VGF-7 VASCULAR GRAFT FLOWMETER

K973198 · Medicard , Ltd. · DPW · Oct 14, 1998 · Cardiovascular

Device Facts

• Record ID: K973198
• Device Name: VGF-7 VASCULAR GRAFT FLOWMETER
• Applicant: Medicard , Ltd.
• Product Code: DPW · Cardiovascular
• Decision Date: Oct 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2100
• Device Class: Class 2

Indications for Use

The VGF-7 Vascular Graft Flowmeter is device for measuring the flow of saline or other fluid through a graft when driven by a constant steady pressure or a controlled pulsatile pressure. It is indicated during coronary artery bypass surgery for assisting the surgeon in intra-operatively assessing the ability of a given vein graft preparation to support fluid flow.

Device Story

VGF-7 Vascular Graft Flowmeter measures fluid flow through grafts during surgery. Device uses automatic syringe to inject saline or blood into proximal end of vein graft at controlled physiological pressure. System utilizes servo mechanism controlled by microprocessor to maintain constant pressure loop. Flow rate is calculated based on liquid pressure and graft flow resistance; result displayed on digital readout. Used in OR by surgeons during coronary artery bypass or other vascular surgeries. Provides intra-operative assessment of graft patency/flow capacity to inform surgical decision-making.

Clinical Evidence

Bench testing only. Non-clinical tests were conducted to validate the accuracy of flow determinations over the specified range of flows. The device was tested for electrical safety and electromagnetic compatibility per EN 60601.

Technological Characteristics

System includes automatic syringe, PVC tubing, and graft cannula. Operates via servo-controlled pressure loop managed by a microprocessor. Measures flow by injecting fluid at controlled pressure and calculating resistance. Electrical safety and EMC tested per EN 60601.

Indications for Use

Indicated for use during coronary artery bypass and other blood vessel surgeries to assist surgeons in intra-operatively assessing the ability of a graft preparation to support fluid flow.

Regulatory Classification

Identification

A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.

Predicate Devices

• Model FM701D Cliniflow® II (Carolina Medical Electronics, Inc.)
• Transonic Flowmeter (Transonic Systems, Inc.)
• Vessel Cannula #30003 (D L P Inc.)

Submission Summary (Full Text)

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OCT 1 4 1998

K973198

## 510(K) SUMMARY FOR MEDICARD LTD. VGF-7 Vascular Graft Flowmeter

- Date this summary was prepared: August 22, 1997 1.
- 2. Submitter's Name and Address

Medicard Ltd. P. O. Box 250 Upper Yoqneam 20692, Israel

- Contact Person 3.
Mr. Peter Dartal

| Telephone | 011 972 4 879 2732 |
|-----------|--------------------|
| Telefax | 011 972 4 959 1283 |

- Device Name 4.

| Trade/Proprietary Name: | VGF-7 Vascular Graft Flowmeter |
|-------------------------|--------------------------------|
| Common Name: | Graft Flowmeter |
| Classification Names: | Cardiovascular blood flowmeter |

- ડ . Predicate Devices
The legally marketed devices to which equivalence is being claimed are:

- . Model FM701D Cliniflow® II manufactured by Carolina Medical Electronics, Inc.
- . Transonic Flowmeter manufactured by Transonic Systems, Inc.
- . Vessel Cannula #30003 manufactured by the D L P Inc.

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## Device Description 6.

The VGF-7 consists of an automatic syringe that injects blood or saline solution into proximal end of the vein graft at a controlled physiological pressure. The resulting flow rate is displayed on a digital readout.

The system consists of a servo mechanism controlled by a microprocessor. The microprocessor activates a controlled pressure loop to maintain a predetermined pressure of liquid in a syringe during injection. The liquid is injected from the syringe through a PVC tube and small graft cannula into the graft. The flowrate is the outcome of the liquid pressure and the graft flow resistance.

- 7. Intended Use
The VGF-7 Vascular Graft Flowmeter is device for measuring the flow of saline or other fluid through a graft when driven by a constant steady pressure or a controlled pulsatile pressure. It is indicated during coronary artery bypass surgery for assisting the surgeon in intra-operatively assessing the ability of a given vein graft preparation to support fluid flow.

- 8. Comparison of Technological Characteristics
The VGF-7 Vascular Graft Flowmeter works by injecting blood or saline into the graft at a controlled pressure and measuring the resultant flow. The Carolina Cliniflow® II works by generating a varying magnetic field in the blood vessel and measuring the electromotive force induced by the motion of the blood. This EMF is proportional to the strength of the magnetic field, the velocity of the flow, and the diameter of the vessel. The Transonic Medical Flowmeter works according to a proprietary "Ultrasound Transit-Time Technology."

- 9. Nonclinical Tests Used in Determination of Substantial Equivalence
The design of the Vein Graft Flowmeter has been thoroughly verified at the unit and system level. Non-clinical tests were conducted to validate the accuracy of flow determinations over the specified range of flows. The VGF-7 Vascular Graft Flowmeter has been tested to the electrical safety requirements and the Electromagnetic Compatibility requirements of EN 60601.

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- Conclusions From Nonclinical Testing 10.
The testing of the VGF-7 Vascular Graft Flowmeter demonstrates that the performance is substantially equivalent to the predicate devices cited above.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures in profile, arranged in a row. The figures are black and are oriented to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

OCT 1 4 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medicard, Ltd. c/o Ms. Mary McNamara-Cullinane Staff Consultant Medical Device Consultant, Inc. 49 Plain Street North Attleboro, MA 02760

K973198 Re: Medicard VGF-7 Vascular Graft Flowmeter Requlatory Class: II Product Code: DPW Dated: July 16, 1998 Received: July 17, 1998

Dear Ms. McNamara-Cullinane:

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 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 Requlation (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 Register. Please note: this response to your premarket notification submission does not affect any obliqation you miqht 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 - Ms. Mary McNamara-Cullinane

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 leqally 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 requlation entitled, "Misbranding by reference to premarket notification" (21 Other general information on your responsibilities CFR 807.97). 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/dsma/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

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## 510(k) Number (if known): _((97 3 1 9 8

Device Name: __ VGF-7 Vascular Graft Flowmeter___

Indications For Use:

The VGF-7 Vascular Graft Flowmeter is indicated during artery bypass and other blood vessel surgeries for assisting the surgeon in intra-operatively assessing the ability of a given graft preparation to support fluid flow.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | <div> <span style="text-decoration: overline;">Axa Sharker for BLL</span> </div> (Division Sign-Off) |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K973198 |
| Prescription Use | <div> </div> |
| (Per 21 CAR 801.109) | OR Over-The-Counter Use |