(36 days)
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.
The Weck Hem-o-Lok® ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. The clips are intended for use in procedures involving ligation of vessels or tissue structures.
The Hem-o-Lok® clips are made from a non-absorbable acetyl polymer and are available in various sizes. Surgeons select 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.
The document provided does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria based on metrics like accuracy, sensitivity, or specificity. This 510(k) summary (K063914) for the Hem-o-Lok® Ligating Clip primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance:
Not applicable. The document does not specify quantitative acceptance criteria or performance metrics such as accuracy, sensitivity, or specificity for the device. The basis for clearance is substantial equivalence to predicate devices, implying that its performance is considered comparable.
2. Sample size used for the test set and the data provenance:
Not applicable. No new performance study or test set is described in this 510(k) summary. The submission relies on the established safety and effectiveness of predicate devices.
3. 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 is described for a new study.
4. Adjudication method for the test set:
Not applicable.
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 device is a passive implantable clip and not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies and AI assistance metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
Not applicable. The clearance is based on substantial equivalence, implying that the established safety and effectiveness of the predicate devices serve as the "ground truth" for the current device's acceptability.
8. The sample size for the training set:
Not applicable. No new training set is described for this submission.
9. How the ground truth for the training set was established:
Not applicable.
Summary of Device and Regulatory Action:
- Device Name: Hem-o-Lok® Ligating Clip
- Device Description: Manually applied hemostatic clip made from non-absorbable acetyl polymer, available in various sizes.
- Intended Use: For use in procedures involving ligation of vessels or tissue structures.
- Regulatory Basis: Substantial equivalence to predicate devices (K982941, K993157, K003337, K030311, and K021808). The FDA determined that the device is substantially equivalent to legally marketed predicate devices. This means that direct, new performance studies with specific acceptance criteria are not typically required for this type of submission when substantial equivalence can be demonstrated.
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Image /page/0/Picture/1 description: The image shows the logo for Teleflex Medical. The word "Teleflex" is in a bold, sans-serif font, with a stylized "T" that resembles a bent tube. Below "Teleflex" is the word "MEDICAL" in a smaller, sans-serif font. The logo is black and white.
Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, II. 60015 USA Phone: 847-572-8002 Fax: 847-572-8001 www.teleflex.com
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Hem-o-Lok® Ligating Clips
A. Name, Address, Phone and Fax Number of Applicant
Telefiex Medical 2345 Waukegan Road Suite 120 Bannockburn, IL 60015
NOV - 2 2006
B. Contact Person
Lori Hays Senior Manager Regulatory Affairs
C. Date Prepared
September 21, 2006
D. Device Name
Trade Name: Hem-o-Lok® Ligating Clip Common Name: Ligating Clip Classification Name: Implantable Clip Product Code: FZP Regulation Number: 21 CFR 878.4300 Class: Il
E. Device Description
The Weck Hem-o-Lok® ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. The clips are intended for use in procedures involving ligation of vessels or tissue structures.
The Hem-o-Lok® clips are made from a non-absorbable acetyl polymer and are available in various sizes. Surgeons select 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.
F. Intended Use
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.
G. Substantial Equivalence
The Weck Hem-o-Lok® ligating clips are substantially equivalent to the The Weck Hemo-Lok® clips previously cleared under 510(k)s: K982941, K993157, K003337, K030311. and the Hem-o-Lok® ML Automatic Endoscopic Applier cleared under 510(k) K021808.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a series of flowing lines. The symbol is composed of three curved lines that converge at the bottom, creating a sense of movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Teleflex Medical Group % Ms. Lori Hays, MT, RAC Senior Manager, Regulatory Affairs 2345 Waukegan Road Bannockbun, Illinois 60015
NOV - 2 2006
Re: K062914
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: September 21, 2006 Received: September 27, 2006
Dear Ms. Hays:
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 - Ms. Lori Hays, MT, RAC
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 (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Hem-o-Lok® Ligating Clip
Indications For Use:
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 vessels or tissue structure to be ligated such the clip completely encompasses the vessel or tissue structure
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of General, Restorativo
and Neurological Devices
510(k) Number L022914
§ 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.