QUANTIX/ND DEVICE

K023431 · Cardiosonix, Ltd. · DPW · Nov 13, 2002 · Cardiovascular

Device Facts

• Record ID: K023431
• Device Name: QUANTIX/ND DEVICE
• Applicant: Cardiosonix, Ltd.
• Product Code: DPW · Cardiovascular
• Decision Date: Nov 13, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2100
• Device Class: Class 2

Intended Use

The Quantix/ND device is intended for non-invasive, peripheral vessel examinations of blood flow measurements

Device Story

Quantix/ND is dual-beam, angle-independent, pulse-wave Doppler ultrasound system; performs non-invasive peripheral vessel examinations. Inputs: ultrasound Doppler signals from target blood vessels. Processing: derives flow velocity from Doppler shift frequency; calculates volume blood flow by multiplying velocity by vessel cross-sectional area. Output: real-time blood flow velocity and volume measurements. Used in clinical settings by healthcare providers. Output assists clinicians in assessing peripheral vascular status; aids in diagnostic decision-making regarding blood flow.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance comparisons to the predicate device.

Technological Characteristics

Dual-beam, angle-independent, pulse-wave Doppler ultrasound system. Operates at 4 MHz. Includes round pen-probe (4 mm) and elliptic pen-probe (6 mm) transducers. Calculates volume blood flow via velocity and cross-sectional area derivation. Class II device.

Indications for Use

Indicated for non-invasive peripheral vascular blood flow measurements in patients requiring diagnostic assessment of blood flow velocity and volume.

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 (K013803)

Submission Summary (Full Text)

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# SECTION 6 - SUMMARY OF SAFETY AND EFFECTIVENESS

K023431

(Premarket Notification [510(k)] Number)

## 1. Applicant

Cardiosonix Ltd. Beit Milenium 3 Hatidhar Str. Rananna, 43654 ISRAEL Tel: [phone] Fax: [phone]

Corresponding Official:

Name: Ahava M. Stein, Consultant Address: A. Stein - Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba ISRAEL Tel: [phone] Fax: [phone]

### 2. Device Name

| Device trade/proprietary name: | Quantix/ND Device |
|--------------------------------|----------------------------------------------------|
| Common Name: | Blood Flowmeter |
| Classification Name: | Cardiovascular Blood Flowmeter, Class II, 870.2100 |

### 3. Predicate Devices

The Quantix/ND device is substantially equivalent to the following device:

| Device | Manufacturer | 510(k) No. |
|-----------|---------------|------------|
| FlowGuard | Biosonix Ltd. | K013803 |

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### 4. Intended Use

The Quantix/ND device is intended for non-invasive, peripheral vessel examinations of blood flow measurements

### 5. Description of the Device

The Quantix/ND is a dual-beam, angle-independent, pulse-wave Doppler ultrasound system used for non-invasive (peripheral vessel) volume blood flow measurements, including blood flow velocity and volume blood flow. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix/ND technology utilizes special applications of ultrasound Doppler methods to obtain real-time measurements according to the definition of volume blood flow in target blood vessels. By definition, blood flow is the product of velocity and 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-section area of the blood vessel.

#### 6. Technological Characteristics Compared to Predicate Device

The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Quantix/ND device are substantially equivalent to the predicate device cited above.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

NOV 1 3 2002

Cardiosonix Ltd. c/o Mr. Ahava M. Stein 1 A Stein - Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba ISRAEL

Re: K023431

Quantix/ND Device Regulation Number: 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: II (two) Product Code: 74 DPW Dated: October 1, 2002 Received: October 15, 2002

Dear Mr. Stein:

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. Ahava M. Stein

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely vours.

Oma; Kleenku for
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 Form

Fill out one form for each ultrasound system and each transducer. 510(k) No.: K018303 Intended Use: Diagnostic Blood Flow Measurements

Round pen-probe, 4 MHz, 4 mmφ

Transducer:

| Mode of Operation | | | | | | | | | | |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Clinical<br>Application | A | B | C | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral | | | | | | | | | | |
| Vascular | | | | P | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-Skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

N= New Indication; P = Previously cleared by FDA; E = Added under Appendix E

Additional Comments: _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K023431

11/12/02

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## Indications for Use Form

Fill out one form for each ultrasound system and each transducer. 510(k) No.: K018303 Intended Use: Diagnostic Blood Flow Measurements

Elliptic pen-probe, 4 MHz, 6 mmo Transducer:

| | | | Mode of Operation | | | | | | | |
|----------------------------------|---|---|-------------------|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Clinical<br>Application | A | B | C | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(Specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral | | | | | | | | | | |
| Vascular | | | E | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-Skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

Mode of Operation

N= New Indication; P = Previously cleared by FDA; E = Added under Appendix E

Additional Comments:___

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Division of Cardinvascylar & Respiratory Devices 510(k) Number

Doria Slushie 14/12