(186 days)
Not Found
No
The summary describes a synthetic surgical mesh and its material properties and performance in animal studies, with no mention of AI or ML.
No.
The device is a surgical mesh primarily used for reinforcement of soft tissue, not for providing therapy or treatment as its main function. It physically reinforces weak tissue by providing structural support.
No
Explanation: This device is a surgical mesh primarily used for the "reinforcement of soft tissue where weakness exists," which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a surgical mesh knitted from synthetic resorbable fibers, indicating it is a physical implantable device, 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 "reinforcement of soft tissue where weakness exists." This describes a surgical implant used directly on the patient's body for structural support.
- Device Description: The description details a surgical mesh made of synthetic resorbable fibers. This is consistent with a surgical implant, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are specifically designed to be used in vitro (in glass, or outside the living organism) to analyze samples from the human body. This device is clearly intended for in vivo (in the living organism) use.
N/A
Intended Use / Indications for Use
TIGR Matrix Surgical Mesh is intended for use in reinforcement of soft tissue where weakness exists.
TIGR™ Matrix Surgical Mesh is indicated for use in reinforcement of soft tissue where weakness exists.
Product codes (comma separated list FDA assigned to the subject device)
FTL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, abdominal wall
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)
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.
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.
Prolene Mesh (K001122), Mersilene Mesh (K851086), Ultrapro Mesh (K033337)
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
Page 1 of 2
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
1
Page 2 of 2
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.
2
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
3
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
4
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