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PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH

Q: Who is the manufacturer of PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH?

ETHICON, Inc. filed the 510(k) submission for PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH (K972412).

Q: What is the FDA product code for PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH?

FTL. It is classified under 21 CFR 878.3300 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH?

BARD® Marlex® Mesh PerFix® Plug (K972412).

K972412 · ETHICON, Inc. · FTL · Sep 10, 1997 · General, Plastic Surgery

Device Facts

Record ID	K972412
Device Name	PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
Applicant	ETHICON, Inc.
Product Code	FTL · General, Plastic Surgery
Decision Date	Sep 10, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.3300
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The PROLENE Mesh Hernia Device is intended to be used for the repair of indirect and direct inguinal hernia defects..

Device Story

PROLENE Polypropylene Mesh Hernia Device is a sterile, pre-shaped, three-dimensional surgical implant; consists of an onlay patch connected by a mesh cylinder to a circular underlay patch. Constructed of knitted, non-absorbable polypropylene filaments identical to those used in PROLENE surgical sutures. Used by surgeons in clinical settings for inguinal hernia repair. Device design allows for placement without the need for securing sutures, unlike the predicate device which requires suturing of a fluted mesh. Provides structural support for hernia repair; promotes tissue ingrowth; maintains position in the inguinal canal.

Clinical Evidence

Bench testing only. Preclinical study conducted to demonstrate effectiveness in repairing inguinal hernias, maintaining position in the inguinal canal without sutures, and confirming postoperative tissue ingrowth and functionality.

Technological Characteristics

Pre-shaped, three-dimensional mesh device. Material: Knitted non-absorbable polypropylene monofilaments (identical to U.S.P. PROLENE surgical sutures). Design: Integrated onlay patch, mesh cylinder, and circular underlay patch. Sterile. Non-electronic, mechanical implant.

Indications for Use

Indicated for the repair of indirect and direct inguinal hernia defects in patients requiring hernia repair.

Regulatory Classification

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.

Predicate Devices

BARD® Marlex® Mesh PerFix® Plug (K972412)

Related Devices

K984220 — MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH · ETHICON, Inc. · Feb 23, 1999
K963141 — KUGEL HERNIA PATCH · Douglas Bueschel · Oct 11, 1996
K043191 — REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH · Angiologica B. M. Srl · May 16, 2005
K181268 — PROLENE (Polypropylene) 3D Patch · ETHICON, Inc. · Jul 26, 2018
K180829 — PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh · ETHICON, Inc. · Jun 28, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ K972412 # SEP 1 0 1997 ﻤﺴﺌ #### SECTION 7 # 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. | |-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | NEW DEVICE NAME: ETHICON PROLENE* Polypropylene Mesh Hernia Device Nonabsorbable Synthetic Surgical Mesh Implant. | | | PREDICATE DEVICE NAME: BARD® Marlex® Mesh PerFix® Plug Nonabsorbable Polypropylene Surgical Mesh Device. | | | 510(k) SUMMARY | | Device Description | The PROLENE Polypropylene Mesh Hernia Device is a sterile, pre-shaped, three dimensional device constructed of an onlay patch connected by a mesh cylinder to a circular 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 Mesh Hernia Device is intended to be used for the repair of indirect and direct inguinal hernia defects.. | | Indications Statement | The PROLENE Mesh Hernia Device is indicated for the repair of inguinal hernia defects, both indirect and direct. | | Technological Characteristics | The modified device has comparable technological characteristics to the predicate device. Both devices are pre-shaped, three dimensional devices constructed of knitted polypropylene monofilaments. | | | When compared to the predicate device, the PROLENE Mesh Hernia Device is a single device which requires no sutures to secure into place. The PerFix Plug is available as two separate pieces in which the fluted mesh must be sutured into place. | | Performance Data | ETHICON, Inc has conducted a preclinical study to show that the PROLENE Mesh Hernia Device is effective in repairing inguinal hernias, maintaining its position in the inguinal canal without the aid of sutures. Postoperative tissue ingrowth and functionality were demonstrated. | | Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the modified device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act. | PROLENE Polypropylene Mesh Hernia Device ETHICON, Inc. ・・・・・ {1}------------------------------------------------ # SUMMARY OF SAFETY AND EFFECTIVENESS, Continued 510(k) SUMMARY, Continued Continued on next page * Trademark PROLENE Polypropylene Mesh Hernia Device ETHICON, Inc. . ・ : {2}------------------------------------------------ #### SUMMARY OF SAFETY AND EFFECTIVENESS, Continued Contact Gregory R. Jones Director, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151 Date June 25, 1997 PROLENE Polypropylene Mesh Hernia Device ETHICON, Inc. 21 . . . . . : ・. {3}------------------------------------------------ Image /page/3/Picture/11 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with its wings spread. The eagle is facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 1 0 1997 Mr. Gregory R. Jones Director, Regulatory Affairs ETHICON, Inc. PO Box 151 Somerville, New Jersey 08876-0151 Re: K972412 Trade Name: PROLENE Polypropylene Mesh Hernia Device Regulatory Class: II Product Code: FTL Dated: June 25, 1997 Received: June 26, 1997 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 requirements , as set forth in the Quality System Regulation (OS) 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. {4}------------------------------------------------ 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. tsoblef 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 {5}------------------------------------------------ K972412 and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contributi # INDICATIONS FOR USE 510(k) Number (if known): Device Name: A. A. M. Indications for Use: PROLENE Polypropylene Mesh Hernia Device_ The PROLENE Polypropylene Mesh Hernia Device is indicated for the repair of indirect and direct inguinal hernia defects. #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | <img height="10" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAUAAAAFCAYAAACNbyblAAAAHElEQVQI12P4//8/w+Y0AIQYGBiYGBgYGBgYGBgYAAKkAA76mO0AAAAASUVORK5CYII=" width="10"/> | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | (Division Sign-Off) | | | Division of General Restorative Devices | | | 510(k) Number | K97241 | | Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The Counter Use | |---------------------------------------|---|----|----------------------| |---------------------------------------|---|----|----------------------| (Optional Format 1-2-9G)