(88 days)
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.
The 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.
The provided document is a 510(k) premarket notification for the Inbrace Orthodontic System. It does not include detailed information regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/software performance study.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Insignia, K121524) based on:
- Intended Use and Indications for Use: Stating they are the same as the predicate device.
- Technological Characteristics, Principles of Operation, Mode of Use, Manufacturing Methodology: Demonstrating similarities to the predicate device.
- Biocompatibility Testing: Conducted in accordance with ISO 10993-1.
- Software Verification and Validation: Conducted in accordance with ISO/IEC 62304 and FDA guidance for software in medical devices.
Crucially, "No clinical testing was conducted for this device to support substantial equivalence." This means there is no performance study (clinical or even a rigorous retrospective study) described in this document that would provide the requested details about acceptance criteria, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
Therefore, I cannot extract the information requested for point 1 through 9. This device's clearance was based on substantial equivalence to an existing device, and not on a new performance study demonstrating the outlined criteria.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
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: | Inbrace Orthodontic System |
|---|---|
| Common Name: | Orthodontic Software and Appliance |
| Device Class: | II |
| Classification Name: | Orthodontic Plastic Bracket, 21 CFR § 872.5470 |
| Product Codes: | PNN (Orthodontic Software),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 OrthodonticSystem- subject device | Insignia - K121524 | Comparison |
|---|---|---|---|
| Intended use | Inbrace OrthodonticSystem is a computer-guided system intended foruse as an aid inorthodontic treatmentplanning for use by dentalorthodontic professionalstrained in orthodontictreatment includingradiographic analyses andtreatment planning.Inbrace contains patient-specific individuallydesigned arch wires andwire-specific brackets thatapply continuous gentleforce to reposition theteeth. It also uses patient-specific indirect bondingtrays to affix the bracketsin position | Insignia is a computer -guided system intended foruse as an aid in orthodontictreatment planning for useby dental orthodonticprofessionals trained inorthodontic treatmentincluding radiographicanalyses and treatmentplanning.Insignia is intended for usewith commerciallyavailable and /orindividually modifiedbrackets and wires thatapply continuous gentleforce to reposition theteeth. It uses patientspecific foam placementjigs to affix the brackets inposition | Intended forsame purpose– movement ofteeth, thussubstantiallyequivalent |
| Indication foruse statement | Inbrace OrthodonticSystem is a treatmentplanning software andorthodontic appliancesystem used to correctmalocclusions inorthodontic patients usingappliances individualizedfor the orthodontic patient. | Insignia OrthodonticSystem is a treatmentplanning software andorthodontic appliancesystem used to correctmalocclusions inorthodontic patients usingappliances individualizedfor the orthodontic patient. | Same |
| Principles ofoperation | • A 3D digital scan ofpatient's dentition isprovided by theorthodontist• A 3D end-of-treatmentoutcome model isgenerated• The 3D model is sent tothe orthodontist forreview and approval• Bracket placement trays(indirect bonding (IDB)trays) are manufactured toposition the brackets onthe patient's teeth asprescribed by theorthodontist• Patient-specific archwiresare fabricated based onthe 3D model• Brackets are adhered tothe patient's teeth with acommercially availableadhesive | • A 3D digital model iscreated on a stone modelor a patient's dentalimpression• A 3D end-of-treatmentoutcome model isgenerated• The 3D model is sent tothe orthodontist for review• Bracket placement jigs aremanufactured to positionthe brackets on thepatient's teeth asprescribed by theorthodontist• Patient-specific arch wiresare provided• Brackets are adhered tothe patient's teeth with acommercially availableadhesive | Same.Both consist of1) treatmentusing a 3Ddigital scan,2) 3D model issent toorthodontistfor review andapproval,3) bracketplacementusing either anIDB tray(Inbrace) orplacement jigs(Insignia).The differencein placementdoes not affectperformancethus,substantiallyequivalent. |
| Mode of Use | Inbrace brackets arefabricated and fixed to thepatient's teeth usingpatient-specific indirectbonding trays.Patient-specific archwiresof traditional metallurgyare fabricated andprovided.The appliances are fixedto the teeth with thecommercially availableadhesives. | Either patient-specific(individually modified) orstandard appliances arefixed to the patient's teethusing patient specificfoam placement trays.Patient specific archwiresof traditional metallurgyare provided.The appliances are fixedto the teeth withcommercially availableadhesives. | Same |
| Bracketmaterial | Stainless steel /nickel-titanium | Stainless steel /ceramic/plastic | Same for metalbrackets.Inbrace systemdoes not useplastic orceramicbrackets. |
| Arch wirematerial | Nickel-titanium/copper-nickel-titanium | Stainless steel/nickel-titanium/ Beta titanium | Substantiallyequivalent |
| Positioningdevicematerial | Clear 3D printing resin | Plastic foam | No impact onperformancethussubstantiallyequivalent. |
| Description ofapplianceplacement | Affixed and removed byclinician | Affixed and removed byclinician | Same |
| Manufacturingmethod | Final desired arrangementof brackets, wires andindirect bonding trays aredesigned with theguidance of Inbracesoftware based on 3Dscans of the patient'sdentition. The softwareallows the clinician toreview, alter and approve | Final desired arrangementof brackets, wires and jigsare designed with theguidance of computersoftware using3dimentional models ofthe patient. In officesoftware allows theclinician to review, alterand 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. Softwaregenerates codes/imagefile that drives machineryto manufacture theappliances. | generates code that drivesmachinery to manufacturethe 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.
§ 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.