The absorbable VICRYL™ Mesh may be used wherever temporary wound support is required. VICRYL™ Mesh may be cut to the shape or size desired for each specific application.

Device Description

VICRYL™ (polyglactin 910) Mesh is a synthetic absorbable sterile copolymer made from glycolide and L-lactide. The copolymer is identical in composition to that used in VICRYL™ (polyglactin 910) synthetic absorbable suture.

Two weave configurations are available, knitted and woven. VICRYL™ Knitted Mesh is more porous than VICRYL™ Woven Mesh and may be used in instances in which compliant and stretchable support material is desired.

AI/ML Overview

This document, an FDA 510(k) Premarket Notification for VICRYL™ Mesh (K201143), does not describe a study involving an AI/image analysis device. It is a submission for a surgical mesh, and the basis for its clearance is substantial equivalence to a previously cleared device (K191373), with the only change being a revision to the Instructions for Use labeling.

Therefore, many of the requested elements for describing the acceptance criteria and study proving device performance (e.g., sample size for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment) are not applicable to this specific FDA submission.

However, I can extract the general acceptance criteria and "performance" of this device within the context of a 510(k) clearance, which is based on demonstrating substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence for a Medical Device)

Since this document is a 510(k) clearance for a surgical mesh and not an AI/image analysis device, the concept of "acceptance criteria" and "device performance" is framed in terms of demonstrating substantial equivalence to a legally marketed predicate device. The primary "acceptance criteria" for a 510(k) submission like this is that the new device is as safe and effective as a predicate device and does not raise new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance (as stated in the 510(k) Summary)
Fundamental Scientific Technology: Be of the same type of technology.	Both the subject device (VICRYL™ Mesh) and the predicate device (VICRYL™ Mesh, K191373) are synthetic absorbable sterile copolymers.
Intended Use: Have the same intended use.	Both devices are intended for use wherever temporary wound support is required.
Materials: Be composed of the same materials.	Both are made from glycolide and L-lactide copolymer, identical to that used in VICRYL™ (polyglactin 910) synthetic absorbable suture.
Design: Have similar design characteristics (e.g., two weave configurations available: knitted and woven).	Both devices have two weave configurations available (knitted and woven). 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Construction: Be constructed using the same manufacturing processes.	The subject mesh is manufactured within the existing manufacturing processes for the predicate device. No changes to manufacturing, packaging, sterilization processes, or shelf life.
Performance Characteristics: Exhibit comparable performance.	The devices function in the same manner. No changes to performance characteristics were noted or implied by the change only in labeling. 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Impact of differences: Any differences do not raise new questions of safety or effectiveness.	The only stated difference is a revision to the Instructions for Use (labeling) to provide additional clarity to the Indications statement. This change does not alter the fundamental characteristics or function of the device and thus does not raise new questions of safety or effectiveness.

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

Not Applicable. This 510(k) submission did not involve a "test set" in the sense of a dataset for evaluating an AI algorithm's performance. The clearance was based on substantial equivalence, meaning the device itself (VICRYL™ Mesh) was deemed equivalent to a previously cleared version.
Data Provenance: Not applicable as no new clinical or non-clinical testing data were generated or relied upon for this specific submission, other than the updated labeling. The core "data" supporting this clearance is the demonstration of sameness to the predicate device and the predicate's existing clearance history.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable. No ground truth establishment by experts was required for this 510(k) given that no new performance data was submitted or required. The review process is primarily regulatory and technical comparison to a predicate, not clinical validation of performance with a study.

4. Adjudication Method for the Test Set:

Not Applicable. No test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not Applicable. This is not an AI/image analysis device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:

Not Applicable. This is not an AI/image analysis device. Therefore, no standalone algorithm performance was assessed.

7. Type of Ground Truth Used:

Not Applicable. No clinical "ground truth" (e.g., pathology, outcomes data) was used or generated for this submission as it was based on substantial equivalence and a labeling change for an existing device. The "ground truth" in a regulatory sense here is the established safety and effectiveness of the predicate device.

