TRULON™ Non-absorbable Polyamide Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

Device Description

TRULON Nonabsorbable Polyamide Surgical Suture is a nonabsorbable, sterile, flexible monofilament thread composed of long chain aliphatic polymers Nylon 6 and Nylon 6.6. The suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture. The suture may be dyed Logwood Extract, C.175290 conforming to 21 CFR 73.1410. The suture may be provided with or without a standard needle attached.

AI/ML Overview

The provided document is a 510(k) premarket notification for a non-absorbable polyamide surgical suture (TRULON™). It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding study design and performance metrics for an AI/device will not be available in this type of document.

The document describes the device, its intended use, and then compares it to two predicate devices, highlighting similarities in material, design, manufacturing, sterilization, labeling, and performance requirements as defined by the United States Pharmacopeia (USP).

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with reported numerical device performance in the format typically seen for novel device performance studies. Instead, it states that the device "meets or exceeds USP specifications" for various properties, implying that USP standards serve as the acceptance criteria.

Acceptance Criteria (USP 26 Specifications)	Reported Device Performance (TRULON™)
Extractable color	Meets or exceeds USP specifications
Diameter (<861>)	Meets or exceeds USP specifications
Tensile strength (<881>)	Meets or exceeds USP specifications
Needle attachment strength (<871>)	Meets or exceeds USP specifications
Sterility	Meets or exceeds USP specifications
Finished suture Length Requirement (95% of stated label length)	Meets or exceeds USP specifications

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The document refers to testing performed to USP 26 methods, but the specific sample sizes for these tests are not quantified. The data provenance is also not specified; it is assumed to be from internal testing conducted by SUTURES INDIA PVT.LTD.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided. This document is for a physical medical device (suture) and not an AI or diagnostic device that requires expert-established ground truth for performance evaluation. The "ground truth" here is defined by physical and chemical properties and performance standards outlined in the USP.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant for studies involving human interpretation or subjective assessments, which are not part of the described testing for a surgical suture.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. This document is for a surgical suture, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This document is for a surgical suture, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for demonstrating compliance is based on United States Pharmacopeia (USP) standards and specifications for non-absorbable surgical sutures. This includes objective measurements of physical and chemical properties.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Training sets are relevant for machine learning algorithms, not for physical medical devices like sutures.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. See point 8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes several tests performed on the TRULON™ Non-absorbable Polyamide Surgical Suture to demonstrate its equivalence to predicate devices and compliance with established standards.

Study Type: The study is not a clinical trial or a typical "performance study" in the context of an AI or diagnostic device. Instead, it's a series of bench tests and material characterization performed according to the methods outlined in United States Pharmacopeia (USP) 26.
Objective: To demonstrate that the TRULON™ suture "meets or exceeds USP specifications" for various critical properties and is substantially equivalent to legally marketed predicate devices.
Tests Performed:
- Suture Diameter: Tested according to USP 26, method <861>.
- Suture Length: Tested according to USP 26, ensuring 95% of stated label length.
- Knot Pull Tensile Strength: Tested according to USP 26, method <881>.
- Extractable Color: Tested according to USP 26.
- Needle Attachment Strength: Tested according to USP 26, method <871>.
- Sterility: Tested according to USP 26.
- Biocompatibility: Tested as per ISO 10993 standards. (Note: Specific ISO 10993 tests and results are not detailed, but conformance is stated).
Result: The conclusion states that the testing "demonstrates Sutures India TRULON Nonabsorbable Polyamide Surgical suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned predicate devices."

The document serves as a 510(k) summary, which is essentially a declaration and summary of evidence supporting substantial equivalence, rather than a detailed report of a formal performance study with raw data and statistical analysis.

Summary

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KO41510

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SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NONABSORBABLE POLYAMIDE SURGICAL SUTURE

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510K SUMMARY as required by: 21CFR 807.92

A. APPLICANT INFORMATION

Name

: SUTURES INDIA PVT. LTD

: Sutures India Pvt. Ltd. 118, 3rd Phase, Peenya Industrial Address Arca, Bangalore-560058. India

: 91-80-28395150 / 28370367 / 28377856 PH.NO. :91-80-28392280. FAX NO

E mail	: sutures@vsnl.com
Web address	: www.suturesin.com
B. Contact Person	: L.G.Chandrasekhar
	: MANAGING DIRECTOR

: May 07,2004 C. Date Prepared

D. DEVICE TRADE NAME

Trade Name	: TRULON
------------	----------

: Nonabsorbable Surgical Suture,U.S.P. Common name (Monofilament Polyamide)

Classification Name : Nonabsorbable Polyamide Surgical Suture .

