbrace system<br>does not use<br>plastic or<br>ceramic<br>brackets. |
| Arch wire<br>material | Nickel-titanium/<br>copper-nickel-titanium | Stainless steel/nickel-<br>titanium/ Beta titanium | Substantially<br>equivalent |
| Positioning<br>device<br>material | Clear 3D printing resin | Plastic foam | No impact on<br>performance<br>thus<br>substantially<br>equivalent. |
| Description of<br>appliance<br>placement | Affixed and removed by<br>clinician | Affixed and removed by<br>clinician | Same |
| Manufacturing<br>method | Final desired arrangement<br>of brackets, wires and<br>indirect bonding trays are<br>designed with the<br>guidance of Inbrace<br>software based on 3D<br>scans of the patient's<br>dentition. The software<br>allows the clinician to<br>review, alter and approve | Final desired arrangement<br>of brackets, wires and jigs<br>are designed with the<br>guidance of computer<br>software using<br>3dimentional models of<br>the patient. In office<br>software allows the<br>clinician to review, alter<br>and approve desired result | Same |
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Image /page/5/Picture/0 description: The image shows the logo for Swift Health Systems, Inc. The word "SWIFT" is in a light blue color, and the words "Health Systems, Inc." are in a light green color. The logo is simple and modern.
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Image /page/6/Picture/0 description: The image shows the logo for Swift Health Systems, Inc. The word "SWIFT" is in a light blue color, and the words "Health Systems, Inc." are in a light green color. The logo is simple and modern.
Inbrace - 510(k) notification
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| desired result and | and appliances. Software |
|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| appliances. Software<br>generates codes/image<br>file that drives machinery<br>to manufacture the<br>appliances. | generates code that drives<br>machinery to manufacture<br>the appliances. |
## VII. PERFORMANCE DATA
The following information was provided to support the submission:
### Biocompatibility Testing
The biocompatibility evaluation of the Inbrace appliances was conducted in accordance with ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process as recognized by FDA.
The results demonstrate the patient-contacting components including brackets, archwires, and indirect bonding trays are biocompatible, thus safe for their intended use.
### Software Verification and Validation
Inbrace software has been designed, integrated, verified, and validated to confirm its suitability and performance in accordance with the ISO/IEC 62304 standard - Medical device software - software life cycle processes.
The appropriate software documentation consistent with the Level of Concern as described in the FDA guidance titled "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" was included in this submission.
### Clinical Testing
No clinical testing was conducted for this device to support substantial equivalence.
### VIII. CONCLUSION
Inbrace Orthodontic System is substantially equivalent to its predicate device Insignia (K121524) in terms of intended use, indication for use, technical and material characteristics as well as operating principles.
Biocompatibility data and software verification and validation demonstrate that the Inbrace Orthodontic System is safe for its intended use.
