Collagen Tendon Sheet-DDI is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Device Description

Collagen Tendon Sheet-DDI is a resorbable type I collagen matrix that provides a layer of collagen over injured tendons. Collagen Tendon Sheet-DDI is designed to provide a layer between the tendon and the surrounding tissue during healing. When hydrated, Collagen Tendon Sheet-DDI is an easy-to-use, soft, pliable, nonfriable, porous collagen sheet. Collagen Tendon Sheet-DDI is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, and is packaged preloaded in a cartridge, for use with the Rotation Medical Delivery Instrument, in a dual sterile seal tray-in-tray configuration.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called "Collagen Tendon Sheet-DDI." This device is a resorbable type I collagen matrix used for the management and protection of tendon injuries. The key aspect of this submission is that the Collagen Tendon Sheet-DDI is substantially equivalent to a previously cleared predicate device, "Collagen Tendon Sheet-D" (K122048). The only difference between the two is the packaging, which has been modified to facilitate arthroscopic delivery.

Therefore, the "study" proving the device meets acceptance criteria is not a clinical trial in the traditional sense, but rather a series of non-clinical performance tests designed to demonstrate that the change in packaging does not adversely affect the device's safety and effectiveness.

Here's the breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Since this submission is based on substantial equivalence due to packaging changes, the acceptance criteria are linked to ensuring the new packaging and delivery system maintain the integrity and functionality of the core collagen sheet. The document highlights specific tests performed.

Acceptance Criteria / Test Performed	Reported Device Performance
Packaging Performance
Suture Pull-Out Testing	Evaluated to confirm performance of the device in new packaging. (Passed implicitly, as no issues were reported).
Hydrothermal Transition Temperature	Evaluated to confirm performance of the device in new packaging. (Passed implicitly, as no issues were reported).
Endotoxin Testing	Evaluated to confirm performance of the device in new packaging. (Passed implicitly, as no issues were reported).
Cartridge Assembly Performance
Biocompatibility	Evaluated for the cartridge assembly itself. (Passed implicitly, as no issues were reported).
Simulated Use	Evaluated for the cartridge assembly itself. (Passed implicitly, as no issues were reported).
Mechanical Integrity	Evaluated for the cartridge assembly itself. (Passed implicitly, as no issues were reported).
Regulatory Compliance
FDA Blue Book Memorandum G95-1	Passed all applicable testing.
ISO 10993-1 (Biological Evaluation)	Passed all applicable testing.
FDA Guidance for Surgical Mesh	Conducted testing in accordance with this guidance. (Passed implicitly, as no issues were reported).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., number of collagen sheets tested for suture pull-out). These tests are typically performed in a laboratory setting, and the data provenance would be internal to the manufacturer (Rotation Medical, Inc. in Plymouth, MN, USA), and would be considered prospective in the sense that the tests were carried out specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable for this submission. The "ground truth" for non-clinical performance tests like suture pull-out or biocompatibility is established by adherence to recognized standards (e.g., ISO, ASTM) and established industry protocols, not by expert consensus in a clinical context. The performance is measured against quantifiable physical or chemical properties, or established biological response endpoints.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpreting subjective outcomes or imaging results where agreement among multiple evaluators is needed to establish a "ground truth." For the non-clinical tests described, the outcomes are objectively measured.

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

This is not applicable. MRMC studies are related to evaluating diagnostic devices, particularly those involving human interpretation (e.g., radiology scans) often in the context of AI assistance. This submission pertains to a surgical mesh and its delivery system, not a diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This device is a physical implant, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical performance tests is based on:

Established engineering principles and material science standards: For tests like suture pull-out strength, hydrothermal transition temperature, and mechanical integrity.
Recognized biocompatibility standards (e.g., ISO 10993): For evaluating the biological safety of the materials.
Sterility and endotoxin limits: For ensuring the safety of the product related to manufacturing processes.

8. The sample size for the training set

This is not applicable. The Collagen Tendon Sheet-DDI is a physical medical device. There is no "training set" in the context of machine learning or AI, as the device's function is mechanical and biological, not based on learned patterns from data.

9. How the ground truth for the training set was established

This is not applicable as there is no training set.

Summary

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pg. 1 of 2 K140300

510(k) Summary

Applicant Information

Applicant Name:	Rotation Medical, Inc.
Applicant Address:	15350 25th Avenue North, Suite 100Plymouth, MN 55447
Telephone:	763-746-7502
Fax:	763-746-7501
Contact Person:	Jeff SimsVice President, Clinical Programs and Regulatory Affairs
Date Prepared:	March 19, 2014

Name of Device

Device Common Name: Device Trade Name: Device Classification Name: Tendon Protector Collagen Tendon Sheet-DDI Mesh, Surgical, Collagen, Orthopaedics, Reinforcement of Tendon 878.3300 Class II OWY ORQ

Secondary Classification Code

Legally Marketed Devices to Which Substantial Equivalence is Claimed

Collagen Tendon Sheet-D, K122048 Predicate Device(s): Rotation Medical, Inc.

Description of the Device

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Intended Use

Collagen Tendon Sheet-DDI 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 Sheet-DDI is exactly the same product as its predicate, Collagen Tendon Sheet-D (K122048) in regard to all aspects of the collagen scaffold. Only the packaging has changed between the current device and the predicate device. Collagen Tendon Sheet-DDI is packaged in a cartridge to facilitate arthroscopic delivery and positioning of the collagen matrix.

Past safety, biocompatibility and mechanical characterization tests of the predicate product are directly applicable to the current product. Additional tests to confirm the performance characteristics of the packaging change were performed. To confirm performance of the device in the new packaging: suture pull-out testing, hydrothermal transition temperature, and endotoxin testing were evaluated. To confirm the performance of the cartridge assembly itself biocompatibility, simulated use and mechanical integrity tests were evaluated.

In summary, the Collagen Tendon Sheet-DDI device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices. Testing was conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh.

Conclusion

The purpose of this 510(k) application was to notify the Food and Drug Administration of proposed modifications to the packaging of the previously cleared Collagen Tendon Sheet-D (K122048). Collagen Tendon Sheet-DDI and Collagen Tendon Sheet-D are exactly the same device excepting their respective packaging. The proposed packaging modifications for the new device raise no new questions regarding safety and effectiveness. Therefore, the proposed Collagen Tendon Sheet-DDI is substantially equivalent to the predicate Collagen Tendon Sheet-D.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 26, 2014

Rotation Medical Incorporated Mr. Jeff Sims Vice President, Clinical Programs and Regulatory Affairs 15350 25th Avenue North, Suite 100 Plymouth, Minnesota 55447

Re: K140300

Trade/Device Name: Collagen Tendon Sheet-DDI Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWY, ORQ Dated: February 3, 2014 Received: February 6, 2014

Dear Mr. Sims:

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. 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

Image /page/2/Picture/11 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design that resembles an abstract eagle or bird in flight, composed of three curved lines.

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Page 2 - Mr. Jeff Sims

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140300

Device Name Collagen Tendon Sheet-DDI

Indications for Use (Describe)

Collagen Tendon Sheet-DDI is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Peter L. Hudson -S 2014.03.25 14:50:46 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete time to review the collection. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Regulation Number and Section

§ 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.