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

Device Description

TRUSH.K is a natural nonabsorbable silk surgical suture, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural Nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for "Nonabsorbable Surgical Suture" . Natural Nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive. It will be available with and with out a standard needle attached.

AI/ML Overview

Here's an analysis of the provided document regarding the acceptance criteria and study for the TRUSILK™ Non-absorbable Silk Surgical Suture:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for TRUSILK™ Natural Nonabsorbable Silk Surgical Suture relies on equivalence testing to predicate devices and adherence to United States Pharmacopeia (USP) specifications. The acceptance criteria essentially are to meet or exceed the performance specified by USP 26 for various characteristics, matching the predicate devices.

Acceptance Criteria (Based on USP 26)	Reported Device Performance (TRUSILK™)
Extractable color (Official Monograph)	Meets Official Monograph of USP 26
Diameter (Performance requirements defined in USP 26 <861>)	Meets performance requirements defined in USP 26 <861>
Tensile strength (Performance requirements defined in USP 26 <881>)	Meets performance requirements defined in USP 26 <881>
Needle attachment (Performance requirements defined in USP 26 <871>)	Meets performance requirements defined in USP 26 <871>
Sterility (Official Monograph)	Meets Official Monograph of USP 26
Suture Length	Meets or exceeds USP specifications
Knot Pull Tensile Strength	Meets or exceeds USP specifications
Needle Attachment Strength	Meets or exceeds USP specifications

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

The document does not explicitly state the specific sample sizes used for testing each of the USP 26 criteria (e.g., how many sutures were tested for diameter, tensile strength, etc.). It only states that the testing was performed, and the device "meets or exceeds USP specifications."

Sample Size: Not explicitly stated for individual tests.
Data Provenance: The device is manufactured by Sutures India Pvt. Ltd. in Bangalore, India. The testing would have been conducted as part of their submission process, presumably at their facilities or a contracted lab. The data is retrospective in the sense that the tests were completed before the submission.

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

This type of information is not relevant or provided in a 510(k) submission for a surgical suture. The "ground truth" for the performance of a surgical suture is established by the well-defined, objective, and quantitative specifications set forth in recognized standards like the United States Pharmacopeia (USP). These standards outline the methods and acceptable ranges for physical and performance characteristics. Therefore, expert consensus in the clinical sense is not used to establish the "ground truth" for these measurements.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is determined by objective, measurable criteria defined in USP standards, not by human interpretation requiring adjudication.

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 submission for a physical medical device (surgical suture), not an AI/software as a medical device. Therefore, no MRMC study involving human readers or AI assistance would have been conducted or is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is not an AI/software device.

7. The Type of Ground Truth Used

The ground truth used for proving the device meets acceptance criteria is based on USP 26 specifications for natural nonabsorbable silk surgical sutures. This includes:

Defined ranges for diameter.
Minimum requirements for tensile strength.
Minimum requirements for needle attachment strength.
Qualitative and quantitative criteria for extractable color and sterility.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."

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

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

Summary

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K0415/4
page 1074

3 2005 JUN

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

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.FAX NO	: 91-80-28395150 / 28370367 / 28377856:91-80-28392280.
E mailWeb address	: sutures@vsnl.com: www.suturesin.com
B. Contact Person	: L.G.Chandrasekhar: MANAGING DIRECTOR
C. Date Prepared	: May 15,2004

D. DEVICE TRADE NAME

. Trade Name : TRUSILK Common name . : Nonabsorbable Surgical Suture, U.S.P.
- (Black Braided Silk)
Classification Name :Natural Nonabsorbable Silk Surgical Suture. .

