ArchForm Orthodontic Software System

K213916 · Archform, Inc. · PNN · Dec 16, 2021 · Dental

Device Facts

• Record ID: K213916
• Device Name: ArchForm Orthodontic Software System
• Applicant: Archform, Inc.
• Product Code: PNN · Dental
• Decision Date: Dec 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The ArchForm Orthodontic Software System is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of the ArchForm Orthodontic Software System requires the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Device Story

ArchForm Orthodontic Software System is a standalone software tool for dental professionals; manages 3D digital dental scans; enables systematic inspection, detailed analysis, and treatment simulation; facilitates virtual design of orthodontic appliances (aligners/retainers); outputs STL files for 3D printing of dental casts; used in clinical settings for diagnosis and treatment planning; assists clinicians in evaluating treatment progress and outcomes against objectives; requires specialized orthodontic training.

Clinical Evidence

Bench testing only. No clinical data provided. Software underwent integration, verification, and validation testing per FDA guidance; passed all tests.

Technological Characteristics

Standalone software; imports 3D digital patient scans; supports STL file format; performs virtual tooth movement planning and CAD design for dental casts; compatible with Windows 10 and MacOS Catalina; requires 4GB RAM and dedicated GPU.

Indications for Use

Indicated for orthodontic patients requiring management of dental models, inspection, analysis, treatment simulation, and virtual appliance design (aligners/retainers). Requires trained dental professionals.

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

• Orchestrate 3D Orthodontic Software (K181112)

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 16, 2021

ArchForm, Inc % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K213916

Trade/Device Name: ArchForm Orthodontic Software System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: December 13, 2021 Received: December 15, 2021

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.

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

{1}------------------------------------------------

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 ([e-mail]) or phone [phone] 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) K213916

Device Name ArchForm Orthodontic Software System

#### Indications for Use (Describe)

The ArchForm Orthodontic Software System is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

The use of the ArchForm Orthodontic Software System requires the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

| 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) |

#### 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}------------------------------------------------

Submitter: ArchForm, Inc.

## K213916

### 510(k) Summary

#### ArchForm Orthdontic Software System

| Submitter: | ArchForm,Inc.<br>8421 Blue Heron Drive<br>Bakersfield, CA 93312 |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Andrew S. Martz<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | December 10, 2021 |
| Trade Name: | ArchForm Orthodontic Software System |
| Classification Name: | Orthodontic Plastic Brackets (Software) |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 872.5470 |
| Product Code: | PNN |
| Review Panel: | Dental |
| Predicate Device: | Orchestrate 3D Orthodontic Software - K181112 |
| Device Description: | The ArchForm Orthodontic Software System is an orthodontic<br>appliance design and treatment simulation software. This software<br>is for use by Dental professionals to diagnose and design solutions<br>for patients. Digital scans (3D) of a patient's dentition can be loaded<br>into the software and the dental professional can then create<br>treatment plans for each individual patient and their needs. The<br>system can be used to fabricate dental casts using standard<br>stereolithographic (STL) files for use in 3D printers. Dental casts<br>printed can then be used to manufacture sequential aligner trays<br>and retainers. |
| Indications for Use: | The ArchForm Orthodontic Software System is indicated for use as<br>a front-end software tool for management of orthodontic models,<br>systematic inspection, detailed analysis, treatment simulation and |
| Submitter:<br>ArchForm, Inc. | ArchForm Orthodontic Software System<br>Premarket Notification: Traditional 510(k) |
| | of an orthodontic treatment. It can also be applied during the<br>treatment to inspect and analyze the progress of the treatment. It<br>can be used at the end of the treatment to evaluate if the outcome<br>is consistent with the planned/desired treatment objectives. |
| | The use of the ArchForm Orthodontic Software System requires the<br>user to have the necessary training and domain knowledge in the<br>practice of orthodontics, as well as to have received a dedicated<br>training in the use of the software. |
| Substantial Equivalence<br>Discussion: | The ArchForm Orthodontic Software System is functionally<br>equivalent to the Orchestrate 3D Orthodontic Software predicate<br>device (K181112) cleared November 26, 2018). The following<br>table demonstrates that the functional characteristics of the<br>ArchForm Orthodontic Software System are substantially<br>equivalent to the predicate device. |
| Comparison of Indications for | Use to Predicate Device: Based on the comparison below, the indications for use of the<br>ArchForm Orthodontic Software System is similar to that of the<br>Orchestrate 3D Orthodontic Software. Therefore, the ArchForm<br>Orthodontic Software System can be considered substantially<br>equivalent to its predicate device. |
| Comparison of Technological Features<br>to Predicate Device: | Based on the comparison below, the design, construction, and<br>performance characteristics of the ArchForm Orthodontic Software<br>System is similar to that of Orchestrate 3D Orthodontic Software.<br>Therefore, the ArchForm Orthodontic Software System can be<br>considered substantially equivalent to its predicate device. |
| Summary of Performance Data and | Substantial Equivalence: Utilizing FDA Guidance document "Guidance for the Content of<br>Premarket Submissions for Software Contained in Medical<br>Devices" (issued May 11, 2005), the ArchForm Orthodontic |

{4}------------------------------------------------

Software System underwent appropriate integration, verification,
and validation testing. The software passed the testing and performed per its intended use.

