VersaWrap Tendon Protector

K160364 · Alafair Biosciences, Inc. · OWW · Jun 10, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K160364
• Device Name: VersaWrap Tendon Protector
• Applicant: Alafair Biosciences, Inc.
• Product Code: OWW · General, Plastic Surgery
• Decision Date: Jun 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VersaWrap Tendon Protector 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 providing a non-constricting, protective interface between injured tendons and surrounding tissues/sheaths. The device consists of a thin, conformable sheet (crosslinked calcium alginate and glycosaminoglycan) and an aqueous citrate wetting solution. During surgery, the clinician places the sheet around the injured tendon and applies the solution to the sheet to facilitate placement. The device acts as a physical barrier to separate damaged tissues during the healing process, thereby improving tendon mobility. It is intended for single use in a clinical/surgical setting.

Clinical Evidence

No human clinical data provided. Evidence includes bench testing (visual inspection, dimensions, weight, puncture strength, handling, tissue adherence/conformance) and an animal study (chicken flexor tendon repair model). Biocompatibility testing performed per ISO 10993 standards, including cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, genotoxicity, subchronic toxicity, and muscle implantation.

Technological Characteristics

Absorbable implant composed of crosslinked calcium alginate and glycosaminoglycan sheet with aqueous citrate wetting solution. Sterile, single-use, non-pyrogenic. Biocompatibility verified per ISO 10993-3, 5, 6, 10, and 11. Physical properties include conformability and puncture strength.

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

• Tendon Wrap Tendon Protector (K053655)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three overlapping shapes.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 10, 2016

Alafair Biosciences Inc. Ben Walthall, Ph.D. Chief Regulatory Officer 3925 W. Braker Lane, Floor #3 Austin, Texas 78759

Re: K160364

Trade/Device Name: Versawrap Tendon Protector Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWW Dated: May 9, 2016 Received: May 11, 2016

Dear Dr. Walthall:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K160364

Device Name VersaWrap Tendon Protector

Indications for Use (Describe)

The VersaWrap Tendon Protector 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

### 510(k) Summary VersaWrap™ Tendon Protector Submitted by: Alafair Biosciences Incorporated 3925 West Braker Lane, Third Floor Austin, Texas 78759 Telephone: [phone] Ben Walthall, Ph.D. Contact: Chief Regulatory Officer Date prepared: May 9, 2016 Name of the device: Proprietary Name: VersaWrap™ Tendon Protector Common Name: Tendon Protector Class II Regulation Number: 21 CFR 878.3300 Product Code: OWW Review Panel: General & Plastic Surgery VersaWrap™ Tendon Protector (VersaWrap) is substantially Predicate Device: equivalent in construction, function and intended use to Integra Lifesciences Corporation's Tendon Wrap™ Tendon Protector (Tendon Wrap), K053655. Device Description: VersaWrap is an absorbable implant (device), designed to serve as an interface between the tendon and tendon sheath or the surrounding tissues, which provides a non-constricting, protective encasement for injured tendons. VersaWrap consists of a Sheet and a wetting Solution. The Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for easy under, around. or over the injured placement tendon. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet after the Sheet is positioned onto damaged tissue. The Solution is comprised of aqueous citrate and is provided in a dropper packaged in a double peel pouch. The Solution is sterile, non-pyrogenic, and is intended for single use only.

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

{4}------------------------------------------------

| Principle of<br>Operation: | The mechanism of action of VersaWrap is to protect tendon by<br>keeping damaged tissues physically separated during healing. |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional and<br>Safety Testing: | To verify that device design met functional and performance<br>requirements, representative samples of the device underwent<br>bench testing in accordance to applicable standards and guidance.<br><br>These data provide an acceptable assurance of the safety and<br>effectiveness of VersaWrap and demonstrate that the device is<br>equivalent to the predicate.<br><br>Biocompatibility studies have demonstrated that VersaWrap is<br>non-cytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-<br>toxic, and non-genotoxic. Results of physical testing and animal<br>studies have demonstrated that the VersaWrap alginate-<br>glycosaminoglycan matrix provides a protective interface to<br>improve mobility of repaired tendons. |
| Comparative<br>Technology<br>Characteristics: | A comparison of the characteristics of the proposed device and the<br>predicate device shows VersaWrap to have the same technological<br>characteristics to the predicate that has received 510(k) clearance.<br><br>Equivalence is based upon intended use, indications for use,<br>operating principle and fundamental scientific technology.<br><br>Both devices are intended for the management and protection of<br>tendon injuries. Minor differences in technological characteristics<br>do not raise different questions of safety and effectiveness. |
| Non-Clinical Tests<br>Submitted | The following tests were performed to support substantial<br>equivalence. Performance Testing, including: Visual inspection Dimensional and weight measurements Puncture strength Handling Tissue adherence and conformance Chicken flexor tendon repair model Biocompatibility Testing, including: Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Irritation - Intracutaneous Reactivity (ISO10993-10) Acute Systemic Toxicity (ISO10993-11) Pyrogenicity (ISO 10993-11) Genotoxicity (ISO 10993-3) |

{5}------------------------------------------------

- Subchronic toxicity (13 weeks, ISO 10993-11 and ISO . 10993-6)
- Muscle implantation toxicity/irritation (ISO 10993-6) .

Conclusion: Alafair considers VersaWrap to be equivalent to the predicate device. This conclusion is based upon the fact that the devices have an equivalent intended use, and there are no differences that raise new types of questions of safety and effectiveness.