(81 days)
The Microvascular Anastomotic COUPLER is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures.
The device is a sterile (gamma irradiation), single-use, implantable pair of rings molded out of high density polyethylene with six stainless steel pins on each of the ring. A probe-holder feature is molded on each of the paired rings to be a point of attachment for a sensor/probe at the site of anastomosis.
This document is a 510(k) premarket notification for the Microvascular Anastomotic Coupler and does not contain information regarding acceptance criteria or a study proving the device meets said criteria.
The document outlines the device's indications for use, technological comparison to a predicate device (GEM Microvascular Anastomotic Coupler; K861985), and asserts substantial equivalence in terms of biocompatibility, manufacturing, performance, sterilization, shelf life, packaging, safety, and efficacy to the predicate device.
Therefore, I cannot provide the requested information from the given text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 2004
Ms. Daisy P. Sin, MT Synovis Surgical Innovations 2575 university Avenue W. St. Paul., Minnesota 55114
Re: K040163
Trade/Device Name: Microvascular Anastomotic Coupler Regulatory Class: unclassified Product Code: MVR Dated: January 23, 2004 Received: January 26, 2004
Dear Ms. Sin:
This letter corrects our substantially equivalent letter of April 7, 2004 regarding the Indications for Use of your device.
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. 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part
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Page 2 - Ms. Daisy P. Sin, MT
807.97). You may obtain other general information on your responsibilities under the Act 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
[ • Cella M. witten, rn.U., 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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Indications for Use
K040163 510(k) Number (if known):
Device Name: Microvascular Anastomotic COUPLER
Indications for Use:
The Microvascular Anastomotic COUPLER is to be used in the anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K040163
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APR 1 6 2004
Synovis™ Micro Companies Alliance, Inc. Microvascular Anastomotic COUPLER
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitted by: | Synovis™ Micro Companies Alliance, Inc.A Subsidiary of Synovis Life Technologies, Inc.439 Industrial LaneBirmingham, AL 35211-4464 USAFDA Registration #: 1062741 |
|---|---|
| Date Prepared: | April 6, 2004 |
| Contact Person: | Daisy P. Sin, MT (ASCP), RAC (RAPS)Synovis Surgical Innovations,A Division of Synovis Life Technologies, Inc.2575 University Ave. W.St. Paul, MN 55114651-796-7399, 651-603-5203 or 1-800-225-4018651-796-7499 (Fax) or 651-603-5211 (Fax) |
| Device Trade Name: | To be determined |
| Common Name: | Microvascular Anstomotic Coupler |
| Predicate Device: | GEM Microvascular Anastomotic COUPLER; K861985Image: signature |
| Device Description: | The device is a sterile (gamma irradiation), single-use,implantable pair of rings molded out of high densitypolyethylene with six stainless steel pins on each of thering. A probe-holder feature is molded on each of thepaired rings to be a point of attachment for asensor/probe at the site of anastomosis. |
| Indications for Use: | The device is for use in the anastomosis of veins andarteries normally encountered in microsurgicalprocedures. |
| Technological Comparison: | The proposed device has the same technologicalcharacteristics as the predicate device. |
| Summary: | The device is substantially equivalent to the predicatedevice with respect to biocompatibility, manufacturingprocess, product performance, sterilization, shelf life,packaging, and safety and efficacy. |
§ 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.