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

Device Description

TRULENE Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene.

The polypropylene surgical suture meets united states pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it is dyed with an FDA approved color additive (Phthalocyaninato (2-) copper); and the suture is provided with a standard needle attached.

AI/ML Overview

The provided document is a 510(k) summary for a surgical suture and does not contain information about a device that uses an algorithm or AI. Therefore, it does not include the specific details requested regarding acceptance criteria, study methodologies, ground truth establishment, or human-in-the-loop performance typical of AI/algorithm-based medical devices.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices for a physical medical product. The "acceptance criteria" can be inferred from the performance requirements outlined in the United States Pharmacopeia (USP) for surgical sutures, and the "study" is a series of tests performed to ensure the device meets these USP specifications.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (USP 26 Specifications)	Reported Device Performance (TRULENE™)
Diameter (<861>)	Meets or exceeds USP specifications
Tensile Strength (<881>)	Meets or exceeds USP specifications
Needle Attachment (<871>)	Meets or exceeds USP specifications
Extractable Color (Official Monograph)	Meets or exceeds USP specifications
Length Requirement (95% of stated label)	Meets or exceeds USP specifications
Biocompatibility	Biologically compatible
Sterility	Sterilized by EO method

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. The document mentions "Testing of suture diameter, suture length, knot pull tensile strength, extractable color, needle attachment strength and sterility." This implies a set of samples was tested for each characteristic, but the exact number is not provided.
Data Provenance: Not explicitly stated. The tests were performed by the manufacturer, Sutures India Pvt. Ltd. The country of origin of the data would be India, where the testing was conducted. The nature of the testing is most likely prospective, as it's part of the pre-market submission for a new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable in the context of this device. The "ground truth" for suture performance is established by the United States Pharmacopeia (USP) specifications and standardized testing methods, not by expert consensus in the typical sense of AI/algorithm evaluation. Regulatory bodies like the FDA then review data demonstrating adherence to these established standards.

4. Adjudication method for the test set:

Not applicable. The "adjudication" in this context is the comparison of test results against predefined USP standards. There isn't a process of expert adjudication of individual test outcomes mentioned beyond the general oversight and review by the manufacturer and, subsequently, the FDA.

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:

Not applicable. This is a physical surgical suture, not an AI/algorithm-based diagnostic or assistive device, so MRMC studies do not apply.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used:

Standardized Specifications/Performance Requirements: The "ground truth" is defined by the performance requirements outlined in the United States Pharmacopeia (USP) current edition (USP 26) for nonabsorbable surgical sutures. This includes specifications for diameter, tensile strength (knot pull), needle attachment, extractable color, and length. Biocompatibility and sterility are also key "ground truths" that must be met.

8. The sample size for the training set:

Not applicable. This is a physical product, not an AI/algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

Summary

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JUN 3 - 2005

SECTION NO: 16 PAGE NO: -16-1

510K SUMMARY as required by: 21CFR 807.92

A. APPLICANT INFORMATION

Name	: SUTURES INDIA PVT. LTD
Address	: Sutures India Pvt. Ltd.118, 3rd Phase, Peenya Industrial Area,Bangalore--560058. India
PH.NO.	: 91-80-28395150 / 28370367 / 28377856
FAX NO	: 91-80-28392280.
E mail	: sutures@vsnl.com
Web address	: www.suturesin.com
B. Contact Person	: L.G.Chandrasekhar: MANAGING DIRECTOR
C. Date Prepared	: May 07,2004

D. DEVICE TRADE NAME

Trade Name . : TRULENE Common name : Nonabsorbable Surgical Suture, U.S.P. . (Monofilament Polypropylene)
. Classification Name : Nonabsorbable Polypropylene Surgical Suture

E. PREDICATE DEVICES

. Polypropylene Nonabsorbable surgical suture, 210(K) Number K001185, C.P.Medical, Portland, OR 97232.
Nonabsorbable surgical ● Polypropylene suture, 510(k) Number K961389. R.K.Medical L.L.C. Danbury, CT 06810

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641511

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K041311

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SECTION NO:16	PAGE NO: -16-2
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F. DESCRIPTION OF THE DEVICE

TRULENE Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene.