{5}------------------------------------------------

## Substantial Equivalence Comparison

| Characteristic | ArchForm Orthodontic Software System | Orchestrate 3D Orthodontic Software | Comparison |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | TBD (K213916) | K181112 | N/A |
| Class | Class II | Class II | Same |
| Device<br>Classification<br>Name | Orthodontic Plastic Brackets (Software) | Orthodontic Plastic Brackets (Software) | Same |
| Regulation<br>Number | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Product Code | PNN | PNN | Same |
| Indications for<br>Use | ...is indicated for use as a front-end software<br>tool for management of orthodontic models,<br>systematic inspection, detailed analysis,<br>treatment simulation and virtual appliance<br>design options, including dental casts, which<br>may be used for sequential aligner trays or<br>retainers. These applications are based on<br>3D models of the patient's dentition before<br>the start of an orthodontic treatment. It can<br>also be applied during the treatment to<br>inspect and analyze the progress of the<br>treatment. It can be used at the end of the<br>treatment to evaluate if the outcome is<br>consistent with the planned/desired<br>treatment objectives.<br>The use of the ArchForm Orthodontic<br>Software System requires the user to have<br>the necessary training and domain<br>knowledge in the practice of orthodontics, as<br>well as to have received a dedicated training<br>in the use of the software. | ...is indicated for use as a front-end software<br>tool for management of orthodontic models,<br>systematic inspection, detailed analysis,<br>treatment simulation and virtual appliance<br>design options, including dental casts, which<br>may be used for sequential aligner trays or<br>retainers. These applications are based on<br>3D models of the patient's dentition before<br>the start of an orthodontic treatment. It can<br>also be applied during the treatment to<br>inspect and analyze the progress of the<br>treatment. It can be used at the end of the<br>treatment to evaluate if the outcome is<br>consistent with the planned/desired<br>treatment objectives.<br>The use of the Orchestrate 3D Orthodontic<br>Software System requires the user to have<br>the necessary training and domain<br>knowledge in the practice of orthodontics,<br>as well as to have received a dedicated<br>training in the use of the software. | Same |
| Technological<br>Features | Stand Alone Software Imports Digital Patient Scans Can be used to design Dental Casts Useful for Diagnosis, treatment planning, and CAD design Virtual Planning of tooth movement Supports STL Files | Stand Alone Software Imports Digital Patient Scans Can be used to design Dental Casts Useful for Diagnosis, treatment planning, and CAD design Virtual Planning of tooth movement Supports STL Files | Same |
| Characteristic | ArchForm Orthodontic Software System | Orchestrate 3D Orthodontic Software | Comparison |
| Minimum<br>Hardware /<br>Software<br>Requirements | OS: Windows 10 and MacOS Catalina RAM: 4 GB Monitor Resolution: 1280 X 720 Video Card: HD620 Hard Drive Space: 128 GB CPU: Intel 2nd Gen Core i5 processor or equivalent Mouse: with wheel button | OS: Windows 7, 8, 10 64-bit RAM: 8 GB Monitor Resolution: 1280 X 800 Video Card Memory: 1 GB Hard Drive Space: 10 GB CPU: Intel compatible 2.6 GHz/Dual or Quad Core 2.6 GHz Mouse: with scrolling wheel or button* | Same |
| Supported<br>Anatomic<br>Areas | Maxilla/Mandible | Maxilla/Mandible | Same |
| Intended Use<br>Managing<br>Patient and<br>case base data | Yes | Yes | |
| Collection of<br>study<br>material | Yes | Yes | |
| Alignment of<br>study<br>material | Yes | Yes | |
| Measuring<br>study<br>material | Yes | Yes | |
| Analyzing<br>Study<br>Material | Yes | Yes | Same |
| Treatment<br>Simulation | Yes | Yes | |
| Virtual<br>Appliance<br>Design | Yes | Yes | |
| Surface scan<br>for<br>intraoral<br>scanner | Yes | Yes | |
| Surface scan<br>from STL file | Yes | Yes | |
| Characteristic | ArchForm Orthodontic Software System | Orchestrate 3D Orthodontic Software | Comparison |
| Analysis and<br>Treatment | | | |
| Arch Shape | Yes | Yes | |
| Overbite /<br>Overjet | Yes | Yes | |
| Occlusal Map | Yes | Yes | |
| 3D Treatment<br>Simulation | Yes | Yes | |
| Orthodontic<br>Appliance<br>Virtual<br>Preparation | Yes | Yes | Same |
| Orthodontic<br>Appliance<br>Design | Yes | Yes | |
| Orthodontic<br>Appliance<br>Export | Yes | Yes | |

{6}------------------------------------------------

## Submitter: ArchForm, Inc.

## ArchForm Orthodontic Software System

Premarket Notification: Traditional 510(k)

{7}------------------------------------------------

## Submitter: ArchForm, Inc.

### ArchForm Orthodontic Software System

Premarket Notification: Traditional 510(k)

Conclusion: Based on comparison of indications for use, technological features, performance testing, and software validation testing, the ArchForm Orthodontic Software System has been shown to be appropriate for its indications for use and is substantially equivalent to the legally marketed predicate device.