(56 days)
Not Found
Not Found
No
The summary describes a simple surgical loop device and makes no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No.
The device is used for identification, retraction, or occlusion during surgical procedures, which are temporary mechanical functions, not therapeutic treatments for a disease or condition.
No.
The device's intended use is for temporary intraoperative procedures involving identification, retraction, or occlusion of anatomical structures, not for diagnosing medical conditions.
No
The device description clearly indicates a physical product ("Identi Loops") used for surgical procedures, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries or veins." This describes a device used on the patient during surgery, not a device used to test samples from the patient in a lab setting.
- Device Description: The description reiterates the same intended use, focusing on surgical manipulation of anatomical structures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Identi Loop does not fit this description.
N/A
Intended Use / Indications for Use
The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loop is not designed nor indicated for Implantation.
Product codes
79
Device Description
The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loop is not designed nor indicated for Implantation.
Previously 2 sizes Mini and Maxi were available, we have now added Super Maxi (Extra Maxi).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tendons, ureters, nerves, arteries or veins
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)
We are Substantially Equivalent to ourselves.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a black and white logo for ISO 9002. The logo is circular with the text "ISO 9002" in the center in a bold font. The text "Quality Assured Firm" is written along the bottom of the circle, and the text "Israel Standards Institution of Israel" is written along the top of the circle. The logo appears to be a certification mark indicating that the organization has met the requirements of the ISO 9002 standard.
Image /page/0/Picture/1 description: The image contains two words, "Degumia" and "Silicone". The word "Degumia" is written in a bold, black font on a white background. The word "Silicone" is written in a white font with a black outline on a white background.
Image /page/0/Picture/2 description: The image is a close-up, grainy, black-and-white image. The image is not clear enough to determine what the image is showing.
Degania Silicone Ltd. Degania Bet 15130, Israel. Tel: 972-6-755712, Fax: 972-6-709182
8 1997 JAN
APPENDIX E
510(k) SUMMARY
Trade Name: Degania Silicone Identi Loops
Common Name: Vascular Ties or Loops
Product Code: 79
Device Class: I
Classification Panel: General & Plastic Surgery
Establishment Registration Number: 8030107
This summary of 510K safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807:92.
DEVICE DESCRIPTION AND USE:
The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loop is not designed nor indicated for Implantation.
Previously 2 sizes Mini and Maxi were available, we have now added Super Maxi (Extra Maxi).
MANUFACTURING :
The Identi Loops are manufactured from the same raw materials, from the same vendors and using the same manufacturing processes as our previous 510(k).
SUBSTANTIAL EQUIVALENCE:
We are Substantially Equivalent to ourselves.
Betty Lu
Nov. 11, 1896
Date
Bette Lubin Product Advisor & Regulatory Affairs Degania Silicone
24/2