G. INTENDED USE OF THE DEVICE

Sutures India TRULENE Polypropylene Nonabsorbable Surgical Suture is indicated for use in soft tissue approximation and / or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Comparison items	SuturesIndia Pvt.Ltd	CP Medical	R.K.Medical
Nonabsorbable polypropylene surgical sutureis a monofilament, nonabsorbable, sterile,flexible thread prepared from long-chainpolyolefin polymer known as polypropylene.	Same	Same	Same
The sutures are inert, noncollageneous andnonantigenic.	Same	Same	Same
Polypropylene Nonabsorbable SurgicalSuture is available undyed or dyed with(Phthalocyaninato (2-) copper)	Same	Same	Same
Polypropylene Nonabsorbable SurgicalSuture may be provided with or without astandard needle attached.	Same	Same	Same
Polypropylene Nonabsorbable SurgicalSuture is indicated for use in soft tissueapproximation and / or ligation, including usein cardiovascular, ophthalmic andneurological procedures.	Same	Same	Same
Comparison items	SuturesIndia Pvt.Ltd	C.P. Medical	R.K.Medical
Polypropylene Nonabsorbable SurgicalSuture is supplied for single use only.	Same	Same	Same
Polypropylene Nonabsorbable SurgicalSuture is sterilized by EO method	Same	Same	Same
Polypropylene Nonabsorbable SurgicalSuture is packaged in the same or equivalentmanner, and has the same or equivalentlabeling claims as the predicate devicesincluding indications, warnings, cautions andprecautions	Same	Same	Same
Finished suture material meets theperformance requirements defined in theUnited States Pharmacopeia current editionUSP26 for Diameter<861>	Same	Same	Same
Finished suture material meets theperformance requirements defined in theUnited States Pharmacopeia current editionUSP26 for Tensile strength<881>	Same	Same	Same
Finished suture material meets theperformance requirements defined in theUnited States Pharmacopeia current editionUSP26 for Needle attachment<871>	Same	Same	Same
Polypropylene Nonabsorbable SurgicalSuture meets the Official Monograph of theUnited States Pharmacopeia current editionUSP26 for Extractable color	Same	Same	Same
Finished suture material meets theperformance requirements defined in theUnited States Pharmacopeia current editionUSP26 for finish suture Length Requirement(95% of stated label length)	Same	Same	Same
Finished suture material packaged in a sameor equivalent manner with sterile single ordouble packing having labeling conformingto 21CFR and USP 26	Same	Same	Same
Polypropylene Nonabsorbable SurgicalSuture is biologically compatible when tested	Same	Same	Same

COMPARISON TABLE SUTURES INDIA "TRULENE" NONABSORBABLE SURGICAL SUTURE (POLYPROPYLENE) TO PREDICATE DEVICES

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K041511

SECTION NO:16

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page 1

PAGE NO: -16-4 SECTION NO: 16

CONCLUSION

Sutures India "TRULENE" Polypropylene nonabsorbable 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 (Phthalocyaninato (2-) copper) at a concentration that conforms to the requirements of Title 21 CFR § 73.8045, as are of the predicate devices.

Testing of suture diameter, suture length, knot pull tensile strength, extractable color, needle attachment strength and sterility to methods outlined in USP 26 demonstrates Sutures India "TRULENE" Polypropylene nonabsorbable surgical suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned predicate devices.

$\rightarrow$ - $\vdash$ $\vdash$

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 the HHS logo, which is a stylized human figure with three arms reaching upwards. The logo is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The seal is black and white.

Public Health Service

3 2005 JUN

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: K041511

Trade/Device Name: TRULENE™ Non-absorbable Polypropylene Surgical Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: May 26, 2005 Received: June 1, 2005

Dear Mr. Chandrasekhar:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclobate) to region) the enactment date of the Medical Device Amendments, or to conimered proc to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, uc vices that have been require approval of a premarket approval application (PMA). and Costlictic 71ct (71ct) that to not requent of the general controls provisions of the Act. The I ou may, mercerere, market the Act include requirements for annual registration, listing of general controls provisions 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 your device is etablineal controls. Existing major regulations affecting your device it may be subject to sach additions, 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 I Teast of advised that I Dris Sussantes over device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I caeral statutes and regarments, including, but not limited to: registration and listing (21 Comply with an the Her Frequirements)01); good manufacturing practice requirements as set Of I latt 0077, adoning (21 CFR Part 820); and if applicable, the electronic form in the quality byocally (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) I mis iction will and w you'ls cognifiading of substantial equivalence of your device to a legally prematics notification - The sults 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 If you desire specific durile for your aco) 276-0115 . Also, please note the regulation entitled, eonider and of Crise of Cremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/cdrh/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): K041511

Device Name: TRULENE™ Non-absorbable Polypropylene Surgical Suture

Indications For Use:

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

Prescription Use

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)

f
Neurological Devices
Restorative

Page 1 of 1

Regulation Number and Section

§ 878.5010 Nonabsorbable polypropylene surgical suture.

(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene 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 undyed or dyed with an FDA approved color additive; and 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.