QUANTIX OR VESSEL STABILIZER DEVICE

K041180 · Cardiosonix, Ltd. · DPW · Jun 7, 2004 · Cardiovascular

Device Facts

• Record ID: K041180
• Device Name: QUANTIX OR VESSEL STABILIZER DEVICE
• Applicant: Cardiosonix, Ltd.
• Product Code: DPW · Cardiovascular
• Decision Date: Jun 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2100
• Device Class: Class 2

Intended Use

The Quantix OR + Vessel Stabilizer device is intended for intraoperative examinations of blood flow measurements.

Device Story

Quantix OR + Vessel Stabilizer is a dual-beam, angle-independent, pulse-wave Doppler ultrasound system. Device measures intraoperative blood flow volume in target blood vessels. Principle of operation: derives flow velocity from Doppler shift frequency; calculates volume flow by multiplying velocity by vessel cross-sectional area. Used in operating room settings by clinicians. Output provides real-time blood flow volume measurements to assist intraoperative clinical decision-making and vascular assessment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Dual-beam, angle-independent, pulse-wave Doppler ultrasound system. Operates using 4 MHz and 8 MHz probes. Calculates blood flow volume via velocity and cross-sectional area derivation. Class II device (870.2100).

Indications for Use

Indicated for intraoperative blood flow measurement in patients undergoing surgical procedures requiring 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.

Predicate Devices

• Quantix OR device (K030357)

Submission Summary (Full Text)

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### SECTION 6 - SUMMARY OF SAFETY AND EFFECTIVENESS

## JUN - 7 2004

KD41180

(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: | Vessel Stabilizer | | | |
|----------------------|------------------------------------------------------------------------|--|--|--|
| | Device trade/proprietary name: Quantix OR + Vessel Stabilizer Device | | | |
| Common Name: | Blood Flowmeter | | | |
| Classification Name: | Cardiovascular Blood Flowmeter, Class II, 870.2100 | | | |

#### 3. Predicate Devices

The Quantix OR + Vessel Stabilizer device is substantially equivalent to the following device:

| Device | Manufacturer | 510(k) No. |
|-------------------|------------------|------------|
| Quantix OR device | Cardiosonix Ltd. | K030357 |

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#### 4. Intended Use

The Quantix OR + Vessel Stabilizer device is intended for intraoperative examinations of blood flow measurements.

#### 5. Description of the Device

The Quantix OR + Vessel Stabilizer accessory is a dual-beam, angle-independent, pulsewave Doppler ultrasound system used for intraoperative blood flow volume. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix OR + Vessel Stabilizer technology utilizes special applications of 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 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 OR + Vessel Stabilizer device are substantially equivalent to the predicate device cited above.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 7 2004

Cardiosonix Ltd. c/o Ms. Ahava Stein Regulatory Affairs Consultant Beit Hapa'amon (Box 124) 20 Hata'as Street, 44425 Kfar Saba ISRAEL

Re: K041180

Quantix OR with Vessel Stabilizer Regulation Number: 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: 74 DPW Dated: April 26, 2004 Received: May 6, 2004

Dear Ms. Stein:

We have reviewed your Section 510(k) premarket 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 mersate continered price o hat 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 the general oonlines pro ragistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Bi-Directional Doppler Volume Flowmeter, as described in your premarket notification:

> Model CSN 01095 Model CSN 01094

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#### Page 2 - Ms. Ahava Stein

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your device is enabilitional 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.

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 that I Dr Has Intal statutes and regulations administered by other Federal agencies. You must or any I vath 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 premarket I his lotter will and in your ding of substantial equivalence of your device to a legally marketed predication. - The FD in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please If you debre 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 [phone]. Thise (21 CFR Part 807.97). Other general information on your presponsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". (2017) 113 6597 01 at wind a regarding the content of this letter, please contact Kachi Enyinna at [phone].

Sincerely yours,

Donna R. Vachner

Image /page/3/Picture/7 description: The image contains a signature. The signature appears to be handwritten in cursive. The first letter is a capital B, and the rest of the signature is difficult to read.

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

Enclosures

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#### Indications for Use Statement

Page 1 of 1

# 510(k) Number (if known): K041| 8 O

Quantix OR device Device Name:

Indications for use: The Quantix OR Vessel Stabilizer device is intended for intra-The Quantinations of blood flow measurements.

Prescription Use (Per 21 C.F.R. 801.109) ાર

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dina R. Vachner

(Division Sign-Off) Division of Cardiovascular Devices 25 104 510/k) Number K 02

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# Indications for Use Form

Fill out one form for each ultrasound system and each transducer. 510(k) No.: K0411 80 510(K) No.. - Ico411 80
Intended Use: Intra-operative examination of Blood Flow Measurements

Transducer: 4 MHz probe Mode of Oneration

| 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 | | | | X | | | | | | |
| (Specify) | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| (Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral | | | | | | | | | | |
| Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Muscolo-Skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

Other (opens)
N= New Indication; P = Previously cleared by FDA; E = Added under Appendix E

Additional Comments:__________________________________________________________________________________________________________________________________________________________

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

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.

Prescription Use (Per 21 CFR 801.109)

| Donna R. Lechner | |
|------------------------------------|--|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number K 041180 | |

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## Indications for Use Form

Fill out one form for each ultrasound system and each transducer. KO 411 80 510(k) No.: 10(x) No.. - RD 41) 30
Intended Use: Intra-operative examination of Blood Flow Measurements 8 MHz probe Transducer:

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

Oner (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)

Duna P. Vachaver

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number

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