(167 days)
The TRELLIS Collagen Ribbon 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 TRELLIS Collagen Ribbon 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 subject TRELLIS™ Collagen Ribbon is a narrow, ribbon-like collagen matrix which is identical in material and processing to the predicate WMT Collagen Ribbon (rebranded TRELLISTM Collagen Ribbon - K120019) and includes the sizes of the predicate with an additional thickness offering. The ribbon-like dimensions of the subject device allow for the same surgical techniques as the predicate and the subject has the same intended use-reinforcement of soft tissue in orthopedic applications. The subject TRELLIS™ Collagen Ribbon is the identical source material to the predicate and is manufactured and sterilized in the same manner.
The provided text is a 510(k) summary for the TRELLIS™ Collagen Ribbon. It describes acceptance criteria in terms of performance characteristics. However, it does not describe an AI device, and therefore does not have information related to expert ground truth establishment, sample sizes for training/test sets for AI, or MRMC comparative effectiveness studies.
Here's the information extracted and formatted as requested, with "N/A" for sections not applicable to this non-AI medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Revascularization | No difference from predicate | No difference from predicate |
| Cellular Infiltration | No difference from predicate | No difference from predicate |
| Rehydration Characteristics | Acceptable | Acceptable |
| Tensile Strength | Substantially equivalent to predicate | Substantially equivalent to predicate |
| Suture Retention | Substantially equivalent to predicate | Substantially equivalent to predicate |
Explanation of Acceptance Criteria: The document directly states that "Histology results indicated no difference in revascularization and cellular infiltration for the subject versus the predicate." and "Rehydration, tensile, and suture retention testing... shows acceptable performance characteristics and substantial equivalence to the predicate." This implies that the acceptance criteria for the new device were primarily non-inferiority or substantial equivalence to the predicate device in these specific performance measures.
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated, as this was an animal study and mechanical testing. The document refers to "an animal study" and "tensile, and suture retention testing" without specifying the number of samples or animals.
- Data Provenance: The animal study suggests prospective data collection in an animal model. The country of origin for the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- N/A (This is not an AI device, so ground truth in the context of expert consensus on data interpretation is not applicable here.)
4. Adjudication Method for the Test Set
- N/A (Not an AI device; not applicable for this type of testing.)
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
- N/A (Not an AI device; no human-in-the-loop performance or AI assistance involved.)
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A (Not an AI device; no algorithm performance to evaluate.)
7. The Type of Ground Truth Used
- Animal Histology: For cellular infiltration and revascularization.
- Mechanical Testing Results: For rehydration, tensile strength, and suture retention.
8. The Sample Size for the Training Set
- N/A (Not an AI device; no training set in this context.)
9. How the Ground Truth for the Training Set Was Established
- N/A (Not an AI device; no training set in this context.)
{0}------------------------------------------------
K131143 page 1 of 2
ﺮ ﺍ
、ベ
Create Motion."
Image /page/0/Picture/2 description: The image shows the word "WRIGHT." in bold, sans-serif font. Below the word is a stylized graphic consisting of three horizontal lines that are angled downward and slightly overlap each other. The overall impression is of a logo or brand name.
510(K) SUMMARY
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 510(k) Summary for TRELLIS™ Collagen Ribbon.
(a)(1). Submitted By:
Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002
September 20, 2013
Sarah Holtgrewe, RAC
Date:
OCT 07 2013
Contact Person:
(a)(2). Proprietary Name:
Common Name:
Classification Name and Reference:
Device Product Code, Device Panel:
(a)(3). Predicate Device:
TRELLISTM Collagen Ribbon
Manager, Regulatory Affairs Phone: (901) 867-4476 Fax: (901) 867-4190
Animal-derived, surgical mesh .
21 CFR 878.3300-Class II
OWY: Mesh, Surgical, Collagen, Orthopedic, Reinforcement of Tendon
K120019 - Collagen Ribbon
(a)(4). Device Description
The subject TRELLIS™ Collagen Ribbon is a narrow, ribbon-like collagen matrix which is identical in material and processing to the predicate WMT Collagen Ribbon (rebranded TRELLISTM Collagen Ribbon - K120019) and includes the sizes of the predicate with an additional thickness offering. The ribbon-like dimensions of the subject device allow for the same surgical techniques as the predicate and the subject has the same intended usereinforcement of soft tissue in orthopedic applications. The subject TRELLIS™ Collagen Ribbon is the identical source material to the predicate and is manufactured and sterilized in the same manner.
A3-1
{1}------------------------------------------------
K131143 page 2 of 2
. .
i
Create Motion:
Image /page/1/Picture/2 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word, there are three horizontal lines that appear to be stylized or decorative elements. The overall design is simple and graphic, with a focus on the typography and the arrangement of the lines beneath it.
(a)(5). Intended Use
The TRELLIS™ Collagen Ribbon 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 TRELLIS™ Collagen Ribbon 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 TRELLIS™ are the same as the legally marketed predicate device.
(a)(6). Technological Characteristics Comparison
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 length and width dimensions of both the subject and predicate device allow for the same surgical techniques and intended use-reinforcement of soft tissue in orthopedic applications. The subject includes the thickness of the predicate and an additional thicker size offering.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
An animal study was done to compare the cellular infiltration and revascularization characteristics of the subject 2.1 mm thick product to the predicate 1.3 mm thick product. Histology results indicated no difference in revascularization and cellular infiltration for the subject versus the predicate.
Rehydration, tensile, and suture retention testing of the subject material rehydrated in saline or blood shows acceptable performance characteristics and substantial equivalence to the predicate.
(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 of the thicker size option is confirmed through tensile and suture retention testing, rehydration testing, and animal histology data. The data and evidence presented in this Premarket Notification demonstrate that the subject device maintains the same minimum performance characteristics as the predicate device.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
October 7, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Cantrol Center - WO06-Golby Silver Spring, MD 20993-0002
Wright Medical Technology. Incorporated Ms. Sarah Holterewe Manager, Regulatory Affairs 5677 Airline Road Arlington. Tennessee 38002
Re: K131143
Trade/Device Name: TRELLISTM Collagen Ribbon Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OWY Dated: September 13, 2013 Received: September 23, 2013
Dear Ms. Holtgrewe:
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.
ff 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 device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set
{3}------------------------------------------------
Page 2 - Ms. Sarah Holtgrewe
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson 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
510(k) Number (if known) K131143
Device Name
TRELLIS Collagen Ribbon
Indications for Use (Describe)
The TRELLIS Collagen Ribbon is intended to reinforce soft tissue where weakness exists, specifically, for the reinforcement of soft tissue repaired by suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, peroneal, posterial tibial, and other tendons. The TRELLIS Collogen Ribbon is not intended to replace normal body stracture or provide the full mechanical strength to support tendon repair the tear and subure or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.
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.
A BELL SELL SECTION CAN AND AFOR FDA USE ONLY . I . CHANILL CONLY . I . CULTURE . SEL . ME Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Jiyoung Dang -S
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
§ 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.