MICRINS MICRO ANASTOMOSIS CLAMP

K982278 · Micrins Surgical, Inc. · DXC · Mar 26, 1999 · Cardiovascular

Device Facts

• Record ID: K982278
• Device Name: MICRINS MICRO ANASTOMOSIS CLAMP
• Applicant: Micrins Surgical, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Mar 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Micrins Micro Anastomosis Clamp is a hand held surgical instrument that is designed to be used in Microvascular Surgery to either temporarily occlude or approximate blood vessels during the anastomosis process. The clamps are available in three different size ranges and are to be used on vessels that range in size from 0.4mm to 2.25mm. The clamps are used to facilitate surgical procedures that are typically called "free flaps" or replants. Once the microanastomosis has been completed the micro clamp is removed from the patient

Device Story

Hand-held surgical instrument used by surgeons during microvascular procedures; facilitates anastomosis by temporarily occluding or approximating blood vessels (0.4mm to 2.25mm). Device applied manually by clinician; removed after anastomosis completion. Benefits include improved vessel handling and stabilization during microsurgical free flap or replant procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hand-held surgical clamp; available in three size ranges for vessels 0.4mm-2.25mm. Mechanical design for temporary occlusion/approximation.

Indications for Use

Indicated for use in microvascular surgery to temporarily occlude or approximate blood vessels ranging from 0.4mm to 2.25mm in diameter during anastomosis, specifically for free flap or replant procedures.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 26 1999

Mr. Bernhard Teitz President Micrins, Inc. 28438 Ballard Drive Lake Forest, IL 60045

K982278 Re: Micrins Micro Anastomosis Clamp Trade Name: Regulatory Class: II Product Code: DXC Dated: December 23, 1998 Received: December 29, 1998

Dear Mr. Teitz:

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 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). 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 In addition, FDA may publish further announcements concerning action. your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation

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Page 2 - Mr. Bernhard Teitz

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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21CFR 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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): )( 982228 MICRO ANASTOMOSI Device Name: MICRINS Indications For Use:

The Micrins Micro Anastomosis Clamp is a hand held surgical instrument that is designed to be used in Microvascular Surgery to either temporarily occlude or approximate blood vessels during the anastomosis process. The clamps are available in three different size ranges and are to be used on vessels that range in size from 0.4mm to 2.25mm. The clamps are used to facilitate surgical procedures that are typically called "free flaps" or replants. Once the microanastomosis has been completed the micro clamp is removed from the patient

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Concurrence of CDRH, Office of Device Evaluation (ODE)