PROLENE Soft Polypropylene Mesh may be used 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 Mesh is a sterile, nonabsorbable synthetic surgical mesh designed for the repair of hernias and other fascial defects. 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 3.5 mil 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. The bi-directional elastic property is designed to allow adaption to various stresses encountered in the body.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and performance studies. It appears the document describes a 510(k) premarket notification for a surgical mesh, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study establishing new acceptance criteria or full device performance in the same way an AI/software device would.

Based on the provided text, the device is PROLENE Soft Polypropylene Mesh and the study is focused on demonstrating substantial equivalence to a predicate device (PROLENE Soft Polypropylene Mesh, K001122), particularly for a new larger size (50 cm x 50 cm).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly from testing)	Reported Device Performance (Summary)
Material Composition	Identical materials to predicate device	Yes, composed of knitted filaments of extruded polypropylene, identical to predicate.
Sterility	- EO/ECH residuals within acceptable limits (ISO 10993-7:2008) - Natural Product Resistance Testing & Comparative Resistance Testing met acceptance criteria - Bioburden testing met defined acceptance criteria (ISO 11737-1) - Sterility Assurance Level (SAL) of 10^-9 (for subject device) - SAL of 10^-6 (for comparison with predicate)	All sterility validation tests met acceptance criteria. Achieved SAL of 10^-9.
Biocompatibility	- Evaluation in accordance with ISO 10993-1:2009 - Endotoxin criteria of < 20 EU average/device (ANSI/AAMI ST72:2011)	Evaluated per ISO 10993-1:2009. Endotoxin testing met criteria.
Physical Characteristics (Bench Testing)	- Mesh knitting pattern - Mesh pore size/porosity - Mesh density - Mesh thickness - Mesh stiffness	Not explicitly detailed, but stated that "bench top testing evaluated physical characteristics..." and "No new safety or performance issues were raised during the testing."
Performance Testing (Bench Testing)	- Mesh burst strength - Suture pullout strength	Not explicitly detailed, but stated that "mesh performance testing including mesh burst strength and suture pullout strength" was done and "No new safety or performance issues were raised during the testing."
Flexibility	Approximately 50% more flexible than standard PROLENE Mesh	Device is approximately 50 percent more flexible than standard PROLENE Mesh due to unique design and 3.5 mil diameter monofilament fibers.
Unraveling	Can be cut into any shape/size without unraveling	Construction allows cutting without unraveling.
Elasticity	Bi-directional elasticity	Bi-directional elastic property allows adaptation to stresses.
Safety and Effectiveness	No new safety or performance issues compared to predicate	No new safety or performance issues were raised during testing.

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

This document describes a 510(k) submission for a physical medical device (surgical mesh), not a software or AI device that would typically have a "test set" of data in the same sense. The "test set" here refers to the samples of the mesh device undergoing various physical, chemical, and biological performance tests.

Sample Size: Not explicitly stated for each individual test. The document mentions "the subject device" or "the new device" generically when discussing biocompatibility, sterility, and bench testing, implying a representative number of samples were tested per standard protocols for each type of evaluation.
Data Provenance: The studies were conducted by Ethicon, Inc. (a Johnson & Johnson company) as part of their design validation and verification processes. The data appears to be prospective in the sense that the tests were performed specifically for this 510(k) submission to demonstrate the characteristics of the new, larger mesh size. It's not clinical data from patients, but rather lab/bench test data. The country of origin of the data is not specified, but the submission is to the U.S. FDA, and the company is based in Somerville, New Jersey, USA.

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

This information is not applicable in the context of this 510(k) submission for a physical surgical mesh.

"Ground truth" for physical device testing typically refers to objective measurements and adherence to established standards (e.g., ISO, ANSI/AAMI), not expert consensus on medical images or patient outcomes.
The tests described are laboratory evaluations (biocompatibility, sterility, mechanical properties), not clinical assessments requiring expert interpretation of results.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or AI performance evaluations to reconcile discrepancies among human readers or experts. For the physical and biological testing described, results are typically objective measurements against predefined acceptance criteria, not subjective interpretations requiring adjudication.

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. An MRMC study is a type of clinical study used to evaluate the diagnostic accuracy of imaging systems or AI algorithms by comparing performance with and without the AI. The device in question is a surgical mesh; it does not involve human readers interpreting images or data, nor does it incorporate AI.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This information is not applicable. This refers to the performance of an AI algorithm independent of human interaction. The device is a physical surgical mesh, not an algorithm.

7. The Type of Ground Truth Used

As mentioned in point 3, the concept of "ground truth" for this type of device submission is different from that used for diagnostic AI. The "ground truth" for the tests performed on the PROLENE Soft Polypropylene Mesh is based on:

Objective Measurement Standards: Adherence to established international and national standards (e.g., ISO 10993-1:2009 for biocompatibility, ISO 10993-7:2008 for EO/ECH residuals, ANSI/AAMI ST72:2011 for endotoxins, ISO 11737-1 for bioburden).
Predicate Device Characteristics: Comparison of various physical and performance characteristics to the legally marketed predicate device (K001122). The predicate device itself acts as a benchmark of "known safe and effective" characteristics.
Design Specifications: The device met its internal design and performance specifications as part of design validation and verification.

