(84 days)
Not Found
No
The device description and performance studies focus on a physical clip for ligation, with no mention of AI/ML terms, image processing, or data-driven analysis.
No.
The device is used for ligation, which is a surgical procedure to tie off a blood vessel or other duct in the body. While this could be part of a therapeutic intervention (e.g., sterilization), the device itself is a surgical tool for ligation and not a therapeutic device meant to treat or cure a disease directly.
No
Explanation: The device, VasClip, is intended for ligation (tying off) of the vas deferens, which is a therapeutic rather than a diagnostic function. It is used to perform a procedure, not to identify or assess a medical condition.
No
The device description clearly states it is a "small polymeric self-locking clip," which is a physical hardware component, not software.
No, the VasClip is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- VasClip's Function: The VasClip is a surgical device used directly on the vas deferens within the body for ligation (tying off). It does not analyze any specimens taken from the body.
- Intended Use: The intended use clearly states "ligation of the vas deferens," which is a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, the VasClip falls under the category of a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The VasClip is intended for ligation of the vas deferens.
Product codes (comma separated list FDA assigned to the subject device)
NJC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vas deferens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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AUG 2 0 2002
Kozi 74T
510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | VasClip™ |
| Submitter | VMBC, LLC |
| 3600 Labore Road | |
| Suite 4 | |
| White Bear Lake, MN 55110 | |
| 651-482-8451 | |
| Contact | David Elliot |
| President & 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 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.
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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Image /page/1/Picture/0 description: The image contains a handwritten text string that appears to read "Kozi 745". The text is written in a cursive style, with some characters connected. The writing is dark and stands out against the white background.
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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract symbol consisting of three stylized human profiles facing to the right, with flowing lines above them. The symbol is black, and the background is white.
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
4
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)