(29 days)
VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
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.
The provided text describes a 510(k) premarket notification for the VersaWrap Tendon Protector, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data (such as a multi-reader multi-case comparative effectiveness study or a standalone algorithm-only performance study) with detailed acceptance criteria and performance metrics typically associated with AI/software-as-a-medical-device.
Therefore, much of the requested information regarding acceptance criteria, study design for performance evaluation (test set, training set, ground truth, expert involvement), and comparative effectiveness is not typically found in a 510(k) summary for a physical implantable device.
However, based on the provided text, I can infer the following:
1. A table of acceptance criteria and the reported device performance:
The document indicates that "Functional and Safety Testing" was performed to verify that the device design met functional and performance requirements. The specific type of testing mentioned is "dimensional/visual inspection." While explicit acceptance criteria and corresponding performance results are not detailed in a quantitative table within this document, the implication of the 510(k) clearance is that these tests passed, demonstrating equivalence to the predicate.
| Acceptance Criteria Category | Reported Device Performance (Implied) |
|---|---|
| Functional Requirements | Met requirements |
| Performance Requirements | Met requirements |
| Dimensional/Visual | Met specifications |
| Safety | Demonstrated to be safe |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "representative samples of the device underwent bench testing." It does not specify the exact sample size for these bench tests, the country of origin of the data, or whether it was retrospective or prospective. Given it's bench testing, it refers to product samples rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This type of information is not relevant or provided in a 510(k) for a physical implantable device like the VersaWrap Tendon Protector. "Ground truth" established by experts is typically for diagnostic devices or AI algorithms that interpret medical images or data. The "acceptance criteria" here relate to the physical and functional properties of the device itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for the type of device and testing described. Adjudication methods are typically used in clinical studies or performance evaluations involving human interpretation of data, often with AI.
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. An MRMC comparative effectiveness study is not mentioned. This type of study is primarily for diagnostic devices, particularly those involving AI in image interpretation. The VersaWrap Tendon Protector is an implantable surgical mesh.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This concept is for AI/software devices. The VersaWrap Tendon Protector is an absorbable implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this device, "ground truth" would relate to whether the device physically performs as intended (e.g., integrity, dimensions, sterility, biocompatibility) rather than a diagnostic 'truth'. The text doesn't specify the exact type of "ground truth" but implies that the device's physical and functional properties were evaluated against predefined specifications and requirements.
8. The sample size for the training set:
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. There is no mention of a "training set" or corresponding ground truth establishment process for this device.
Summary of the Study (as described in the 510(k) summary):
The regulatory submission for the VersaWrap Tendon Protector focused on demonstrating substantial equivalence to a predicate device (K160364 VersaWrap® Tendon Protector). This process primarily involves showing that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness.
The study mentioned is bench testing to verify that the device design met functional and performance requirements. This included "dimensional/visual inspection." The conclusion of the submission is that the subject device is equivalent to the predicate device based on equivalent intended use and no technological differences that raise new safety and effectiveness questions. The document does not provide details on the methodology, specific quantitative results, or acceptance criteria for these bench tests beyond their general purpose.
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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) SummaryVersaWrap® Tendon ProtectorK200311 | ||
|---|---|---|
| Submittedby: | Alafair Biosciences, Inc.6101 W Courtyard DriveSte. 2-225Austin, TX 78730800.206.5586; info@alafairbiosciences.com | |
| DatePrepared: | March 6, 2020 | |
| Contact: | Ben Walthall, Ph.D.Chief Regulatory Officer800.206.5586; info@alafairbiosciences.com | |
| ProductName | VersaWrap® Tendon Protector | |
| CommonName | Tendon Protector | |
| Classificationnumber | 21 CFR 878.3300 | |
| Product Code | FTM | |
| PredicateDevice: | K160364 VersaWrap® Tendon Protector | |
| DeviceDescription: | VersaWrap is an absorbable implant (device), designed to serve as an interfacebetween the tendon and tendon sheath or the surrounding tissues, whichprovides a non-constricting, protective encasement for injured tendons.VersaWrap consists of a Sheet and a Wetting Solution. The Sheet is a thinmembrane of crosslinked calcium alginate and glycosaminoglycan.VersaWrap Sheet is easy to handle, conformable, and is designed for easyplacement under, around, or over the injured tendon. VersaWrap Sheet issupplied sterile, non-pyrogenic, for single use, in double peel pouches. TheVersaWrap Solution is applied to the Sheet after the Sheet is positioned ontodamaged tissue. The Solution is comprised of aqueous citrate and is providedin a dropper packaged in a double peel pouch. The Solution is sterile, non-pyrogenic, and is intended for single use only. | |
| Indicationsfor Use: | VersaWrap is indicated for the management and protection of tendon injuriesin which there has been no substantial loss of tendon tissue. | |
| Functionaland SafetyTesting: | To verify that device design met functional and performance requirements,representative samples of the device underwent bench testing. Testingincluded dimensional/visual inspection | |
| Conclusion | Alafair considers the subject device to be equivalent to the predicate device.This conclusion is based upon the fact that the devices have an equivalentintended use and that there are no technological differences that raise newtypes 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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§ 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.