(31 days)
No
The device description and intended use focus on a physical, absorbable implant and solution, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is indicated for the "management and protection of tendon injuries" and "surrounding tissues such as skeletal muscle and ligament", which are therapeutic actions. It also serves as an "absorbable implant" and a "non-constricting, protective encasement" to aid in healing.
No
The device description indicates that VersaWrap is an "absorbable implant (device), designed to serve as an interface between the target tissues and surrounding tissues to provide a non-constricting, protective encasement." Its stated purpose is "management and protection of tendon injuries" and "management and protection of surrounding tissues." These functions are therapeutic and supportive, not diagnostic (i.e., identifying or determining the nature of a disease or condition).
No
The device description explicitly states that VersaWrap is an "absorbable implant (device)" consisting of a "clear Sheet" and a "wetting Solution," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that VersaWrap is an implantable device used for the management and protection of tendon injuries and surrounding tissues within the body.
- The device description focuses on the physical properties and application of the implant. There is no mention of analyzing biological samples or providing diagnostic information.
- The intended use is therapeutic/protective, not diagnostic. The purpose is to manage and protect injured tissues, not to diagnose a condition.
Therefore, VersaWrap is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.
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. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament.
Product codes
FTM
Device Description
VersaWrap® is an absorbable implant (device), designed to serve as an interface between the target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan (GAG). VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet rendering the Sheet a gelatinous, tissue adherent layer. The Solution, comprised of aqueous citrate, is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tendon injuries, surrounding tissues such as skeletal muscle and ligament.
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)
Non-Clinical testing was conducted and results were substantially equivalent the prior non-clinical testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K203600 VersaWrap
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 29, 2021
Alafair Biosciences Inc. Angela Mallery Principal Product Development Strategist, Regulatory 6101 W Courtvard Drive Suite 2-225 Austin, Texas 78730
Re: K213163
Trade/Device Name: VersaWrap Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: September 27, 2021 Received: September 28, 2021
Dear Angela 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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,
Deborah Fellhauer RN, BSN Assistant Director (Acting) 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) K213163
Device Name VersaWrap
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. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament.
| 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 | |
|---|---|
| Submitted by: | Alafair Biosciences, Inc. 6101 W Courtyard Drive Ste. 2-225 Austin, TX 78730 800.206.5586; info@alafairbiosciences.com |
| Date Prepared: | October 29, 2021 |
| Contact: | Ben Walthall, Ph.D. Chief Regulatory Officer 800.206.5586; info@alafairbiosciences.com |
| Product Name | VersaWrap |
| Common Name | Tendon Protector |
| Classification number | 21 CFR 878.3300 |
| Product Code | FTM |
| Predicate Device: | K203600 VersaWrap |
| Device Description: | VersaWrap® is an absorbable implant (device), designed to serve as an interface between the target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan (GAG). VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet rendering the Sheet a gelatinous, tissue adherent layer. The Solution, comprised of aqueous citrate, is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch. |
| 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. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament. |
| Comparative Technology Characteristics: | VersaWrap can be implanted in gel form as compared to the predicate |
| Non-Clinical Tests Performed: | Non-Clinical testing was conducted and results were substantially equivalent the prior non-clinical testing |
| Conclusion | Conclusion(s) drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the identified legally marketed device |