TRULENE MESH

K060018 · Sutures India Pvt., Ltd. · FTL · Jul 26, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060018
• Device Name: TRULENE MESH
• Applicant: Sutures India Pvt., Ltd.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jul 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Trulene mesh may be used for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Story

Trulene Mesh is a nonabsorbable, knitted polypropylene surgical mesh; used for hernia repair and fascial deficiency reinforcement. Device acts as a bridging or reinforcing material to support tissue during surgical repair. Intended for single-use; sterilized via ethylene oxide (E.O.). Operated by surgeons in clinical/OR settings. Provides mechanical support to fascial defects; benefits patient by reinforcing weakened tissue areas to achieve desired surgical outcomes.

Clinical Evidence

Bench testing only. Comparative analysis of physical and mechanical properties (thickness, density, pore size, tensile strength, burst strength, tear resistance, suture pull-out strength) against predicate devices demonstrates equivalence. Biocompatibility testing performed per ISO-10993.

Technological Characteristics

Material: Undyed monofilament polypropylene (synthetic linear polyolefin). Construction: Knitted mesh. Physical specs: Thickness 0.44-0.46 mm; Density 95 g/sqm; Pore size 22-23 pores/inch. Mechanical properties: Tensile strength 14.0-16.0 Kgf; Burst strength 12.0-13.0 Kg/sq.cm; Tear resistance 5.0-6.5 Kgf. Sterilization: Ethylene Oxide (E.O.).

Indications for Use

Indicated for hernia repair and fascial deficiencies requiring reinforcing or bridging material.

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

• Nonabsorbable Polypropylene Surgical Mesh (K905655)
• Minimesh (K041632)

Submission Summary (Full Text)

{0}------------------------------------------------

# JUL 26 2006

K060018

1/4

#### SECTION NO: 3.0 PAGE NO: - 3.0-1

# 510 (k) SUMMARY OF INFORMATIONS, AS REQUIRED BY 21 CFR 807,92 REGARDING PERFORMANCE, SAFETY AND EFFECTIVENESS UPON WHICH AN EQUIVALENCE DETERMINATION CAN BE MADE.

## A. APPLICANT INFORMATION

| Name of the Manufacturer | : SUTURES INDIA PVT.LTD. |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Address | : 472 D, 13 th Cross, 4 th Phase,<br>Peenya Industrial Area,<br>Bangalore 560058, India. |
| Phone Number<br>Fax Number | : 91-80-41868000 to 8030 (30 lines)<br>: 91-80-41171056 |
| E.Mail<br>Web Address | : [e-mail]<br>: www.suturesin.com |
| B. OFFICIAL CORRESPONDENT: L.G.Chandrasekhar<br>Managing Director | |
| C. DEVICE NAME | |

| Trade Name | : <b>TRULENE MESH</b> |
|---------------------|---------------------------------------------|
| Common Name | : Nonabsorbable Polypropylene Surgical Mesh |
| Classification Name | : Mesh Surgical Polymeric |

# D. PREDICATE DEVICES:

- (1) Device Name: Nonabsorbable Polypropylene Surgical Mesh 510(k) Number: K 905655
Manufacturer: United States Surgicals, A Division of Tyco Health,

150, Glover Ave, Norwalk CT 06856

- (2) Device Name (Proprietary): Minimesh
Generic / Common Name: Polymeric Surgical Mesh

510 (k) Number : K 041632

Manufacturer: Mpathy Medical Devices Ltd,

150, Aran Hill road, Fairfield, CT 06824 1712

E. REGULATION NUMBER: 878.3300 PRODUCT CODE: FTL

{1}------------------------------------------------

#### SECTION NO: 3.0 PAGE NO: - 3.0-2

K060018

2/ பு

## E. DESCRIPTION OF THE DEVICE:

Trulene Mesh is Nonabsorbable Polypropylene Surgical Mesh, produced by knitting

filaments of extruded undyed Monofilament Polypropylene, a synthetic linear Poly

olefin.

# F. INTENDED USE OF THE DEVICE:

Trulene mesh may be used for the repair of hernia and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

