Who is the manufacturer of TRULENE MESH?

Sutures India Pvt., Ltd. filed the 510(k) submission for TRULENE MESH (K060018).

What is the FDA product code for TRULENE MESH?

FTL. It is classified under 21 CFR 878.3300 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for TRULENE MESH?

510(k) clearance (submission type: Traditional).

What are the predicate devices for TRULENE MESH?

Nonabsorbable Polypropylene Surgical Mesh (K905655); Minimesh (K041632).

Who can help prepare an FDA 510(k) submission like TRULENE MESH?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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)

Related Devices

K043081 — GORE POLYPROPYLENE HERNIA MESH · W. L. Gore & Associates, Inc. · Dec 22, 2004
K163152 — PROLENE Soft Polypropylene Mesh · ETHICON, Inc. · Mar 11, 2017
K061704 — OPTILENE MESH · Aesculap, Inc. · Jul 19, 2006
K963141 — KUGEL HERNIA PATCH · Douglas Bueschel · Oct 11, 1996
K223218 — Parietene Macroporous Mesh · Sofradim Production · Dec 2, 2022

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, Peenya Industrial Area, Bangalore 560058, India. | | Phone Number Fax Number | : 91-80-41868000 to 8030 (30 lines) : 91-80-41171056 | | E.Mail Web Address | : sutures@suturesin.com : www.suturesin.com | | B. OFFICIAL CORRESPONDENT: L.G.Chandrasekhar Managing Director | | | C. DEVICE NAME | | | Trade Name | : TRULENE MESH | |---------------------|---------------------------------------------| | 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 India | United States Surgicals. | MPathy Surgical | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------------------|---------------------------| | Raw Material used: Undyed Monofilament Nonabsorbable polypropylene, flexible thread prepared from long-chain polyolefin polymer known as Polypropylene . | Same | Same | Same | | U.S.P. Size of the Polypropylene thread Diameter of the raw material (Metric Size) | 5-0 0.1 to 0.149 mm | Same | Same | | Knot Pull Tensile Strength of raw material | NLT 0.5 Kgf | Same | Same | | Linear Tensile Strength of raw material | 0.75 +/ 0.05 Kgf | Same | Same | | 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. | Same | Same | Same | | Comparison items | Sutures India | Ethicon | U.S.Surgicals | | Trulene Polypropylene Nonabsorbable Surgical Mesh is supplied for single use only | Same | Same | Same | | Trulene Polypropylene Nonabsorbable Surgical Mesh is sterilized by E.O. method | Same | Same | Same | | Trulene Polypropylene Nonabsorbable Surgical Mesh is packed in the same or equivalent manner, and has the same or equivalent labeling claims as the predicate devices including indications, warnings. cautions and precautions | Same | Same | Same | | Thickness of the Trulene Mesh is | 0.44 - 0.46 mm | approximately the same | approximately the same | | Density of the Trulene Mesh is | 95 Gram per Sq. Meter | approximately the same | approximately the same | | Pore Size of the Trulene Mesh: | 22 to 23 Pores per inch | approximately the same | approximately the same | | Tensile Strength of Trulene Mesh: | 14.0 to 16.0 Kgf | approximately the same | approximately the same | | Burst Strength of Trulene Mesh: | 12.0 to 13.0 Kg/S.Cm | approximately the same | approximately the same | | Tear resistance of Trulene Mesh | 5.0 to 6.5 Kgf | approximately the same | approximately the same | | Suture Pull out Strength | 6.25 to 7.5 Kgf | approximately the same | approximately the same | | Trulene Polypropylene Nonabsorbable Surgical Mesh is biologically compatible 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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 (Part 21 CFR 801 Subpart D) | ✓ | AND / OR | Over -The - Counter Use (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 | |---------------|---------| |---------------|---------|