MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH

K984220 · ETHICON, Inc. · FTL · Feb 23, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K984220
• Device Name: MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
• Applicant: ETHICON, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Feb 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PROLENE Hernia System is intended to be used for the repair of abdominal wall hernia defects.

Device Story

Sterile, pre-shaped 3D device; consists of onlay patch connected by cylinder to circular or oblong underlay patch. Constructed of undyed, knitted non-absorbable polypropylene filaments; material identical to PROLENE surgical sutures. Used by surgeons for abdominal wall hernia repair. Device provides structural reinforcement for hernia defects; nonreactive; retains strength indefinitely in vivo.

Clinical Evidence

No clinical data; nonclinical laboratory testing was not performed.

Technological Characteristics

Material: Undyed, knitted non-absorbable polypropylene filaments (identical to U.S.P. surgical sutures). Form factor: 3D pre-shaped device with onlay patch, connecting cylinder, and underlay patch. Sterilization: Sterile.

Indications for Use

Indicated for the repair of abdominal wall hernia defects.

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

• PROLENE (Polypropylene) Hernia System (K984220)

Submission Summary (Full Text)

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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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# SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

### 510(k) SUMMARY, Continued

| Indications Statement | The PROLENE Hernia System is indicated for the repair of<br>abdominal wall hernia defects. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The modified device has identical technological characteristics to<br>the predicate device. |
| Performance Data | Nonclinical laboratory testing was not performed. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR<br>807) and the information provided herein, we conclude that the<br>new device is substantially equivalent to the Predicate Device<br>under the Federal Food, Drug, and Cosmetic Act. |
| Contact | Gregory R. Jones<br>Director, Regulatory Affairs<br>ETHICON, Inc.<br>Rt. #22, West<br>Somerville, NJ 08876-0151 |
| Date | |

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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# 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.

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div style="text-align:center;">X</div> |
|---------------------------------------|-----------------------------------------|
| | 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.

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