The PROLENE Hernia System is a sterile, pre-shaped three dimensional device constructed of an onlay patch connected by a cylinder to a circular or oblong underlay patch. The material is undyed PROLENE* Polypropylene mesh constructed of knitted non-absorbable polypropylene filaments identical to that used in PROLENE* Polypropylene non-absorbable surgical sutures, U.S.P (ETHICON, Inc.). This material, when used as a suture, has been reported to be nonreactive, and to retain its strength indefinitely in clinical use.

AI/ML Overview

The provided text describes a 510(k) summary for the PROLENE* (Polypropylene) Hernia System, a medical device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document explicitly states: "Nonclinical laboratory testing was not performed." and concludes that the "new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act."

Based on the information provided, it is not possible to complete the requested table or answer the questions related to acceptance criteria and a study proving device performance, as such a study with quantifiable metrics and ground truth establishment was not performed or reported in this 510(k) submission.

Summary of available information regarding performance:

Acceptance Criteria	Reported Device Performance
Not applicable	"The modified device has identical technological characteristics to the predicate device."

Explanation for other criteria where information is not available:

Sample sized used for the test set and the data provenance: Not applicable, as no dedicated test set or clinical study was performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth was established through expert review for a performance study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 physical hernia repair system, not an AI-based diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical hernia repair system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no specific performance study requiring ground truth was conducted.
The sample size for the training set: Not applicable, as no training set for an algorithm was used.
How the ground truth for the training set was established: Not applicable.

The submission focuses on the device's technological characteristics being identical to a predicate device, supporting substantial equivalence rather than a de novo demonstration of performance against predefined acceptance criteria.

Summary

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FEB-18-1999 ଉପ: 55 ETHICON REG. AFF.

2/03/99

SECTION 7 K984220

SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summary of Safety 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: PROLENE* (Polypropylene) Hernia System
	PREDICATE DEVICE NAME: PROLENE* (Polypropylene) Hernia System
	510(k) SUMMARY
Device Description	The PROLENE Hernia System is a sterile, pre-shaped three dimensional device constructed of an onlay patch connected by a cylinder to a circular or oblong underlay patch. The material is undyed PROLENE* Polypropylene mesh constructed of knitted non-absorbable polypropylene filaments identical to that used in PROLENE* Polypropylene nonabsorbable surgical sutures, U.S.P (ETHICON, Inc.). This material, when used as a suture, has been reported to be nonreactive, and to retain its strength indefinitely in clinical use.
Intended Use	The PROLENE Hernia System is intended to be used for the repair of abdominal wall hernia defects.

Continued on next page

PROLENE* (Polypropylene) Hernia System ETHICON, Inc.

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FEB-18-1999 088:56

SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

510(k) SUMMARY, Continued

Indications Statement	The PROLENE Hernia System is indicated for the repair ofabdominal wall hernia defects.
TechnologicalCharacteristics	The modified device has identical technological characteristics tothe predicate device.
Performance Data	Nonclinical laboratory testing was not performed.
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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure with three wavy lines extending from the head, resembling hair or a symbolic representation of health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 1999

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

Re: K984220 Trade Name: PROLENE* (Polypropylene) HERNIA SYSTEM Regulatory Class: II Product Code: FTL Dated: November 24, 1998 Received: November 25, 1998

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 (QS) 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,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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16:19 FEB-18-1899

ETHICON, INC. NED/GT

Image /page/4/Picture/3 description: The image shows a series of numbers and letters in a stylized, handwritten font. The characters appear to be 'K94220'. The characters are bold and black, contrasting with the white background. The style of the characters gives the image an artistic or calligraphic feel.

INDICATION FOR USE

PROLENE* (Polypropylene) HERNIA SYSTEM.

510(k) Number (if known):

K984220

Device Name:

Indications for Use:

The PROLENE (Polypropylene) Hemia System is indicated for the
rs of the controllers in defects The PROLEINE (1 Siffect propped and hernia defects.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON

CE IN SEE OF AND NOTWER BAGE JE NEEDED) ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	X
	OR
	Over-The Counter Use

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number	K984220
---------------	---------

(Optional Format 1-2-9G)

PROLENE* (Polypropylene) Hemia System 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.