The VasClip is a small polymeric self-locking clip that encircles the vas deferens and provides ligation. The device is identical to the Hem-O-Lok device in materials, manufacturing methods and sterilization cycle. The device is provided sterile and is intended for single use only. It is not intended to be resterilized or reused.

AI/ML Overview

The provided text states that "As the VasClip is identical to the Weck Closure Systems Hem-o-lok ligating clip, no additional testing was required." The acceptance criteria for the VasClip are therefore implicitly tied to the performance and clearance of its predicate device, the Hem-O-Lok ligating clip (K003337).

However, a study was conducted. The text mentions: "A study involving 124 men was conducted at a single center. The results of this study confirm the indication for ligation of the vas deferens." This study was conducted to confirm the indication for the ligation of the vas deferens, which is already a broader indication for the predicate device.

Given the information, we can deduce the following:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Ligation of the vas deferens	Confirmed indication for ligation of the vas deferens in 124 men.

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

Sample Size: 124 men
Data Provenance: Single center, retrospective or prospective is not explicitly stated. The nature of "confirming the indication" suggests it was likely a prospective study or an observational study following the use of the device.

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

This information is not provided in the text. The text does not detail how the "results of this study confirm the indication."

4. Adjudication Method for the Test Set:

This information is not provided in the text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. The study involved 124 men and aimed to confirm the indication, not to compare human readers with and without AI assistance.

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

This question is not applicable as the device is a physical ligating clip, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The text states "The results of this study confirm the indication for ligation of the vas deferens." The ground truth would likely be clinical success in achieving ligation, which could be measured by post-procedure patency tests or clinical follow-up. However, the specific method for establishing this clinical ground truth is not detailed.

8. The Sample Size for the Training Set:

This question is not applicable as the device is a physical ligating clip, not an algorithm that requires a training set.

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

This question is not applicable as the device is a physical ligating clip, not an algorithm that requires a training set.

Summary

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AUG 2 0 2002

Kozi 74T

510(k) Summary

General Information

Classification	Class II
Trade Name	VasClip™
Submitter	VMBC, LLC3600 Labore RoadSuite 4White Bear Lake, MN 55110651-482-8451
Contact	David ElliotPresident & CEO

Intended Use

The VasClip is intended for ligation of the vas deferens.

Predicate Devices

K003337 Hem-O-Lok Ligating Clip Weck Closure Systems

Device Description

The device is provided sterile and is intended for single use only. It is not intended to be resterilized or reused.

Materials

All materials used in the manufacture of the VasClip are suitable for this use, have been used in numerous previously cleared products and are the same as used in the previously cleared Weck Closure System Hem-O-Lok ligating clip.

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Testing

As the VasClip is identical to the Weck Closure Systems Hem-o-lok ligating clip, no additional testing was required. A study involving 124 men was conducted at a single center. The results of this study confirm the indication for ligation of the vas deferens. This indication is found within the broader indication currently commercialized by Weck Closure Systems in the predicate Hem-o-lok device.

Summary of Substantial Equivalence

The VasClip is identical to the predicate products. The indication for use is within the indications for use of the proviously cleared Hem-()-Lok ligating clip indications. Further, the manufacturing procedures, materials and sterilization cycle are identical as well. Therefore, VMBC, LLC believes the VasClip is substantially equivalent to existing legally marketed devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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AUG 2 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Elliot, Jr. President and CEO VMBC. LLC 3600 LaBore Road, Suite 4 White Bear Lake, Minnesota 55110

Re: K021745 Trade/Device Name: Vasclip Regulation Number: 878.4300 Regulation Name: Implantable Clip Regulatory Class: II Product Code: NJC Dated: May 24, 2002 Received: May 28, 2002

Dear Mr. Elliot:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The effectiveness of using the Vasclip for permanent male sterilization has not been evaluated in comparison to standard vasectomy procedures.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Mr. David Elliot, Jr.

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.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally 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,

Bernard F. Statland, M.D., Ph.D.

Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO21745

Indications for Use

510(k) Number (if known):

This application

Device Name:

VasClip™

Indications for Use:

The VasClip is intended for ligation of the vas deferens.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format 1-2-96)

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.