TIGR SURGICAL MESH , MODEL WK-6

K092224 · Novus Scientific Pte, Ltd. · FTL · Jan 25, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K092224
• Device Name: TIGR SURGICAL MESH , MODEL WK-6
• Applicant: Novus Scientific Pte, Ltd.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jan 25, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

TIGR Matrix Surgical Mesh is intended for use in reinforcement of soft tissue where weakness exists.

Device Story

TIGR Matrix Surgical Mesh is a knitted, synthetic, resorbable surgical mesh. It consists of two fiber types with different degradation profiles: 40% by weight is a copolymer of polyglycolide, polylactide, and polytrimethylene carbonate (functional life ~2 weeks; fully absorbed ~4 months); 60% by weight is a copolymer of polylactide and polytrimethylene carbonate (functional life ~9 months; fully absorbed ~36 months). Both fibers degrade via bulk hydrolysis. The device is used by surgeons for soft tissue reinforcement. It provides mechanical support during the healing process and is gradually absorbed by the body, eliminating the long-term presence of permanent foreign material.

Clinical Evidence

No human clinical data provided. Effectiveness was demonstrated via an in vivo study in a sheep hernia repair model comparing the subject device to Prolene Mesh. Results indicated equivalent performance regarding tissue integration and local tolerance. Biocompatibility and safety were evaluated in accordance with ISO 10993 and 21 CFR Part 58 (GLP), confirming the device is non-toxic, non-mutagenic, non-sensitizing, and biocompatible.

Technological Characteristics

Knitted synthetic resorbable mesh. Materials: Copolymer of polyglycolide, polylactide, and polytrimethylene carbonate (40%); copolymer of polylactide and polytrimethylene carbonate (60%). Degradation mechanism: Bulk hydrolysis. Performance metrics: Mesh thickness, density, pore diameter, suture retention strength, tear strength, and burst strength. Biocompatibility testing per ISO 10993.

Indications for Use

Indicated for reinforcement of soft tissue where weakness exists in patients requiring surgical mesh repair.

Regulatory Classification

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.

Predicate Devices

• Prolene Mesh (K001122)
• Mersilene Mesh (K851086)
• Ultrapro Mesh (K033337)

Submission Summary (Full Text)

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K092224

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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 [phone] 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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K092224

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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 [phone] or [phone] 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:

K092224

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