(90 days)
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.
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.
This document is a 510(k) summary for the VersaWrap device, which is a resubmission (K203600) based on a previously cleared device (K200311). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from the given document.
Here's what can be extracted and inferred based on the nature of a 510(k) submission for a device that is "identical to the predicate device" with "differences in the indication for use" that "do not affect the safety and effectiveness":
1. Table of Acceptance Criteria and Reported Device Performance:
No specific "acceptance criteria" for performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this 510(k) submission. This is because it's a re-submission of an "identical" device. The acceptance criteria for this submission would have been demonstrating:
- Substantial Equivalence: That the device is as safe and effective as a legally marketed predicate device.
- Safety and Effectiveness for Modified Indications: That the modified indications for use still fall within the demonstrated safety and effectiveness profile of the original device and its predicate.
| Acceptance Criteria (Implied for 510(k) Resubmission) | Reported Device Performance (Implied from Summary) |
|---|---|
| Device is identical to predicate K200311. | Confirmed: "VersaWrap is identical to the predicate device." |
| Differences in Indications do not affect safety/effectiveness. | Confirmed: "Differences in the indication for use are not critical to the intended therapeutic... because the differences do not affect the safety and effectiveness of the device when used as labeled." |
| Non-clinical testing supports modified indications. | Confirmed: "The prior non-clinical testing and animal model studies were used to support the modified indications." |
| Device is as safe and effective as legally marketed predicate. | Confirmed: "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." |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not applicable for this 510(k) submission, as it relies on previous testing of the identical predicate device. No new test set data is presented.
- Data Provenance: No new data provenance information is provided as the submission relies on "prior non-clinical testing and animal model studies" for the predicate device. The document does not specify the country of origin or whether these prior studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no new test set requiring new ground truth establishment is detailed in this 510(k) summary. The summary refers to existing non-clinical and animal model studies, but does not provide details on how ground truth was established within those studies.
4. Adjudication method for the test set:
- Not applicable, as no new test set or clinical study requiring adjudication is detailed in this 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The VersaWrap device is a surgical mesh/implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- No. This device is a physical surgical implant, not an algorithm or software. Standalone algorithm performance is not applicable.
7. The type of ground truth used:
- For the original predicate device (K200311), the ground truth for safety and effectiveness would have been established through a combination of:
- Non-clinical testing: (e.g., mechanical properties, biocompatibility, degradation profiles).
- Animal model studies: (e.g., observation of healing, adhesion formation, tissue response in vivo).
- Literature review and comparison to existing similar devices.
- This 510(k) summary (K203600) states that "The prior non-clinical testing and animal model studies were used to support the modified indications." This implies the same types of ground truth from the predicate were leveraged.
8. The sample size for the training set:
- Not applicable. This device is not an AI model, so there is no concept of a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of medical device.
In summary: This 510(k) submission (K203600) is for a physical surgical implant (VersaWrap) that is identical to an already cleared predicate device (K200311), with minor modifications to the Indications for Use that do not impact its fundamental safety or effectiveness. Therefore, the submission primarily focuses on demonstrating this equivalence and does not present new clinical study data, detailed acceptance criteria, or performance metrics in the way an innovative diagnostic or AI device might. The "study" proving the device meets the (implicit) acceptance criteria is the demonstration of substantial equivalence through comparison to the predicate and leveraging its existing non-clinical and animal model data.
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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
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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. 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) 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) SummaryVersaWrapK203600 | |
|---|---|
| Submitted by: | Alafair Biosciences, Inc.6101 W Courtyard DriveSte. 2-225Austin, TX 78730800.206.5586; info@alafairbiosciences.com |
| Date Prepared: | February 4, 2021 |
| Contact: | Ben Walthall, Ph.D.Chief Regulatory Officer800.206.5586; info@alafairbiosciences.com |
| Trade/Device Name: | VersaWrap Tendon Protector |
| Regulation NumberRegulation Name:Regulatory Class:Product Code: | 21 CFR 878.3300Surgical MeshClass IIFTM |
| Primary Predicate: | K200311 VersaWrap |
| Reference Device: | K201631 VersaWrap |
| Device Description: | VersaWrap® is an absorbable implant (device), designed to serve as an interface betweenthe target tissues and surrounding tissues to provide a non-constricting, protectiveencasement. Versa Wrap consists of a clear Sheet and a wetting Solution. The clear Sheet isa 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 suppliedsterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution isapplied to the Sheet after the Sheet is positioned. The Solution, comprised of aqueouscitrate, is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a doublepeel pouch. |
| Indications for Use: | VersaWrap is indicated for the management and protection of tendon injuries in which therehas been no substantial loss of tendon tissue. The device may also be used in themanagement and protection of surrounding tissues such as skeletal muscle and ligament. |
| ComparativeTechnologyCharacteristics: | VersaWrap is identical to the predicate device. Differences in the indication for use are notcritical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the devicebecause the differences do not affect the safety and effectiveness of the device when used aslabeled. |
| Non-Clinical TestsPerformed: | No additional testing was conducted. The prior non-clinical testing and animal modelstudies were used to support the modified indications. |
| Conclusion | Conclusion(s) drawn from the nonclinical tests demonstrate that the device is as safe, aseffective, and performs as well as or better than the identified legally marketed device. |
§ 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.