E. PREDICATE DEVICES

Nylon Nonabsorbable Surgical Suture, 510(k) Number K001173, C.P.Medical, . Portland, OR 97232.
Nylon Nonabsorbable Surgical Suture, 510(k) Number K960327. R.K.Medical . L.L.C, Danbury, CT 06810

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F. DESCRIPTION OF THE DEVICE

TRULON Nonabsorbable Polyamide Surgical Suture is a nonabsorbable, sterile, flexible TKOLON Tronaosoroable Feed of long chain aliphatic polymers Nylon 6 and Nylon 6.6. Monomathen Intead Composed Suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture . Nonabsorbable (0.5.1 ) monograph requee may be dyed Logwood Extract, C.175290 conforming to I oryannae Surgieur Strare may 2017 CFR 73.1410 . The suture may be provided with or without a standard needle attached.

G. INTENDED USE OF THE DEVICE

Suture India TRULON Nonabsorbable Ployamide Surgical suture, is indicated for use in soft tissue approximation and/ or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

COMPARISON TABLE SUTURES INDIA'S "TRULON" POLYAMIDE NONABSORBABLE SURGICAL SUTURE TO PREDICATE DEVICES

Comparison items	SuturesIndia Pvt.Ltd	C.P.Medical	R.K.Medical
Nonabsorbable Polyamide surgical suture isa nonabsorbable, sterile, flexiblemonofilament thread composed of long chainaliphatic polymers Nylon 6 and Nylon 6.6.	Same	Same	Same
The sutures are inert, noncollageneous andnonantigenic.	Same	Same	Same
Nonabsorbable Polyamide surgical suture isavailable dyed with logwood extract	Same	Similar	Similar
Nonabsorbable Polyamide surgical suture isoffered uncoated	Same	Coated oruncoated	Coated oruncoated
Nonabsorbable Polyamide suture is indicatedfor use in soft tissue approximation and/ orligation, including use in cardiovascular,ophthalmic and neurological procedures.	Same	Same	Same
Comparison items	SuturesIndia Pvt.1.td	C.P.Medical	R.K.Medical
Nnonabsorbable sterile Polyamide sutureis supplied for single use only.	Same	Same	Same
Nnonabsorbable sterile Polyamide sutureis sterilized by EO method	Same	Same	Same
Nnonabsorbable sterile Polyamide sutureis packaged in the same or equivalentmanner, and has the same or equivalentlabeling claims as the predicate devicesincluding indications, warnings, cautionsand precautions	Same	Same	Same
Nnonabsorbable sterile Polyamide suturemeets the Official Monograph of theUnited States Pharmacopeia currentedition USP26 for extractable color.	Same	Same	Same
Finished suture material meets theperformance requirements defined in theUnited States Pharmacopeia currentedition USP26 for Diameter<861>	Same	Same	Same
Finished suture material meets theperformance requirements defined in theUnited States Pharmacopeia currentedition USP26 for Tensile strength<881>	Same	Same	Same
Finished suture material meets theperformance requirements defined in theUnited States Pharmacopeiacurrentedition USP26 forNeedleattachment<871>	Same	Same	Same
Finished suture material meets theperformance requirements defined in theUnited States Pharmacopeiacurrentedition USP26 for Sterility	Same	Same	Same
Finished suture material meets theperformance requirements defined in theUnited States Pharmacopeia currentedition USP26 for Finish suture LengthRequirement (95% of stated label length)	Same	Same	Same
Comparison items	SuturesIndia Pvt.Ltd	C.P.Medical	R.K.Medical
Finished suture material packaged in asame or equivalent manner with sterilesingle or double packing having labelingconforming to 21CFR and USP 26	Same	Same	Same
Nonabsorbable Polyamide Surgicalsuture is biologically compatible whentested as per ISO-10993	Same	Same	Same

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CONCLUSION

Suture India TRULON Nonabsorbable Polyamide Surgical suture is composed of the same material, as are the predicated devices and has the same design, as do the predicate devices. The suture is manufactured in a manner typical of the industry and equivalent to that used to produce predicate devices. Further the subject device is offered with the same colorant Logwood extract at a concentration that conforms to the requirements of Title 21 CFR & 73.1410 or similar FDA approved color, as are of the predicate devices.

Testing of suture diameter, suture length, knot pull tensite strength, extractable color and needle attachment strength and sterility to methods outlined in USP 26 demonstrates Sutures India TRULON Nonabsorbable Polyamide Surgical suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned predicate devices.

Datz

L.G.Chandrasekhar Managing Director

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circle around the eagle.

JUN 2 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. L.G. Chandrasekhar Managing Director Sutures India Private Limited 472 D, 13th Cross, 4th Phase Peenya Industrial Area. Bangalore 560058, India

Re: K041510

Trade/Device Name: TRULON™ Non-absorbable Polyamide Surgical Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: II Product Code: GAR Dated: May 3. 2005 Received: May 6, 2005

Dear Mr. 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, 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 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 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); good manufacturing practice requirements as set 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.

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Page 2- Mr. L.G. Chandrasekhar

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, permits 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours.

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K041510

Device Name: TRULON™ Non-absorbable Polyamide Surgical Suture

Indications For Use:

TRULON™ Non-absorbable Polyamide Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

Prescription Use _ _ _ _ x_

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Elen

tive
rological Devices
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Regulation Number and Section

§ 878.5020 Nonabsorbable polyamide surgical suture.

(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.