Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Device Description

The Weck Hem-O-Lok™ ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. Hem-o-Lok™ causes hemostasis through vessel ligation. The modified XL size clip is a larger version of the existing Hem-o-lok clip.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device. This type of document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo clinical study data to prove acceptance criteria in the way a new AI/software device might.

Based on the provided text, there is no information available regarding "acceptance criteria" for device performance in the context of a study, nor is there a study described that proves the device meets such criteria. This document is a regulatory submission for a physical medical device (a ligating clip), not an AI/software device, and thus the questions about AI-specific metrics and study designs are not applicable.

Here's why each point cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance: Not present. The document focuses on technological characteristics being the same as or equivalent to a predicate device, rather than quantitative performance metrics against specific acceptance thresholds.
Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of performance evaluation as you might find for an AI device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary based on the document:

The document describes the Hem-O-Lok® Ligating Clip (specifically, a modified XL size clip) and asserts its substantial equivalence to previously cleared Weck Hem-o-lok® clip sizes. The primary argument is that the technological characteristics are the same as or equivalent to the predicate device, and a dimensional specification change does not adversely affect safety and effectiveness.

To clarify, this type of regulatory submission (510(k)) for a conventional medical device typically involves:

Comparison to a predicate device: Demonstrating that the new device is as safe and effective as a legally marketed device.
Performance Benchmarking (if applicable): For some devices, specific bench testing or engineering evaluations might be conducted to confirm that the changes (e.g., in dimensions) do not compromise key functional aspects like clip strength, locking mechanism, material integrity, etc. However, the provided text does not detail such studies or specific quantitative acceptance criteria for those tests.
No AI or software component: The questions about AI-specific studies and metrics are entirely irrelevant to this device and its submission.

Summary

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K 030311

SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Weck submits this summary of safety and effectiveness.

Submitter Name, Address, and Date of Submission 1.

FEB 2 6 2003

Brian Young Sr. Regulatory Affairs Manager Weck Closure Systems One Weck Drive Research Triangle Park, NC 27709 Telephone: (919) 361-4041 Facsimile: (919) 361-3914 January 29, 2003 Submitted:

2. Name of the Device, Common, Proprietary (if known), and Classification

Classification Name: Common Name: Proprietary Name: Classification:

Implantable clip Ligating clip Hem-O-Lok® Ligating Clip Class II, 21CFR §878.4300

1. Identification of the legally marketed device to which the submitter claims equivalence
  The XL size clip described in this submission is substantially equivalent to previously cleared Weck Hem-o-lok® clip sizes.

4. Description of the Device

5. Intended Use of the Device

6. Summary of Technological Characteristics

The technological characteristics are the same as or equivalent to the predicate device. The dimensional specification change does not adversely affect safety and effectiveness.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head, composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle's head.

Public Health Service

FEB 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brian Young Senior Regulatory Affairs Manager Weck Closure Systems One Weck Drive Research Triangle Park, North Carolina 27709

Re: K030311

Trade/Device Name: Hem-o-lok®Ligating Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: January 29, 2003 Received: January 30, 2003

Dear Mr. Young:

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.

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Page 2 - Mr. Brian Young

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K0305311

Statement of Indications For Use

510(k) Number (if known): New Application

Hem-o-lok™ Ligating Clip Device Name:

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Use
(Per 21 CRF 801.109)

Over-The-Counter

(Optional Format 1-2-96)

Muriam C. Provoost

Division of General, Restorative and Neurological Device

510(k) Number K030311

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.