Who is the manufacturer of Inbrace Orthodontic System?

Swift Health Systems, Inc. filed the 510(k) submission for Inbrace Orthodontic System (K203442).

What is the FDA product code for Inbrace Orthodontic System?

PNN. It is classified under 21 CFR 872.5470 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Inbrace Orthodontic System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Inbrace Orthodontic System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Inbrace Orthodontic System

K203442 · Swift Health Systems, Inc. · PNN · Feb 19, 2021 · Dental

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

Intended 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)

Related Devices

K121524 — INSIGNIA · Ormco Corp. · Aug 9, 2012
K182338 — Blue Sky Bio Computerized Orthodontic Bracket System · Blue Sky Bio · Nov 9, 2018
K123416 — INSIGNIA WITH ITERO · Ormco Corp. · Mar 13, 2013
K082207 — ORTHOCAD IQ · Cadent, Inc. · Oct 23, 2009
K192701 — DIBS (Digital Indirect Bonding System) · Orthoselect, LLC · Apr 21, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 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. {4}------------------------------------------------ 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 System- subject device | Insignia - K121524 | Comparison | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | Inbrace Orthodontic System is a computer- guided system intended for use as an aid in orthodontic treatment planning for use by dental orthodontic professionals trained in orthodontic treatment including radiographic analyses and treatment planning. Inbrace contains patient- specific individually designed arch wires and wire-specific brackets that apply continuous gentle force to reposition the teeth. It also uses patient- specific indirect bonding trays to affix the brackets in position | Insignia is a computer - guided system intended for use as an aid in orthodontic treatment planning for use by dental orthodontic professionals trained in orthodontic treatment including radiographic analyses and treatment planning. Insignia is intended for use with commercially available and /or individually modified brackets and wires that apply continuous gentle force to reposition the teeth. It uses patient specific foam placement jigs to affix the brackets in position | Intended for same purpose – movement of teeth, thus substantially equivalent | | Indication for use statement | 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. | Insignia 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. | Same | | Principles of operation | • A 3D digital scan of patient's dentition is provided by the orthodontist • A 3D end-of-treatment outcome model is generated • The 3D model is sent to the orthodontist for review and approval • Bracket placement trays (indirect bonding (IDB) trays) are manufactured to position the brackets on the patient's teeth as prescribed by the orthodontist • Patient-specific archwires are fabricated based on the 3D model • Brackets are adhered to the patient's teeth with a commercially available adhesive | • A 3D digital model is created on a stone model or a patient's dental impression • A 3D end-of-treatment outcome model is generated • The 3D model is sent to the orthodontist for review • Bracket placement jigs are manufactured to position the brackets on the patient's teeth as prescribed by the orthodontist • Patient-specific arch wires are provided • Brackets are adhered to the patient's teeth with a commercially available adhesive | Same. Both consist of 1) treatment using a 3D digital scan, 2) 3D model is sent to orthodontist for review and approval, 3) bracket placement using either an IDB tray (Inbrace) or placement jigs (Insignia). The difference in placement does not affect performance thus, substantially equivalent. | | | | | | | Mode of Use | Inbrace brackets are fabricated and fixed to the patient's teeth using patient-specific indirect bonding trays. Patient-specific archwires of traditional metallurgy are fabricated and provided. The appliances are fixed to the teeth with the commercially available adhesives. | Either patient-specific (individually modified) or standard appliances are fixed to the patient's teeth using patient specific foam placement trays. Patient specific archwires of traditional metallurgy are provided. The appliances are fixed to the teeth with commercially available adhesives. | Same | | Bracket material | Stainless steel /nickel- titanium | Stainless steel /ceramic/ plastic | Same for metal brackets. Inbrace system does not use plastic or ceramic brackets. | | Arch wire material | Nickel-titanium/ copper-nickel-titanium | Stainless steel/nickel- titanium/ Beta titanium | Substantially equivalent | | Positioning device material | Clear 3D printing resin | Plastic foam | No impact on performance thus substantially equivalent. | | Description of appliance placement | Affixed and removed by clinician | Affixed and removed by clinician | Same | | Manufacturing method | Final desired arrangement of brackets, wires and indirect bonding trays are designed with the guidance of Inbrace software based on 3D scans of the patient's dentition. The software allows the clinician to review, alter and approve | Final desired arrangement of brackets, wires and jigs are designed with the guidance of computer software using 3dimentional models of the patient. In office software allows the clinician to review, alter and approve desired result | Same | {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 {7}------------------------------------------------ | desired result and | and appliances. Software | |------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------| | appliances. Software generates codes/image file that drives machinery to manufacture the appliances. | generates code that drives machinery to manufacture 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.