The PROLENE Soft (Polypropylene) Mesh is indicated for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Device Description

PROLENE Soft* polypropylene 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. 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the PROLENE Soft (Polypropylene) Mesh:

Summary of Acceptance Criteria and Device Performance (PROLENE Soft Mesh)

The document focuses on demonstrating substantial equivalence to predicate devices (PROLENE Mesh and MERSILENE Mesh) rather than defining specific numerical acceptance criteria for a novel performance study. Therefore, the "acceptance criteria" are implicitly met by demonstrating that the new device is either identical in material/intended use or offers improvements without compromising safety and effectiveness.

Acceptance Criteria (Implicit)	Reported Device Performance and Substantiation
Material Composition Equivalence (No change in base polymer that would significantly alter biological response or durability)	PROLENE Soft mesh is constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE Polypropylene Suture (ETHICON, INC.). This directly addresses material composition and leverages the known safety profile of PROLENE suture.
Intended Use Equivalence (Same indications as predicate devices)	Intended Use: "This mesh is intended for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result." This is identical to the indicated uses of predicate surgical meshes.
Safety and Effectiveness (Equivalent or improved safety/effectiveness compared to predicates, without new hazards)	Technological Characteristics: "For technological characteristics, the values established for PROLENE Soft mesh are less than those of PROLENE mesh, but greater than those of MERSILENE mesh. Both PROLENE Soft mesh and PROLENE mesh are constructed of polypropylene fibers. PROLENE Soft mesh offers a 50% more flexible monofilament mesh." This suggests that while some mechanical properties might differ from PROLENE, they are within the range of established meshes (including MERSILENE) and the increased flexibility is presented as a benefit.
Biocompatibility (Material is biocompatible, non-reactive, and retains strength in clinical use)	"This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use." This statement leverages the known biocompatibility and long-term strength retention of polypropylene used in sutures, from which the mesh material is derived.
Physical/Mechanical Properties (adequate for intended use) (Sufficient strength, durability, tissue ingrowth, and adaptability)	"The mesh affords excellent strength, durability and surgical adaptability, with sufficient porosity for necessary tissue ingrowth." "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."
Nonclinical Performance (when technological differences exist but don't alter clinical use/safety) (Sufficient bench testing to address differences)	"Nonclinical laboratory testing was not performed as there is no change to the clinical intended use as compared to the two predicate devices. Sufficient bench testing was conducted in accordance with the FDA guidance document "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh." " The document implies that the bench testing (though not detailed) was sufficient to demonstrate equivalence despite the 50% increased flexibility.

Study Details:

The document describes a submission for substantial equivalence based on comparisons to predicate devices, rather than a standalone clinical or formal non-clinical performance study with a defined test set and ground truth in the traditional sense for an AI/device performance.

Sample size used for the test set and the data provenance:
- No specific "test set" or clinical data is detailed for the PROLENE Soft Mesh itself. The submission relies on the established safety and effectiveness of its predicate devices and the material (polypropylene).
- The "performance data" section explicitly states: "Nonclinical laboratory testing was not performed as there is no change to the clinical intended use as compared to the two predicate devices."
- It mentions "Sufficient bench testing was conducted," but no details on sample size or specific results are provided. This bench testing would likely involve physical property measurements (e.g., flexibility, tensile strength) on samples of the mesh material itself against the predicate devices. Data provenance for this bench testing is not explicitly stated.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no "test set" requiring expert ground truth in this context. The evaluation was a regulatory comparison to predicate devices, relying on existing established knowledge.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication process for a test set was described.
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 is a medical device (surgical mesh), not an AI-powered diagnostic, so MRMC studies involving human readers or AI assistance are not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implicit "ground truth" derived from established clinical history and performance of predicate devices (PROLENE Mesh and MERSILENE Mesh), and the well-known properties of PROLENE polypropylene suture. The "ground truth" here is the long-standing clinical acceptance and safety profile of the base material and similar devices.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of this device submission.
How the ground truth for the training set was established:
- Not applicable. No training set was used.

Summary

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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 CosmeticAct, respecting safety and effectiveness is summarized below. Forthe convenience 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: PROLENE Soft* (Polypropylene)Mesh
	PREDICATE DEVICE NAME: PROLENE* (Polypropylene)Mesh and MERSILENE* Mesh
	510(k) SUMMARY
Device Description	PROLENE Soft* polypropylene mesh is constructed of knittedfilaments of extruded polypropylene identical in composition tothat used in PROLENE* Polypropylene Suture, NonabsorbableSurgical Sutures, U.S.P. (ETHICON, INC.). The mesh affordsexcellent strength, durability and surgical adaptability, withsufficient porosity for necessary tissue ingrowth. Blue PROLENEmonofilaments have been incorporated to produce contrast stripingin the mesh. The mesh is constructed of reduced diametermonofilament fibers, knitted into a unique design that results in amesh that is approximately 50 percent more flexible than standardPROLENE mesh. This material, when used as a suture, has beenreported to be non-reactive and to retain its strength indefinitely inclinical use.

Continued on next page

PROLENE* Soft (Polypropylene) Mesh ETHICON, Inc.

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

510(k) SUMMARY, Continued

Description (continued)	PROLENE Soft mesh is knitted by a process which interlinks eachfiber junction and which provides for elasticity in both directions.This construction permits the mesh to be cut into any desired shapeor size without unraveling. The bi-directional elastic propertyallows adaption to various stresses encountered in the 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 established forPROLENE Soft mesh are less than those of PROLENE mesh, butgreater than those of MERSILENE mesh. Both PROLENE Softmesh and PROLENE mesh are constructed of polypropylenefibers. PROLENE Soft mesh offers a 50% more flexiblemonofilament mesh.
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."

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

Conclusions	Based on the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that thenew device is substantially equivalent to the Predicate Deviceunder the Federal Food, Drug, and Cosmetic Act.
Contact	Gregory R. JonesDirector, Regulatory AffairsETHICON, Inc.Rt. #22, WestSomerville, NJ 08876-0151
Date	April 6, 2000

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human profile with three lines extending from the head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2000

Mr. Gregory R. Jones Director, Regulatory Affairs Ethicon, Inc. Route 22 Somerville, New Jersey 08876

Re: K001122 Trade Name: PROLENE Soft (Polypropylene) Mesh Regulatory Class: II Product Code: FTL Dated: April 6, 2000 Received: April 7, 2000

Dear Mr. Jones:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Gregory R. Jones

This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Dinna R. Lechner.

OCelia 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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INDICATION FOR USE

510(k) Number (if known):	K001132
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Device Name:

Indications for Use:

PROLENE Soft* (Polypropylene) Mesh.

(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)

(Division Sign-Off) Division of General Restorative Devices 510(k) Number_Kool | 2 乙

Over-The Counter Use

(Optional Format 1-2-9G)

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.