CORONARY VEIN GRAFT TAG MARKER

K971966 · Med-Edge, Inc. · KPK · Jan 26, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K971966
• Device Name: CORONARY VEIN GRAFT TAG MARKER
• Applicant: Med-Edge, Inc.
• Product Code: KPK · General, Plastic Surgery
• Decision Date: Jan 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4650
• Device Class: Class 2

Intended 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.

Device Story

Radiopaque marker; attached to coronary vein graft anastomosis sites during CABG surgery by surgeons. Serves as landmark for cardiologists during subsequent cardiac catheterization; visualized via fluoroscopy. Facilitates identification of graft location; aids clinical decision-making during follow-up imaging. No electronic components or software.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiopaque marker; physical implantable device. No software, energy source, or connectivity.

Indications for Use

Indicated for use in patients undergoing coronary artery bypass graft (CABG) surgery to mark distal and/or proximal anastomosis sites for subsequent identification by cardiologists during cardiac catheterization.

Submission Summary (Full Text)

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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 [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,

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

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| 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 |
|---------------------------------------|---|----|----------------------|
|---------------------------------------|---|----|----------------------|

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