(51 days)
Not Found
No
The summary describes a collagen tissue matrix for soft tissue reinforcement and focuses on material properties, manufacturing, and performance testing related to biocompatibility and mechanical strength. There is no mention of AI or ML.
Yes.
The device is intended to reinforce soft tissue where weakness exists, specifically for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, which indicates a therapeutic purpose.
No
Explanation: The device is a Collagen Ribbon Tissue Matrix intended to reinforce soft tissue during tendon repair surgery. Its purpose is to physically reinforce tissue, not to diagnose medical conditions or analyze data for diagnostic purposes.
No
The device description clearly states it is a "Collagen Ribbon Tissue Matrix," which is a physical material intended for surgical implantation. The summary discusses manufacturing, sterilization, biocompatibility, and mechanical testing, all related to a physical product, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for reinforcing soft tissue during tendon repair surgery. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a collagen matrix used for surgical reinforcement.
- Lack of IVD Indicators: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The text focuses on its physical application during surgery.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The Collagen Ribbon Tissue Matrix is intended to reinforce soft tissue where weakness exists, specifically, for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, peroneal, posterial tibial, and other tendons. The Collagen Ribbon Tissue Matrix is not intended to replace normal body structure or provide the full mechanical . strength to support tendon repair. Sutures used to repair the tear and suture or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
The subject Collagen Ribbon Tissue Matrix is a narrow, ribbon-like version of the predicate WMT Collagen Dermal Matrix (rebranded BIOTAPE XM® Tissue Matrix - K073219). The ribbon-like dimensions of the subject device allow for new surgical techniques compared to the predicate without changing the intended use-reinforcement of soft tissue in orthopedic applications. The subject Collagen Ribbon is the identical source material to the predicate and is manufactured and sterifized in the same manner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, rotator cuff, patellar, Achilles, biceps, quadriceps, peroneal, posterial tibial, tendons
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)
Due to the similarities of the subject device with the predicate, biocompatibility, animal. histological, and bench testing results from 510(k) K073219 are applicable to this submission. The subject material has passed all biocompatibility testing including: cvtotoxicity, maximization test, intracutaneous reactivity, systemic toxicity implantation (2wk & 13 wk), pyrogenicity, subchronic toxicity & chronic toxicity, carcinogenicity, hemolysis, and genotoxicity. The biocompatibility testing that was previously conducted was in compliance with U.S. Food and Drug Administration regulations set forth in 21 CFR, Part 58. Exempt from Good Laboratory Practice were the characterization and stability of the test article, according to 21 CFR, Parts 58.105 and 58.113. Animal results indicated cellular infiltration and revascularization characteristics. Histology results indicated that the Collagen Ribbon is a decellularized, intact collagen matrix.
A Design Failure Modes and Effects Analysis was used to identify appropriate testing to demonstrate specification conformance for Collagen Ribbon material. Mechanical testing presented in K073219 characterized the suitability of this material in orthopedic applications. Functional and in vivo performance testing confirms that the addition of a second Tyvek barrier to packaging does not alter performance of the material. In addition, mechanical and rehydration testing of Collagen Ribbon demonstrate that Collagen Ribbon maintains the same minimum performance characteristics as the predicate device.
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
FEB 2 3 2012
K120019 Page 1/2
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the Collagen Ribbon Tissue Matrix.
| (a)(1). Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| 5677 Airline Road | |
| Arlington, TN 38002 | |
| Date: | December 29, 2011 |
| Contact Person: | Leslie Fitch |
| Regulatory Affairs Specialist | |
| (901) 867-4120 | |
| (a)(2). Proprietary Name: | Collagen Ribbon Tissue Matrix |
| Common Name: | Animal-derived, surgical mesh |
| Classification Name and Reference: | 21 CFR 878.3300 - Class II |
| Device Product Code and Panel Code: | FTM: Surgical Mesh |
| (a)(3). Predicate Device: | K073219 - WMT Collagen Ribbon |
(a)(4). Device Description
The subject Collagen Ribbon Tissue Matrix is a narrow, ribbon-like version of the predicate WMT Collagen Dermal Matrix (rebranded BIOTAPE XM® Tissue Matrix - K073219). The ribbon-like dimensions of the subject device allow for new surgical techniques compared to the predicate without changing the intended use-reinforcement of soft tissue in orthopedic applications. The subject Collagen Ribbon is the identical source material to the predicate and is manufactured and sterifized in the same manner.
