AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER

K071406 · United States Surgical, A Division of Tyco Healthc · FZP · Nov 21, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071406
• Device Name: AUTOSUTURE 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 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Auto Suture™ Endo Clip III™ 5mm Clip Applier is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic markings.

Device Story

Autosuture™ ENDO CLIP™ III 5mm Clip Applier is a manual surgical instrument for laparoscopic procedures. Device contains 18 titanium clips; features trigger handle, shaft rotation knob, clip counter window, and 33 cm shaft with distal jaws. Operated by surgeons through trocar sleeves. Squeezing handle loads clip into jaws and closes them onto vessels, ducts, or tubular structures for occlusion or radiographic marking. Device facilitates tissue manipulation and dissection during minimally invasive surgery.

Clinical Evidence

In-vitro and in-vivo animal testing performed to validate the expanded indications for use regarding tissue manipulation and dissection.

Technological Characteristics

Manual clip applier; 33 cm shaft; 18 titanium clips. Materials compliant with ISO 10993-1. Mechanical operation via trigger handle and jaw mechanism. No software or energy source.

Indications for Use

Indicated for patients undergoing laparoscopic surgical procedures requiring dissection and occlusion of blood vessels, ducts, and other tubular structures, or for radiographic markings.

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

• Autosuture™ ENDO CLIP™ III 5mm Clip Applier (K061288)

Submission Summary (Full Text)

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

## 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]<br>Fax No.: [phone] |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | NOV 2 1 2007<br>Jennifer Brennan<br>Manager, Regulatory Affairs |
| DATE PREPARED: | February 21, 2007 |
| TRADE/PROPRIETARY NAME: | Autosuture™ ENDO CLIP™ III 5mm Clip Applier |
| COMMON/USUAL NAME: | Implantable Clip |
| CLASSIFICATION NAME: | Implantable Clip |
| PREDICATE DEVICE(S): | Autosuture™ ENDO CLIP™ III 5mm Clip Applier (K061288) |
| DEVICE DESCRIPTION: | The Autosuture™ ENDO CLIP™ III 5mm Clip Applier contains<br>18 titanium clips. The applier is designed for introduction and<br>use through an appropriately sized Trocar sleeve, or larger<br>with the use of a converter. The ENDO CLIP™ III 5mm Clip<br>Applier consists of a trigger handle, shaft rotation knob, clip<br>counter window and a 33 cm shaft with jaws at its distal end.<br>Squeezing the handle places a titanium clip in the jaws and<br>closes the jaws to close the clip on the vessel or structure. |
| INTENDED USE: | The Auto Suture™ Endo Clip III™ 5mm Clip Applier is<br>primarily indicated for patients undergoing laparoscopic<br>surgical procedures involving dissection and occlusion of blood<br>vessels, ducts and other tubular structures, and for<br>radiographic markings. |
| TECHNOLOGICAL<br>CHARACTERISTICS: | The Autosuture™ ENDO CLIP™ III 5mm Clip Applier is<br>identical to the predicate device. The only change is the<br>inclusion of "manipulation of tissue and the dissection of blood<br>vessels and other tubular structures" to the general indications<br>for the Autosuture™ ENDO CLIP™ III 5mm Clip Applier. |
| MATERIALS: | All components of the Autosuture™ 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 animal tests were performed to support the<br>inclusion of "manipulation of tissue and the dissection of blood<br>vessels and other tubular structures" to the general indications<br>for the Autosuture™ ENDO CLIP™ III 5mm Clip Applier. |

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

United States Surgical % Ms. Jennifer Brennan Manager, Regulatory Affairs 150 Glover Avenue

NOV 2 1 2007

Re: K071406

Norwalk, Connecticut 06856

Trade/Device Name: Autosuture™ ENDO CLIP™ III 5 mm Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP, GDO Dated: October 24, 2007 Received: November 15, 2007

Dear Ms. Brennan:

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 -- Ms. Jennifer Brennan

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 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 N Millman

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

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

## Indications for Use

510(k) Number (if known): K071406

Device Name: Autosuture™ ENDO CLIP™ III 5 mm Clip Applier

Indications for Use:

The Auto Suture™ Endo Clip III™ 5mm Clip Applier is primarily indicated for patients undergoing laparoscopic surgical procedures involving dissection and occlusion of blood vessels, ducts and other tubular structures, and for radiographic markings.

Mark M. Milliman

(Division Sign-Cal (Division of General. Restorative, Divisiourological Devices

510(k) Number_

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)