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

Device Description

PROLENE™ Soft Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of abdominal wall hernias and abdominal wall deficiencies. The implant device is composed of knitted filaments of extruded polypropylene. Blue PROLENE™ monofilaments have been integrated to produce contrast striping in the mesh.

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.). 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. Polypropylene 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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called PROLENE™ Soft Polypropylene Mesh. It is a submission to the FDA demonstrating substantial equivalence to previously cleared devices. Therefore, it does not describe a study proving the device meets acceptance criteria in the typical sense of a clinical trial or performance characterization study that would establish specific performance metrics against an established ground truth.

Instead, the core of this document is to demonstrate that the new device is "substantially equivalent" to existing, legally marketed predicate devices. This means that the acceptance criteria are essentially met if the new device is shown to be as safe and effective as the predicates, based on having the same technological characteristics and intended use, or different characteristics that do not raise new questions of safety and effectiveness.

Here's an breakdown based on your request, with the understanding that the context is a 510(k) submission for substantial equivalence rather than a de novo performance study:

1. Table of acceptance criteria and the reported device performance

The "acceptance criteria" for a 510(k) are typically met by demonstrating substantial equivalence to a predicate device, as opposed to meeting specific numerical performance thresholds.

Acceptance Criterion (for 510(k) Substantial Equivalence)	Reported Device Performance (PROLENE™ Soft Polypropylene Mesh)
Same intended use as predicate device(s)	Indications for Use are for "repair of abdominal wall deficiencies that require the addition of a reinforcing material to obtain the desired surgical result," which is consistent with the predicate devices. The indication statement was modified for clarity but does not introduce new indications or expand the patient population.
Same technological characteristics as predicate device(s)	"Identical to the PROLENE™ Soft Polypropylene Mesh (K163152) and PROLENE™ Soft (Polypropylene). Nonabsorbabale Synthetic Surgical Mesh (K001122) marketed mesh with respect to technological characteristics." This includes material (knitted filaments of extruded polypropylene), construction, specification, manufacturing, and sterilization process.
Does not raise new questions of safety or effectiveness	No material, construction, specification, manufacturing, or sterilization process changes. Changes are limited to labeling (Instructions for Use) to add a new Contraindication and reword/reformat for clarity. These changes do not introduce new safety or effectiveness concerns.

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

This document does not describe a "test set" in the context of an AI/algorithm performance study. A 510(k) submission for substantial equivalence primarily relies on existing data and characteristics of the predicate devices. No new clinical or performance data from a specific test set is presented.

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)

Not applicable. The ground truth in this context is the regulatory clearance and established safety and effectiveness of the predicate devices. There is no new "ground truth" establishment for a test set described in this document.

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

Not applicable. There is no test set or adjudication process 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

Not applicable. This device is a surgical mesh, not an AI-powered diagnostic tool, so an MRMC study is irrelevant to this submission.

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

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

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

The "ground truth" in this context is the established safety and effectiveness of the predicate devices (PROLENE™ Soft Polypropylene Mesh K163152 and PROLENE™ Soft (Polypropylene) Nonabsorbabale Synthetic Surgical Mesh K001122), as determined through their previous FDA clearances based on their own data and clinical history. The current submission's "ground truth" is that these predicate devices are already shown to be safe and effective.

8. The sample size for the training set

Not applicable. This document does not describe a training set as it's not an AI/machine learning device.

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

Not applicable. This document does not describe a training set.

Summary

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

October 5, 2017

Ethicon Incorporated Ms. Stephanie Saati Senior Regulatory Affairs Specialist Route 22 West, P.O. Box 151 Somerville, New Jersey 08876-0151

Re: K172089

Trade/Device Name: PROLENE Soft Polypropylene Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: July 10, 2017 Received: July 11, 2017

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 (reporting of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) 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. 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 Industry and Consumer Education (DICE) 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.

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) K172089

Device Name PROLENE™ Soft Polypropylene Mesh

Indications for Use (Describe)

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

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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100540783 | Rev. 1 K172089 page 1 of 3

HICON a John huson company

510(k) Summary

Submitter:	Ethicon, Inc. a Johnson & Johnson companyP.O. Box 151Route 22 WestSomerville, NJ 08876-0151
Contact Person:	Stephanie SaatiSenior Regulatory Affairs SpecialistPhone: 908-218-3318Fax: 908-218-2595Email: SSaati@its.jnj.com
Date Prepared:	June 30, 2017
Device Trade Name:	PROLENE™ Soft Polypropylene Mesh
Device Common Name:	PROLENE Soft Mesh
Class:	Class II
Classification:	21 CFR 878.3300 – Surgical Mesh
Product Code:	FTI

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Device	Company	Product Code	510(k) Number	Predicate for
PROLENE™ SoftPolypropyleneMeshProduct Code:SPM3XL	Ethicon, Inc.	FTL	K163152	Fundamental ScientificTechnology, Design,Intended Use, Materials,Construction, PerformanceCharacteristics
PROLENE™ Soft(Polypropylene),NonabsorbabaleSyntheticSurgical MeshProduct Codes:SPMHSPMIISPMLISPMSSPMXSSPMXXL	Ethicon, Inc.	FTL	K001122	Fundamental ScientificTechnology, Design,Intended Use, Materials,Construction, PerformanceCharacteristics

Predicate Device:

Device Description:

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Indications for Use:

PROLENE™ Soft 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.

Summary of Technological Characteristics:

PROLENE™ Soft Polypropylene Mesh is identical to the PROLENE™ Soft Polypropylene Mesh (K163152) and PROLENE™ Soft (Polypropylene). Nonabsorbabale Synthetic Surgical Mesh (K001122) marketed mesh with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices differ only in the labeling (Instructions for Use) which has been revised to add a new Contraindication. Additionally, several other sections of the Instructions for Use of the subject device 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™ Soft Polypropylene Mesh is identical to the PROLENE™ Soft Polypropylene Mesh (K163152) and PROLENE™ Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh (K001122) marketed mesh with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices differ only in the labeling (Instructions for Use) which has been revised to add a new Contraindication. Additionally, several other sections of the Instructions for Use of the subject device 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 mesh has been modified to add clarity. The Indication of the subject device does not introduce any new indications or expand patient population of the predicate mesh.

Conclusion:

The subject mesh, PROLENE™ Soft Polypropylene Mesh is identical to the two predicate marketed meshes, PROLENE™ Soft Polypropylene Mesh (K163152) and PROLENE™ Soft (Polypropylene). Nonabsorbabale Synthetic Surgical Mesh (K001122) with respect to intended use, technological characteristics, material, construction, specification, manufacturing and sterilization. In conclusion, the subject PROLENE™ Soft Polypropylene Mesh is substantially equivalent to the two predicate meshes.

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.