(52 days)
Not Found
Not Found
No
The description focuses on a mechanical clip applier and does not mention any computational or data-driven features.
Yes
The device is used to approximate soft tissue, close off vessels, and stop bleeding, which are all actions aimed at treating a medical condition or aiding in healing.
No
This device is described as an applier for clips used to approximate soft tissue, close off vessels, or connect tissues, which are surgical functions, not diagnostic ones.
No
The device description clearly describes a physical, disposable medical device with a plastic handle, working shaft, and titanium clips, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use during laparoscopic procedures for approximating soft tissue, closing vessels, and connecting internal tissues. This describes a surgical tool used in vivo (within the body).
- Device Description: The description details a surgical instrument (clip applier) and implantable clips, which are used directly on tissues within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are specifically designed for testing samples taken from the body to provide diagnostic or other health-related information. This device is a surgical tool used for physical manipulation of tissues during a procedure.
N/A
Intended Use / Indications for Use
The GeniCon Clip Applier and implantable clips are intended for use during laparoscopic procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.
Product codes (comma separated list FDA assigned to the subject device)
FZP, GDO
Device Description
The Genicon Clip Applier is a disposable device with a plastic handle and a working shaft that is approximately 32cm in length. Within the shaft are 20 titanium clips. The handle of the instrument is depressed and a titanium clip, which resides in the distal iaw of the instrument. is pressed together around whatever structure is within the jaw of the instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 series of performance tests were performed on the GeniCon Clip Applier to test such areas as:
-
- Stress/Exposure Testing
-
- Cleaning/Disinfection/Sterilization Testing
The FDA has not adopted performance standards for this product.
- Cleaning/Disinfection/Sterilization Testing
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.
United States Surgical Corporation
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.
0
Section II: 510(k) Summary
MAR 2 0 2003
GeniCon, L.C. Contact: Frank Goldfarb P.O. Box 780038 Orlando, FL 32878-0038 Telephone: 407 616 3019 Fax: 407 306 9356
Date Prepared: February 28, 2003
Trade Name: GeniCon Clip Applier Common Name: GeniCon Clip Applier
Classification Name: According to Section 513 of the Federal Food, Drug, Cosmetic Act, the device classification is Class II, performance Standards (21 CFR 878.4800).
Predicate Device: United States Surgical Corporation
Product Description: The Genicon Clip Applier is a disposable device with a plastic handle and a working shaft that is approximately 32cm in length. Within the shaft are 20 titanium clips. The handle of the instrument is depressed and a titanium clip, which resides in the distal iaw of the instrument. is pressed together around whatever structure is within the jaw of the instrument.
Indications for Use:
The GeniCon Clip applier am implantable clips are intended for use during laparoscopic procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.
Performance:
A series of performance tests were performed on the GeniCon Clip Applier to test such areas as:
-
- Stress/Exposure Testing
-
- Cleaning/Disinfection/Sterilization Testing
The FDA has not adopted performance standards for this product.
Conclusion:
Based on the indications for use, technological characteristics and performance testing, the GeniCon Clip Applier has been shown to be effective for its intended use and substantially equivalent to the predicate device.
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 with three human profiles incorporated into its design. The profiles are facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2003
Mr. Frank Goldfarb Sales Manager GeniCon, L.C. P.O. Box 780038 Orlando, Florida 32878-0038
Re: K030269
Trade/Device Name: Disposable Clip Applier Regulation Number: 21 CFR 878.4300, 21 CFR 878.4800 Regulation Name: Implantable Clip, Surgical Clip Applier Regulatory Class: II Product Code: FZP, GDO Dated: March 3, 2003 Received: March 6, 2003
Dear Mr. Goldfarb:
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. Frank Goldfarb
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.
Mark N Millan
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
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Section I. Indications for Use
Page: I-1
Device Name: Disposable Clip Applier
Indications for Use:
The GeniCon Clip Applier and implantable clips are intended for use during laparoscopic procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
Use ✓
OR
Over-The-Counter
(Optional Format 1-2-96)
Mark N. Mulker
gn-Of era). Restorative
510(k) Number K030269