(48 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a collagen sheet, with no mention of AI or ML technologies.
Yes
The device is indicated for the "management and protection of tendon injuries," which directly addresses a medical condition or ailment, classifying it as therapeutic.
No
The device description and intended use indicate it is a resorbable collagen matrix for protecting and managing tendon injuries, not for diagnosing conditions.
No
The device description clearly states it is a resorbable type I collagen matrix, which is a physical material, not software. It also mentions being packaged in a cartridge for use with a delivery instrument, further indicating it is a hardware device.
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 within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a resorbable collagen matrix that is placed over injured tendons. This is a physical implant or barrier, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Collagen Tendon Sheet-DDI does not fit this description.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OWY, ORQ
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.
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
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for Rotation Medical. The logo consists of a semi-circle of dots, with the top two dots being white, the next dot being gray, and the rest of the dots being black. Below the dots is the word "rotation" in a sans-serif font, and below that is the word "MEDICAL" in a smaller sans-serif font.
pg. 1 of 2 K140300
510(k) Summary
Applicant Information
| Applicant Name: | Rotation Medical, Inc. |
|---|---|
| Applicant Address: | 15350 25th Avenue North, Suite 100 |
| Plymouth, MN 55447 | |
| Telephone: | 763-746-7502 |
| Fax: | 763-746-7501 |
| Contact Person: | Jeff Sims |
| 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.
1
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.
2
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.
3
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
4
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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