(122 days)
The VersaWrap Tendon Protector 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 is a 510(k) summary for the VersaWrap Tendon Protector. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria in the way typically expected for an AI/CADe device.
This document is for a medical device (a tendon protector), not an AI/CADe system. Therefore, many of the requested categories (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable or described in the context of this type of device submission.
Here's a breakdown of the information that can be extracted, and what is missing based on the request:
1. Table of acceptance criteria and reported device performance:
The document describes "Functional and Safety Testing" and "Non-Clinical Tests Submitted." However, it presents these as categories of tests performed rather than specific quantitative acceptance criteria with corresponding reported performance values. For instance, it mentions "Puncture strength" but does not provide a target value for puncture strength or the measured value for the VersaWrap.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional & Performance Requirements | Device design met functional and performance requirements (general statement) |
| Visual Inspection | Performed |
| Dimensional & Weight Measurements | Performed |
| Puncture Strength | Performed (no specific value or criteria given) |
| Handling | Performed (no specific criteria given) |
| Tissue Adherence and Conformance | Performed (no specific criteria given) |
| Chicken Flexor Tendon Repair Model | Performed (no specific criteria or results given) |
| Biocompatibility (ISO 10993 standards) | |
| Non-cytotoxic | Demonstrated |
| Non-pyrogenic | Demonstrated |
| Non-irritating | Demonstrated |
| Non-sensitizing | Demonstrated |
| Non-toxic | Demonstrated |
| Non-genotoxic | Demonstrated |
| Subchronic toxicity (13 weeks) | Performed (no specific criteria or results given) |
| Muscle implantation toxicity/irritation | Performed (no specific criteria or results given) |
| Protective Interface Function | Alginate-glycosaminoglycan matrix provides a protective interface to improve mobility of repaired tendons (demonstrated by physical testing and animal studies) |
Missing: Specific, quantifiable acceptance criteria (e.g., "puncture strength > X Newtons") and the direct numerical results demonstrating the device met those criteria.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of this device. The tests mentioned are bench testing and animal studies, not a "test set" of patient data for an algorithm.
- Data Provenance: The document mentions "animal studies" (specifically, a "Chicken flexor tendon repair model"). No country of origin is specified for these studies. The studies are non-clinical, not retrospective or prospective patient data.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
Not applicable in the context of this device. The ground truth for device performance is established via physical and chemical testing, and observations in animal models, not by expert consensus on clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This concept applies to expert review of clinical cases, not the physical testing of a medical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a physical tendon protector, not an AI or CADe system intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used:
The ground truth for the performance claims would be:
- Physical properties: Measured values from bench tests (e.g., puncture strength, dimensions).
- Biocompatibility standards: Results against defined ISO 10993 criteria.
- Animal study observations: Outcomes from the "Chicken flexor tendon repair model" (e.g., improved mobility, protective interface functionality).
8. The sample size for the training set:
Not applicable. This device does not have a "training set" in the sense of machine learning.
9. How the ground truth for the training set was established:
Not applicable.
In summary: The provided document is a regulatory submission for a physical medical device. It details functional, safety, and biocompatibility testing designed to demonstrate substantial equivalence to a predicate device. It does not contain the types of information (e.g., quantitative acceptance criteria for image analysis performance, clinical test set details, expert ground truth, AI/CADe study methodologies) typically requested for an AI/CADe device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three overlapping shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2016
Alafair Biosciences Inc. Ben Walthall, Ph.D. Chief Regulatory Officer 3925 W. Braker Lane, Floor #3 Austin, Texas 78759
Re: K160364
Trade/Device Name: Versawrap Tendon Protector Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWW Dated: May 9, 2016 Received: May 11, 2016
Dear Dr. Walthall:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160364
Device Name VersaWrap Tendon Protector
Indications for Use (Describe)
The VersaWrap Tendon Protector 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 Submitted by: Alafair Biosciences Incorporated 3925 West Braker Lane, Third Floor Austin, Texas 78759 Telephone: 512-430-4967 Ben Walthall, Ph.D. Contact: Chief Regulatory Officer Date prepared: May 9, 2016 Name of the device: Proprietary Name: VersaWrap™ Tendon Protector Common Name: Tendon Protector Class II Regulation Number: 21 CFR 878.3300 Product Code: OWW Review Panel: General & Plastic Surgery VersaWrap™ Tendon Protector (VersaWrap) is substantially Predicate Device: equivalent in construction, function and intended use to Integra Lifesciences Corporation's Tendon Wrap™ Tendon Protector (Tendon Wrap), K053655. 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 under, around. or over the injured placement 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.
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| Principle ofOperation: | The mechanism of action of VersaWrap is to protect tendon bykeeping damaged tissues physically separated during healing. |
|---|---|
| Functional andSafety Testing: | To verify that device design met functional and performancerequirements, representative samples of the device underwentbench testing in accordance to applicable standards and guidance.These data provide an acceptable assurance of the safety andeffectiveness of VersaWrap and demonstrate that the device isequivalent to the predicate.Biocompatibility studies have demonstrated that VersaWrap isnon-cytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-toxic, and non-genotoxic. Results of physical testing and animalstudies have demonstrated that the VersaWrap alginate-glycosaminoglycan matrix provides a protective interface toimprove mobility of repaired tendons. |
| ComparativeTechnologyCharacteristics: | A comparison of the characteristics of the proposed device and thepredicate device shows VersaWrap to have the same technologicalcharacteristics to the predicate that has received 510(k) clearance.Equivalence is based upon intended use, indications for use,operating principle and fundamental scientific technology.Both devices are intended for the management and protection oftendon injuries. Minor differences in technological characteristicsdo not raise different questions of safety and effectiveness. |
| Non-Clinical TestsSubmitted | The following tests were performed to support substantialequivalence. Performance Testing, including: Visual inspection Dimensional and weight measurements Puncture strength Handling Tissue adherence and conformance Chicken flexor tendon repair model Biocompatibility Testing, including: Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Irritation - Intracutaneous Reactivity (ISO10993-10) Acute Systemic Toxicity (ISO10993-11) Pyrogenicity (ISO 10993-11) Genotoxicity (ISO 10993-3) |
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- Subchronic toxicity (13 weeks, ISO 10993-11 and ISO . 10993-6)
- Muscle implantation toxicity/irritation (ISO 10993-6) .
Conclusion: Alafair considers VersaWrap to be equivalent to the predicate device. This conclusion is based upon the fact that the devices have an equivalent intended use, and there are no differences that raise new types of questions of safety and effectiveness.
§ 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.