(a)(5). Intended Use
The Collagen Ribbon Tissue Matrix is intended to reinforce soft tissue where weakness exists, specifically, for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, peroneal, posterial tibial, and other tendons. The Collagen Ribbon Tissue Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair. Sutures used to repair the tear and suture or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
The indications for Collagen Ribbon are the same as the legally marketed predicate device with the addition of 2 additional specific tendons. The specific tendons were evaluated for safety and effectiveness through a clinical literature review. A summary of the literature review is provided in the Premarket Notification.
(a)(6). Technological Characteristics Comparison
1
K120019 Page 2/2
The technological characteristics of the Collagen Ribbon Tissue Matrix are substantially equivalent to technological characteristics of the predicate identified in this 510(k) submission. The subject Collagen Ribbon is the identical source material to the predicate and is manufactured and sterilized in the same manner. The ribbon-like dimensions of the subject device allow for new surgical techniques compared to the predicate without changing the intended use-reinforcement of soft tissue in orthopedic applications.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Due to the similarities of the subject device with the predicate, biocompatibility, animal. histological, and bench testing results from 510(k) K073219 are applicable to this submission. The subject material has passed all biocompatibility testing including: cvtotoxicity, maximization test, intracutaneous reactivity, systemic toxicity implantation (2wk & 13 wk), pyrogenicity, subchronic toxicity & chronic toxicity, carcinogenicity, hemolysis, and genotoxicity. The biocompatibility testing that was previously conducted was in compliance with U.S. Food and Drug Administration regulations set forth in 21 CFR, Part 58. Exempt from Good Laboratory Practice were the characterization and stability of the test article, according to 21 CFR, Parts 58.105 and 58.113. Animal results indicated cellular infiltration and revascularization characteristics. Histology results indicated that the Collagen Ribbon is a decellularized, intact collagen matrix.
A Design Failure Modes and Effects Analysis was used to identify appropriate testing to demonstrate specification conformance for Collagen Ribbon material. Mechanical testing presented in K073219 characterized the suitability of this material in orthopedic applications. Functional and in vivo performance testing confirms that the addition of a second Tyvek barrier to packaging does not alter performance of the material. In addition, mechanical and rehydration testing of Collagen Ribbon demonstrate that Collagen Ribbon maintains the same minimum performance characteristics as the predicate device.
(b)(2). Substantial Equivalence - Clinical Evidence
N/A
(b)(3). Substantial Equivalence - Conclusions
The subject Collagen Ribbon is the identical source material to the predicate and is manufactured and sterilized in the same manner. Substantial equivalence is confirmed through tensile and suture retention testing, rehydration testing, and surgical technique validation studies. The data and evidence presented in this Premarket Notification, the subject device maintains the same minimum performance characteristics as the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird with outstretched wings. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-W066-G609 Silver Spring, MD 20993-0002
FEB 2 3 2012
Wright Medical Technology, Inc. % Ms. Leslie Fitch 5677 Airline Road Arlington, Tennessee 38002
Re: K120019
Trade/Device Name: Collagen Ribbon Tissue Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: December 29, 2011 Received: January 03, 2012
Dear Ms. Fitch:
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
3
· Page 2 - Ms. Leslie Fitch
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 de rice related duverse overals) (2) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by events (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 desire spective ad resorted to read on the securities CDRH/CDRHOffices/ucm115809.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 note the regulations 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 overn 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 yours,
Mark McMillan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K120019
Device Name: Collagen Ribbon Tissue Matrix
Indications for Use:
The Collagen Ribbon Tissue Matrix is intended to reinforce soft tissue where weakness exists, specifically, for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, dailing tendon ropan ourgal, posterial tibial, and other tendons. The Collagen Ribbon Tissue Marrix is not intended to replace normal body structure or provide the full mechanical . strength to support tendon repair. Sutures used to repair the tear and suture or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
Daniel Kune lu MXM
(Division Sign-Oil) (Division Sign-O-1). Orthopedic, and Restorative Devices
510(k) Number K120019