(27 days)
Not Found
Not Found
No
The summary describes a manually applied ligation clip and makes no mention of AI or ML technology.
No
The device is a ligating clip used for hemostasis, not for therapy or treatment of a disease or condition. It aids in procedures by ligating vessels or tissue structures.
No
This device, the Hem-o-lok ligating clip, is described as being used for "ligation of vessels or tissue structures" and "to connect internal tissues to aid healing" and "causes hemostasis through vessel ligation." These are therapeutic or surgical functions, not diagnostic ones. There is no mention of the device being used to identify, measure, or monitor medical conditions or diseases.
No
The device description clearly states it is a "manually applied hemostatic clip," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ligation of vessels or tissue structures" during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device is a "manually applied hemostatic clip intended to connect internal tissues to aid healing." This describes a physical device used internally.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. The description of the Hem-o-lok clip does not involve any such testing or analysis of specimens.
Therefore, the Hem-o-lok ligating clip is a surgical device used for internal ligation, not an in vitro diagnostic device.
N/A
Intended Use / 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 vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
Product codes
FZP
Device Description
The Weck 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 modified XL size clip is a larger version of the existing Hem-o-lok clip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels or tissue structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
previously cleared Weck Hem-o-lok® clip sizes.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
K 030311
SUMMARY OF SAFETY AND EFFECTIVENESS
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.
FEB 2 6 2003
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 January 29, 2003 Submitted:
2. Name of the Device, Common, Proprietary (if known), and Classification
Classification Name: Common Name: Proprietary Name: Classification:
Implantable clip Ligating clip Hem-O-Lok® Ligating Clip Class II, 21CFR §878.4300
-
- Identification of the legally marketed device to which the submitter claims equivalence
The XL size clip described in this submission is substantially equivalent to previously cleared Weck Hem-o-lok® clip sizes.
- Identification of the legally marketed device to which the submitter claims equivalence
4. Description of the Device
The Weck 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 modified XL size clip is a larger version of the existing Hem-o-lok clip.
5. Intended Use of the Device
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.
6. Summary of Technological Characteristics
The technological characteristics are the same as or equivalent to the predicate device. The dimensional specification change does not adversely affect safety and effectiveness.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head, composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle's head.
Public Health Service
FEB 2 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brian Young Senior Regulatory Affairs Manager Weck Closure Systems One Weck Drive Research Triangle Park, North Carolina 27709
Re: K030311
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: January 29, 2003 Received: January 30, 2003
Dear Mr. Young:
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.
2
Page 2 - Mr. Brian Young
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 (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" (21CFR Part 807.97) you may obtain. 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,
Miriam C. Provost
for Celia 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
3
K0305311
Statement of Indications For Use
510(k) Number (if known): New Application
Hem-o-lok™ Ligating Clip Device Name:
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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Use
(Per 21 CRF 801.109)
OR
Over-The-Counter
(Optional Format 1-2-96)
Muriam C. Provoost
Division of General, Restorative and Neurological Device
510(k) Number K030311