PROLENE™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

The PROLENE™ Hernia System is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect).

Device Description

PROLENE™ Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of abdominal wall hernias and abdominal wall deficiencies. The implant device 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, LLC). This material, when used as a suture, has been reported to be non-reactive and to retain its strength indefinitely in clinical use.

PROLENE™ 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 fiber junctions are not subject to the same work fatigue exhibited by more rigid metallic meshes. This bi-directional, elastic property allows adaptation to various stresses encountered in the body.

PROLENE™ Hernia System is a sterile, pre-shaped, three-dimensional device designed for the repair of abdominal wall hernia defects, including inguinal (direct & indirect). It is constructed of an onlay patch connected by a mesh cylinder to a circular or oblong underlay patch. The material is undyed PROLENE™ (Polypropylene) Mesh constructed of knitted nonabsorbable polypropylene filaments.

AI/ML Overview

This document describes a 510(k) premarket notification for PROLENE™ Polypropylene Mesh and PROLENE™ (Polypropylene) Hernia System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics in the way a novel AI or diagnostic device might.

Therefore, many of the typical questions regarding acceptance criteria and a study proving performance are not applicable in this context. The core of this submission is about demonstrating that the revised labeling does not change the fundamental safety and effectiveness of a device that is already legally marketed.

Here's an analysis based on the provided document:

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

This information is not provided in the document. For a 510(k) submission concerning a change to labeling for an existing surgical mesh, typical acceptance criteria would relate to demonstrating that the change itself does not adversely affect the device's safety or effectiveness, or create new risks. This is usually shown through a comparison to the predicate device and an explanation of why the updated labeling (including the new contraindication and reworded sections) does not alter the fundamental characteristics or performance of the device. Performance is implicitly understood to be equivalent to the predicate device, which has already been deemed safe and effective.

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 applicable/provided. This 510(k) does not describe a clinical performance study with a test set. The submission focuses on demonstrating equivalence to predicate devices based on technological characteristics and a labeling change.

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 applicable/provided. No performance study is described that would require a ground truth established by experts.

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

This information is not applicable/provided. No test set and subsequent adjudication would be relevant for this type of submission.

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 information is not applicable/provided. This is a surgical mesh device, not an AI or diagnostic imaging device that would typically undergo an MRMC study.

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

This information is not applicable/provided. This is a physical surgical mesh, not an algorithm.

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

This information is not applicable/provided. The concept of "ground truth" as it applies to performance studies for new diagnostic or AI devices is not relevant here. The "truth" in this context is that the device, with its updated labeling, remains substantially equivalent to already cleared predicate devices.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" as this is not a machine learning or AI device.

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

This information is not applicable/provided. As there is no training set, there is no ground truth to establish for it.

Summary of the Document's Approach to Acceptance Criteria:

Instead of demonstrating performance against specific numerical acceptance criteria through a clinical study, this 510(k) submission for the PROLENE™ devices relies on the concept of substantial equivalence to predicate devices (K962530 and K984220).

The "acceptance criteria" here are implicitly met by demonstrating that:

The intended use of the devices remains the same.
The fundamental scientific technology, design, materials, and construction are unchanged from the predicate devices.
The performance characteristics are equivalent to the predicate devices.
The labeling changes (addition of a new contraindication, reworded/reformatted sections) do not introduce any new indications or expand the patient population, nor do they negatively impact the device's safety or effectiveness as established by the predicate.

The document explicitly states:

"PROLENE™ Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh is substantially equivalent to the PROLENE™ Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh (K962530) predicate device with respect to technological characteristics." (Page 5)
"PROLENE™ (Polypropylene) Hernia System. Nonabsorbable Synthetic Surgical Mesh is substantially equivalent to the PROLENE™ (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh (K984220) predicate device with respect to technological characteristics." (Page 5)
The conclusion further reiterates that based on intended use, technology, and characteristics, the devices "are considered to be substantially equivalent to their predicate devices". (Page 7)

Therefore, the "study" proving the device meets acceptance criteria is the 510(k) submission itself, which provides a comparative analysis to already cleared predicate devices, demonstrating that the current devices, even with updated labeling, remain safe and effective for their intended use. It is a regulatory demonstration of equivalence, not a clinical performance study.

Summary

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June 28, 2018

Ethicon, Inc % Ms. Stephanie Saati Senior Regulatory Affairs Program Lead Route 22 West, P.O. Box 151 Somerville, New Jersey 08876

Re: K180829

Trade/Device Name: PROLENE™ Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE™ (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh Regulation Number: 21 CFR 878.3300

Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: March 29, 2018 Received: March 30, 2018

Dear Ms. Saati:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180829

Device Name

PROLENE™ Mesh Polypropylene Non-Absorbable Synthetic Surgical Mesh

PROLENE™ (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh

Indications for Use (Describe)

PROLENE™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

The PROLENE™ Hernia System is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect).