E. PREDICATI: DEVICES

Silkam Nonabsorbable surgical suture, 510(k) Number K990089, AESCULAP, . South San Fransisco, California.
Silk Nonabsorbable surgical suture, 510(k) Number K960328. R.K.Medical . L.L.C. Danbury , CT06810

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

PAGE NO: -16-2 SECTION NO: 16

F. DESCRIPTION OF THE DEVICE

G. INTENDED USE OF THE DEVICE

Sutures India TRUSH.K Natural nonabsorbable silk suture, is indicated for use in soft tissue approximation and/ or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Comparison items	SuturesIndiaPvt.Ltd	Aesculap	R.K.Medical
Natural Nonabsorbable silk surgical suture isa nonabsorbable, sterile,flexiblemultifilament thread composed of an organicprotein called fibroin. This protein is derivedfrom the domesticated species Bombyx mori(B. mori) of the family Bombycidae.	Same	Same	Same
The sutures are inert, noncollageneous andnonantigenic.	Same	Same	Same
Natural nonabsorbable silk surgical suture isavailable undyed or dyed with logwoodextract	Same	Same	Same
Natural nonabsorbable silk surgical suture isoffered both uncoated, and treated withbiocompatible coatings to enhance itshandling properties.	Same	Same	Same
Natural Nonabsorbable silk suture isindicated for use in soft tissue approximationand/ or ligation, including use incardiovascular, ophthalmic and neurologicalprocedures.	Same	Same	Same
SECTION NO:16	PAGE NO: -16-3
Comparison items	SuturesIndiaPvt.ltd	Aesculap	R.K.Medical
Natural nonabsorbable sterile silk suture issupplied for single use only.	Same	Same	Same
Natural nonabsorbable sterile silk suture issterilized by EO method	Same	Same	Same
Natural nonabsorbable silk suture ispackaged in the same or equivalent manner,and has the same or equivalent labelingclaims as the predicate devices includingindications, warnings, cautions andprecautions	Same	Same	Same
Natural nonabsorbable silk suture meets theOfficial Monograph of the United StatesPharmacopeia current edition USP26 forextractable color	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
Natural nonabsorbable silk suture meets theOfficial Monograph of the United StatesPharmacopcia current edition USP26 forSterility	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
Nonabsorbable Surgical Suture (BraidedSilk Black) is biologically compatible when	Same	Same	Same

COMPARISON TABLE SUTURES INDIA `S "TRUSILK" NATURAL SILK NONABSORBABLE SURGICAL SUTURE TO PREDICATE DEVICES

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K04514
page 3 of 4

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

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K041514 page 494

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

SECTION NO: 16 PAGE NO: - 16-4

CONCLUSION

Sutures India's TRUSILK is Natural Nonabsorbable silk suture, 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, as are of the predicate devices.

Testing of suture diameter, suture length, knot pull tensile strength and needle attachment strength, extractable color and sterility to methods outlined in USP 26 demonstrates Sutures India's TRUSILK, Natural Nonabsorbable silk suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned predicate devices.

Robert F

L.G.Chandrasekhar Managing Director

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping figures suggesting community or support.

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: K041514

Trade/Device Name: TRUSILK™ Non-absorbable Silk Surgical Suture Regulation Number: 21 CFR 878.5030 Regulation Name: Natural nonabsorbable silk surgical suture Regulatory Class: II Product Code: GAP 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 we have teviewed your becalled by (4) personally equivalent (for the indications for use stated in above and nave determined the ad predicate devices marketed in interstate commerce prior to the chelosure) to regary mantowe of the Medical Device Amendments, or to devices that have been May 20, 1770, the chartinent and on the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the do not require upproval or a premails provisions of the Act. The general controls provisions of the device, dolor to the gallery 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 be subject to such 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 that I case or advised that 12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I DA ilas made a deceminations administered by other Federal agencies. You must comply with all the I caral states and regarding, 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) (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) 276-0120 . 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/cdrh/industry/support/index.html.

Sincerely yours,

Signature

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): K041514

Device Name: TRUSILK™ Non-absorbable Silk Surgical Suture

Indications For Use:

TRUSILK" Non-absorbable Silk 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) Page 1 of 1

Regulation Number and Section

§ 878.5030 Natural nonabsorbable silk surgical suture.

(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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.