(90 days)
No
The device description and supporting information do not mention any AI or ML components or functionalities.
Yes
The device is used for the management and protection of tendon injuries and surrounding tissues, indicating a therapeutic purpose.
No
Explanation: The device description and intended use indicate that VersaWrap is an absorbable implant designed for physical management and protection of tissues, not for diagnosing conditions.
No
The device description clearly states that VersaWrap is an "absorbable implant (device)" consisting of a physical "clear Sheet" and a "wetting Solution," indicating it is a physical medical device, not software.
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" and "management and protection of surrounding tissues." 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 "under, around, or over injured tissues." This is a physical implant used in vivo, not a reagent or instrument used to analyze samples in vitro.
- 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. VersaWrap does not fit this 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. 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 after the Sheet is positioned. 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
No additional testing was conducted. The prior non-clinical testing and animal model studies were used to support the modified indications.
Key Metrics
Not Found
Predicate Device(s)
K200311 VersaWrap
Reference Device(s)
K201631 VersaWrap
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, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
March 9, 2021
Alafair Biosciences Inc % Angela Mallery Regulatory Consultant Namsa 400 Highway 169 South, Ste 500 Minneapolis, Minnesota 55426
Re: K203600
Trade/Device Name: VersaWrap Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: December 8, 2020 Received: December 9, 2020
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); 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. 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
2
Indications for Use
510(k) Number (if known) K203600
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)
| ☑ Examination Use Only (375 IAC 1-6-1) | ☐ For-Hire Instruction (375 IAC 1-6-1) |
|---|---|
| ---------------------------------------- | ---------------------------------------- |
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
| K203600 | |
|---|---|
| Submitted by: | Alafair Biosciences, Inc. |
| 6101 W Courtyard Drive | |
| Ste. 2-225 | |
| Austin, TX 78730 | |
| 800.206.5586; info@alafairbiosciences.com | |
| Date Prepared: | February 4, 2021 |
| Contact: | Ben Walthall, Ph.D. |
| Chief Regulatory Officer | |
| 800.206.5586; info@alafairbiosciences.com | |
| Trade/Device Name: | VersaWrap Tendon Protector |
| Regulation Number | |
| Regulation Name: | |
| Regulatory Class: | |
| Product Code: | 21 CFR 878.3300 |
| Surgical Mesh | |
| Class II | |
| FTM | |
| Primary Predicate: | K200311 VersaWrap |
| Reference Device: | K201631 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. Versa Wrap 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 after the Sheet is positioned. 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 is identical to the predicate device. Differences in the indication for use are not |
| critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device | |
| because the differences do not affect the safety and effectiveness of the device when used as | |
| labeled. | |
| Non-Clinical Tests | |
| Performed: | No additional testing was conducted. The prior non-clinical testing and animal model |
| studies were used to support the modified indications. | |
| Conclusion | Conclusion(s) drawn from the nonclinical tests demonstrate that the device is as safe, as |
| effective, and performs as well as or better than the identified legally marketed device. |