(88 days)
Not Found
No
The description focuses on technician-assisted treatment planning using 3D models and software, with no mention of AI or ML algorithms for analysis or decision-making.
Yes
The device is described as an "orthodontic appliance system used to correct malocclusions," indicating its direct involvement in treating a medical condition.
No
The device is described as treatment planning software and an orthodontic appliance system, not for diagnosing conditions. Its primary function is to determine bracket placement and facilitate the correction of malocclusions.
No
The device description explicitly states it is a "treatment planning software and orthodontic appliance system" and details the fabrication and use of physical components (metal brackets, arch wires, placement trays) that are part of the medical device system. While software is a key component, it is not the sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Inbrace System Function: The Inbrace Orthodontic System is used to correct malocclusions by physically repositioning teeth using customized appliances. It uses digital scans of the teeth for planning and fabrication, but it does not analyze biological specimens from the patient's body.
- Intended Use: The intended use clearly states it's for "correct[ing] malocclusions in orthodontic patients." This is a treatment, not a diagnostic process based on analyzing biological samples.
- Device Description: The description focuses on the software for planning and the physical orthodontic appliances (brackets, wires, trays) that are affixed to the teeth. There is no mention of analyzing biological samples.
The Inbrace Orthodontic System is a medical device used for treatment, specifically in the field of orthodontics. It falls under the category of devices used to physically alter the structure or function of the body.
N/A
Intended Use / 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.
Product codes
PNN, EJF, DZC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D digital scan of patient's dentition
Anatomical Site
Teeth / Dentition
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthodontic patients (intended use)
Dental orthodontic professionals trained in orthodontic treatment including radiographic analyses and treatment planning (intended user)
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
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.
Key Metrics
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.
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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
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
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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 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
- treatment
using a 3D
digital scan, - 3D model is
sent to
orthodontist
for review and
approval, - 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 |
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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 | |
| 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.