PARIETENE POLYPROPYLENE MESH

K991400 · Sofradim Production · FTL · Jul 12, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991400
• Device Name: PARIETENE POLYPROPYLENE MESH
• Applicant: Sofradim Production
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jul 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Parietene® Polypropylene Mesh is a polypropylene mesh intended for the reinforcement of tissue during surgical repair. It is indicated for inguinal hernias, parietal reinforcement of tissues and abdominal wall hernia repair.

Device Story

Parietene® Polypropylene Mesh is a surgical implant used for tissue reinforcement during open or laparoscopic surgical procedures. The device consists of polypropylene monofilament stitches formed into square or rectangular meshes with rounded edges. Some models include a polyvinylidene fluoride thread to assist in folding the mesh for insertion through a trocar during laparoscopic procedures; this thread is removed post-unfolding. The mesh is secured to the patient using staples or sutures. It is intended for use by surgeons in clinical settings to provide structural support for abdominal wall and hernia repairs, potentially improving patient outcomes by reinforcing weakened tissue.

Clinical Evidence

Bench testing only. Performance characteristics including density, thickness, elongation, breaking strength, tear resistance, burst resistance, and tensile strength were evaluated by an independent laboratory (ITF de LYON) following ISO standards. Testing compared the subject device against Atrium and Visilex predicate meshes, demonstrating similar performance.

Technological Characteristics

Constructed from polypropylene monofilament stitches; some models include a polyvinylidene fluoride thread for insertion. Available in various square/rectangular sizes with rounded edges. Single-use. Fixed via staples or sutures. Evaluated for density, thickness, elongation, breaking strength, tear resistance, burst resistance, and tensile strength per ISO standards.

Indications for Use

Indicated for patients requiring surgical repair of inguinal hernias, parietal reinforcement of tissues, and abdominal wall 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-Davol Visilex® Mesh
• Atrium Medical Corporation Atrium® Mesh
• Sofradim Parietex® Meshes

Submission Summary (Full Text)

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JUL 12 999

K991400

## 510(k) Summary for Parietene® Polypropylene Mesh

SPONSOR 1.

·

Sofradim Production 197 Avenue Theodore Kraun 69400 Villefranche sur Saone France

Patrice Becker Contact: 33 04 74 60 03 27 Telephone: Facsimile: 33 04 74 60 03 66

- 2. DEVICE NAME

| Proprietary Name: | Parietene® Polypropylene Mesh |
|----------------------|-------------------------------|
| Common/Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh |

- 3. PREDICATE DEVICES
Bard-Davol Visilex® Mesh Atrium Medical Corporation Atrium® Mesh Sofradim Parictex® Meshes

#### DEVICE DESCRIPTION 4.

The Parietene® Polypropylene Mesh is used during open (laparounny) procedures The or during laparoscopic (transperitoneal or preperttoneal) procedures. Parietene® Polypropylene Mesh is offered in several sizes and designs to accommodate the type and approach of the operation as described below:

Parietene® Polypropylene Mesh Models PP 0611, 1510, 1515, 2020, and Parietene® PP 3030 can be used during oven or laparoscopic procedures. Parietence PP 1410, and 1510 are used only during laparoscopic procedures.

All of the models are made from polyethylenc and are available in various sizes.

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The Parietene® Polypropylene Mesh are nude from polypropylene sealed monofilament stitches and are offered in square and rectangular shapes with rounded edges. The Parietene® Pulypropylene Mesh are fixed to the patient by either staples or sutures.

The Parietene® Polypropylene Mesh Model 1410 contains a thread made from polyvinyl diffuorene. This thread is used to keep the mesh folded during insertion through a trocar during laparoscopic procedures. The thread is removed when the mesh has been unfolded in the trocar.

#### INTENDED USB 5.

The Parietene® Polypropylene Mesh is a polypropylene mesh intended for the reinforcement of tissue during surgical repair. It is indicated for inguinal hernias, parietal reinforcement of tissues and abdominal wall repair.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE ર્ભ.

The Parietene® Polypropyiene Mesh is substantially equivalent to the Sofradim Parietex® Mesbes, the Bard-Davol Visilex® Mesh, and the Atrium Medical Corporation Atrium® Mesh. The Parietene® Polypropylene Mesh and the predicate devices have the same intended use in that they are all used for reinforcement of tissue during surgical repair. The Parietene®, Parietex® Polypropylene Mesth and the Atrium Mesh are inserted either through open or laparoscopic methous whereas the Bard-Davol Visilex is inserted laparoscopically only.

The Parietene® Polypropylene Mesh. the Bard-Davol Visilex and Atrium Mesh predicate devices are all made from polypropylene scaled monofilament stitches. The Softadim Parietex® mesh is made from polyethylene terephtalate. The proposed and predicate devices all offer various sizes and shapes to accommodate different surgical procedures. The proposed Parietene® Mesh is also offered with a lateral slit for cord for easier insertion during laparoscopic procedures. All of the devices are fixed to the patient by either staples or sutures and are single use devices only.

#### 7. PERFORMANCE TESTING

Testing was performed to determine the performance characteristics of the Mesh. The density, thickness, clongation, breaking strength, tear resistance, burst resistance, tensile strength were sil evaluated by ITF de LYON, a test laboratory in France. All of the testing was performed using Atrium and Visilex Mesh

7/1/99

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predicate devices for comparative purposes and followed ISO standards. The test proults showed that the Sofradim and predicate devices were similar in performance charactcristics.

Sofradim 21000 Sofradim Parietene® Polypropylene Mesh

7/1/99 ·

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1:2 1999

Sofradim Production c/o Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K991400

> Trade Name: Perietene Polypropylene Mesh Regulatory Class: II Product Code: FTL Dated: April 21, 1999 Received: April 22, 1999

Dear Ms. McNamara:

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 - Ms. Mary McNamara-Cullinane, RAC

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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### K991400 510(k) Number (if known): _

Sofredim Parietung® Polypropylene Mesh Device Name:_

Indications For Use:

The Parleten® Palypropylene Meslu is a polypropylene mosh intended for the reinforcement of tissue during surgical repair. It is indicated for inguinal hermia», parietal reinforcement of tissues and abdominal wall hernia repair.

(PLEASH IN NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IP NECESSARY

Concurrentes of CDRH, Office of Device Evaluation (ODF.) Forman Sigh-Off in of General Restorative Devices (COO, 1400 ﻟﻠﺘﻨﺎ 510(k) Number -OR Over-The-Counter I.Jan Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Sofradim 7/1/99 510(k) Sofradim Parietene® Polypropylene Mesh Page v