← Product Code [FTL](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL) · K061704

# OPTILENE MESH (K061704)

_Aesculap, Inc. · FTL · Jul 19, 2006 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL/K061704

## Device Facts

- **Applicant:** Aesculap, Inc.
- **Product Code:** [FTL](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FTL.md)
- **Decision Date:** Jul 19, 2006
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 878.3300
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Indications for Use

Optilene Meshes (Standard, Universal, and Elastic) are indicated for hernioplasty and repair of other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

## Device Story

Optilene Mesh is a synthetic, implantable surgical mesh used for reinforcement of connective tissue structures. Device consists of monofilament polypropylene knitted into a thin, flexible, dimensionally stable net. Available in various sizes and shapes; provided as sterile, single-use device. Intended for use by surgeons in clinical settings for hernioplasty and fascial defect repair. Provides mechanical support to tissue, facilitating surgical repair and patient recovery.

## Clinical Evidence

Bench testing only; conducted in accordance with FDA guidance 'Guidance for the Preparation of a Premarket Notification for a Surgical Mesh'.

## Technological Characteristics

Material: monofilament polypropylene nonabsorbable suture material. Construction: knitted net. Form factor: thin, flexible sheet in various sizes/shapes. Sterilization: sterile single-use.

## Regulatory 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

- Aesculap Optilene® Mesh LP ([K053158](/device/K053158.md))

## Submission Summary (Full Text)

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Optilene® Mesh Line Er

# JUL 1 9 2006

Page 1 of 1

#### B. 510(k) SUMMARY (as required by 21 CFR 807.92)

#### Optilene® Mesh Line Extension June 14, 2006

| COMPANY:             | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT:             | Lisa M. Boyle<br>610-984-9274 (phone)<br>610-791-6882 (fax)                                                        |
| TRADE NAME:          | Optilene® Mesh                                                                                                     |
| COMMON NAME:         | Surgical Mesh                                                                                                      |
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric                                                                                          |
| REGULATION NUMBER:   | 878.3300                                                                                                           |
| PRODUCT CODE:        | FTL                                                                                                                |

## SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Optilene® Mesh is substantially equivalent to:

- Aesculap Optilene® Mesh LP (K053158) .
### DEVICE DESCRIPTION

Optilene® Mesh is a synthetic implantable sheet for the reinforcement of connective tissue structures. It consists of monofilament polypropylene, which is knitted into a dimensionally stable, thin, and flexible net that is cut into various sizes and shapes.

### INDICATIONS FOR USE

The Optilene® Meshes (Standard, Universal and Elastic) are indicated for hernioplasty and repair of other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

### TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s)}

All meshes are woven from monofilament polypropylene nonabsorbable suture material. Optilene® Meshes and Optilene® Mesh LP are also marketed in similar shapes and sizes that are packaged as sterile single use devices.

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# PERFORMANCE DATA

Sufficient bench testing was conducted in accordance with the FDA guidance document "Guidance for the Preparation of a Premarket Notification for a Surgical Mesh" to show that Aesculap's Optilene® Meshes are comparable to the predicate surgical mesh.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized depiction of a human figure, represented by three curved lines, enclosed within a circle. The words "U.S. Department of Health and Human Services" are arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2006

Aesculap®, Inc. % Ms. Lisa M. Boyle Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K061704

Trade/Device Name: Optilene® Mesh Line Extension Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: June 14, 2006 Received: June 22, 2006

Dear Ms. Boyle:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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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Page 2 – Ms. Lisa M. Boyle

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prarketed 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), please 11 you t the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buehum

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Optilene® Mesh Line Extension

Page 1 of 1

#### A. INDICATIONS FOR USE STATEMENT

510(k) Number: K06/704

Device Name: Optilene® Mesh Line Extension

Indications for Use:

Optilene Meshes (Standard, Universal, and Elastic) are indicated for hernioplasty and repair of other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

and/or Over-the-Counter Use Prescription Use (per 21 CFR 801 Subpart D) (per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

houbare Buchim

Division of General, Restorative, and Neurological Devices

**510(k) Number** K061704

2.

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