Modified Coated VICRYL* suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, 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 is coated with a mixture composed of equal parts of a copolymer of glycolide and lactide (Polyglactin 370) and calcium stearate and a small amount of an antimicrobial agent, Irgacare MP (triclosan).

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

Analysis of Acceptance Criteria and Study Data for K022715

Based on the provided document, the K022715 submission pertains to a "Modified Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture." This is a medical device, not an AI/ML algorithm, and therefore the standard questions related to AI/ML device studies (such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not directly applicable.

The document describes the device's substantial equivalence to a predicate device based on its material characteristics and performance in non-clinical laboratory and in-vivo/in-vitro testing. It does not involve human readers interpreting data or AI algorithms making predictions.

However, I can extract the information related to the device's performance against established standards, which serve as its "acceptance criteria" in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Reference Standard)	Performance Metric	Reported Device Performance
USP Monograph for absorbable surgical sutures	Conformance to characteristics (except diameter)	Conformed to USP Monograph (except for diameter)
Intended Use Performance	Device operation as intended	Performed as intended and as claimed
Stated Claims Performance	Device operation as claimed	Performed as intended and as claimed

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

Sample Size (Test Set): Not specified in the provided document. The testing mentioned refers to non-clinical laboratory testing and in-vivo/in-vitro testing.
Data Provenance: Not specified. The testing seems to be internal to the manufacturer (Ethicon, Inc.). It is non-clinical, meaning it does not involve human patient data.

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

This question is not applicable as the device is a surgical suture, not an AI/ML diagnostic tool. Ground truth would be established by physical measurements and biological responses in laboratory and animal models, not expert interpretation of data.

4. Adjudication method for the test set

Not applicable for a physical medical device. Performance is objectively measured against established standards.

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 device is not an AI/ML algorithm and does not involve human readers or AI assistance.

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

Not applicable as this is a physical medical device. The "standalone performance" would be its inherent physical and biological characteristics.

7. The type of ground truth used

For the non-clinical laboratory testing, the ground truth would be physical and chemical specifications (e.g., tensile strength, knot security, degradation profile, antimicrobial efficacy) defined by standards like the USP Monograph.
For the in-vivo/in-vitro testing, the ground truth would be biological responses and functional performance in an experimental setting (e.g., absorption rate, tissue reaction, wound healing in animal models or cell cultures).

8. The sample size for the training set

Not applicable. There is no training set for a physical medical device in the context of an algorithm.

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

Not applicable. There is no training set. The "ground truth" for the device's design and manufacturing would be established through material science, engineering principles, and extensive research and development in biomaterials.

Summary

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K022715 page 1/2

SECTION 8

SUMMARY OF SAFETY AND EFFECTIVENESS DEC 1 9 2002

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: Modified VICRYL* (Polyglactin910) Synthetic Absorbable SuturePREDICATE 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 is coated with a mixture composed of equal partsof a copolymer of glycolide and lactide (Polyglactin 370) andcalcium stearate and a small amount of an antimicrobial agent,Irgacare MP (triclosan).
Intended Use	Modified Coated VICRYL* suture is intended for use in generalsoft tissue approximation and/or ligation, except for use inophthalmic, cardiovascular and neurological tissues.
Indications Statement	Modified Coated VICRYL* Plus Antimicrobial suture is indicatedfor use in general soft tissue approximation and/or ligation, exceptfor ophthalmic, cardiovascular and neurological tissues.
TechnologicalCharacteristics	The modified device has similar technological characteristics as thepredicate devices. Like the currently marketed Coated VICRYLsuture device, it is a sterile, braided synthetic absorbable suturethat conforms to the USP Monograph for absorbable surgicalsutures, except for diameter. Like several previously cleareddevices, the modified device contains the antimicrobial agent,triclosan.
Performance Data	Non-clinical laboratory testing was performed demonstrating thatthe device conformed to the USP Monograph for absorbablesurgical sutures. Additionally, in-vivo/in-vitro testing wasprovided showing that the device performed as intended and asclaimed.
Conclusions	Based on the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that themodified device is substantially equivalent to the PredicateDevices under the Federal Food, Drug, and Cosmetic Act.
Contact	Rey LibrojoSenior Project Manager, Regulatory AffairsETHICON ProductsETHICON, Inc.Rt. #22, WestSomerville, NJ 08876-0151
Date	August 14, 2002

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rey Librojo Senior Project Manager Ethicon, Inc. Division of Johnson & Johnson Medical P.O. Box 151 Somerville, New Jersey 08876-0151

Re: K022715

Trade/Device Name: Coated VICRYL™ Antimicrobial (Polyglactin 910) Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(glycolide/L-lactide) Surgical Suture Regulatory Class: II Product Code: GAM Dated: November 19, 2002 Received: November 20, 2002

Dear Mr. Librojo:

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. 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.

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Page 2 - Mr. Rey Librojo

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21CFR 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 vours,

Miriam C Provost

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

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Indications for Use:

KO22715

Modified Coated VICRYL* (Polyglactin 910) Synthetic Absorbable Suture

Modified Coated VICRYL* suture is indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, 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 _ (Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-9G)

Muriam C. Provost

nston Sun-OR) ision of General, Restorative I Neurologic of Levices

KO 22715

Trademark

Page iii

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.