K Number
K200311
Device Name
VersaWrap Tendon Protector
Date Cleared
2020-03-06

(29 days)

Product Code
Regulation Number
878.3300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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 placement under, around, or over the injured 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.
More Information

Not Found

No
The device description and performance studies focus on the physical properties and function of an absorbable implant for tendon protection, with no mention of AI or ML technologies.

Yes
The device is intended for the management and protection of tendon injuries, which falls under therapeutic use.

No
The device description and intended use indicate that VersaWrap is an absorbable implant used for the management and protection of tendon injuries, acting as a physical encasement. It does not mention any function related to identifying, analyzing, or diagnosing medical conditions.

No

The device description clearly states that VersaWrap is an "absorbable implant" consisting of a "Sheet" and a "Wetting Solution," which are physical components. It also mentions "bench testing" of "representative samples of the device," indicating hardware testing.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the "management and protection of tendon injuries." This describes a therapeutic or protective function within the body, not a diagnostic test performed on samples taken from the body.
  • Device Description: The device is an "absorbable implant" designed to be placed around injured tendons. This is a physical device used in surgery or treatment, not a reagent or instrument used to analyze biological samples.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

N/A

Intended Use / 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.

Product codes

FTM

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 placement under, around, or over the injured 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

To verify that device design met functional and performance requirements, representative samples of the device underwent bench testing. Testing included dimensional/visual inspection

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K160364 VersaWrap Tendon Protector

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 878.3300 Surgical mesh.

(a)
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.(b)
Classification. Class II.

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
VersaWrap® Tendon Protector

K200311
Submitted
by:Alafair Biosciences, Inc.
6101 W Courtyard Drive
Ste. 2-225
Austin, TX 78730
800.206.5586; info@alafairbiosciences.com
Date
Prepared:March 6, 2020
Contact:Ben Walthall, Ph.D.
Chief Regulatory Officer
800.206.5586; info@alafairbiosciences.com
Product
NameVersaWrap® Tendon Protector
Common
NameTendon Protector
Classification
number21 CFR 878.3300
Product CodeFTM
Predicate
Device:K160364 VersaWrap® Tendon Protector
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
placement under, around, or over the injured 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.
Functional
and Safety
Testing:To verify that device design met functional and performance requirements,
representative samples of the device underwent bench testing. Testing
included dimensional/visual inspection
ConclusionAlafair considers the subject device to be equivalent to the predicate device.
This conclusion is based upon the fact that the devices have an equivalent
intended use and that there are no technological differences that raise new
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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