(35 days)
Not Found
No
The device description and performance studies focus on the material properties and biological interaction of the collagen-GAG matrix, with no mention of AI or ML technologies.
No
The device is described as an "absorbable implant" that provides a "protective encasement for injured tendons" to "improve mobility of repaired tendons," but it does not claim to treat, cure, or prevent any disease.
No.
The device is a protective wrap for injured tendons, designed for management and protection, not for diagnosing a condition.
No
The device description explicitly states it is an "absorbable implant (device)" comprised of "cross-linked bovine Type I collagen and glycosaminoglycan (GAG)," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to provide information about a person's health.
- Device Description: The Tendon Wrap is described as an "absorbable implant (device)" that is placed within the body to protect injured tendons. It is a physical barrier and support structure.
- Intended Use: The intended use is for the "management and protection of tendon injuries," which is a therapeutic or supportive function performed in vivo (within the body).
The description clearly indicates that this device is an implant used directly on the injured tendon within the body, not a test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
Tendon Wrap™ 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
FTM
Device Description
Tendon Wrap is an absorbable implant (device) that provides a non-constricting, protective encasement for injured tendons, it is comprised of a porous matrix of cross-linked bovine Type I collagen and glycosaminoglycan (GAG). "Tendon Wrap is designed to serve as an interface between the tendon sheath or the surrounding tissues. Tendon Wrap is an easy to handle, conformable, porous collagen-GAG sheet designed for easy placement under, around or over the injured tendon. Tendon Wrap is supplied sterile, non-pyrogenic, for single use, in double peel packages in a variety of sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tendon
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)
Biocompatibility studies have demonstrated Tendon Protector to be noncytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-toxic, non- genotoxic and non-hemolytic. Results of physical testing, animal studies and clinical experience have demonstrated the Tendon Wrap collagen-glycosaminoglycan matrix provides a protective interface that improves mobility of repaired tendons.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
510(K) SUMMARY
Tendon Wrap™ Tendon Protector
FEB 3 2006
Submitter's name and address:
Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA
Contact person and telephone number:
Diana Bordon Manager, Regulatory Affairs Telephone: (609) 275-0500 (609) 275-9445 Fax:
Date Summary was prepared:
December 29, 2005
Name of the device:
| Proprietary Name: | Tendon Wrap |
|---|---|
| Common Name: | Tendon Protector |
| Classification Name: | Unclassified |
Substantial Equivalence:
Tendon Wrap™ Tendon Protector is substantially equivalent in function and intended use to the following products which have been cleared to market under Premarket Notifications 510(k): NeuraWrap® K041620 Nerve Protector and Medist International Tendon Spacer 510 K 000019.
Device Description:
Tendon Wrap is an absorbable implant (device) that provides a non-constricting, protective encasement for injured tendons, it is comprised of a porous matrix of cross-linked bovine Type I collagen and glycosaminoglycan (GAG). "Tendon Wrap is designed to serve as an interface between the tendon sheath or the surrounding tissues. Tendon Wrap is an easy to handle, conformable, porous collagen-GAG sheet designed for easy placement under, around or over the injured tendon. Tendon Wrap is supplied sterile, non-pyrogenic, for single use, in double peel packages in a variety of sizes.
Intended Use:
Tendon Wrap™ Tendon Protector is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Testing and Test Results:
Biocompatibility studies have demonstrated Tendon Protector to be noncytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-toxic, non- genotoxic and non-hemolytic. Results of physical testing, animal studies and clinical experience have demonstrated the Tendon Wrap collagen-glycosaminoglycan matrix provides a protective interface that improves mobility of repaired tendons.
Conclusion
Tendon Wrap Tendon Protector is safe and effective under the proposed conditions of use, and substantially equivalent to its predicate devices. Safety and efficacy are supported through physician experience with the collagen-glycosaminoglycan matrix, animal testing, biocompatibility, and physical property testing.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of an abstract caduceus, a symbol often associated with healthcare. The caduceus consists of three vertical lines that curve and merge into a single line at the bottom.
FEB 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Diana M. Bordon Manager, Regulatory Affairs Integra LifeSciences Corp. 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K053655
Trade/Device Name: Tendon Wrap™ Tendon Protector Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: December 29, 2005 Received: January 3, 2006
Dear Ms. Bordon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosuly to regars actment date of the Medical Device Amendments, or to continerec prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (71cc) that do novice, subject to the general controls provisions of the Act. The r ou may, mercetore, market are act include requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Eederal 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 or any I vatural the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
2
Page 2 - Ms. Bordon
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Mace Ecturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Muenn
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
053655
Indications for Use
510(k) Number (if known):
Tendon Wrap™ Tendon Protector Device Name:
Indications For Use:
Tendon Wrap™ Tendon Protector is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchund for YAM
storative, Division of Gener and Neurological Devices
Page 1 of 1
510(k) Number 2053655
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