QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER

K050088 · Neoprobe Corp. · DPW · Feb 8, 2005 · Cardiovascular

Device Facts

• Record ID: K050088
• Device Name: QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER
• Applicant: Neoprobe Corp.
• Product Code: DPW · Cardiovascular
• Decision Date: Feb 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2100
• Device Class: Class 2

Intended Use

The Quantix/OR™ Flexible Probe and optional Vessel Stabilizers are intended for invasive and noninvasive diagnostic blood flow measurements.

Device Story

Quantix/OR Blood Flow Monitor is a dual-beam, angle-independent, pulse-wave Doppler ultrasound system. Device measures blood flow velocity and volume in blood vessels. Input: ultrasound Doppler signals. Processing: derives flow velocity from Doppler shift frequency; calculates volume flow by multiplying velocity by vessel cross-sectional area. Output: real-time blood flow measurements. Used in clinical settings (e.g., OR) by healthcare providers to assess vascular flow. Provides quantitative data to assist in clinical decision-making regarding blood vessel patency and perfusion. Benefits include non-invasive or invasive diagnostic capability for monitoring blood flow.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance comparisons to predicate devices.

Technological Characteristics

Dual-beam, angle-independent, pulse-wave Doppler ultrasound system. Components include flexible probe and vessel stabilizer. Operates via Doppler shift frequency analysis to calculate blood flow volume (velocity x cross-sectional area).

Indications for Use

Indicated for invasive and noninvasive diagnostic blood flow measurements in patients requiring such monitoring. Prescription use only.

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

• FlowGuard probe (K018303)
• Quantix/ORTM Blood Flow Monitor (Rigid probe) (K030357)
• Quantix/ORTM Vessel Stabilizer (Flexible probe) (K041180)
• Butterfly Flowmeter BF1000 – BF2004 (K992305)
• Flowmeter (K872048)

Submission Summary (Full Text)

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# FEB - 8 2005

# 1.8 - Summary of Safety and Effectiveness

Premarket Notification

K050088

## 1.8.1 Applicant

Cardiosonix, Ltd. A Neoprobe Company 425 Metro Place North, Suite 300 Dublin, Ohio 43017-1367 U.S.A. Telephone: [phone] Facsimile: [phone]

### 1.8.2 Official Correspondent

| Name: | Rodger A. Brown |
|------------|-------------------------------|
| Address: | 425 Metro Place North |
| | Suite 300 |
| | Dublin, Ohio 43017-1367 U.S.A |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| E-mail: | [e-mail] |

#### 1.8.2 Device Identification

| Device Name: | Quantix/OR TM Blood Flow Monitor |
|-----------------------------------|------------------------------------------------------------------|
| Device Trade or proprietary Name: | Quantix/OR TM Flexible Probe; Quantix/OR TM<br>Vessel Stabilizer |
| Common Name: | Blood Flowmeter |
| Classification Name: | Cardiovascular Blood Flowmeter, Class II,<br>870.2100 |

### 1.8.3 Predicate Device

The Quantix/OR™ Blood Flow Monitor with Flexible Probe and vessel Stabilizer is substantially equivalent to the following device(s):

| Device | Manufacturer | 510(k) No |
|-------------------------------------------------|-------------------|-----------|
| FlowGuard probe | Biosonix, Ltd. | K018303 |
| Quantix/ORTM Blood Flow Monitor (Rigid probe) | Cardiosonix, Ltd. | K030357 |
| Quantix/ORTM Vessel Stabilizer (Flexible probe) | Cardiosonix, Ltd. | K041180 |
| Butterfly Flowmeter BF1000 – BF2004 | Medi-Stim | K992305 |
| Flowmeter | Transonic | K872048 |

### 1.8.4 Intended Use

The Quantix/OR™ Flexible Probe and optional Vessel Stabilizers are intended for invasive and noninvasive diagnostic blood flow measurements.

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#### 1.8.5 Description of the Device

The Quantix/OR™ Blood Flow Monitor with Flexible Probe and Vessel Stabilizer is a dualbeam, angle independent, pulse-wave Doppler ultrasound system for the invasive and noninvasive blood vessel flow measurements. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix/ORTM Flexible Probe technology utilizes ultrasound Doppler methods to obtain real-time measurements according to the definition of blood flow volume to target blood vessels. By definition, blood flow is the product of velocity cross-sectional area. In other words, the volume blood flow is calculated by deriving flow velocity from the Doppler shift frequency using the basic standard formula and then multiplying the velocity by the cross-sectional area of the blood vessel.

#### 1.8.6 Technological Characteristics

The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Flexible Probe and Vessel Stabilizer modifications are substantially equivalent to the predicate devices cited above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/11 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head.

Public Health Service

FEB - 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Neoprobe Corporation c/o Mr. Rodger A. Brown Vice President, Regulatory Affairs and Quality Assurance 425 Metro Place North, Suite 300 Dubin, OH 43017-1367

Re: K050088

Quantix/OR™ Blood Flow Monitor, Flexible Probe with optional Vessel Stabilizer Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: DPW Dated: January 10, 2005 Received: January 13, 2005

Dear Mr. Brown:

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. Rodger A. Brown

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]. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsmamain.html

Sincerely yours,

Durna D. Jochner

( 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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## 1.1 - Indications for Use Statement

Page 1 of 1

#### K050088 510(k) Number (if known):

Device Name: Quantix/OR™ Blood Flow Monitor

### Indications for use:

The Quantix/OR Blood Flow Monitor is intended for invasive and noninvasive diagnostic blood flow measurements.

Prescription Use 区 (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use [ (Optional Format 1-2-96)

008

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Diving Lecture 1

(Di ision Sign-Off) Di ion of Cardiovascular Devices

1 Number 105008 8