DEGANIA SILICONE IDENTI LOOPS

K981956 · Degania Silicone , Ltd. · DXC · Jul 9, 1998 · Cardiovascular

Device Facts

• Record ID: K981956
• Device Name: DEGANIA SILICONE IDENTI LOOPS
• Applicant: Degania Silicone , Ltd.
• Product Code: DXC · Cardiovascular
• Decision Date: Jul 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2

Intended 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 Loops is not designed nor indicated for implantation.

Device Story

Degania Silicone Identi Loops are silicone rubber loops used intraoperatively by surgeons to identify, retract, or occlude anatomical structures including tendons, ureters, nerves, arteries, and veins. The device is a manual surgical tool; it does not involve electronic inputs, algorithms, or software. It is intended for temporary use only and is not designed for implantation. The device is provided in three sizes: Mini, Maxi, and Super Maxi.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Silicone rubber. Form factor: Loops available in Mini, Maxi, and Super Maxi sizes. Sterilization: Same process as predicate. No electronic components, software, or energy sources.

Indications for Use

Indicated for temporary intraoperative identification, retraction, or occlusion of tendons, ureters, nerves, arteries, or veins during general surgical procedures. Not for implantation.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Submission Summary (Full Text)

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a 1998 JUL

Image /page/0/Picture/1 description: The image shows the words "Degania Silicone" in a split-screen format. The word "Degania" is written in white letters on a black background. The word "Silicone" is written in black letters on a white background.

The Standards Institution of Israel

ISO
9002

Quality Assured Firm

Degania Silicone Ltd.

Degania Bet 15130, Isracl. Tel: [phone], Fax: [phone]

R981956

# APPENDIX E 510(K) Summary

Trade Name: Degania Silicone Identi Loops Common Name: Vascular Ties or Loops Product Code: DXC/GCZ Device Class: II Classification Panel: General and Plastic Surgery Establishment Registration Number: 8030107

This summary of 510(k) 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 Loops is not designed nor indicated for implantation.

### Manufacturing:

The Identi Loops are manufactured using the same manufacturing processes as our previous 510(k). Both this 510(k) and our previous 510(k) are from silicone rubber.

#### Technical Characteristics:

The Degania Silicone Identi Loops have similar technical and performance characteristics to the Substantially Equivalent Identi Loops. Both Identi Loops are available in Mini. Maxi and Super Maxi.

### Sterilization:

The Identi Loops and the Identi Loops to which they are Substantially Equivalent are sterilized by the same process.

Substantial Equivalence: We are substantially equivalent to ourselves.

Bett

Bette Lubin Product Advisor & Regulatory Affairs Degania Silicone Ltd.

Date 2 June 1998

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### a 1008 JUL

Ms. Bette Lubin Product Advisor & Regulatory Affairs Degania Silicone, Ltd. Degania Bet 15130, Israel

Re: K981956 Trade Name: Degania Silicone Identi Loops Regulatory Class: II Product Code: DXC Dated: June 2, 1998 Received: June 4, 1998

Dear Ms. Lubin:

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 (OS) 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 Register. 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.

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.

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Page 2 - Ms. Bette Lubin

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows the words "Degania Silicone" in a bold, sans-serif font. The word "Degania" is in white text on a black background, while the word "Silicone" is in black text with a white outline on a white background. The two words are placed side by side, creating a contrast between the dark and light backgrounds.

Image /page/3/Picture/1 description: The image shows a seal or logo with the text "The Standards Institution of Israel" arranged in a semi-circular fashion at the top and "Quality Assured Firm" at the bottom, also in a semi-circular arrangement. In the center of the seal, the text "ISO 9002" is prominently displayed. The seal appears to be a mark of quality assurance or certification from The Standards Institution of Israel, indicating compliance with ISO 9002 standards.

Degania Silicone Ltd. Degania Bet 15130, Isracl. Tel: [phone], Fax: [phone]

## INDICATIONS FOR USE

Device Name: Degania Silicone Identi Loops

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 Loops is not designed nor indicated for implantation.

## PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: [X]
or
Over- the -Counter: [ ]
(Per 21 CFR 801.109

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K981956
(Optional Format 1-2-96)