# COMPARISON TABLE SUTURES INDIA'S "TRULENE MESH" NONABSORBABLE SURGICAL MESH (POLYPROPYLENE) TO PREDICATE DEVICES

| Comparison items | Sutures<br>India | United States<br>Surgicals. | MPathy<br>Surgical |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------------------|---------------------------|
| Raw Material used:<br>Undyed Monofilament Nonabsorbable<br>polypropylene, flexible thread prepared from<br>long-chain polyolefin polymer known as<br>Polypropylene . | Same | Same | Same |
| U.S.P. Size of the Polypropylene thread<br>Diameter of the raw material (Metric Size) | 5-0<br>0.1 to<br>0.149 mm | Same | Same |
| Knot Pull Tensile Strength of raw material | NLT 0.5<br>Kgf | Same | Same |
| Linear Tensile Strength of raw material | 0.75 +/<br>0.05 Kgf | Same | Same |
| Trulene mesh may be used for the repair of<br>hernia and other fascial deficiencies that<br>require the addition of a reinforcing or<br>bridging material to obtain the desired<br>surgical result. | Same | Same | Same |
| Comparison items | Sutures<br>India | Ethicon | U.S.Surgicals |
| Trulene Polypropylene Nonabsorbable<br>Surgical Mesh is supplied for single use only | Same | Same | Same |
| Trulene Polypropylene Nonabsorbable<br>Surgical Mesh is sterilized by E.O. method | Same | Same | Same |
| Trulene<br>Polypropylene<br>Nonabsorbable<br>Surgical Mesh is packed in the same or<br>equivalent manner, and has the same or<br>equivalent labeling claims as the predicate<br>devices including indications,<br>warnings.<br>cautions and precautions | Same | Same | Same |
| Thickness of the Trulene Mesh is | 0.44 -<br>0.46 mm | approximately<br>the same | approximately<br>the same |
| Density of the Trulene Mesh is | 95 Gram<br>per<br>Sq. Meter | approximately<br>the same | approximately<br>the same |
| Pore Size of the Trulene Mesh: | 22 to 23<br>Pores per<br>inch | approximately<br>the same | approximately<br>the same |
| Tensile Strength of Trulene Mesh: | 14.0 to<br>16.0 Kgf | approximately<br>the same | approximately<br>the same |
| Burst Strength of Trulene Mesh: | 12.0 to<br>13.0<br>Kg/S.Cm | approximately<br>the same | approximately<br>the same |
| Tear resistance of Trulene Mesh | 5.0 to 6.5<br>Kgf | approximately<br>the same | approximately<br>the same |
| Suture Pull out Strength | 6.25 to<br>7.5 Kgf | approximately<br>the same | approximately<br>the same |
| Trulene Polypropylene Nonabsorbable<br>Surgical Mesh is biologically compatible<br>when tested as per ISO-10993 standards | Same | Same | Same |

{2}------------------------------------------------

#### SECTION NO: 3.0 PAGE NO: - 3.0-3

.

{3}------------------------------------------------

K060018

4/4

#### SECTION NO: 3.0 PAGE NO: - 3.0-4

### CONCLUSION

Trulene Polypropylene Nonabsorbable surgical Mesh is composed of the same material, as are the predicate devices and has similar knit design, as do the predicate devices. The mesh is manufactured in a manner typical of the industry and equivalent to abat to produce the predicate devices.

Testing of Trulene Mesh and the substantially equivalent devices for the parameters, viz, Thickness, Density, Pore Size, Burst Strength, Tensile Strength, Tear Resistance, cleanliness, Sterility requirements demonstrates that "TRULENE" Polypropylede Nonabsorbable surgical suture meets or exceeds the requirements and are equivalent in terms of the above mentioned predicate devices.

L.G.Chandrasekhar Managing Director

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 2006

Sutures India Pvt. Ltd. % L.G. Chandrasekhar Managing Director 472-D, 13th Cross, 4th Phase Peenya Industria Area Bangalore - 560 058 India

Re: K060018

Trade/Device Name: TRULENE MESH Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: June 14, 2006 Received: June 19, 2006

Dear L.G. Chandrasekhar:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such 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 vour 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): good manufacturing practice requirements as set

{5}------------------------------------------------

Page 2 – L.G. Chandrasekhar

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permitts your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincerely yours,

Halen Lemmer
Mark N. Muller

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

{6}------------------------------------------------

KOGOOIS

### INDICATIONS FOR USE

510(K) No. : K 060018

: TRULENE MESH DEVICE NAME NONABSORBABLE POLYPROPYLENE SURGICAL MESH

## INDICATIONS FOR USE:

TRULENE MESH, NONABSORBABLE POLYPROPYLENE SURGICAL MESH IS INDICATED FOR USE IN HERNIA REPAIR AND OTHER FASCIAL DEFICIENCIES THAT REQUIRE THE ADDITION OF A REINFORCING OR BRIDGING MATERIAL TO OBTAIN THE DESIRED SURGICAL RESULT.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <span style="text-align:center;"><b>✓</b></span> | AND / OR | Over -The - Counter Use<br>(21 CFR 801 Subpart C) |
|-------------------------------------------------|--------------------------------------------------|----------|---------------------------------------------------|
|-------------------------------------------------|--------------------------------------------------|----------|---------------------------------------------------|

Concurrence of CDRH, Office of Device Evaluation (ODE)

*(Division Sign-Off)*

Division of General, Restorative, Page 1 of 1
and Neurological Devices

| 510(k) Number | K060018 |
|---------------|---------|
|---------------|---------|