Modified Coated VICRYL* suture is intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.

Device Description

Modified Coated VICRYL* (Polyglactin 910) suture is a synthetic absorbable sterile surgical suture composed of a copolymer made from 90% glycolide and 10% L-lactide. Modified Coated VICRYL* suture, which is prepared by coating VICRYL* suture material with a copolymer of 90% caprolactone and 10% glycolide and subsequently with a mixture composed of equal parts of a copolymer of glycolide and lactide (Polyglactin 370) with calcium stearate.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, which generally does not include the detailed study design elements requested for AI/ML performance evaluations. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical and in-vivo testing.

Therefore, many of the requested categories related to AI/ML specific studies (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of submission.

However, I can extract the available information regarding acceptance criteria and the studies performed to meet them.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Conformance to USP Monograph for absorbable surgical sutures (except for diameter).	Device conformed to the USP Monograph for absorbable surgical sutures.
Device performs as intended for general soft tissue approximation and/or ligation.	In-vivo testing demonstrated the device performed as intended.
Substantial equivalence to the predicate device (Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture).	Concluded to be substantially equivalent based on 510(k) summaries and information provided.

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

Not Applicable in the context of AI/ML. The provided document does not specify sample sizes for non-clinical or in-vivo testing in terms of a "test set" for algorithm performance. It refers to "non-clinical laboratory testing" and "in-vivo testing."
Data Provenance: Not specified beyond "non-clinical laboratory testing" and "in-vivo testing." No country of origin is mentioned, nor whether it was retrospective or prospective.

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

Not Applicable. Ground truth, in the AI/ML sense, is not mentioned. The evaluation relies on standardized tests (USP Monograph) and in-vivo performance, which would be assessed by trained professionals following established protocols, rather than expert consensus on data annotations.

4. Adjudication method for the test set:

Not Applicable. Adjudication methods are not described as this is not an AI/ML study involving human interpretation consensus.

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:

No, an MRMC study was not done. This device is a surgical suture, not an AI/ML diagnostic or assistive tool for human readers.

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

Not Applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

For the non-clinical laboratory testing, the "ground truth" would be established by the definitions and specifications outlined in the USP Monograph for absorbable surgical sutures.
For the in-vivo testing, the "ground truth" would be the observed performance of the suture in live biological systems according to predefined success criteria for tissue approximation and/or ligation.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML model that requires a training set.

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

Not Applicable. This is not an AI/ML model that requires a training set or ground truth for training.

Summary

{0}------------------------------------------------

K022269

Age 1/2

SEP 1 3 2002

SECTION 8

SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summary ofSafety and Effectiveness
	Information supporting claims of substantial equivalence. asdefined under the Federal Food, Drug and Cosmetic Act,respecting safety and effectiveness is summarized below. For theconvenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule " 510(k) Summaries and510(k) Statements" (21 CFR 807) and can be used to provide asubstantial equivalence summary to anyone requesting it from theAgency.
	MODIFIED DEVICE NAME: Coated VICRYL* (Polyglactin910) Synthetic Absorbable Suture
	PREDICATE DEVICES NAME: Coated VICRYL* (Polyglactin910) Synthetic Absorbable Suture.
Device Description	Modified Coated VICRYL* (Polyglactin 910) suture is a syntheticabsorbable sterile surgical suture composed of a copolymer madefrom 90% glycolide and 10% L-lactide. Modified CoatedVICRYL* suture, which is prepared by coating VICRYL* suturematerial with a copolymer of 90% caprolactone and 10% glycolideand subsequently with a mixture composed of equal parts of acopolymer of glycolide and lactide (Polyglactin 370) with calciumstearate.
Intended Use	Modified Coated VICRYL* suture is intended for use in generalsoft tissue approximation and/or ligation, including use inophthalmic procedures, but not for use in cardiovascular andneurological tissues.
	Modified Coated VICRYL* suture has the same intended use asthe predicate device, current Coated VICRYL* suture.

{1}------------------------------------------------

KO22269 Page 2/3

Section 8 – Summary of Safety and Effectiveness, Continued

Indications Statement Modified Coated VICRYL* suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues. Technological Characteristics The new device has similar technological characteristics as the predicate devices. Like the predicate device, it is a sterile, braided synthetic absorbable suture that conforms to the USP Monograph for absorbable surgical sutures, except for diameter. Performance Data Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP Monograph for absorbable surgical sutures. Additionally, in-vivo testing was provided showing that the device performed as intended. Conclusions Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Devices under the Federal Food, Drug, and Cosmetic Act. Contact Lea Ann Conway Director, Regulatory Affairs and Quality Assurance Ethicon Products ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151 July 10, 2002 Date

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

SFP 1 3 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ethicon. Inc Lea Ann Conway Director, Regulatory Affairs and Quality Assurance Route 22. West Somerville, New Jersey 08876

Re: K022269

Trade/Device Name: Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture Regulation Number: 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: July 10, 2002 Received: July 15, 2002

Dear Ms. Conway:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If vour 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.

{3}------------------------------------------------

Page 2 – Ms. Lea Ann Conway

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

022269

510(k) Number (if known):

Device Name:

Indications for Use:

Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture

Coated VICRYL* suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
--	--------------------------------------------------------

Prescription Use		OR	Over-The Counter Use
(Per 21 CFR 801.109)

(Division Sign-Off)		(Optional Format 1-2-9G)
Division of General, Restorative and Neurological Devices

510(k) Number	K022269
---------------	---------

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.