LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER

K050344 · Ethicon Endo Surgery, Inc. · FZP · Mar 14, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050344
• Device Name: LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER
• Applicant: Ethicon Endo Surgery, Inc.
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Mar 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LIGACLIP® 5 M/L 5 mm Endoscopic Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with the size of the clip.

Device Story

LIGACLIP® 5 M/L is a sterile, single-patient-use, disposable endoscopic surgical instrument; used for ligation of tubular structures or vessels. Device features pistol grip handle, actuation trigger, rotation knob, and 5.5mm diameter/33cm length shaft. Distal jaws form 15 pre-loaded metal ligating clips. Operated by surgeons during endoscopic procedures; device inserted through appropriately sized trocar. Surgeon manually triggers clip deployment to ligate tissue. Provides mechanical vessel occlusion; benefits patient by enabling secure hemostasis or tissue closure during minimally invasive surgery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Sterile, single-use, disposable endoscopic instrument. 5.5mm diameter shaft, 33cm length. Pistol grip handle with trigger and rotation knob. Mechanical jaw-based clip applier. Contains 15 metal ligating clips.

Indications for Use

Indicated for ligation of tubular structures or vessels requiring metal ligating clips. Patient population includes individuals undergoing endoscopic procedures where vessel or tissue ligation is necessary.

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

• LIGACLIP® ERCA Endoscopic Rotating Multiple Clip Applier (K0864102)
• Titanium Clips (K830503)

Submission Summary (Full Text)

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# LIGACLIP® 5 M/L 510(k) Summary of Safety and Effectiveness

#### Company

Ethicon Endo-Surgery, Inc. 4545 Creck Rd. Cincinnati, OH 45242

MAR I 4 2005

#### Contact

Kimberly Shoemaker Manager, Regulatory Affairs

#### Date Prepared:

February 10, 2005

#### Name of Device

Trade Name: LIGACLIP® 5M/L Endoscopic Multiple Clip Applier Classification Name: Implantable Clip

#### Predicate Devices:

Trade Name: LIGACLIP® ERCA Endoscopic Rotating Multiple Clip Applier Cleared under 510(k) numbers K0864102 on November 5, 1986. The Titanium Clips used with the applier were cleared March 9, 1983 under K830503.

#### Device Description

The LIGACLIP® 5 M/L Endoscopic Multiple Clip Applier is a sterile, single patient use, disposable surgical instrument designed to provide a means of ligation through an appropriately sized trocar. The instrument configuration consists of a pistol grip hadle, an actuation trigger, a rotation knob, a shaft having an outer diameter of 5.5mm and a length of 33cm. At the distal end of the shaft is a set of jaws for forming ligating cligs. The device contains 15 clips.

### Indications for Use

The LIGACLIP® 5 M/L 5 mm Endoscopic Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with the size of the clip.

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## Technological Characteristics

The LIGACLIP® 5 M/L 5 mm Endoscopic Multiple Clip Applier is identical to the predicate device with respect to intended use. The device is operated in a manner similar to the predicate device.

### Performance Data

Bench testing was performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance.

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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. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an eagle with its wings spread, facing to the left. The eagle is a stylized representation, with three distinct lines forming its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2005

Ms. Kimberly Shoemaker Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K050344

K030544
Trade/Device Name: LIGACLIP® 5M/L 5mm Endoscopic Multiple Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: February 10, 2005 Received: February 11, 2005

Dear Mr. Shoemaker:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to tegantly the Medical Device Amendments. or to commerce provide to May 20, 1976, the enacement with the provisions of the Federal Food. Drug. devices that have been reclasined in asseroval of a premarket approval application (PMA). and Cosment Act (Tel) that to hot require appt to the general controls provisions of the Act. The r ou may, merciolo, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (500 above) this. Existing major regulations affecting your device can may be subject to subject to submitted and ever and the may be and . In addition. FDA may be found in the over ments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Drive issualites your device complies with other requirements of the Act that I DA has made a actuations administered by other Federal agencies. You must or ally it catal statutes and regalations and admited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY an 607), adomig (21 OFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Ms. Kimberly Shoemaker

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin marketing your and equivalence of your device to a legally premitired notification. The FDA mining of cation 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 If you desire specific advice for your as not 15. Also, please note the regulation entitled. Comacit the Office of Compullios in (21CFR Part 807.97). You may obtain of Small other general miorination on your response Assistance at its toll-free number [phone] or Manufacturers, International und Ochsander 16.000 viedrh/industry/support/index.html

Sincerely yours,

sincerely yours,

Mark A. Millican

Miriam C. Provost. Ph.D. Acting Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Ethicon Endo-Surgery, Inc., a Johnson & Johnson company. The logo includes a graphic element on the left and the company name and affiliation on the right. Below the company information is the address: 4545 Creek Road, Cincinnati, Ohio 45242-2839.

# Indications for Use

510(k) Number (if known): 4050344

Device Name: 1.IGACLIP® 5.M/I. 5 mm Endoscopic Multiple Clip Applier

Indications for Use:

The LIGACLIP® 5 M/L 5 mm Endoscopic Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.

| Prescription Use (Part 21 CFR 801 Subpart D) | x |
|----------------------------------------------|--------|
| | 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)

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Division of General, Restorative, and Neurological Devices

K050344

**510(k) Number**