(86 days)
Not Found
No
The device description and performance studies focus on the material properties and biological interactions of a collagen matrix, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the "management and protection of tendon injuries," which indicates a therapeutic purpose.
No
The device, Collagen Tendon Wrap, is a resorbable matrix designed to encase injured tendons for protection and management, not to diagnose conditions. Its function is to provide physical support and interface, as opposed to identifying or characterizing a disease or injury.
No
The device description clearly states that the device is a "resorbable type I collagen matrix" and a "conformable, porous collagen sheet," indicating it is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Description: The Collagen Tendon Wrap is a physical matrix designed to be surgically placed around an injured tendon. It is a resorbable material that provides a physical barrier and support.
- Intended Use: The intended use is for the "management and protection of tendon injuries," which is a therapeutic and protective function, not a diagnostic one based on analyzing bodily specimens.
The device is a therapeutic device used directly on the patient's tissue, not a diagnostic tool used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
Collagen Tendon Wrap 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)
FTM
Device Description
Collagen Tendon Wrap is a resorbable type I collagen matrix that provides a nonconstricting encasement for injured tendons. Collagen Tendon Wrap is designed to be an interface between the tendon and tendon sheath or the surrounding tissue. When hydrated, Collagen Tendon Wrap is a conformable, porous collagen sheet designed for easy placement under, around or over the injured tendon. Collagen Tendon Wrap is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, in double peel packages.
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
Not Found
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)
Animal studies were conducted to demonstrate the effectiveness of the Collagen Tendon Wrap. The results of the animal studies, in vitro product characterization studies, and in vitro and in vivo biocompatibility studies show that Collagen Tendon Wrap is safe and substantially equivalent to its predicates.
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
K080452 1/2
510(k) Summary of Safety and Effectiveness
MAY 15 2008
| Applicant Name and Address: | Collagen Matrix, Inc.
509 Commerce Street
Franklin Lakes, New Jersey 07417 |
|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peggy Hansen, RAC
Sr. Director, Clinical, Regulatory, and Quality Assurance
Tel: (201) 405-1477
Fax: (201) 405-1355 |
| Date of Summary: | February 15, 2008 |
| Device Common Name: | Tendon Protector |
| Device Trade Name: | Collagen Tendon Wrap |
| Device Classification Name:
Regulation Number:
Device Class:
Product Code: | Mesh, Surgical
878.3300
Class II
FTM |
| Predicate Device(s): | Tendon Wrap™ Tendon Protector, K053655
Integra LifeSciences Corporation, Plainsboro, NJ
Collagen Nerve Wrap, K060952
Collagen Matrix, Inc., Franklin Lakes, NJ |
Description of the Device
Collagen Tendon Wrap is a resorbable type I collagen matrix that provides a nonconstricting encasement for injured tendons. Collagen Tendon Wrap is designed to be an interface between the tendon and tendon sheath or the surrounding tissue. When hydrated, Collagen Tendon Wrap is a conformable, porous collagen sheet designed for easy placement under, around or over the injured tendon. Collagen Tendon Wrap is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, in double peel packages.
Intended Use
Collagen Tendon Wrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Summary/Comparison of Technical Characteristics
Collagen Tendon Wrap and its predicates have the same technological characteristics. In particular, Collagen Tendon Wrap and their predicates are the same with respect to intended use, design, materials, material characterization, form, and sizes.
1
Safety
Collagen Tendon Wrap has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all selected FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.
Effectiveness and Substantial Equivalence
The characteristics of the Collagen Tendon Wrap meet the design requirements for an effective tendon protector. Animal studies were conducted to demonstrate the effectiveness of the Collagen Tendon Wrap.
Conclusion
The results of the animal studies, in vitro product characterization studies, and in vitro and in vivo biocompatibility studies show that Collagen Tendon Wrap is safe and substantially equivalent to its predicates.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing the agency's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2008
Collagen Matrix, Inc. % Ms. Peggy Hansen, RAC Sr. Director, Clinical, Regulatory and Quality Assurance 509 Commerce Street Franklin Lakes, New Jersey 07417
Re: K080452
Trade/Device Name: Collagen Tendon Wrap Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: May 2, 2008 Received: May 5, 2008
Dear Ms. Hansen:
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.
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 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); good manufacturing practice requirements as set
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Page 2 - Ms. Peggy Hansen, RAC
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prostmarlet, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events, (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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lc080452 111
Indications for Use
| 510(k) Number (if known): | K080452 |
|---|---|
| --------------------------- | --------- |
Device Name: Collagen Tendon Wrap
Indications for Use:
Collagen Tendon Wrap 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)
Nil RP Oglin for mkm
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
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510(k) Number K080452