VersaWrap Tendon Protector

K200311 · Alafair Biosciences, Inc. · FTM · Mar 6, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K200311
• Device Name: VersaWrap Tendon Protector
• Applicant: Alafair Biosciences, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Mar 6, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Device Story

VersaWrap is an absorbable implant designed to provide a non-constricting, protective encasement for injured tendons. It acts as an interface between the tendon and surrounding tissues to physically separate damaged tissues during healing. The device consists of a thin, conformable sheet made of crosslinked calcium alginate and glycosaminoglycan, and an aqueous citrate wetting solution. The sheet is placed under, around, or over the injured tendon by a surgeon, followed by application of the wetting solution. The device is supplied sterile for single-use. It benefits patients by facilitating tendon healing through physical separation of tissues.

Clinical Evidence

Bench testing only. Testing included dimensional and visual inspection to verify that device design met functional and performance requirements.

Technological Characteristics

Absorbable implant consisting of a crosslinked calcium alginate and glycosaminoglycan sheet and an aqueous citrate wetting solution. Supplied sterile, non-pyrogenic, for single use in double peel pouches.

Indications for Use

Indicated for management and protection of tendon injuries without substantial loss of tendon tissue.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• VersaWrap Tendon Protector (K160364)

Submission Summary (Full Text)

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March 6, 2020

Alafair Biosciences Inc % Angela Mallery Regulatory Consultant Namsa 400 Highway 169 South, Ste 500 Minneapolis, Minnesota 55426

Re: K200311

Trade/Device Name: VersaWrap Tendon Protector Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: February 5, 2020 Received: February 6, 2020

Dear Ms. Mallery:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control 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) K200311

Device Name VersaWrap Tendon Protector

Indications for Use (Describe)

VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Type of Use (Select one or both, as applicable)

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<br>VersaWrap® Tendon Protector<br>K200311 | | |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitted<br>by: | Alafair Biosciences, Inc.<br>6101 W Courtyard Drive<br>Ste. 2-225<br>Austin, TX 78730<br>800.206.5586; [e-mail] | |
| Date<br>Prepared: | March 6, 2020 | |
| Contact: | Ben Walthall, Ph.D.<br>Chief Regulatory Officer<br>800.206.5586; [e-mail] | |
| Product<br>Name | VersaWrap® Tendon Protector | |
| Common<br>Name | Tendon Protector | |
| Classification<br>number | 21 CFR 878.3300 | |
| Product Code | FTM | |
| Predicate<br>Device: | K160364 VersaWrap® Tendon Protector | |
| Device<br>Description: | VersaWrap is an absorbable implant (device), designed to serve as an interface<br>between the tendon and tendon sheath or the surrounding tissues, which<br>provides a non-constricting, protective encasement for injured tendons.<br>VersaWrap consists of a Sheet and a Wetting Solution. The Sheet is a thin<br>membrane of crosslinked calcium alginate and glycosaminoglycan.<br>VersaWrap Sheet is easy to handle, conformable, and is designed for easy<br>placement under, around, or over the injured tendon. VersaWrap Sheet is<br>supplied sterile, non-pyrogenic, for single use, in double peel pouches. The<br>VersaWrap Solution is applied to the Sheet after the Sheet is positioned onto<br>damaged tissue. The Solution is comprised of aqueous citrate and is provided<br>in a dropper packaged in a double peel pouch. The Solution is sterile, non-<br>pyrogenic, and is intended for single use only. | |
| Indications<br>for Use: | VersaWrap is indicated for the management and protection of tendon injuries<br>in which there has been no substantial loss of tendon tissue. | |
| Functional<br>and Safety<br>Testing: | To verify that device design met functional and performance requirements,<br>representative samples of the device underwent bench testing. Testing<br>included dimensional/visual inspection | |
| Conclusion | Alafair considers the subject device to be equivalent to the predicate device.<br>This conclusion is based upon the fact that the devices have an equivalent<br>intended use and that there are no technological differences that raise new<br>types of questions of safety and effectiveness. | |

The mechanism of action of VersaWrap is to protect tendon by keeping Principle of Operation: damaged tissues physically separated during healing.

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