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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the LIGACLIP® 5 M/L Endoscopic Multiple Clip Applier. The submission asserts substantial equivalence to a predicate device based on similar intended use and operation.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated	"All testing results demonstrated satisfactory performance."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified.
Data Provenance: Not specified, but implied to be bench testing. The country of origin and whether it was retrospective or prospective is not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

Number of Experts: Not applicable, as ground truth typically refers to clinical data or expert review for diagnostic devices. This device is a surgical instrument.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. This is a surgical instrument, not a diagnostic device requiring adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic devices to assess human reader performance with and without AI assistance. This device is a surgical instrument.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Standalone Study: Not applicable. This device is a manual surgical instrument, not an algorithm.

7. The Type of Ground Truth Used:

Type of Ground Truth: Not applicable in the traditional sense for diagnostic AI. For a surgical instrument, "ground truth" would relate to its mechanical function and safety. The text states "Bench testing was performed to ensure that the device performs as intended," implying functional and performance tests.

8. The Sample Size for the Training Set:

Sample Size: Not applicable. This device is a surgical instrument, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.

Summary of the Study:

The document states: "Bench testing was performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance." This indicates that the study was limited to bench testing, which assessed the device's mechanical and functional performance, likely against internal specifications or engineering requirements. The specific acceptance criteria and detailed results of this bench testing are not provided in the summary. The basis for clearance is substantial equivalence to an existing predicate device, implying that its performance is considered acceptable if it performs comparably to the predicate for its intended use.

Summary

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K050344 Page 1/2

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

Indications for Use

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K050344 Agycz/2

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 (800) 638-2041 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)

Page 1 of 1

Division of General, Restorative, and Neurological Devices

K050344

510(k) Number

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.