Weck Hem-o-lok Automatic Ligating Clip Appliers are indicated for use as delivery devices for Hem-o-lok non-absorbable polymer ligating clips. 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 structures to be ligated such that the clip completely encompasses the vessel or tissue structure.

Device Description

The Weck device is a sterile, single use, automatic ligating clip applier consisting of a handle, shaft containing 15 Hem-o-lok® locking polymer clips, and jaw. The major functions of the device are clip feeding, approximation (positioning the clip around the vessel), and closure. The applier is discarded after the surgical procedure whereas the applied non-absorbable polymer clips remain in the patient. Two models are offered: endoscopic and open surgery.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the Weck Hem-o-Lok™ Automatic Ligating Clip Applier. The document focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving performance against them.

Therefore, the requested information elements related to specific performance metrics, sample sizes for test and training sets, expert involvement, and ground truth establishment are not available in the provided text, as this type of detail is typically part of specific validation reports or clinical studies, not generally found in a 510(k) summary focused on substantial equivalence.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied): The primary "acceptance criteria" for a 510(k) submission are demonstrating substantial equivalence to existing legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.
Reported Device Performance: The document states:
- "The results of bench and animal testing demonstrate that any differences between the new device and its predicates do not adversely affect performance or safety."

Criterion (Implied by 510(k) Process)	Reported Device Performance
Substantial Equivalence to Predicate Devices	"The results of bench and animal testing demonstrate that any differences between the new device and its predicates do not adversely affect performance or safety." Technological characteristics are equivalent to predicate devices.
Functionality (Clip feeding, approximation, closure)	Device performs "clip feeding, approximation (positioning the clip around the vessel), and closure."
Safety	"bench and animal testing demonstrate that... differences... do not adversely affect performance or safety."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available in the provided text. The document refers to "bench and animal testing" but does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/available. This type of detail is typically for AI/imaging device studies. This device is a surgical instrument. The evaluation would likely involve engineering tests and animal models, reviewed by regulatory bodies and internal engineering/medical staff, rather than "experts establishing ground truth" in the diagnostic sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/available. As above, this is generally for diagnostic and AI studies, not for a surgical instrument's substantial equivalence pathway.

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 pertains to AI-assisted diagnostic devices, not a surgical ligating clip applier.

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

Not applicable. This pertains to AI algorithms, not a manual surgical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Implied Ground Truth: For a device like this, "ground truth" would relate to successful ligation, clip integrity, and lack of adverse events in preclinical (bench and animal) testing. The document states "bench and animal testing demonstrate that any differences between the new device and its predicates do not adversely affect performance or safety." This suggests the "ground truth" was established based on the functional performance criteria of the device in these controlled environments, likely involving criteria like clip deployment success rate, clip retention force, and absence of tissue damage or bleeding in animal models. The document doesn't explicitly state the methodology for establishing this.

8. The sample size for the training set

Not applicable/available. No "training set" in the machine learning sense is mentioned or implied for this mechanical device.

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

Not applicable/available. As above, no "training set" exists for this type of device submission.

Summary

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

K021808

PART 9 SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) SUMMARY

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.
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 May 13, 2002 Prepared:
Name of the Device, Common, Proprietary (if known), and Classification 2. Implantable clip Classification Name: Common Name: Ligating clip Weck Hem-o-Lok® Automatic Ligating Clip Applier Proprietary Name:
Identification of the legally marketed device to which the submitter claims 3. equivalence

The clips delivered by the proposed automatic applier described in this submission are substantially equivalent to Weck Hem-o-lok® clips. The delivery mechanism is substantially equivalent to the U.S.S.C. AutoSuture® Endoclip 5mm Disposable Clip Applier, and Weck reusable ligating clip appliers.

4. Description of the Device

5. Intended Use of the Device

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

Surgeons should apply the appropriate size clip for the size of the vessel or tissue structures to be ligated such that the clip completely encompasses the vessel or tissue structure.

Summary of Technological Characteristics 6.

The technological characteristics are equivalent to the predicate devices. The results of bench and animal testing demonstrate that any differences between the new device and its predicates do not adversely affect performance or safety.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.

AUG 1 4 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Weck James Lucky

Vice-President, Regulatory Affairs and Quality Assurance 2917 Weck Drive Durham, North Carolina 27709

Re: K021808

Trade/Device Name: Hem-o-Lok™ Automatic Ligating Clip Applier Regulation Number: 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: FZP Dated: May 31, 2002 Received: June 3, 2002

Dear Mr. Lucky:

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,

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

Page 2 – Mr. James Lucky .

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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" (21 CFR Part 807.97). 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 ia 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

{4}------------------------------------------------

KO21808

INDICATION FOR USE

Statement of Indications For Use

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

Hem-o-lok™ Automatic Ligating Clip Appliers Device Name:

Weck Hem-o-lok Automatic Ligating Clip Appliers are indicated for use as delivery devices for Hem-o-lok non-absorbable polymer ligating clips. Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeone should apply the appropriate size clip for the size of the vessel or tissue structures to be ligated such that the clip completely encompasses the vessel or tissue structure.

Note: The indications section of the labeling for the endoscopic model will refer to endoscopic use.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CRF 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Stupt. Rhodes

on of General. Restorative

510(k) Number K021808

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.