GYNEMESH PROLENE Soft (Polypropylene) Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Device Description

GYNEMESH PROLENE Soft Mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE* Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth. Blue PROLENE monofilaments have been incorporated to produce contrast striping in the mesh. The mesh is constructed of reduced diameter monofilament fibers, knitted into a unique design that results in a mesh that is approximately 50 percent more flexible than standard PROLENE Mesh. This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use.

GYNEMESH PROLENE Soft Mesh is knitted by a process which interlinks each fiber junction and which provides for elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling. The bi-directional elastic property allows adaption to various stresses encountered in the body.

AI/ML Overview

The provided text is a K013718 510(k) Summary for GYNEMESH PROLENE Soft (Polypropylene) Mesh. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it explicitly states that nonclinical laboratory testing was not performed, and it relies on published clinical data on the predicate devices (PROLENE Mesh and MERSILENE mesh) to support the use of the new material.

Therefore, many of the requested sections regarding acceptance criteria and performance studies of the specific device (GYNEMESH PROLENE Soft Mesh) cannot be extracted from this document, as such studies were not conducted or reported for this device in this submission.

Here's a breakdown of what can and cannot be extracted:

1. Table of acceptance criteria and the reported device performance

This information is not available within this document. The document states: "Nonclinical laboratory testing was not performed as there is no change to the clinical intended use as compared to the two predicate devices." Instead, it refers to "Sufficient bench testing...in accordance with the FDA guidance document 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh.'" and "Published clinical data on the use of PROLENE Mesh and MERSILENE mesh was submitted to support the used of these materials as reinforcing or bridging materials in fascial deficiencies of the pelvic wall." No specific performance data or acceptance criteria for GYNEMESH PROLENE Soft Mesh are reported.

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

This information is not available for GYNEMESH PROLENE Soft Mesh as no specific clinical test set was used for this device in this submission. The document refers to "Published clinical data on the use of PROLENE Mesh and MERSILENE mesh," but does not provide details about these studies' sample sizes or provenance.

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)

This information is not available as no specific clinical test set for GYNEMESH PROLENE Soft Mesh is described.

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

This information is not available as no specific clinical test set for GYNEMESH PROLENE Soft Mesh is described.

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

This is not applicable. The device is a surgical mesh, not an AI or imaging device that would involve human readers.

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

This is not applicable. The device is a surgical mesh, not an algorithm.

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

This information is not available for GYNEMESH PROLENE Soft Mesh. The submission relies on the established clinical history of the predicate devices.

8. The sample size for the training set

This information is not applicable/available as no training set for an algorithm is relevant to this device submission.

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

This information is not applicable/available for the same reason mentioned above.

In summary, the K013718 submission for GYNEMESH PROLENE Soft Mesh relies on showing substantial equivalence to existing predicate devices (PROLENE Soft Mesh, PROLENE Mesh, and MERSILENE Mesh) based on similar materials, construction principles, and intended use, rather than presenting new clinical study data for the device itself.

Summary

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K013718

8 2002 JAN

SECTION 7

SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summary ofSafety 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.MODIFIED DEVICE NAME: GYNEMESH PROLENE Soft (Polypropylene) MeshPREDICATE DEVICE NAME: PROLENE Soft (Polypropylene) Mesh, PROLENE* (Polypropylene) Mesh and MERSILENE* Mesh510(k) SUMMARY
Device Description	GYNEMESH PROLENE Soft Mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE* Polypropylene Suture, Nonabsorbable Surgical Sutures, U.S.P. (ETHICON, INC.). The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth. Blue PROLENE monofilaments have been incorporated to produce contrast striping in the mesh. The mesh is constructed of reduced diameter monofilament fibers, knitted into a unique design that results in a mesh that is approximately 50 percent more flexible than standard PROLENE Mesh. This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use.
	510(k) SUMMARY, Continued
Description (continued)	GYNEMESH PROLENE Soft Mesh is knitted by a process whichinterlinks each fiber junction and which provides for elasticity inboth directions. This construction permits the mesh to be cut intoany desired shape or size without unraveling. The bi-directionalelastic property allows adaption to various stresses encountered inthe body.
Intended Use	This mesh is intended for the repair of hernia or other fascialdefects that require the addition of a reinforcing or bridgingmaterial to obtain the desired surgical result.
Indications Statement	This mesh is used for the repair of hernia or other fascial defectsthat require the addition of a reinforcing or bridging material toobtain the desired surgical result.
TechnologicalCharacteristics	For technological characteristics, the values are the same asPROLENE Soft Mesh and are less than those of PROLENE Mesh,but greater than those of MERSILENE Mesh do. GYNEMESHPROLENE Soft Mesh, PROLENE Soft Mesh and PROLENE Mesh areconstructed of polypropylene fibers. GYNEMESH PROLENE Soft Mand PROLENE Soft Mesh offers a 50% more flexible monofilamentmesh.
Performance Data	Nonclinical laboratory testing was not performed as there is nochange to the clinical intended use as compared to the twopredicate devices. Sufficient bench testing was conducted inaccordance with the FDA guidance document 'Guidance for thePreparation of a Premarket Notification Application for a SurgicalMesh.'
	Published clinical data on the use of PROLENE Mesh andMERSILENE mesh was submitted to support the used of thesematerials as reinforcing or bridging materials in fascial deficienciesof the pelvic wall.
	Continued on next page

Continued on next page

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

Based on the 510(k) summaries and 510(k) statements (21 CFR Conclusions 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act. Gregory R. Jones Contact Director, GYNECARE QA/RA ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151

Date

November 6, 2001

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circle's perimeter. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Gregory R. Jones Director, GYNECARE RA/QA Ethicon, Inc. P.O. Box 151 SOMERVILLE NJ 08876

SEP 2 8 2012

Re: K013718 Trade/Device Name: GYNEMESH PROLENE Soft Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor Repair Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: November 6, 2001 Received: November 8, 2001

Dear Mr. Jones:

This letter corrects our substantially equivalent letter of January 8, 2002.

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 (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 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

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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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE ાળી રેમવ

510(k) Number (if known):

Device Name:

Indications for Use:

GYNEMESH PROLENE* Soft (Polypropylene) Mesh

lro for cmw

Division Sign-Off) Division of General, Restorative and Neurological Devices

<013718 510(k) Number -

(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)

GYNEMESH PROLENE* Soft (Polypropylene) Mesh ETHICON, Inc.

iii

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.