(203 days)
K 905655, K 041632
K 905655, K 041632
No
The description focuses on the material properties and intended use of a surgical mesh, with no mention of AI or ML.
No
The device is a surgical mesh used for hernia repair and other fascial deficiencies, acting as a reinforcing or bridging material. While it aids in a surgical procedure, its primary function is structural support rather than directly treating a disease or condition in a therapeutic manner.
No
Explanation: The device description and intended use clearly state that Trulene Mesh is a surgical mesh used for reinforcing or bridging material in hernia repair and other fascial deficiencies. It performs a structural, not diagnostic, function.
No
The device description clearly states it is a "Nonabsorbable Polypropylene Surgical Mesh," which is a physical, hardware-based implant.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hernia repair and other fascial deficiencies that require the addition of a reinforcing or bridging material". This describes a surgical implant used directly on a patient's body to repair tissue.
- Device Description: The device is a "Nonabsorbable Polypropylene Surgical Mesh". This is a physical material implanted during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVDs are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / 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.
Product codes
FTL
Device Description
Trulene Mesh is Nonabsorbable Polypropylene Surgical Mesh, produced by knitting filaments of extruded undyed Monofilament Polypropylene, a synthetic linear Poly olefin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 905655, K 041632
Reference Device(s)
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
JUL 26 2006
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
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
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 |
|---|---|
| --------------- | --------- |