(1 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on traditional software functionalities for orthodontic planning and design.
No.
The device is a front-end software tool for managing orthodontic models, systematic inspection, analysis, treatment simulation, and virtual appliance design, rather than directly providing therapy.
Yes
The "Device Description" explicitly states that the software is "for use by Dental professionals to diagnose and design solutions for patients."
Yes
The device description explicitly states it is an "orthodontic appliance design and treatment simulation software" and its function is based on processing "Digital scans (3D)" of a patient's dentition. There is no mention of accompanying hardware components that are part of the regulated device itself.
Based on the provided information, the ArchForm Orthodontic Software System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The ArchForm software analyzes digital scans (3D models) of the patient's dentition. While these scans are derived from the patient, they are not biological samples like blood, urine, or tissue that are typically analyzed by IVDs to provide diagnostic information about a disease or condition.
- The intended use is for treatment planning and appliance design. The software is used by dental professionals to manage models, analyze dentition, simulate treatment, and design virtual appliances (like aligners or retainers). This is a treatment planning and design tool, not a diagnostic test performed on a biological sample.
- The output is for fabricating dental casts and appliances. The software generates STL files for 3D printing dental casts, which are then used to manufacture physical appliances. This is a step in the treatment process, not a diagnostic result.
The software falls under the category of medical device software used for treatment planning and design based on imaging data.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
PNN, LLZ
Device Description
The ArchForm Orthodontic Software System is an orthodontic appliance design and treatment simulation software. This software is for use by Dental professionals to diagnose and design solutions for patients. Digital scans (3D) of a patient's dentition can be loaded into the software and the dental professional can then create treatment plans for each individual patient and their needs. The system can be used to fabricate dental casts using standard stereolithographic (STL) files for use in 3D printers. Dental casts printed can then be used to manufacture sequential aligner trays and retainers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Surface scan for intraoral scanner, Surface scan from STL file
Anatomical Site
Maxilla/Mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professionals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Utilizing FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005), the ArchForm Orthodontic Software System underwent appropriate integration, verification, and validation testing. The software passed the testing and performed per its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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 (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) 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) |
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3
Submitter: ArchForm, Inc.
K213916
510(k) Summary
ArchForm Orthdontic Software System
| Submitter: | ArchForm,Inc.
8421 Blue Heron Drive
Bakersfield, CA 93312 |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Andrew S. Martz
Phone: 661-304-8575
andrew@archform.co |
| 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
appliance design and treatment simulation software. This software
is for use by Dental professionals to diagnose and design solutions
for patients. Digital scans (3D) of a patient's dentition can be loaded
into the software and the dental professional can then create
treatment plans for each individual patient and their needs. The
system can be used to fabricate dental casts using standard
stereolithographic (STL) files for use in 3D printers. Dental casts
printed can then be used to manufacture sequential aligner trays
and retainers. |
| Indications for 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 |
| Submitter:
ArchForm, Inc. | ArchForm Orthodontic Software System
Premarket Notification: Traditional 510(k) |
| | 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 end of 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
user to have 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. |
| Substantial Equivalence
Discussion: | The ArchForm Orthodontic Software System is functionally
equivalent to the Orchestrate 3D Orthodontic Software predicate
device (K181112) cleared November 26, 2018). The following
table demonstrates that the functional characteristics of the
ArchForm Orthodontic Software System are substantially
equivalent to the predicate device. |
| Comparison of Indications for | Use to Predicate Device: Based on the comparison below, the indications for use of the
ArchForm Orthodontic Software System is similar to that of the
Orchestrate 3D Orthodontic Software. Therefore, the ArchForm
Orthodontic Software System can be considered substantially
equivalent to its predicate device. |
| Comparison of Technological Features
to Predicate Device: | Based on the comparison below, the design, construction, and
performance characteristics of the ArchForm Orthodontic Software
System is similar to that of Orchestrate 3D Orthodontic Software.
Therefore, the ArchForm Orthodontic Software System can be
considered substantially equivalent to its predicate device. |
| Summary of Performance Data and | Substantial Equivalence: Utilizing FDA Guidance document "Guidance for the Content of
Premarket Submissions for Software Contained in Medical
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 | |||
| Classification | |||
| Name | Orthodontic Plastic Brackets (Software) | Orthodontic Plastic Brackets (Software) | Same |
| Regulation | |||
| Number | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Product Code | PNN | PNN | Same |
| Indications for | |||
| Use | ...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 end of 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 user to have | |||
| 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. | ...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 end of the | |||
| treatment to evaluate if the outcome is | |||
| consistent with the planned/desired | |||
| treatment objectives. | |||
| The use of the Orchestrate 3D Orthodontic | |||
| Software System requires the user to have | |||
| 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. | Same | ||
| Technological | |||
| 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 | |||
| Hardware / | |||
| Software | |||
| 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 | |||
| Anatomic | |||
| Areas | Maxilla/Mandible | Maxilla/Mandible | Same |
| Intended Use | |||
| Managing | |||
| Patient and | |||
| case base data | Yes | Yes | |
| Collection of | |||
| study | |||
| material | Yes | Yes | |
| Alignment of | |||
| study | |||
| material | Yes | Yes | |
| Measuring | |||
| study | |||
| material | Yes | Yes | |
| Analyzing | |||
| Study | |||
| Material | Yes | Yes | Same |
| Treatment | |||
| Simulation | Yes | Yes | |
| Virtual | |||
| Appliance | |||
| Design | Yes | Yes | |
| Surface scan | |||
| for | |||
| intraoral | |||
| scanner | Yes | Yes | |
| Surface scan | |||
| from STL file | Yes | Yes | |
| Characteristic | ArchForm Orthodontic Software System | Orchestrate 3D Orthodontic Software | Comparison |
| Analysis and | |||
| Treatment | |||
| Arch Shape | Yes | Yes | |
| Overbite / | |||
| Overjet | Yes | Yes | |
| Occlusal Map | Yes | Yes | |
| 3D Treatment | |||
| Simulation | Yes | Yes | |
| Orthodontic | |||
| Appliance | |||
| Virtual | |||
| Preparation | Yes | Yes | Same |
| Orthodontic | |||
| Appliance | |||
| Design | Yes | Yes | |
| Orthodontic | |||
| Appliance | |||
| 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.