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

Weck Closure System's 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 clip is nonabsorbable and is manufactured from polyacetal.

The clips are housed in a cartridge and packaged in a rigid plastic blister with Tyvek coated lidding which is sold sterile. The method of sterilization will be EtO with a SAL of 10°. The blister packs are fitted into an overpack carton which serves as the sales unit.

AI/ML Overview

This document is a 510(k) Premarket Notification summary for the Hem-O-Lok® Ligation Clips. It describes the device, its intended use, and claims substantial equivalence to a previously cleared device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically found for AI/ML-based medical devices.

The information provided describes a traditional
medical device (ligation clips), not an AI/ML-based device. Therefore, many of the typical acceptance criteria and study components for AI/ML devices (like sample size for test/training sets, ground truth methodology, expert qualifications, MRMC studies, standalone performance) are not applicable or not reported in this type of submission for a physical device.

Here's an analysis based on the provided document, addressing the relevant points and noting where information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify formal "acceptance criteria" and "reported device performance" in the context of a statistical study for efficacy or performance as would be expected for a diagnostic or AI/ML device. For a physical device like a ligation clip, acceptance is typically based on:

Acceptance Criterion	Reported Device Performance / Equivalence Claim
Biocompatibility	Polyacetal material is shown to be biocompatible.
Sterility	Sterilized by EtO with a SAL of 10⁻³ (This is a standard for sterility and implies the device meets this standard).
Functionality	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. (Implies functional performance similar to predicate).
Material	Manufactured from polyacetal (same as predicate).
Non-absorbable	Non-absorbable (as per predicate).
Packaging	Clips housed in a cartridge, packaged in a rigid plastic blister with Tyvek coated lidding, sold sterile. (Meets quality and integrity standards).
Substantial Equivalence	The device is substantially equivalent to Hem-O-Lok® clips cleared under Weck's previous 510(k) filing number 982941.

2. Sample size used for the test set and the data provenance

Not applicable. This is a physical, manually applied surgical device. Its performance is demonstrated through material properties, manufacturing controls, and equivalence to a predicate device, not through a "test set" of data in the AI/ML sense. Data provenance regarding country of origin or retrospective/prospective does not apply here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the context of an AI/ML device for disease detection or measurement, is not relevant for this physical surgical clip.

4. Adjudication method for the test set

Not applicable. An adjudication method for a test set is not relevant for this physical surgical clip.

5. 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 a physical surgical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical surgical device, not an algorithm.

7. The type of ground truth used

Not applicable. Ground truth is not a concept applied to the evaluation of a physical surgical clip in this context. The "truth" is its physical and material properties, and its ability to achieve ligation, which is established through manufacturing, standards, and clinical use history of similar devices.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. There is no AI/ML algorithm requiring a training set and associated ground truth.

Summary of Study (Substantial Equivalence Determination)

The "study" or justification proving the device meets acceptance criteria (primarily substantial equivalence) is based on the following:

Comparison to a Predicate Device: The Hem-O-Lok® clip is deemed substantially equivalent to Weck's previous Hem-O-Lok® clips cleared under 510(k) filing number 982941. This means the new device shares similar technological characteristics, intended use, and performance claims as a device already on the market.
Technological Characteristics: The document states that the technological characteristics are the "same as or equivalent to the predicate device." This includes the polyacetal material used, which is confirmed to be biocompatible.
Intended Use: The intended use "for procedures involving ligation of vessels or tissue structures" is identical to the predicate.
Manufacturing and Sterilization: The device is manufactured from polyacetal, is nonabsorbable, housed in a cartridge, sterile-packaged, and sterilized by EtO with a SAL of 10⁻⁶. These are standard practices and properties for such devices, implying compliance with established safety and performance benchmarks.

In essence, the "study" for this device is a demonstration of equivalence to an already legally marketed device, supported by known material properties and manufacturing processes, rather than a prospective clinical trial or performance evaluation against a diagnostic ground truth.

Summary

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Premarket Notification [510(k)] Summary for Hem-O-Lok® Ligation Clips

Submitter Name, Address, and Date of Submission 1.

Brian Young Regulatory Affairs Manager Weck Closure Systems One Weck Drive Research Triangle Park, NC 27709

Telephone: (919) 361-4041 Facsimile: (919) 361-3914

August 26, 1999 Submitted:

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

Classification Name:	Implantable clip
Common Name:	Ligating clip
Proprietary Name:	Hem-O-Lok® Ligating clip

Identification of the legally marketed device to which the submitter claims 3. equivalence

The Weck Closure Systems Hem-O-Lok® clip is substantially equivalent to Hem-O-Loke clips cleared under Weck's previous 510(k) filing number 982941.

4. Description of the Device

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Intended Use of the Device ನ.

Summary of Technological Characteristics 6.

The technological characteristics are the same as or equivalent to the predicate device. The polyacetal material used in the clips is shown to be biocompatible.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, which is a common symbol used by the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 1999

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

K993157 Re: Trade Name: Hem-O-Lok SMX Polymer Clips, Model 544220 Regulatory Class: II Product Code: FZP Dated: September 7, 1999 Received: September 21, 1999

Dear Mr. Young:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Brian J. Young

This letter will allow you to begin marketing vour device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Neil R.P. Ogden

James E. Dillard I Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2 Statement of indications for use

510(k) Number (if assigned): Device Name:

Hem-O-Lok® ligating clips

INDICATIONS FOR USE

Hem-O-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tion o box "higating onps 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.

NRO for
(Division Sior Off)
Division of Ceneral Restorative Devices
510(k) Number K993157

Concurrence of CDRH, Office of Device Evaluation (ODE)

. . . .
. . . . . . .
. . . . . . . .

X Prescription use

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.