(81 days)
Not Found
No
The summary describes a purely mechanical device for surgical anastomosis and explicitly states that AI/ML is "Not Found".
Yes
The device is used in the anastomosis of veins and arteries, which is a medical procedure to connect blood vessels. This directly implies a therapeutic use to restore blood flow or repair damaged vessels, rather than just diagnostic or assistive purposes.
No
The device is described as an implantable pair of rings used for anastomosis, which is a surgical procedure to connect vessels. Its primary function is mechanical coupling of veins and arteries, not the detection or diagnosis of conditions.
No
The device description clearly states it is an implantable pair of rings made of high-density polyethylene with stainless steel pins, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states the device is an "implantable pair of rings" used for the "anastomosis of veins and arteries." This is a surgical procedure performed directly on the patient's body, not a test performed on a sample outside the body.
- Intended Use: The intended use is for "anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures." This describes a surgical intervention, not a diagnostic test.
The device is a surgical implant used to connect blood vessels, which falls under the category of medical devices used for treatment or repair, not diagnosis.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MVR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
veins and arteries
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): 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.
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
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
1
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
2
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
3
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 Lane
Birmingham, AL 35211-4464 USA
FDA 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 55114
651-796-7399, 651-603-5203 or 1-800-225-4018
651-796-7499 (Fax) or 651-603-5211 (Fax) |
| Device Trade Name: | To be determined |
| Common Name: | Microvascular Anstomotic Coupler |
| Predicate Device: | GEM Microvascular Anastomotic COUPLER; K861985
Image: signature |
| Device Description: | 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. |
| Indications for Use: | The device is for use in the anastomosis of veins and
arteries normally encountered in microsurgical
procedures. |
| Technological Comparison: | The proposed device has the same technological
characteristics as the predicate device. |
| Summary: | The device is substantially equivalent to the predicate
device with respect to biocompatibility, manufacturing
process, product performance, sterilization, shelf life,
packaging, and safety and efficacy. |