VICRYL Mesh Bag consists of a VICRYL Mesh adapted to the form and size of kidney, spleen, or liver and tied with VICRYL sutures (dyed and undyed). The integrated strands of VICRYL sutures are threaded along the periphery of the mesh, which facilitates its use as organ support for the kidney, spleen, or liver. The VICRYL Mesh is prepared from polyglactin 910, a synthetic absorbable copolymer of glycolide and lactide, derived respectively from glycolic acid and lactic acids. The mesh is prepared from uncoated, undyed fiber identical in composition to that used in VICRYL (polyglactin 910) synthetic absorbable suture, which has been found to be inert, nonantigenic, and nonpyrogenic and to elicit only a milc tissue reaction during absorption.

AI/ML Overview

The provided document describes a medical device called the VICRYL Mesh Bag. Since this is a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device, not necessarily to establish de novo safety and effectiveness through extensive performance studies against acceptance criteria in the same way a PMA device would.

Here's an analysis of the provided information, focusing on the absence of typical acceptance criteria and study data often found in AI/diagnostic device submissions:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not Applicable	VICRYL Mesh Bag has similar technological characteristics as the predicate device. The VICRYL Mesh Bag is essentially VICRYL Mesh that has been preshaped to specific sizes to facilitate its application. Prior data supporting the predicate device demonstrate that VICRYL Mesh Bag performs as intended.

Explanation: The submission for the VICRYL Mesh Bag does not define explicit acceptance criteria or report specific device performance metrics in the way a diagnostic or AI device would (e.g., sensitivity, specificity, AUC). Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device (VICRYL Mesh). The "performance data" section states that "Prior data supporting the predicate device demonstrate that VICRYL Mesh Bag performs as intended," implying that the performance of the new device is inherent in its similarity to the established predicate.

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

Sample Size: Not applicable. No specific "test set" of patient data was used to evaluate the VICRYL Mesh Bag's performance against defined metrics.
Data Provenance: Not applicable. The performance is inferred from the predicate device's existing data and the design similarity.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. There was no "ground truth" to establish for a test set in the context of this device's submission. The device is a surgical mesh for support, not a diagnostic tool requiring expert interpretation of results.

4. Adjudication Method for the Test Set:

Not applicable. No adjudication was necessary as there wasn't a diagnostic outcome being evaluated by experts.

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

Not applicable. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. The VICRYL Mesh Bag is a physical surgical implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is not an algorithm or AI system.

7. Type of Ground Truth Used:

Not applicable. The performance is based on the known characteristics and prior data of the predicate VICRYL Mesh for surgical support. The "ground truth" here is the established safety and efficacy of the material as an absorbable surgical mesh.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model that requires a training set. The "design" of the VICRYL Mesh Bag is a physical modification (pre-shaping) of an existing, approved material.

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

Not applicable.

Summary of Approach in the Document:

The provided document details a 510(k) Premarket Notification for the VICRYL Mesh Bag. The core of a 510(k) submission, as evidenced here, is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (in this case, VICRYL Mesh).

Instead of presenting new clinical study data with acceptance criteria, the manufacturer (Ethicon, Inc.) argued that:

The new device (VICRYL Mesh Bag) has "similar technological characteristics" to the predicate (VICRYL Mesh).
The VICRYL Mesh Bag is "essentially VICRYL Mesh that has been preshaped to specific sizes."
"Prior data supporting the predicate device demonstrate that VICRYL Mesh Bag performs as intended."

This approach relies on the established safety and effectiveness of the predicate device and argues that the minor modification (pre-shaping) does not raise new questions of safety or effectiveness. Therefore, the "acceptance criteria" and "study data" are implicitly tied to the regulatory framework of demonstrating substantial equivalence rather than independent performance evaluation against predefined numerical thresholds.

Summary

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KOS1701

SEP 2 9 2005

SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summary of Safety and Effectiveness

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

NEW DEVICE NAME: VICRYL* Mesh Bag

PREDICATE DEVICES NAME: VICRYL Mesh

Device Description

VICRYL Mesh Bag consists of a VICRYL Mesh adapted to the form and size of kidney, spleen, or liver and tied with VICRYL sutures (dyed and undyed).

The integrated strands of VICRYL sutures are threaded along the periphery of the mesh, which facilitates its use as organ support for the kidney, spleen, or liver. The VICRYL Mesh is prepared from polyglactin 910, a synthetic absorbable copolymer of glycolide and lactide, derived respectively from glycolic acid and lactic acids. The mesh is prepared from uncoated, undyed fiber identical in composition to that used in VICRYL (polyglactin 910) synthetic absorbable suture, which has been found to be inert, nonantigenic, and nonpyrogenic and to elicit only a milc tissue reaction during absorption.

Intended Use

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

Indications Statement

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

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Technological Characteristics

VICRYL Mesh Bag has similar technological characteristics as the predicate device. The VICRYL Mesh Bag is essentially VICRYL Mesh that has been preshaped to specific sizes to facilitate its application.

Performance Data

Prior data supporting the predicate device demonstrate that VICRYL Mesh Bag performs 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

Jennifer Paine Manager, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151 908-218-3323

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (DHHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The caduceus is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The text is written in capital letters and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 2005

Ms. Jennifer M. Paine, M.S. Manager, Regulatory Affairs Ethicon, Inc. Route 22 West Somerville, New Jersey 08876

Rc: K051701

Trade/Device Name: VICRYI Mesh Bag Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: August 26, 2005 Received: August 29, 2005

Dear Ms. Paine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became of one device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the 28, 1976. the enactment date of the Medical Device Amendments, or to commerce pror co may 2011-11-11 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 1 ou may outrols 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 may be sabyeet to back at 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 I hat 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 or any I 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 form in the qualify by over provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Ms. Jennifer M. Paine, M.S.

This letter will allow you to begin marketing your device as described in your Section 510(k) This ictier will anow you to begin manisting your device of your device to a legally premits tourneadon. The PIPA mainig of cation 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 If you desire specific advice for your do november 10 - 11 5. Also, please note the regulation entitled, Colliact the Office of Complance at (21 t ) stiffication" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response 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,

Mark N. Millersen

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOS1701

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: VICRYL Mesh Bag

Indications for Use:

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

AND/OR Over-The-Counter Use _ Prescription Use X . (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Melkman

(Division Sign-Off) (Division Signeral, Restorative, and Neurological Devices man 510(k) Number_ KOS1701

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.