VTI INTRAOPERATIVE DOPPLER SYSTEMS

K082870 · Vascular Technology Incorporated · DPW · Oct 28, 2008 · Cardiovascular

Device Facts

• Record ID: K082870
• Device Name: VTI INTRAOPERATIVE DOPPLER SYSTEMS
• Applicant: Vascular Technology Incorporated
• Product Code: DPW · Cardiovascular
• Decision Date: Oct 28, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2100
• Device Class: Class 2

Intended Use

The VTI Intraoperative Doppler Systems are intended for the intraoperative and transcutaneous evaluation of blood flow. Indications for Use form filed with the FDA for the VTI Doppler Probes lists the clinical applications as Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.

Device Story

VTI Intraoperative Doppler Systems utilize ultrasonic transducers to detect blood flow velocity; device processes reflected ultrasound signals to provide audible and/or visual feedback of blood flow; used intraoperatively or transcutaneously by physicians in surgical or clinical settings; assists in real-time assessment of vessel patency and blood flow dynamics; aids clinical decision-making during vascular, neurological, and laparoscopic procedures; benefits patients by enabling immediate intraoperative verification of surgical outcomes.

Clinical Evidence

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

Technological Characteristics

Ultrasonic Doppler flowmeter; consists of probe/transducer assembly and signal processing unit; provides audible/visual blood flow output; intended for intraoperative and transcutaneous use; Class II device (21 CFR 870.2100).

Indications for Use

Indicated for intraoperative and transcutaneous blood flow evaluation in patients requiring microvascular, vascular, neurological, transesophageal, transrectal, laparoscopic, or peripheral vascular 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 28 2008

Vascular Technology, Inc. c/o Mr. David L. Regan Vice President - Sales 12 Murphy Drive Nashua, NH 03062

Re: K082870

VTI Intraoperative Doppler Systems Regulation Number: 21 CFR 870.2100 Regulation Name: Flowmeter, Blood Cardiovascular Regulatory Class: Class II (two) Product Code: DPW Dated: September 22, 2008 Received: September 29, 2008

Dear Mr. Regan:

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. David L. Regan

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 (OS) 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/industry/support/index.html.

Sincerely yours,

V

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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## Attachment 2 - Indications for Use

510(k) Number (if known): K082870

Device Name: VTI Intraoperative Doppler Systems

Indications for Use:

The VTI Intraoperative Doppler Systems are intended for the intraoperative and transcutaneous evaluation of blood flow.

Indications for Use form filed with the FDA for the VTI Doppler Probes lists the clinical applications as Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.

Prescription Use

OR

Over-The-Counter-Use

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21CFR 801.109)

(Division/Sign-OfM
Division of Cardiovascular Devices
510(k) Number K082870