(121 days)
K0080452
Not Found
No
The device description and performance studies focus on the material properties and biological interactions of a collagen matrix, with no mention of AI/ML algorithms or data processing.
No.
The device description and intended use indicate it is a resorbable collagen matrix for managing and protecting tendon injuries by providing a physical layer, rather than actively treating or alleviating a disease or condition through non-physical means.
No
The device description and intended use clearly state that it is a resorbable collagen matrix for managing and protecting tendon injuries, acting as a physical layer, not detecting or diagnosing conditions.
No
The device description clearly states it is a "resorbable type I collagen matrix" and a "collagen sheet," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "management and protection of tendon injuries." This describes a therapeutic or protective function applied directly to the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a "resorbable type I collagen matrix" that is applied as a "layer between the tendon and the surrounding tissue." This is a physical barrier and support, not a diagnostic reagent or instrument.
- Lack of Diagnostic Function: There is no mention of analyzing samples (blood, tissue, etc.) or providing diagnostic information about a patient's health status.
- Performance Studies: The studies described focus on material properties, biocompatibility, and animal efficacy, which are typical for implantable or therapeutic devices, not IVDs.
IVDs are devices used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
FTM
Device Description
Collagen Tendon Sheet is a resorbable type I collagen matrix that provides a layer of collagen over injured tendons. Collagen Tendon Sheet is designed to provide a layer between the tendon and the surrounding tissue. When hydrated, Collagen Tendon Sheet is an easy-to-use, soft, pliable, nonfriable, porous collagen sheet. Collagen Tendon Sheet is provided sterile, non-pyrogenic, for single use only, in a variety of sizes, in double peel packages.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tendon
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The substantial equivalence of the Collagen Tendon Sheet and its predicate was demonstrated primarily based on in vitro characterization studies, biocompatibility studies, an animal efficacy study, and clinical experience of the predicate device. In vitro characterization studies included evaluation of material properties, biological properties, chemical and physical properties.
Collagen Tendon Sheets have been evaluated in a number of in vitro and in vivo tests to assess its safety/biocompatibility. The device passed all applicable FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.
An animal efficacy study was conducted to evaluate the device as compared to its predicate device. No clinical tests were performed on the product; however clinical history of the predicate device was referenced in the submission.
Viral inactivation studies were performed to ensure the viral safety of the product.
The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, as well as the animal efficacy study show that Collagen Tendon Sheet is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K0080452
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
K112423 > | of 2
Image /page/0/Picture/1 description: The image shows the logo for Rotation Medical. The logo consists of a circular arrangement of dots above the word "rotation" in a stylized font. Below "rotation" is the word "MEDICAL" in a smaller, sans-serif font.
DEC 2 2 2011
510(k) Summary
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 August 22, 2011/November 14, 2011/December 13, 2011
Date Prepared/Revised:
Name of Device
Device Common Name: Device Trade Name: Device Classification Name:
Tendon Protector Collagen Tendon Sheet Mesh, Surgical 878.3300 Class II FTM
Legally Marketed Devices to Which Substantial Equivalence is Claimed
Predicate Device(s):
Collagen Tendon Wrap. K0080452 Collagen Matrix, Inc., Oakland, NJ
Description of the Device
Collagen Tendon Sheet is a resorbable type I collagen matrix that provides a layer of collagen over injured tendons. Collagen Tendon Sheet is designed to provide a layer between the tendon and the surrounding tissue. When hydrated, Collagen Tendon Sheet is an easy-to-use, soft, pliable, nonfriable, porous collagen sheet. Collagen Tendon Sheet 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.
1
Summary/Comparison of Technical Characteristics
Collagen Tendon Sheet and its predicate device have the same technological characteristics. In particular, Collagen Tendon Sheet and its predicate are the same with respect to intended use, design, material characterization. The substantial equivalence of the Collagen Tendon Sheet and its predicate was demonstrated primarily based on in vitro characterization studies, biocompatibility studies, an animal efficacy study, and clinical experience of the predicate device. In vitro characterization studies included evaluation of material properties, biological properties, chemical and physical properties.
The Collagen Tendon Sheet and its predicate device are manufactured with similar processing, in the same facilities, by the same manufacturer, using the same raw materials. They vary with respect to size and thickness. In addition, the Collagen Tendon sheet is provided in a flat form.
Collagen Tendon Sheet and its predicate have been characterized for chemical composition, purity, density, and strength to demonstrate substantial equivalence. Testing was conducted in accordance to FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh.
Collagen Tendon Sheets have been evaluated in a number of in vitro and in vivo tests to assess its safety/biocompatibility. The device passed all applicable FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.
An animal efficacy study was conducted to evaluate the device as compared to its predicate device. No clinical tests were performed on the product; however clinical history of the predicate device was referenced in the submission.
Viral inactivation studies were performed to ensure the viral safety of the product.
Conclusion of Non-clinical Studies
The results of the in vitro product characterization studies, in vitro and in vivo biocompatibility studies, as well as the animal efficacy study show that Collagen Tendon Sheet is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing health, services, and people. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 2 2011
Rotation Medical, Incorporated % Mr. Jeff Sims Vice President, Clinical Programs and Regulatory Affairs 15350 25th Avenue North, Suite 100 Plymouth, Minnesota 55447
Re: K112423
Trade/Device Name: Collagen Tendon Sheet Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: December 16, 2011 Received: December 16, 2011
Dear Mr. Sim:
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
3
Page 2 - Mr. Jeff Sims
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Clice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rice related duverse oversion (21 CFR Part 820); and if applicable, the electronic forth in the quand on 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 n you dosire specific ad 100 500 your PDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misoranding 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 Tou may 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/Resourcesfor You/Industry/default.htm.
Sincerely vor
For
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Confidential Rotation Medical, Inc.
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: __Collagen Tendon Sheet
Indications for 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.
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 Keane for MKM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112423
Page 1 of _1