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

X 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:	Stephanie SaatiSenior Regulatory Affairs Program LeadPhone: 908-218-3318Fax: 908-218-2595Email: SSaati@its.jnj.com
Date Prepared:	March 28, 2018
Device Trade Name:	PROLENE™ Polypropylene Mesh Non-AbsorbableSynthetic Surgical Mesh
	PROLENE™ (Polypropylene) Hernia System,Nonabsorbable Synthetic Surgical Mesh
Device Common Name:	PROLENE™ Mesh
	PROLENE™ Hernia System
Class:	Class II
Classification:	21 CFR 878.3300 – Surgical Mesh
Product Code:	FTL

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Predicate Devices:

PROLENE™ Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh

Device	Company	Product Code	510(k) Number	Predicate for
PROLENE™PolypropyleneMeshNonabsorbableSyntheticSurgical Mesh	Ethicon,Inc.	FTL	K962530	Fundamental ScientificTechnology, Design,Intended Use, Materials,Construction,PerformanceCharacteristics

PROLENE™ (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh

Device	Company	Product Code	510(k) Number	Predicate for
Modification ofPROLENETM(Polypropylene)Hernia System,NonabsorbableSyntheticSurgical Mesh	Ethicon,Inc.	FTL	K984220	Fundamental ScientificTechnology, Design,Intended Use, Materials,Construction,PerformanceCharacteristics

Device Description:

PROLENE™ Mesh is knitted by a process which interlinks each fiber junction and which provides for elasticity in both directions. This construction permits the mesh

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to be cut into any desired shape or size without unraveling. The fiber junctions are not subject to the same work fatigue exhibited by more rigid metallic meshes. This bi-directional, elastic property allows adaptation to various stresses encountered in the body.

Indications for Use:

PROLENE™ Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result.

The PROLENE™ Hernia System is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect).

Summary of Technological Characteristics:

PROLENETM Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh is substantially equivalent to the PROLENE™ Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh (K962530) predicate device with respect to technological characteristics. Both the subject and predicate devices are constructed of knitted filaments of extruded polypropylene. The devices function in the same manner and are designed to provide reinforcement to repair abdominal wall hernias and abdominal wall deficiencies. 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.

PROLENE™ (Polypropylene) Hernia System. Nonabsorbable Synthetic Surgical Mesh is substantially equivalent to the PROLENE™ (Polypropylene) Hernia

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System, Nonabsorbable Synthetic Surgical Mesh (K984220) predicate device with respect to technological characteristics. Both the subject and predicate devices are sterile, pre-shaped, three-dimensional devices constructed of an onlay patch connected by a mesh cylinder to a circular or oblong underlay patch. The material used in both devices is undyed PROLENE™ (Polypropylene) mesh constructed of knitted nonabsorbable polypropylene filaments. Both the subject and predicate devices function in the same manner and are designed for the repair of abdominal wall hernia defects, including inguinal (direct & indirect). There are no changes to the manufacturing, packaging, and sterilization processes, or shelf life of the currently marketed device.

The subject PROLENETM Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh and PROLENE™ (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh, for which this 510(k) Premarket Notification- Change being Effected is being submitted, differs from the currently marketed devices, K962530 and K984220, in the labeling (Instructions for Use). The Instructions for Use has been revised to add a new Contraindication. Additionally, several other sections of the Instructions for Use of the subject devices have been reworded/ reformatted for clarity to address evolving regulatory expectations and bring the contents of the Instructions for Use up to date.

Substantial Equivalence:

PROLENE™ Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh is substantially equivalent to the PROLENE™ Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh (K962530) predicate device. Both the subject and predicate devices are constructed of knitted filaments of extruded polypropylene identical in composition to that used in PROLENE™ Polypropylene Suture, nonabsorbable surgical sutures. The principle of operation of the subject PROLENE™ Mesh, which is to provide reinforcement to repair abdominal wall hernias and abdominal wall deficiencies, is equivalent to that of the predicate device. The subject device is manufactured within the existing manufacturing processes for the predicate device. There are no changes to the packaging, sterilization processes, or shelf life of the currently marketed device.

PROLENE™ (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh is substantially equivalent to the PROLENE™ (Polypropylene) Hernia

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System, Nonabsorbable Synthetic Surgical Mesh (K984220) predicate device. Both the subject and predicate devices are sterile, pre-shaped, three-dimensional devices constructed of an onlay patch connected by a mesh cylinder to a circular or oblong underlay patch. The material is undyed PROLENE™ (Polypropylene) mesh constructed of knitted nonabsorbable polypropylene filaments. The principle of operation of the subject PROLENE™ (Polypropylene) Hernia System, which is to provide reinforcement to repair abdominal wall hernia defects, including inguinal (direct & indirect) hernias, is equivalent to that of the predicate device. There are no changes to the manufacturing, packaging, and sterilization processes, or shelf life of the currently marketed device.

The subject PROLENE™ Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh and PROLENE™ (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh differ from their respective predicate devices, K962530 and K984220, in the labeling (Instructions for Use). The Instructions for Use has been revised to add a new Contraindication. Additionally, several other sections of the Instructions for Use of the subject devices have been reworded/ reformatted for clarity to address evolving regulatory expectations and bring the contents of the Instructions for Use up to date. The Indication statement of the subject devices has been modified to add clarity and does not introduce any new indications or expand patient population of the predicate device.

Conclusion:

Based on the intended use, fundamental scientific technology and, technological characteristics, the subject devices PROLENE™ Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh and PROLENE™ (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh are considered to be substantially equivalent to their predicate devices, K962530 and K984220 respectively.

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.