(40 days)
Not Found
Not Found
No
The summary describes a physical ligating clip and contains no mention of AI, ML, image processing, or software that would suggest the use of such technologies.
No
The device, "Horizon ligating clips," is used for procedures involving vessels or anatomic structures. This is a surgical tool used to ligate or close off vessels/structures, which is a procedural/interventional function, not a therapeutic one. Therapeutic devices are typically those that administer treatment (e.g., medication delivery, radiation therapy, or stimulation therapy) rather than performing a physical repair or closure.
No
The provided text for "Intended Use / Indications for Use" states that Horizon ligating clips are "indicated for procedures involving vessels or anatomic structures where Horizon ligating this are the best clip size, type and material based upon experience, judgement and needs." This describes a surgical or procedural tool for joining or closing vessels/structures, not a device used to identify, detect, or monitor a disease or condition.
No
The device description is not found, but the intended use clearly describes "ligating clips," which are physical medical devices used in surgical procedures. This indicates the device is hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used in procedures involving vessels or anatomic structures for ligation. This is an in vivo application (within a living organism).
- IVD Definition: In vitro diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not fit that description.
The device is a surgical clip used internally during procedures, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
Horizon ligating clips are indicated for procedures involving vessels or anatomic structures where I iorizon ligating this are the best clip size, type and material based upon experience, judgement and needs.
Product codes
FZP
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels or anatomic structures
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 1998
Mr. Brian J. Young Requlatory Affairs Manaqer Weck Closure Systems One Weck Drive P.O. Box 12600 27709 Research Triangle Park, North Carolina
K982313 Re: Trade Name: Horizon Ligation Clips Regulatory Class: II Product Code: FZP Dated: June 30, 1998 Received: July 1, 1998
Dear Mr. Young:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Brian J. Young
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colvin M. Whitten, Ph.D., M.
- Celya M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
2 Statement of indications for use
INDICATIONS FOR USE
INDICATIONS FOR USE
Horizon ligating clips are indicated for procedures involving vessels or anatomic structures where I iorizon ligating this are the best clip size, type and material based upon experience, judgement and needs.
\prescription
device
(Division)Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number __