VICRYL™ Mesh may be used wherever temporary wound or organ support is required (kidney, liver, spleen). 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.

VICRYL™ Knitted Mesh, which is more porous than VICRYL™ Woven Mesh, may be used in instances in which compliant and stretchable support material is desired.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the VICRYL™ Mesh device. It asserts substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study with performance metrics.

Therefore, many of the requested categories regarding acceptance criteria, study design, ground truth, and statistical analysis are not applicable (N/A) because this type of submission focuses on demonstrating equivalence to existing devices, not on presenting novel performance data from a clinical or analytical study with defined acceptance criteria.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (N/A for 510(k) Substantial Equivalence)	Reported Device Performance (N/A for 510(k) Substantial Equivalence)
No explicit acceptance criteria based on specific performance metrics are defined in this 510(k). The submission relies on substantial equivalence to predicate devices.	No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the VICRYL™ Mesh itself, as the submission relies on substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

N/A. This 510(k) submission does not describe a test set or data provenance for a performance study. It's a regulatory submission demonstrating substantial equivalence based on technological characteristics and intended use, not clinical performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

N/A. As no test set performance study is described, there's no mention of experts establishing ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

N/A. No test set performance study is described, therefore no adjudication method.

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

N/A. This is a medical device (surgical mesh), not an AI-based diagnostic tool. No MRMC study was conducted or described.

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

N/A. This is a physical medical device (surgical mesh), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A. No new performance study requiring ground truth is described. The basis for clearance is substantial equivalence to legally marketed predicate devices, meaning their known safety and effectiveness serve as the "ground truth" for the category.

8. The sample size for the training set

N/A. This 510(k) submission pertains to a physical medical device (surgical mesh) and does not involve an algorithm or an AI model with a training set.

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

N/A. As there is no training set for an algorithm, there's no ground truth establishment for it.

Summary of the 510(k) Submission:

The submission for VICRYL™ Mesh (K191373) focuses on demonstrating substantial equivalence to two predicate devices: VICRYL™ (Polyglactin 910) Mesh (K810428) and VICRYL™ Mesh Bag (K051701).

The core argument for equivalence is:

Technological Characteristics: Both the subject and predicate devices are synthetic absorbable sterile copolymers made from glycolide and L-lactide.
Intended Use: All devices are designed for temporary wound or organ support (kidney, liver, spleen) and can be cut to size.
Manufacturing and Sterilization: The subject mesh is manufactured within existing processes for the predicate device, with no changes to manufacturing, packaging, sterilization, or shelf life.
Differences: The only notable difference for the subject device is a revision to the Instructions for Use (IFU) to clarify indications and align with evolving regulatory expectations.

Therefore, Ethicon, Inc. did not conduct a performance study with acceptance criteria and a test set to "prove the device meets the acceptance criteria" in the manner typically expected for a novel device or AI algorithm. Instead, they demonstrated that their device is fundamentally the same as already cleared devices, making it "as safe and effective as the predicates."

Summary

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October 22, 2019

Ethicon, Inc. Melina Escobar Regulatory Affairs Specialist II Route 22 West, P.O. Box 151 Somerville, New Jersey 08876-0151

Re: K191373

Trade/Device Name: VICRYL Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: May 22, 2019 Received: May 23, 2019

Dear Melina Escobar:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

For 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) K191373

Device Name VICRYL Mesh

Indications for Use (Describe)

VICRYL Mesh may be used wherever temporary wound or organ support is required (kidney, liver, spleen). VICRYL Mesh may be cut to the shape or size desired for each specific application.

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is written in large, red, sans-serif letters. Below the company name, the text "a Johnson & Johnson company" is written in a smaller, cursive font. The logo is simple and clean, with a focus on the company name.

510(k) Summary

Submission Date: 10/23/2019

K191373

SUBMITTER INFORMATION:

Company Name:	Ethicon, Inc. a Johnson & Johnson compan
Company Address:	P.O. Box 151Route 22 WestSomerville, NJ 08876-0151
Contact Person:	Melina EscobarRegulatory Affairs Specialist IIPhone: 908-218-2583Fax: 908-218-2595Email: mescob14@its.jnj.com
Device Trade Name:	VICRYL™ Mesh
Device Common Name:	VICRYL™ Mesh
Class:	Class II
Classification:	21 CFR 878.3300 – Surgical Mesh
Product Code:	FTL

Predicate Devices:

Device	Company	ProductCode	510(k)Number	Predicate for
VICRYLTM(Polyglactin910) Mesh	Ethicon,Inc.	FTL	K810428	Fundamental Scientific Technology,Design, Intended Use, Materials,Construction, PerformanceCharacteristics

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Image /page/4/Picture/0 description: The image shows the logo for Ethicon, a Johnson & Johnson company. The word "ETHICON" is written in large, red, serif font. Below the company name, the words "a Johnson & Johnson company" are written in a smaller, cursive font.

Device	Company	ProductCode	510(k)Number	Predicate for
VICRYLTMMesh Bag	Ethicon, Inc.	FTL	K051701	Fundamental Scientific Technology,Design, Intended Use, Materials,Construction, PerformanceCharacteristics

Device Description:

VICRYL™ Knitted Mesh, which is more porous than VICRYL™ Woven Mesh, may be used in instances in which compliant and stretchable support material is desired.

Indications for Use:

VICRYL™ Mesh may be used wherever temporary wound or organ support is required (kidney, liver, spleen). 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 VICRYL™ Mesh (K810428) and VICRYL™ Mesh Bag (K051701) predicate devices with respect to technological characteristics. Both the subject and predicate devices are synthetic absorbable sterile copolymer. The devices function in the same manner and are designed to be used wherever temporary wound or organ support is required (kidney, liver, spleen). 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 currently marketed device.

The subject VICRYL™ Mesh, for which this 510(k) Premarket Notification is being submitted, differs from the currently marketed device, K810428, in the labeling (Instructions for Use). The Instructions for Use has been revised to clarify the indications. Additionally, several other sections of the Instructions for Use of the subject devices have been reworded/ reformatted for clarity to address and align with evolving regulatory expectations.

Substantial Equivalence:

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VICRYL™ Mesh is substantially equivalent to the VICRYL™ Mesh (K810428) and VICRYL™ Mesh Bag (K051701) predicate devices 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 or organ support is required (kidney, liver, spleen). 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 currently marketed device.

The subject VICRYL™ Mesh, for which this 510(k) Premarket Notification is being submitted, differs from the currently marketed device. K810428, in the labeling (Instructions for Use). The Instructions for Use has been revised to clarify the indications. Additionally, several other sections of the Instructions for Use of the subject devices have been reworded/ reformatted for clarity to address evolving regulatory expectations.

Conclusion:

VICRYL™ Mesh is substantially equivalent to the predicate devices, K810428 and K051701 in indications for use, fundamental scientific technology, and technological characteristics. It is as safe and effective as the predicates. Ethicon considers VICRYL™ Mesh to be substantially equivalent to the predicate devices.

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.