(122 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of the implant and do not mention any computational or data-driven components. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for the management and protection of tendon injuries, providing a protective encasement that improves mobility of repaired tendons, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as an absorbable implant intended for the management and protection of tendon injuries, providing a protective encasement for injured tendons. Its function is to serve as an interface, not to diagnose a condition.
No
The device description clearly states that VersaWrap is an "absorbable implant (device)" consisting of a "Sheet" and a "wetting Solution," which are physical components.
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." 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 around injured tendons. This is a physical device intended for direct interaction with tissue within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VersaWrap Tendon Protector does not fit this description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OWW
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
To verify that device design met functional and performance requirements, representative samples of the device underwent bench testing in accordance to applicable standards and guidance. These data provide an acceptable assurance of the safety and effectiveness of VersaWrap and demonstrate that the device is equivalent to the predicate. Biocompatibility studies have demonstrated that VersaWrap is non-cytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-toxic, and non-genotoxic. Results of physical testing and animal studies have demonstrated that the VersaWrap alginate-glycosaminoglycan matrix provides a protective interface to improve mobility of repaired tendons.
Non-Clinical Tests Submitted:
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)
- Subchronic toxicity (13 weeks, ISO 10993-11 and ISO 10993-6)
- Muscle implantation toxicity/irritation (ISO 10993-6)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/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.
1
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
2
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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3
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 of
Operation: | The mechanism of action of VersaWrap is to protect tendon by
keeping damaged tissues physically separated during healing. |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional and
Safety Testing: | To verify that device design met functional and performance
requirements, representative samples of the device underwent
bench testing in accordance to applicable standards and guidance.
These data provide an acceptable assurance of the safety and
effectiveness of VersaWrap and demonstrate that the device is
equivalent to the predicate.
Biocompatibility studies have demonstrated that VersaWrap is
non-cytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-
toxic, and non-genotoxic. Results of physical testing and animal
studies have demonstrated that the VersaWrap alginate-
glycosaminoglycan matrix provides a protective interface to
improve mobility of repaired tendons. |
| Comparative
Technology
Characteristics: | A comparison of the characteristics of the proposed device and the
predicate device shows VersaWrap to have the same technological
characteristics 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 of
tendon injuries. Minor differences in technological characteristics
do not raise different questions of safety and effectiveness. |
| Non-Clinical Tests
Submitted | The following tests were performed to support substantial
equivalence. 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) |
5
- 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.