8. Sample Size for the Training Set:

Not Applicable. As this is not an AI/image analysis device, there was no "training set."

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

Not Applicable. As there was no "training set," there was no ground truth to establish for it.

Summary

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August 6, 2020

Ethicon, Inc. Valerie Bever Associate Director, Regulatory Affairs Route 22 West, P.O. Box 151 Somerville, New Jersey 08876-0151

Re: K201143

Trade/Device Name: VICRYL Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: April 28, 2020 Received: April 29, 2020

Dear Valerie Beyer:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201143

Device Name VICRYL™ (Polyglactin 910) Mesh

Indications for Use (Describe)

The absorbable VICRYL™ Mesh may be used wherever temporary wound support is required. VICRYL™ Mesh may be cut to the shape or size desired for each specific application.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Research Use Only (Part 51.533 Subject to Change)
For Therapeutic Use (51.533.000)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter:	Ethicon, Inc. a Johnson & Johnson companyP.O. Box 151Route 22 WestSomerville, NJ 08876-0151
Contact Person:	Valerie Smith BeyerAssociate Director, Regulatory AffairsPhone: 908-218-2914Fax: 908-218-2595Email: vsmith28@its.jnj.com
Date Prepared:	August 4, 2020
Device Trade Name:	VICRYL™ Mesh
Device Common Name:	VICRYL™ Mesh
Class:	Class II
Classification:	21 CFR 878.3300 – Surgical Mesh
Product Code:	FTL

Predicate Device:

Device	Company	Product Code	510(k) Number	Predicate for
VICRYLTM(Polyglactin910) Mesh	Ethicon,Inc.	FTL	K191373	Fundamental ScientificTechnology, Design,Intended Use, Materials,Construction,PerformanceCharacteristics

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Device Description:

Indications for Use:

The absorbable VICRYL™ Mesh may be used wherever temporary wound support is required. VICRYL™ Mesh may be cut to the shape or size desired for each specific application.

Summary of Technological Characteristics:

VICRYL™ Mesh is substantially equivalent to the VICRYLTM Mesh (K191373) predicate device with respect to technological characteristics. Both the subject and predicate device are synthetic absorbable sterile copolymer. The devices function in the same manner and are designed to be used wherever temporary wound support is required. The subject mesh is manufactured within the existing manufacturing processes for the predicate device. There are no changes to the manufacturing, packaging, sterilization processes, or shelf life of the subject device.

The subject VICRYLTM Mesh, for which this 510(k) Premarket Notification is being submitted, differs from the predicate device, K191373, only in the labeling (Instructions for Use). The Instructions for Use for the subject VICRYL™ Mesh has been revised to provide additional clarity to the Indications statement.

Substantial Equivalence:

The subject VICRYL™ Mesh is substantially equivalent to the VICRYL™ Mesh (K191373) predicate device with respect to technological characteristics. Both the subject and predicate device are synthetic absorbable sterile copolymer. The devices function in the same manner and are designed to be used wherever temporary wound support is required. The subject mesh is manufactured within the existing manufacturing processes for the predicate device. There are no changes to

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the manufacturing, packaging, sterilization processes, or shelf life of the predicate device.

The subject VICRYL™ Mesh, for which this 510(k) Premarket Notification is being submitted, differs from the predicate device, K191373, only in the labeling (Instructions for Use). The Instructions for Use for the subject VICRYL™ Mesh has been revised to further clarify the Indications statement.

Non-Clinical Testing:

No additional clinical or non-clinical testing has been relied upon because the subject device remains unchanged from the legally marketed device except for the updated Instructions for Use.

Conclusion:

Based on the intended use, fundamental scientific technology and, technological characteristics, the subject device VICRYL™ Mesh is substantially equivalent to the predicate device, K191373.

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.