WellsForm Tricuspid Annuloplasty Band is indicated for the surgical reconstruction or remodeling of diseased or damaged tricuspid valves. The band provides support for and restricts expansion of the tricuspid annulus.

Device Description

The WellsForm™ Tricuspid Annuloplasty Band is an implantable ring intended for surgical repair of the tricuspid heart valve. WellsForm Tricuspid Annuloplasty Band is indicated for the surgical reconstruction or remodeling of diseased or damaged tricuspid valves. The band provides support for and restricts expansion of the tricuspid annulus.

The WellsForm™ Tricuspid Annuloplasty Band consists of a braided textile polyester body with a semi-rigid (stiflened) portion at the septal and aortic segments. The flexible section runs from the aortic segment, about half of the posteroseptal commissure to help remodel and stabilize the enlarged portion of the tricuspid annulus found in patients with functional tricuspid requrgitation.

The size range of the WellsForm Tricuspid Annuloplasty Band is from 26mm in 2mm increments (sizes: 26, 28, 30, 34, and 36).

AI/ML Overview

I'm sorry, but the provided text describes a medical device submission (510(k)) for a Tricuspid Annuloplasty Band. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing (e.g., computational structural analysis, tensile strength, sterilization validation, biocompatibility tests like cytotoxicity, pyrogenicity).

The document does not contain information about:

Acceptance criteria in the context of an AI/ML algorithm's performance.
Clinical study design involving a test set, training set, or ground truth establishment by experts.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Stand-alone algorithm performance.
Any form of artificial intelligence (AI) or machine learning (ML).

Therefore, I cannot extract the information required to answer your questions about acceptance criteria for an AI/ML device and the study proving it meets those criteria. The provided text is relevant to traditional medical device clearance, not AI/ML performance evaluation.

Summary

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May 26, 2023

Genesee Biomedical Inc Woodrow Mathison President and CEO 700 W. Mississippi Ave Unit D-5 Denver. Colorado 80223

Re: K230679

Trade/Device Name: WellsForm Tricuspid Annuloplasty Band (WF) Regulation Number: 21 CFR 870.3800 Regulation Name: Annuloplasty ring Regulatory Class: Class II Product Code: KRH, DTI Dated: March 10, 2023 Received: March 13, 2023

Dear Woodrow Mathison:

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

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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,

Julie B. Mackel -S

For

Jennifer Bastijanic Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230679

Device Name WellsForm Tricuspid Annuloplasty Band (WF)

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Prepared on: 2023-05-25 Contact Details 21 CFR 807.92(a)(1) Genesee Biomedical Inc Applicant Name 700 W. Mississippi Ave Unit D-5 Denver CO 80223 United States Applicant Address 303-777-3000 Applicant Contact Telephone Mr. Woodrow Mathison Applicant Contact Applicant Contact Email wmathison@geneseebiomedical.com Device Name 21 CFR 807.92(a)(2) WellsForm Tricuspid Annuloplasty Band (WF) Device Trade Name Annuloplasty ring Common Name Ring, Annuloplasty Classification Name 870.3800 Regulation Number KRH Product Code Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate Trade Name (Primary Predicate is listed first) Predicate # Product Code K093903 Tri-Ad Semi-Flexible Annuloplasty Ring Model 900SFC KRH Device Description Summary 21 CFR 807.92(a)(4)

The size range of the WellsForm Tricuspid Annuloplasty Band is from 26mm in 2mm increments (sizes: 26, 28, 30, 34, and 36).

Intended Use/Indications for Use

Indications for Use Comparison

A comparison of the characteristics of the proposed device and/or reference device show that there are no differences between the subject device and the predicate device with respects, indications and intended use. Both devices have the same principle and mechanism of operation. The WellsForm Tricuspid Annuloplasty Band is determined to be substantially equivalent to the predicate device.

21 CFR 807.92(a)(5)

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Technological Comparison

Technological aspects were assessed for substantial equivalence. The subject devices have similar size, shape, and material composition. The subject device, the WellsForm Tricuspid Annuloplasty Band, will be manufactured under equivalent conditions as the predicate device.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The following non-clinical and/or clinical tests were completed on the WellsForm Tricuspid Annuloplasty Band:

Computational Structural Analysis (SFEA) Braid tensile strength Suture pull out/tensile strength Sterilization Validation Cytotoxicity Pyrogenicity

Due to the substantially equivalent materials and reference devices, the following non-clinical and/or clinical tests were not completed on the WelsForm Tricuspid Annuloplasty Band and the results of the previously approved devices were leveraged:

Sensitivity Irritation Systemic Toxicity Genotoxicity Implantation Testing Haemocompatibility Carcinogenicity Packaging and Shelf Life Study
Genesee BioMedical, Inc. considers the WellsForm™ Tricuspid Annuloplasty Band to the predicate device. This conclusion is based upon the fact that devices have an equivalent intended use, and there are no clinical, or biological differences in performance testing that raise new questions of safety and effectiveness.

Regulation Number and Section

§ 870.3800 Annuloplasty ring.

(a)
Identification. An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Annuloplasty Rings 510(k) Submissions.”