(1178 days)
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.
Devices are intraoral thermoformed plastic aligner trays for tooth malocclusion correction.
The provided text describes the regulatory clearance of an orthodontic device called "Archworx." It details the device's intended use, manufacturing process, and comparison to a predicate device for substantial equivalence. However, the document does not contain information about the acceptance criteria and the results of a study (especially a clinical or AI-related study) that proves the device meets those criteria.
Specifically, the document mentions:
- Biocompatibility testing: "Biocompatibility testing was conducted...and that the device met the acceptance criteria for all tests." It does not specify what these criteria were or provide the results.
- 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." Again, the criteria and results are not detailed.
- 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." This is the closest to study results, but it's very high-level and lacks specific quantitative data or acceptance criteria. It also doesn't fit the typical structure of an AI/human-in-the-loop study.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or details about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training sets, or how ground truth was established, as this information is not present in the provided text.
The information provided is largely for a 510(k) submission for a physical medical device (orthodontic aligners), not an AI/ML-driven device that would necessitate the study details inquired about. The only software mentioned is "3Shape Ortho System Software (K180941)" which is used for scanning and designing models, implying it's a tool used in the manufacturing process rather than an AI-driven component of the "Archworx" device itself that requires clinical performance validation as per the prompt's implied context (e.g., diagnostic AI).
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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) 904-20066526 State StreetMurray, 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 fortooth malocclusion correction. | |
| Indications for Use Statement | Archworx is indicated for the treatment of toothmalocclusion in patients with full, permanent dentition (i.e.,all second molars). Archworx is intended to position teethby way of continuous gentle force. | |
| Intended Use | Archworx are a series of sequential aligner trays used totreat malocclusion in patients with full, permanentdentition by way of continuous gentle force; used under thedirection 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 allowingfor tooth movement by using a gentle continuous force tothe final, aligned tooth position. | |
| Mechanism of Action | Prescribing Dentist or Orthodontist approved customizedappliances that move teeth in small increments from theiroriginal misaligned and malposed state to a final alignedstate. | |
| Method of Fabrication | Aligners are manufactured based on impressions or scanssent to the manufacturer by the Prescribing Dentist orOrthodontist after the Prescribing Dentist or Orthodontist;or clinician has performed a clinical assessment of thepatient's teeth, taken intraoral scans or impressions of thepatients teeth and designed a treatment plan. | |
| Method of Treatment | Prior to the start of the aligner manufacturing process andprinting the 3D Models, the lab formulates the alignertreatment plan which is sent to the Prescribing Dentist orOrthodontist for review and approval and that only afterapproval of the treatment plan is the fabrication processstarted. | |
| Software Used | Models are fabricated after the impressions which are thenscanned using the 3Shape Ortho System Software(K180941); and the applications used are the ApplianceDesigner and the Ortho Analyzer. | |
| Material of Fabrication | Thermoformed Polycarbonate (Plastic) - Digital files areused to produce the aligners series using Zendura FLX. | |
| Fabrication | Plastic disk is thermoformed over the model, then alignersare inspected, cleaned and trimmed. | |
| Distribution | Aligners are sent directly to the Prescribing Dentist orOrthodontist for dispensing to patience in sequential stageswhere the Prescribing Dentist or Orthodontist monitors thepatient throughout the entire treatment process. | |
| Biocompatibility | Biocompatibility testing was conducted by the materialmanufacturer for cytotoxicity, sensitization, irritation, andoral mucosal irritation according to the ISO 10993 | |
| standards and that the device met the acceptance criteriafor all tests. | ||
| Bench Performance Testing | Physical properties testing was conducted, and testinginformation was obtained from the material manufacturer.All the physical properties testing met the pre-specifiedacceptance criteria. | |
| Verification and Validation Testing | Yes, Performed. For 3 different patient cases, aligners wereevaluated at 3 different points through the sequence foreach sequence point, 3 critical dimensions based onintended positions of these critical tooth structures. Testingindicated the aligner designed in the software meets theplanned 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).
§ 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.