(186 days)
TIGR™ Matrix Surgical Mesh is indicated for use in reinforcement of soft tissue where weakness exists.
TIGR Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers, possessing different degradation characteristics. The first fiber, making up 40% of the matrix by weight, is a copolymer of polyglycolide, polylactide, and polytrimethylene carbonate. The second fiber, making up 60% of the matrix by weight, is a copolymer of polylactide, and polytrimethylene carbonate. Both fibers degrade by bulk hydrolysis once implanted, resulting in a decreasing strength retention followed by mass loss of the fibers.
The provided text describes a 510(k) summary for the TIGR Matrix Surgical Mesh, which is a medical device. The information is related to demonstrating substantial equivalence to predicate devices, not establishing new performance criteria through a study with acceptance criteria in the typical sense of AI/software performance. Therefore, many of the requested fields are not applicable.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Benchmarking/Equivalence Criteria) | Reported Device Performance |
|---|---|
| Technological Characteristics: | |
| Mesh thickness similar to predicate devices | "TIGR Matrix Surgical Mesh... has similar performance characteristics to the currently marketed predicate devices." |
| Density similar to predicate devices | "TIGR Matrix Surgical Mesh... has similar performance characteristics to the currently marketed predicate devices." |
| Pore diameter similar to predicate devices | "TIGR Matrix Surgical Mesh... has similar performance characteristics to the currently marketed predicate devices." |
| Mesh knit characteristics similar to predicate devices | "TIGR Matrix Surgical Mesh... has similar performance characteristics to the currently marketed predicate devices." |
| Suture retention strength similar to predicate devices | "TIGR Matrix Surgical Mesh... has similar performance characteristics to the currently marketed predicate devices." |
| Tear strength similar to predicate devices | "TIGR Matrix Surgical Mesh... has similar performance characteristics to the currently marketed predicate devices." |
| Burst strength similar to predicate devices | "TIGR Matrix Surgical Mesh... has similar performance characteristics to the currently marketed predicate devices." |
| Biocompatibility and Safety: | |
| Non-toxic | "TIGR Matrix Surgical Mesh is considered to be non-toxic, nonmutagenic, non-sensitizing, biocompatible and safe for its intended use." |
| Non-mutagenic | "TIGR Matrix Surgical Mesh is considered to be non-toxic, nonmutagenic, non-sensitizing, biocompatible and safe for its intended use." |
| Non-sensitizing | "TIGR Matrix Surgical Mesh is considered to be non-toxic, nonmutagenic, non-sensitizing, biocompatible and safe for its intended use." |
| Biocompatible and safe for intended use | "TIGR Matrix Surgical Mesh is considered to be non-toxic, nonmutagenic, non-sensitizing, biocompatible and safe for its intended use." |
| Effectiveness (In Vivo): | |
| Overall performance (tissue integration, local tolerance) equivalent to predicate device | "The overall performance of TIGR Matrix Surgical Mesh, including tissue integration, local tolerance was equivalent to its predicate device [Prolene Mesh]." |
| Absorption of first fiber after 4 months (in vivo) | "in vivo studies in the abdominal wall of sheep showed that the first fiber was fully absorbed after 4 months." |
| Absorption of second fiber after approximately 36 months (in vivo) | "in vivo studies in the abdominal wall of sheep indicated that the second fiber should be absorbed after approximately 36 months." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number. The document mentions "in vivo studies in the abdominal wall of sheep" and "a Sheep hernia repair model." It does not specify the number of sheep used in these studies.
- Data Provenance: Prospective animal studies (sheep). The country of origin is not specified but the submitter is based in Singapore.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable: This type of information is relevant for AI/software performance studies where ground truth is established by human experts (e.g., radiologists interpreting images). For a surgical mesh, the "ground truth" for performance is based on direct observation in animal models and histological analysis, not human expert consensus on interpretations.
4. Adjudication Method for the Test Set
- Not Applicable: Similar to point 3, adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations in diagnostic studies, not for evaluating the direct physical and biological performance of a surgical mesh in an animal model.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: An MRMC comparative effectiveness study is specific to evaluating the impact of a diagnostic AI tool on human reader performance. This device is a surgical mesh, not a diagnostic tool, and the studies performed are direct comparisons in animal models.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable: This concept is for AI algorithms. The device is a surgical mesh, not an algorithm.
7. The Type of Ground Truth Used
- Animal Studies / Histopathology / Direct Observation: The studies described rely on direct observation in live animal models (sheep hernia repair), tissue integration, local tolerance, and potentially histological examination to determine absorption rates and tissue response. Pathology would be involved in analyzing tissue samples.
