(1178 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the physical aligner trays and their intended use. While software is mentioned in the reference device, there is no indication that AI/ML is used in the design or function of the Archworx device itself.
Yes
The device is indicated for the "treatment of tooth malocclusion," which is a medical condition, making it a therapeutic device.
No
The device is described as an intraoral thermoformed plastic aligner tray indicated for the treatment of tooth malocclusion, not for diagnosis.
No
The device description explicitly states the device is "intraoral thermoformed plastic aligner trays," which are physical hardware components.
Based on the provided information, the Archworx device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of tooth malocclusion" and "to position teeth." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is described as "intraoral thermoformed plastic aligner trays." These are physical devices used for treatment, not for analyzing biological samples to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood, tissue, or any other biological sample to provide information about a patient's health status or disease.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Archworx is used in vivo (inside the body) for treatment.
N/A
Intended Use / Indications for Use
Archworx is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Archworx is intended to position teeth by way of continuous gentle force.
Product codes
NXC
Device Description
Devices are intraoral thermoformed plastic aligner trays for tooth malocclusion correction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
impressions or scans
Anatomical Site
teeth
Indicated Patient Age Range
patients with permanent dentition (i.e. all second molars)
Intended User / Care Setting
Prescribing Dentist or Orthodontist
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
Bench Performance Testing: Physical properties testing was conducted, and testing information was obtained from the material manufacturer. All the physical properties testing met the pre-specified acceptance criteria.
Verification and Validation Testing: For 3 different patient cases, aligners were evaluated at 3 different points through the sequence for each sequence point, 3 critical dimensions based on intended positions of these critical tooth structures. Testing indicated the aligner designed in the software meets the planned location, positions and all dimensions as expected; and as prescribed.
Key Metrics
Not Found
Predicate Device(s)
Argen Clear Aligner and Argen Clear Aligner Premium (K192846)
Reference Device(s)
3Shape Ortho System Software (K180941)
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 26, 2021
Utah Medical Products and Services Brandon Farley Business Owner and President DBA Cottonwood Laboratories 6526 South State Street Suite #301 Murray, Utah 84107
Re: K173738
Trade/Device Name: Archworx Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: January 14, 2021 Received: January 19, 2021
Dear Brandon Farley:
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) K173738
Device Name Archworx
Indications for Use (Describe)
Archworx is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Archworx is intended to position teeth by way of continuous gentle force.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Cottonwood Laboratories. The logo features a stylized drawing of a human face in profile, with the brain highlighted in red. Next to the drawing is the company name, "Cottonwood LABORATORIES," with "LABORATORIES" in smaller font. Below the name is the company website address, "www.cottonwoodortholab.com."
| Manufacturer Name/Submitter | Utah Medical Products and Services
(DBA Cottonwood Laboratories) | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Brandon Farley | |
| Phone Number and Address | (801) 904-2006
6526 State Street
Murray, UT 84107 | |
| Device Name | Archworx | |
| 510K Number | K17378 | |
| Device Classification Name | Orthodontic Plastic Brackets (Sequential Aligners) | |
| Regulation Number | 21 CFR 872.5470 | |
| Product Classification Code | NXC | |
| Product Class | 2 | |
| Review Panel | Dental | |
| Prescription or Over the Counter | Prescription | |
| Supplied Sterile | No | |
| Single Patient Use | Yes | |
| Physical Properties/Image | | |
| Concise Description | Devices are intraoral thermoformed plastic aligner trays for
tooth malocclusion correction. | |
| Indications for Use Statement | Archworx is indicated for the treatment of tooth
malocclusion in patients with full, permanent dentition (i.e.,
all second molars). Archworx is intended to position teeth
by way of continuous gentle force. | |
| Intended Use | Archworx are a series of sequential aligner trays used to
treat malocclusion in patients with full, permanent
dentition by way of continuous gentle force; used under the
direction of a Prescribing Dentist or Orthodontist. | |
| Device Duration | Permanent Duration Contact (Greater Than 30-Days) | |
| Schedule of Use | Aligners are used in a sequence with each aligner allowing
for tooth movement by using a gentle continuous force to
the final, aligned tooth position. | |
| Mechanism of Action | Prescribing Dentist or Orthodontist approved customized
appliances that move teeth in small increments from their
original misaligned and malposed state to a final aligned
state. | |
| Method of Fabrication | Aligners are manufactured based on impressions or scans
sent to the manufacturer by the Prescribing Dentist or
Orthodontist after the Prescribing Dentist or Orthodontist;
or clinician has performed a clinical assessment of the
patient's teeth, taken intraoral scans or impressions of the
patients teeth and designed a treatment plan. | |
| Method of Treatment | Prior to the start of the aligner manufacturing process and
printing the 3D Models, the lab formulates the aligner
treatment plan which is sent to the Prescribing Dentist or
Orthodontist for review and approval and that only after
approval of the treatment plan is the fabrication process
started. | |
| Software Used | Models are fabricated after the impressions which are then
scanned using the 3Shape Ortho System Software
(K180941); and the applications used are the Appliance
Designer and the Ortho Analyzer. | |
| Material of Fabrication | Thermoformed Polycarbonate (Plastic) - Digital files are
used to produce the aligners series using Zendura FLX. | |
| Fabrication | Plastic disk is thermoformed over the model, then aligners
are inspected, cleaned and trimmed. | |
| Distribution | Aligners are sent directly to the Prescribing Dentist or
Orthodontist for dispensing to patience in sequential stages
where the Prescribing Dentist or Orthodontist monitors the
patient throughout the entire treatment process. | |
| Biocompatibility | Biocompatibility testing was conducted by the material
manufacturer for cytotoxicity, sensitization, irritation, and
oral mucosal irritation according to the ISO 10993 | |
| | | standards and that the device met the acceptance criteria
for all tests. |
| | Bench Performance Testing | Physical properties testing was conducted, and testing
information was obtained from the material manufacturer.
All the physical properties testing met the pre-specified
acceptance criteria. |
| | Verification and Validation Testing | Yes, Performed. For 3 different patient cases, aligners were
evaluated at 3 different points through the sequence for
each sequence point, 3 critical dimensions based on
intended positions of these critical tooth structures. Testing
indicated the aligner designed in the software meets the
planned location, positions and all dimensions as expected;
and as prescribed. |
| | Primary Predicate | Argen Clear Aligner and Argen Clear Aligner Premium
(K192846) |
| | Reference Device | 3Shape Ortho System Software (K180941) |
Due to the updates within this submission, a 510K Summary Table is provided:
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Image /page/4/Picture/0 description: The image shows the logo for Cottonwood Laboratories. The logo features a stylized letter "C" in a dark blue color, with the words "ottonwood LABORATORIES" written to the right of the "C". Below the word "LABORATORIES" is the website address "www.cottonwoodortholab.com". To the left of the "C" is a red and gray graphic that appears to be an abstract design.
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Image /page/5/Picture/0 description: The image shows the logo for Cottonwood Laboratories. The logo features a stylized tree branch with red leaves on the left side. To the right of the branch is the company name, "Cottonwood LABORATORIES," in a combination of bold and regular fonts. Below the company name is the website address, "www.cottonwoodortholab.com."
Conclusion
Comparison of the Proposed Device and the Primary Predicate Device demonstrate:
- Indications for Use ●
- Mechanism of Action ●
- Length, Duration, and Schedule of Use
- Design technology
- Material
- . Fabrication and composition
of Archworx, is substantially equivalent to the Primary Predicate Device; Argen Clear Aligner and Argen Clear Aligner Premium (K192846).