(184 days)
Not Found
No
The summary describes a passive collagen patch for tissue reinforcement and does not mention any computational or analytical capabilities.
Yes
The device is intended for the reinforcement of soft tissues during rotator cuff repair surgery, which directly addresses a medical condition to improve health.
No
Explanation: The device, Collagen Repair Patch, is described as intended for "reinforcement of soft tissues" and to "provide a scaffold," not for diagnosing conditions.
No
The device description and performance studies clearly indicate a physical implantable device (Collagen Repair Patch) and not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Collagen Repair Patch is for the "reinforcement of soft tissues which are repaired by sutures or suture anchors, during rotator cuff repair surgery." This describes a device used in vivo (within the body) during a surgical procedure to support tissue repair.
- 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. The Collagen Repair Patch does not perform any such testing.
- Device Description (though not found): While the description is missing, the intended use and the nature of a "patch" for tissue repair strongly suggest a physical implant used during surgery, not a diagnostic test.
- Lack of Diagnostic Information: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Collagen Repair Patch is a surgical implant intended for tissue repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Zimmer® Collagen Repair Patch is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during rotator cuff repair surgery.
Zimmer® Collagen Repair Patch is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Zimmer® Collagen Repair Patch reinforces soft tissue and provides a scaffold that is eventually incorporated into the patients own soft tissue.
Product codes
FTM
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, rotator cuff
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
Biocompatibility and bench studies have been completed and support the safety and effectiveness of Zimmer® Collagen Repair Patch for its intended use.
The biocompatibility test results show that the material used in the design and manufacture of the devices are non-toxic and non-sensitizing to biological tissues consistent with their intended use. Test results demonstrate that the materials chosen and the design utilized in manufacturing the Zimmer® Collagen Repair Patch will meet the established specification necessary for consistent performance during its intended use.
Key Metrics
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
JUN 2 3 2006
V2
510(k) SUMMARY
Tissue Science Laboratories, plc Zimmer® Collagen Repair Patch
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Angela L. Bunn, RAC Tissue Science Laboratories, plc 1141 Clark Street Covington, Georgia 30014 USA Tel: (678) 342 - 7808 Fax: (678) 342 - 7844 Email: abunn@tissuescience.com
Angela L. Bunn, RAC Contact Person:
14th June 2006 Date Prepared:
Name of Device and Name/Address of Sponsor
Tissue Science Laboratories, plc 7th Floor, Victoria House Victoria Road Aldreshot Hampshire GU11 1 EJ United Kingdom
Trade Name
Zimmer® Collagen Repair Patch
Common or Usual Name
Surgical Mesh
Classification Name
Surgical Mesh
Predicate Devices
1
- Tissue Science Laboratories, plc, Permacol® Surgical Implant . (K021056)
- DePuy, Inc., Restore® Orthobiologic Soft Tissue Implant (K031969) .
- Organogenesis, Inc., CuffPatch™ (K042809) .
Intended Use
Zimmer® Collagen Repair Patch is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during rotator cuff repair surgery.
Zimmer® Collagen Repair Patch is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Zimmer® Collagen Repair Patch reinforces soft tissue and provides a scaffold that is eventually incorporated into the patients own soft tissue.
Technological Characteristics and Substantial Equivalence
Zimmer® Collagen Repair Patch is substantially equivalent to the predicate devices because it has the same intended use and very similar technological characteristics.
Performance Data
Biocompatibility and bench studies have been completed and support the safety and effectiveness of Zimmer® Collagen Repair Patch for its intended use.
The biocompatibility test results show that the material used in the design and manufacture of the devices are non-toxic and non-sensitizing to biological tissues consistent with their intended use. Test results demonstrate that the materials chosen and the design utilized in manufacturing the Zimmer® Collagen Repair Patch will meet the established specification necessary for consistent performance during its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that form the body, wings, and tail feathers. The text is in all caps and is evenly spaced around the circle.
Public Health Service
FEB 26 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Covidien % Ms. Angela L. Bunn, RAC Associate Manager 60 Middletown Avenue North Haven, Connecticut 06473
Re: K053562
Trade/Device Name: Collagen Repair Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: April 24, 2006 Received: April 25, 2006
Dear Ms. Bunn:
This letter corrects our substantially equivalent letter of June 23, 2006.
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 (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 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 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.
3
Page 2 - Ms. Angela L. Bunn, RAC
This letter will allow you to continue 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 v contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html.
Sincerely yours
Mark N.Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Collagen Repair Patch
Indication for Use:
Collagen Repair Patch is intended for the reinforcement of soft tissues which are repaired by sutures or suture anchors, during rotator cuff repair surgery. Collagen Repair Patch is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator cuff repair. Collagen Repair Patch reinforces soft tissue and provides a scaffold that is eventually incorporated into the patients own soft tissue.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pete Numan
Division Sign-
Division of General, Restorative, and Neurological Devices
Number 14053562