MODIFICATION TO ENDOFAST RELIANT SYSTEM

K080836 · Endogun Medical Systems · FTL · Apr 21, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080836
• Device Name: MODIFICATION TO ENDOFAST RELIANT SYSTEM
• Applicant: Endogun Medical Systems
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Apr 21, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EndoFast Reliant™ System is indicated for fixation of surgical mesh to tissues for tissue reinforcement during minimally invasive procedures.

Device Story

The EndoFast Reliant™ System is a sterile, single-use surgical instrument set used for mesh fixation during minimally invasive procedures. The system includes a handle, a plastic fixation device preloaded with a Spider Fastener, and a plastic extraction device. The fixation device features an angulated distal end and requires locking into the handle to discharge the fastener. The extraction device utilizes a thread-guided mechanism for fastener removal under direct vision. The system also includes polypropylene monofilament surgical mesh provided in pre-cut shapes. The device is operated by a surgeon in a clinical setting. It facilitates tissue reinforcement by securing surgical mesh, with the extraction mechanism allowing for fastener retrieval if necessary.

Clinical Evidence

Bench testing only. Testing included reliability and insertion force of the fixation device, handle, and fastener; pullout strength of the fastener; reliability and force testing of the thread-guided extraction device; cadaver study; biocompatibility testing; and sterility/packaging validation.

Technological Characteristics

System components include plastic fixation and extraction devices, a handle, and polypropylene monofilament surgical mesh. The fixation device features an angulated distal end and a handle-locking mechanism. The extraction device uses a thread-guided mechanism. The system is sterile and single-use. No software or electronic components are described.

Indications for Use

Indicated for fixation of surgical mesh to tissues for tissue reinforcement during minimally invasive procedures.

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

• EndoFast Reliant™ System (K060329)

Submission Summary (Full Text)

{0}------------------------------------------------

K080836 page 1/3

#### 510(K) SUMMARY

APR 2 1 2008

# EndoGun Medical Systems Ltd EndoFast Reliant™ System

# 6.1.1 Applicant's Name:

EndoGun Medical Systems Ltd. Kibbutz Haogen, Israel, 42880 Tel: [phone] Fax: [phone] Email: [e-mail]

### 6.1.2 Contact Person:

Dorit Winitz, Ph. D Biomedical Strategy (2004) Ltd. Moshe Aviv Tower, 34th Floor, 7 Jabotinsky Street Ramat Gan 52520, Israel Tel: [phone] Fax: [phone] [e-mail]

## 6.1.3 Date Prepared:

March, 2008

## 6.1.4 Trade Name:

EndoFast Reliant™ System

### 6.1.5 Common Name:

Minimal invasive fastening device with surgical polymenric mesh.

# 6.1.6 Classification:

21 CFR 876.1500, 21 CFR 878.3300 Class:II KOG and GCI (Endoscope and accessories). FTL (Mesh, Surgical Polymeric)

# 6.1.7 Predicate Devices

EndoGun EndoFast Reliant™ Susyem, clered under K060329.

{1}------------------------------------------------

# K080636 page 2/3

## 6.1.8 Device Description:

The EndoFast Reliant™ System is a sterile, single use system, consisting of the following componnents:

- 1. Plastic Fixation Devices (X5) and a Handle. Each Fixation Device is preloaded with a Spider Fastener.
The Spider Fastener is provided with a Retrieval Unit, which together with the Extraction Device (described below), enables facile retrieval of the deployed Fastener when needed.

- 2. A plastic Extraction Device, provided for easy removal of the Fastener when needed, under direct vision.
- 3. Polypropylene monofilament Surgical Mesh

## 6.1.9 Intended Use:

The EndoFast Reliant™ System is indicated for fixation of surgical mesh tissues for tissue reinforcement during minimally to invasive procedures.

## 6.1.10 Performance Data & Substantial Equivalence

The EndoFast Reliant™ System is substantially equivalent in all aspects. e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available EndoFast Reliant™ System, cleared under K060329.

The principle changes between the devices include:

- The materials of the Fixation Device and the Extraction Device were 1. changed from stainless steel to plastic (the material of the stainless steel Fastener were not changed).
- The Fixation Device was angulated in its distal end. is
- A separate handle was added to the Fixation Device, thus discharge 3. of the Fastener can be accomplished only after the Fixation Device is locked in the Handle.
- The Extraction mechanism was changed to include a thread guided 4. mechanism.
- The pacakging of the device was changed to blister packaging. 5.
- The flat polypropylene monofilament surgical mesh is provided pre-6. cut in two shapes instead of one rectangular shape, to better suit different anatomies. The mesh with the 4 pouches at the corners is not used with the modified device.

{2}------------------------------------------------

K080836 Page 3/3

A series of safety and performance testing, including bench testing were performed to demonstrate that the modified EndoFast Reliant™ System does not raise any new questions of safety and efficacy. These tests include:

- Performance testing, including the reliability and insertion force test of I the Fixation Device and Handle and the Fastener, the reliability of the Fastener in expending and holding forces (pullout strength), the Extraction Device with Thread Reliability and force test, and the Cadaver study.
- 이 Biocompatibility testing.
- 8 Sterility and packaging testing.

Based on these tests results, EndoGun Medical Systems Ltd. believes that the modified EndoFast Reliant™ System is substantially equivalent to the cleared EndoFast Reliant™ System without raising new safety and/or effectiveness issues.

{3}------------------------------------------------

Public Health Service

Image /page/3/Picture/2 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" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2008

Endogun Medical Systems % Biomedical Strategy Dorit Winitz Jabotinsky St 7 Ramat Gan 52520 Israel

Re: K080836

Trade/Device Name: EndoFast Reliant™ System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 19, 2008 Received: March 25, 2008

Dear Dorit Winitz:

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.

{4}------------------------------------------------

Page 2 - Dorit Winitz

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 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millican

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

Enclosure

{5}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K080836

Device Name: EndoFast Reliant™ System

Indications for Use:

The EndoFast Reliant™ System is indicated for fixation of surgical mesh to tissues for tissue reinforcement during minimally invasive procedures.

Prescription Use _ V (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Oglan Forman

(Division Division of General, Restorative, and Neurological Devices

**510(k) Number** K080836

6-10