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" in the context of demonstrating substantial equivalence for a physical medical device like a surgical mesh. This term applies to machine learning models.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set, this question is not relevant.
Summary of Device Performance and Equivalence Claim:
The TIGR Matrix Surgical Mesh demonstrates substantial equivalence to predicate devices (Prolene Mesh, Mersilene Mesh, Ultrapro Mesh) by showing:
- Similar Technological Characteristics: Physical and mechanical properties like mesh thickness, density, pore diameter, knit characteristics, suture retention strength, tear strength, and burst strength are similar to predicates.
- Biocompatibility and Safety: The mesh passed ISO 10993 tests (conducted under 21 CFR, Part 58, Good Laboratory Practices) and was determined to be non-toxic, non-mutagenic, non-sensitizing, biocompatible, and safe.
- Equivalent Effectiveness (In Vivo): In a sheep hernia repair model, the overall performance, including tissue integration and local tolerance, was equivalent to the Prolene Mesh predicate device.
- Degradation/Absorption Profile: The two fibers in the mesh have distinct degradation characteristics, with the first fiber absorbing within 4 months and the second within approximately 36 months in sheep models.
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510(k) Summary
Submitter's Information:
Name: Address:
Phone: Contact Person:
Date of Preparation:
Device Name:
Trade Name: Common Name: Classification Name: Classification Product Code: Regulatory number:
Predicate Device Names:
Novus Scientific Pte Ltd Nordic European Centre, 3 International Business Park #01-20 (S) 609927 +65 68900360 Kelvin Koh
17 July 2009
TIGR Matrix Surgical Mesh Surgical Mesh Mesh. Surgical, Polymeric FTL $878.3300
Prolene Mesh (K001122) Mersilene Mesh (K851086) Ultrapro Mesh (K033337)
Device Description:
TIGR Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers, possessing different degradation characteristics. The first fiber, making up 40% of the matrix by weight, is a copolymer of polyglycolide, polylactide, and polytrimethylene carbonate.
The second fiber, making up 60% of the matrix by weight, is a copolymer of polylactide, and polytrimethylene carbonate. Both fibers degrade by bulk hydrolysis once implanted, resulting in a decreasing strength retention followed by mass loss of the fibers.
Based on the product's absorption characteristics, in vitro testing showed that the first fiber (polyglycolide, polylactide, and polytrimethylene carbonate) loses its functional capabilities after 2 weeks and in vivo studies in the abdominal wall of sheep showed that the first fiber was fully absorbed after 4 months. The same in vitro testing showed that the second fiber (polylactide, and polytrimethylene carbonate) loses its functional capabilities after 9 months and in vivo studies in the abdominal wall of sheep indicated that the second fiber should be absorbed after approximately 36 months.
JAN 9 5 2010
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Intended Use:
TIGR Matrix Surgical Mesh is intended for use in reinforcement of soft tissue where weakness exists.
Technological Characteristics:
The physical and mechanical properties of the TIGR Matrix Surgical Mesh, such as mesh thickness, density, pore diameter, mesh knit characteristics, suture retention strength, tear strength, and burst strength, has similar performance characteristics to the currently marketed predicate devices.
Performance data:
The biocompatibility and safety tests conducted for TIGR Matrix Surgical Mesh were selected in accordance with "ISO 10993, Biological Evaluation of Medical Devices Part I: Evaluation and Testing." All studies were conducted in accordance to 21 CFR, Part 58, Good Laboratory Practices. Based on the results from these studies, TIGR Matrix Surgical Mesh is considered to be non-toxic, nonmutagenic, non-sensitizing, biocompatible and safe for its intended use.
The effectiveness of TIGR Matrix Surgical Mesh was compared in vivo in a Sheep hernia repair model to the Prolene Mesh. The overall performance of TIGR Matrix Surgical Mesh, including tissue integration, local tolerance was equivalent to its predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Novus Scientific, Pte, Ltd. % Mr. Kelvin Koh Nordic European Centre 3 International Business Park #01-20 Singapore 609927
JAN 2 5 2010
Rc: K092224
Trade/Device Name: TIGR Matrix Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh, Polymeric Regulatory Class: Class II Product Code: FTL Dated: November 18, 2009 Received: November 23, 2009
Dear Mr. Koh:
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.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Kelvin Koh
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 go to http://www.fda.gov/AboutFDA/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, "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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millikenn
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K09 2224
Indications for Use
510(k) Number:
Device Name:
TIGR Matrix Surgical Mesh
Indications for Use:
TIGR™ Matrix Surgical Mesh is indicated for use in reinforcement of soft tissue where weakness exists.
X Prescription Use_
(Per 21 CFR 801 Subpart D)
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)
David Kramer for MXM
(Division Sign (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092224
§ 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.