(243 days)
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Not Found
No
The summary describes a physical radiopaque marker used for identification during medical procedures and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a marker used for identification during medical procedures, not for treating a disease or condition.
No
The device is a radiopaque marker used during surgery to identify a coronary vein graft. It serves as a landmark for a cardiologist using fluoroscopy but does not diagnose a condition itself.
No
The description clearly states the device is a "radiopaque marker," which is a physical object used during surgery and visualized with fluoroscopy. This indicates a hardware component, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The described device is a radiopaque marker that is implanted into the body during surgery. Its function is to be visible under fluoroscopy within the body to help identify a specific anatomical location.
- No Specimen Testing: The device does not involve the testing of any biological specimens taken from the patient.
Therefore, based on its intended use and how it functions, this device falls under the category of an implantable medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
A radiopaque marker used to identify the coronary vein graft which is commonly used to revascularize the blood supply to the heart. The marker is attached to the distal and / or proximal anastomosis sites of the graft by the surgeon during the CABG procedure. The marker can subsequently be used by the cardiologist during cardiac catheterization as a landmark to easily identify the anastomosis site of the vein graft utilizing fluoroscopy.
Product codes
KPK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
coronary vein graft, heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, cardiologist
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them that resemble waves or ribbons.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 26 1998
Mr. Steve Owenby Med-Edge, Inc. 1843 Pinehurst Drive 27012 Clemmons, North Carolina
K971966 Re : Coronary Vein Graft Tag Marker II (Two) Requlatory Class: Product Code: KPK October 28, 1997 Dated: October 31, 1997 Received:
Dear Mr. Steve Owenby:
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 Existing major regulations affecting your device additional controls. can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 Reqister. 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.
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Page 2 - Mr. Steve Owenby
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Page | 1 |
|---|---|
| ------ | --- |
| 510(k) Number (if known): | K971966 |
|---|---|
| Device Name: | Coronary Vein Graft Tag |
Indications For Use:Indications for use:
Coronary Vein Graft Tag Marker ( Med-Edge, Inc. ) 510 ( K ) # K971966
A radiopaque marker used to identify the coronary vein graft which is commonly used to revascularize the blood supply to the heart. The marker is attached to the distal and / or proximal anastomosis sites of the graft by the surgeon during the CABG procedure. The marker can subsequently be used by the cardiologist during cardiac catheterization as a landmark to easily identify the anastomosis site of the vein graft utilizing fluoroscopy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K 971966 |
| Prescription Use (Per 21 CFR 801.109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- |
(Optional Format 1-2-96)