VTI 20 MHZ GATED DOPPLER

K031091 · Vascular Technology Incorporated · DPW · Apr 23, 2003 · Cardiovascular

Device Facts

• Record ID: K031091
• Device Name: VTI 20 MHZ GATED DOPPLER
• Applicant: Vascular Technology Incorporated
• Product Code: DPW · Cardiovascular
• Decision Date: Apr 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2100
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The VTI 20 MHz Gated Doppler is intended for the intraoperative and transcutaneous evaluation of blood flow.

Device Story

VTI 20 MHz Gated Doppler; ultrasonic device for blood flow evaluation. Operates via 20 MHz Doppler ultrasound transducer; detects blood velocity/flow patterns. Used intraoperatively or transcutaneously; operated by clinicians. Provides real-time blood flow data to assist in surgical or diagnostic decision-making; aids in assessing vascular patency or flow characteristics. Benefits include non-invasive or intraoperative monitoring of blood flow to guide clinical interventions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

20 MHz Doppler ultrasound transducer; cardiovascular blood flowmeter; Class II device; product code DPW.

Indications for Use

Indicated for intraoperative and transcutaneous evaluation of blood flow in patients requiring cardiovascular assessment.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2003

Vascular Technology Incorporated c/o Mr.Ned Devine Entela, Inc. Responsible Third Party Official 3033 Madison Ave. SE Grand Rapids, MI 49548

Re: K031091

Trade Name: VTI 20 MHz Gated Doppler Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular blood flowmeter Regulatory Class: Class II (two) Product Code: DPW Dated: March 14, 2003 Received: April 7, 2003

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (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.

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Page 2 - Mr.Ned Devine

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if Known) K03 | 09 |

Device Name: VTI 20 MHz Gated Doppler

Indications for Use:

The VTI 20 MHz Gated Doppler is intended for the intraoperative and transcutaneous evaluation of blood flow.

(Division Sign-Off)
Division Cardiovascular Devices
510(k) number K03/09/

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

(Per 21CFR 801.109)