AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER

K061288 · United States Surgical, A Division of Tyco Healthc · FZP · Nov 2, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061288
• Device Name: AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Nov 2, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier has applications in many types of endoscopic procedures to achieve hemostasis following transection of vessels and other tubular structures, and for radiographic markings.

Device Story

The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier is a manual surgical instrument used in endoscopic procedures. It contains 16 titanium clips. The device is inserted through a trocar sleeve. The operator, typically a surgeon, uses a trigger handle to place a clip into the jaws and close them around a vessel or tubular structure to achieve hemostasis. It also serves for radiographic marking. The device provides a mechanical means to ligate structures, aiding in surgical control of bleeding and anatomical identification.

Clinical Evidence

Bench testing only. In-vitro and in-vivo tests were performed to verify the device's ability to occlude vessels and tubular structures and to validate intended performance.

Technological Characteristics

Manual clip applier; 33 cm shaft; 16 titanium clips; trigger handle; shaft rotation knob; clip counter window. Materials comply with ISO 10993-1. Mechanical operation.

Indications for Use

Indicated for patients undergoing endoscopic procedures requiring hemostasis of vessels or tubular structures, or for radiographic marking purposes.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Auto Suture™ ENDO CLIP™ Disposable Clip Applier (K883018)

Submission Summary (Full Text)

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

K061288

## 510(k) Summary of Safety and Effectiveness

| SUBMITTER: | United States Surgical, a division of Tyco Healthcare Group LP<br>150 Glover Avenue<br>Norwalk, CT 06856<br>Tel. No.: [phone] |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Frank Gianelli<br>Senior Associate, Regulatory Affairs<br>NOV - 2 2006 |
| DATE PREPARED: | October 2, 2006 |
| TRADE/PROPRIETARY NAME: | Auto Suture™ ENDO CLIP™ III 5mm Clip Applier |
| COMMON/USUAL NAME: | Implantable Clip |
| CLASSIFICATION NAME: | Implantable Clip |
| PREDICATE DEVICE(S): | Auto Suture™ ENDO CLIP™ Disposable Clip Applier (K883018) |
| DEVICE DESCRIPTION: | The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier<br>contains 16 titanium clips. The applier is designed for<br>introduction and use through an appropriately sized trocar<br>sleeve, or larger with the use of a converter. The ENDO<br>CLIP™ III 5mm Clip Applier consists of a trigger handle, shaft<br>rotation knob, clip counter window and a 33 cm shaft with jaws<br>at its distal end. Squeezing the handle places a titanium clip in<br>the jaws and closes the jaws to close the clip on the vessel or<br>structure. |
| INTENDED USE: | The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier has<br>applications in many types of endoscopic procedures to<br>achieve hemostasis following transection of vessels and other<br>tubular structures, and for radiographic markings. |
| TECHNOLOGICAL<br>CHARACTERISTICS: | The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier is<br>identical to the predicate device in terms of intended use and it<br>operates in a similar manner as the predicate device. |
| MATERIALS: | All components of the Auto Suture™ ENDO CLIP™ III 5mm<br>Clip Applier are comprised of materials which are in<br>accordance with ISO Standard 10993-1. |
| PERFORMANCE DATA: | In-vitro and in-vivo tests were performed to verify that the<br>ENDO CLIP™ III 5mm Clip Applier was substantially<br>equivalent to the predicate device in occluding vessels and<br>other tubular structures and to validate that the ENDO CLIP™<br>Ⅲ 5mm Clip Applier performed as intended. |

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form. The symbol is composed of three curved lines that converge at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

United States Surgical % Mr. Frank Gianelli Senior Associate, Regulatory Affairs 195 McDermott Road North Haven, Connecticut 06473

NOV - 2 2006

Re: K061288

Trade/Device Name: Auto Suture™ ENDO CLIP™ III 5mm Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: October 3, 2006 Received: October 4, 2006

Dear Mr. Gianelli:

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.

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

Page 2 - Mr. Frank Gianelli

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 Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly vours,

For Mark N. Mellon

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

Enclosure

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

K061288

## Indications For Use

510(k) Number (if known):

Device Name: Auto Suture™ ENDO CLIP™ III 5mm Clip Applier

Indications For Use:

The Auto Suture™ ENDO CLIP™ III 5mm Clip Applier has applications in many types of endoscopic procedures to achieve hemostasis following transection of vessels and other tubular structures, and for radiographic markings.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

(Division Sign-On)

Division of General, Restorative, and Neurological Devices

510(k) Number K061264