TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture is indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures

Device Description

Absorbable Surgical Suture,Synthetic (Polyglycolic Acid)

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device: "TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture."

This document is a regulatory approval letter from the FDA, a 510(k) summary, and an indications for use statement. It does NOT contain information about acceptance criteria, a specific study proving device performance against acceptance criteria, or any details regarding sample sizes, ground truth, expert qualifications, or MRMC studies.

The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices based on the information provided in the 510(k) submission. This substantial equivalence is typically established by demonstrating that the new device has the same intended use, technological characteristics, and performance as a predicate device, or that any differences do not raise new questions of safety or effectiveness.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text. The document focuses on regulatory approval based on equivalence, not on a detailed clinical or performance study with defined acceptance criteria in the way you've described.

Summary

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JUN - 6 2005

Food and Drug Administration 9200 CorporateBoulevard 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: K041515

Trade/Device Name: TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(glycolide/L-lactide) Surgical Suture Regulatory Class: II Product Code: GAM Dated: March 17, 2005 Received: March 21, 2005

Dear Mr. Chandrasekhar:

This letter corrects our substantially equivalent letter of April 8, 2005 regarding the trade name.

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) 276-0120 . 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,

R.C.K

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): K041515

TRUGLYDE Absorbable Polyglycolic Acid Surgical Suture Device Name:

Indications For Use:

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)

Concurreace of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative
Neurological Devices

K041515

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APR 8 2005

SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR ABSORBABLE POLYGLYCOLIC ACID SUTURE

SECTION NO: 17 PAGE NO: -17-1

1041515

510K SUMMARY as required by: 21CFR 807.92

A. APPLICANT INFORMATION

Name	: SUTURES INDIA PVT. LTD
Address	: 472 D 13 th Cross, 4 th Phase,Peenya Industrial Area,Bangalore-560058. India
PHONE NO.	: 91-80-51272102 / 51272103 / 51272104
FAX NO.	: 91-80-51171056
E mail	: sutures@vsnl.com
Web Address	: www.suturesin com
B. Contact Person	: L.G.Chandrasekhar
	: MANAGING DIRECTOR
C. Date Prepared	: May 15,2004

D. DEVICE TRADE NAME

: TRUGLYDE Trade Name .
: Absorbable Surgical Suture,Synthetic (Polyglycolic Acid) . Common name
Classification Name: Absorbable (poly glycolic acid) suture .

E. PREDICATE DEVICES

Maxon Absorbable Polyglycolic acid Suture, 510(k) Number K990951, . United States Surgical Corporation, Norwalk, CT 06856
Surgisorb PGA absorbable suture, 510(k) Number K984374. Samyang . Corporation , Seoul, Korea.

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.