8. The Sample Size for the Training Set

This information is not applicable. A "training set" is relevant for machine learning algorithms. This device is a physical medical implant.

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

This information is not applicable for the same reason as point 8.

Summary

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

March 11, 2017

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

Re: K163152

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: February 10, 2017 Received: February 13, 2017

Dear Ms. Fazen:

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 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 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) K163152

Device Name Prolene Soft Polypropylene Mesh

Indications for Use (Describe)

Prolene Soft Polypropylene Mesh may be used 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.

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

☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Submitter:	Ethicon, Inc. a Johnson & Johnson companyP.O. Box 151Route 22 WestSomerville, NJ 08876-0151
Contact Person:	Debbie FazenSenior Regulatory Affairs Program LeadPh: (908) 218-3196Fax: (908) 218-2595Email: Dfazen@its.jnj.com
510(k) Number:	K163152
Date Prepared:	March 10, 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:	FTL
Predicate Device:

510(k) Summary
In accordance with 21 CFR 807.87(h) and 21 CFR 807.92

Device	Company	Product Code	510(k) Number	Predicate for
PROLENE® SoftPolypropyleneMesh	Ethicon, Inc.	FTL	K001122	FundamentalScientificTechnology, Design,Intended Use,Materials,Construction,PerformanceCharacteristics

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Device Description

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 3.5 mil 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. The bi-directional elastic property is designed to allow adaption to various stresses encountered in the body.

Indications for Use

The PROLENE Soft Polypropylene Mesh may be used 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. The Indications for Use on the Prolene Soft Mesh 50 cm x 50 cm subject device is identical to the predicate device.

Summary of Technological Characteristics

The predicate and subject devices function in the same manner. They are designed as prosthetic material for the repair of hernias and other fascial deficiencies by providing reinforcement or acting as bridging materials. The technological characteristics of the subject device are different as compared to the predicate device. Both predicate and subject PROLENE Soft Mesh devices are composed of a macro porous non-absorbable synthetic surgical mesh. The additional size (50 cm x 50 cm) of the subject device has been developed to satisfy customer needs.

The safety and effectiveness and substantial equivalence of the predicate device and subject device has been demonstrated via data collected during design validation and design verification. The results of these tests provide reasonable assurance that the subject device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing. All materials used in the proposed device are the same as the predicate device and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process.

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Performance Data

The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility PROLENE Soft Mesh is a permanent (>30 days) implant device 1. contacting tissue. The biocompatibility for PROLENE Soft Mesh 50 cm x 50 cm has been evaluated in accordance with ISO 10993-1:2009 "Biological Evaluation of Medical Devices - Evaluation and Testing", and ANSI/AAMI ST72:2011 "Bacterial endotoxins -Test methods, routine monitoring, and alternatives to batch testing." Endotoxin testing was performed in accordance with ANSI/AAMI ST72:2011 and met criteria of < 20 EU average/device.
1. Sterility EO/ECH residual testing in accordance with ISO 10993-7:2008 was completed to verify that acceptable EO and ECH limits can be achieved for the subject device after exposure to the validated sterilization cycles. In conclusion, the subject device has a relatively low affinity for EO/ECH sterilization residues. Natural Product Resistance Testing (NPRT) and Comparative Resistance Testing was performed and results confirmed the subject device had met acceptance criteria. Bioburden testing, in accordance with ISO 11737-1, confirmed that the subject device had met the defined acceptance criteria. Overall, the sterility validation demonstrated that subject PROLENE Soft Mesh (50 cm x 50 cm) achieves a sterility assurance level of 10-9.
1. Bench Testing Bench top testing was performed to assess the physical/performance characteristics of the new device. In accordance with FDA's "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh" (March 2, 1999). the bench top testing evaluated physical characteristics of mesh including mesh knitting pattern, mesh pore size/porosity, mesh density, mesh thickness, and mesh stiffness as well as mesh performance testing including mesh burst strength and suture pullout strength.

Summary of Substantial Equivalence Comparison

The subject device, PROLENE Soft Mesh 50 cm, is equivalent to the predicate PROLENE Soft Mesh described in 510(k) K001122 with the exception of the size of the mesh patch. In accordance with Appendix A, 510(k) Decision Making flow chart from FDA's guidance "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", the predicate device is legally marketed, the labeling is consistent with the IFU statements, the devices (predicate and subject) have the same intended use. The larger size is a new technological characteristic, however, it does not raise questions of safety and effectiveness.

The subject device and the predicate device share:

the same operating principle,
. the same intended use,
. the same materials.
the same packaging materials, ●
the same labeling components,
the same sterilization process (Ethylene Oxide),

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the same sterility assurance level (SAL) is 10-6 and ●
. the same shelf life

In summary, the proposed device, PROLENE Soft Mesh 50 cm x 50 cm, is substantially equivalent to the predicate device.

Conclusions

Clinical literature evidence and performance data support that the device is as safe and as effective as the predicate device for the intended use. Thus we conclude that the proposed device is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act

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.