(184 days)
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.
Not Found
The provided text describes a 510(k) premarket notification for the Zimmer® Collagen Repair Patch, a surgical mesh intended for reinforcing soft tissues during rotator cuff repair surgery. However, the document does not contain specific acceptance criteria or detailed study results that would enable the construction of the requested table and the comprehensive answers to the questions about a device performance study.
Here's a breakdown of what can be extracted and what information is missing:
Information Present:
- Device Name: Zimmer® Collagen Repair Patch
- Intended Use: Reinforcement of soft tissues repaired by sutures or suture anchors, during rotator cuff repair surgery. It's not intended to replace normal body structure or provide full mechanical strength, but to reinforce soft tissue and provide a scaffold for incorporation into the patient's own tissue.
- Predicate Devices: Permacol® Surgical Implant (K021056), Restore® Orthobiologic Soft Tissue Implant (K031969), CuffPatch™ (K042809).
- Performance Data Mentioned: "Biocompatibility and bench studies have been completed and support the safety and effectiveness of Zimmer® Collagen Repair Patch for its intended use." It states that "biocompatibility test results show that the material... are non-toxic and non-sensitizing..." and "Test results demonstrate that the materials chosen and the design utilized... will meet the established specification necessary for consistent performance during its intended use."
Missing Information Crucial for Your Request:
The document does not provide:
- Specific acceptance criteria (numerical or descriptive targets).
- Reported device performance data (e.g., tensile strength, degradation rate, cell infiltration, etc.) quantified with actual values.
- Sample sizes for any tests mentioned (e.g., number of specimens in bench studies, number of animals in biocompatibility).
- Data provenance (country of origin, retrospective/prospective for any study). The studies mentioned are general "biocompatibility and bench studies."
- Number of experts, their qualifications, or adjudication methods. These generally apply to clinical studies involving human interpretation or pathology, which are not detailed here.
- Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies. These are typically for diagnostic devices, not surgical meshes.
- Information about standalone algorithm performance. This is irrelevant as the device is a physical surgical mesh, not a software algorithm.
- Type of ground truth used. Similarly, this is generally for diagnostic or prognostic algorithms.
- Sample size for training sets. Again, irrelevant for a physical medical device.
- How ground truth for training data was established.
Based on the provided text, I cannot complete the requested tables and answers comprehensively. The document focuses on regulatory submission (510(k) summary) rather than detailed study results.
However, I can structure what is available and highlight the gaps:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state acceptance criteria or specific numerical performance data. The "Performance Data" section makes general statements about meeting specifications. Therefore, this table cannot be filled with concrete values.
| Acceptance Criteria (e.g., Tensile Strength > X MPa, Biocompatibility: Non-cytotoxic) | Reported Device Performance (e.g., Tensile Strength = Y MPa, Biocompatibility: Meets ISO 10993) |
|---|---|
| Not specified in the provided text. | Biocompatibility: Non-toxic, non-sensitizing to biological tissues. Materials and design meet established specifications for consistent performance. |
| (Likely would include mechanical properties, degradation rates, cellular response in vivo/vitro) | (Actual quantitative results for the above are not provided.) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document mentions "biocompatibility and bench studies" but does not give sample sizes for these tests (e.g., number of samples tested for tensile strength, number of animals for in-vivo biocompatibility).
- Data Provenance: Not specified. The studies mentioned ("biocompatibility and bench studies") are not described with details about their origin (e.g., country) or whether they were internal lab studies, external contract studies, etc. They are inherently prospective lab/bench studies in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. This information is typically relevant for studies involving human interpretation of data (e.g., radiologists reading images for an AI device). For a physical medical device like a surgical mesh, "ground truth" would be established by scientific measurements and histological analyses, not by expert consensus in the same way. The document does not discuss any such expert panel for the given studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not specified. As above, this applies to expert reviews, typically for AI or diagnostic device studies.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Zimmer® Collagen Repair Patch is a physical surgical mesh, not an AI or diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This question pertains to AI algorithms. The device is a physical surgical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For "biocompatibility and bench studies," the "ground truth" would implicitly be based on:
- Standardized test methods: (e.g., ISO standards for cytotoxicity, sensitization, irritation).
- Quantitative measurements: (e.g., tensile strength, elongation, burst strength for bench studies).
- Histological assessment: (for tissue response in vivo in biocompatibility studies, typically interpreted by pathologists or toxicologists).
The document does not detail which specific ground truth metrics were used, only that the material was found to be "non-toxic and non-sensitizing" and met "established specifications."
8. The sample size for the training set
Not applicable. There is no "training set" in the context of developing a physical surgical mesh. This term is relevant for machine learning algorithms.
9. How the ground truth for the training set was established
Not applicable, for the same reason as above.
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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
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- 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.
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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.
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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
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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
§ 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.