(180 days)
Collagen Tendon Sheet-D is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Collagen Tendon Sheet-D is a resorbable type I collagen matrix that provides a layer of collagen over injured tendons. Collagen Tendon Sheet-D is designed to provide a layer between the tendon and the surrounding tissue. When hydrated, Collagen Tendon Sheet-D is an easy-to-use, soft, pliable, nonfriable, porous collagen sheet. Collagen Tendon Sheet-D is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, in double peel packages.
This 510(k) summary (K122048) describes the Collagen Tendon Sheet-D, a resorbable type I collagen matrix. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Collagen Tendon Sheet, K112423) through a comparison of technical characteristics and non-clinical studies. There is no information provided about a clinical study involving human participants, AI, or specific performance metrics like sensitivity, specificity, or accuracy for a device that relies on such evaluation.
Therefore, the following information is not available in the provided document:
- A table of acceptance criteria and reported device performance related to clinical outcomes.
- Sample size used for a test set (as no clinical test set for performance evaluation is described).
- Data provenance for a clinical test set.
- Number of experts used to establish ground truth.
- Qualifications of experts.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Effect size of human readers with AI vs. without AI.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How the ground truth for the training set was established.
Based on the provided document, the device met the acceptance criteria by demonstrating substantial equivalence to a legally marketed predicate device through non-clinical studies.
Here's the relevant information that is available:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety/Biocompatibility: | |
| Cytotoxicity (agarose overlay, liquid and extract methods) | Passed |
| Pyrogenicity | Passed |
| Systemic toxicity | Passed |
| Hemolysis | Passed |
| Genotoxicity (bacterial and mammalian mutation, chromosomal aberration) | Passed |
| Intracutaneous reactivity | Passed |
| Muscle implantation tissue response tests | Passed |
| Compliance with FDA Blue Book Memorandum G95-1 and ISO 10993-1 | Device passed all applicable testing. |
| Material Characterization: | |
| Chemical composition and purity (SDS-PAGE analysis, collagen typing, residual testing, viral inactivation) | Characterized; same as predicate device. |
| Mechanical Characterization: | |
| Density | Characterized; intended to demonstrate substantial equivalence with predicate. |
| Strength | Characterized; intended to demonstrate substantial equivalence with predicate. |
| Stiffness | Characterized; intended to demonstrate substantial equivalence with predicate. |
| Tear resistance | Characterized; intended to demonstrate substantial equivalence with predicate. |
| Compliance with FDA's Guidance for the Preparation of a Premarket Notification for a Surgical Mesh | Testing conducted in accordance with this guidance. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The submission focuses on non-clinical studies (in vitro and in vivo animal studies for biocompatibility, chemical, and mechanical characterization). There is no mention of a clinical test set involving human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth determination by experts is not described as part of this non-clinical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No clinical test set or adjudication process is mentioned.
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:
- No such study was done or reported. This device is a medical implant (collagen matrix), not an AI diagnostic or assistive device, so MRMC studies involving AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No such study was done or reported. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- For biocompatibility: Standardized assay results (e.g., cell viability, toxicity assessments, tissue response).
- For material and mechanical characterization: Laboratory measurements and analytical techniques.
- Not applicable in the context of expert-derived clinical ground truth.
8. The sample size for the training set:
- Not applicable / Not provided. No training set, as this is not an AI/algorithmic device.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. No training set for ground truth establishment.
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Image /page/0/Picture/1 description: The image shows the logo for Rotation Medical. The logo consists of the word "rotation" in a bold, sans-serif font, with the word "MEDICAL" in a smaller, sans-serif font underneath. Above the word "rotation" is a semi-circle of circles.
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510(k) Summary
JAN 0 8 2013
:
Applicant Information
Applicant Name: Applicant Address:
Telephone: Fax: Contact Person: Rotation Medical, Inc. 15350 25th Avenue North, Suite 100 Plymouth, MN 55447 763-746-7502 763-746-7501 Jeff Sims Vice President, Clinical Programs and Regulatory Affairs January 7, 2013
Date Prepared:
Name of Device
Device Common Name: Device Trade Name: -Device Classification Name: Tendon Protector Collagen Tendon Sheet-D Mesh, Surgical 878.3300 Class II FTM
Legally Marketed Devices to Which Substantial Equivalence is Claimed
Predicate Device(s):
Collagen Tendon Sheet, K112423 Rotation Medical, Inc.
Description of the Device
Collagen Tendon Sheet-D is a resorbable type I collagen matrix that provides a layer of collagen over injured tendons. Collagen Tendon Sheet-D is designed to provide a layer between the tendon and the surrounding tissue. When hydrated, Collagen Tendon Sheet-D is an easy-touse, soft, pliable, nonfriable, porous collagen sheet. Collagen Tendon Sheet-D is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, in double peel packages.
Intended Use
Collagen Tendon Sheet 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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Image /page/1/Picture/1 description: The image shows the logo for Rotation Medical. The logo consists of the word "rotation" in a stylized font with a line underneath it. Below the word "rotation" is the word "MEDICAL" in a smaller, sans-serif font. Above the word "rotation" is a semi-circle made of circles.
Summary/Comparison of Technical Characteristics
Collagen Tendon Sheet-D is the same product as its predicate Collagen Tendon Sheet (K112423) in all regards excepting the addition of a small amount of FD&C Blue #2 on the perimeter of the upper surface to provide contrast with surrounding tissue during fixation.
Collagen Tendon Sheet-D has been evaluated in a number of in vitro and in vivo tests to assess its safety/biocompatibility, including: cytotoxicity (agarose overlay, liquid and extract methods), tto ourotyplooompanisms reactivity, systemic toxicity, hemolysis, genotoxicity (bacterial and Schildtion, intraductions routing) , and muscle implantation tissue response tests. The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices.
Collagen Tendon Sheet-D and its predicate share base material that has been characterized for chemical composition and purity using SDS-PAGE analysis, collagen typing, residual testing and viral inactivation (four appropriate viruses selected for assessment). Mechanical characterization included density, strength, stiffness and tear resistance to demonstrate substantial equivalence. Testing was conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification for a Surgical Mesh.
Conclusion of Non-clinical Studies
The results of the in vitro product characterization studies, and in vitro and in vivo biocompatibility studies, demonstrate that Collagen Tendon Sheet-D is substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Rotation Medical, Incorporated % Mr. Jeff Sims Vice President, Clinical Programs and Regulatory Affairs 15350 25th Avenue North, Suite 100 Plymouth, Minnesota 55447
Re: K122048
Trade/Device Name: Collagen Tendon Sheet-D Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM. OWY Dated: December 06, 2012 Received: December 11, 2012
January 8, 2013
Dear Mr. Sims:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Jeff Sims
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm] 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K12-2048
Confidential Rotation Medical, Inc.
Indications for Use
510(k) Number (if known):
Device Name: _ Collagen Tendon Sheet-D
Indications for Use:
Collagen Tendon Sheet-D 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)
Daniel Kime for MXM
(Division Sign-Off)
Division of Sure
510(k) Numb
§ 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.