COLLAGEN TENDON SHEET-DDI (CTS-DDI)

K140300 · Rotation Medical, Inc. · OWY · Mar 26, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140300
• Device Name: COLLAGEN TENDON SHEET-DDI (CTS-DDI)
• Applicant: Rotation Medical, Inc.
• Product Code: OWY · General, Plastic Surgery
• Decision Date: Mar 26, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Resorbable type I collagen matrix; provides protective layer between injured tendon and surrounding tissue during healing. Supplied sterile, non-pyrogenic, single-use; packaged in cartridge for arthroscopic delivery via Rotation Medical Delivery Instrument. Used by surgeons in clinical settings to manage tendon injuries. Device acts as physical barrier; facilitates healing. Benefits patient by protecting tendon site.

Clinical Evidence

Bench testing only. No clinical data. Testing included suture pull-out, hydrothermal transition temperature, endotoxin testing, biocompatibility, and simulated use/mechanical integrity of the cartridge assembly per ISO 10993-1 and FDA surgical mesh guidance.

Technological Characteristics

Resorbable type I collagen matrix; porous, soft, pliable, nonfriable sheet. Provided sterile in dual tray-in-tray configuration. Packaging includes cartridge for arthroscopic delivery. Tested per ISO 10993-1 and FDA Blue Book Memorandum G95-1.

Indications for Use

Indicated for management and protection of tendon injuries without substantial loss of tendon tissue.

Regulatory Classification

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.

Predicate Devices

• Collagen Tendon Sheet-D (K122048)

Submission Summary (Full Text)

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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 100<br>Plymouth, MN 55447 |
| Telephone: | 763-746-7502 |
| Fax: | 763-746-7501 |
| Contact Person: | Jeff Sims<br>Vice 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

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.

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Image /page/1/Picture/2 description: The image shows the logo for Rotation Medical. The logo consists of a semi-circle of dots, with the top dot being white, the second dot being gray, and the rest of the dots being black. Below the semi-circle of dots is the word "rotation" in a sans-serif font, with a line underneath it. Below the line is the word "MEDICAL" in a smaller sans-serif font.

#### 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 [phone] or [phone] 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 [phone] or [phone] 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'

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