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.

AI/ML Overview

This document is a 510(k) premarket notification for the Quantix OR + Vessel Stabilizer device, a blood flowmeter. It establishes substantial equivalence to a predicate device but does not contain detailed performance studies or specific acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.

Here's an analysis of what can and cannot be provided:

1. A table of acceptance criteria and the reported device performance

Cannot be provided: This document identifies the device and its intended use but does not present specific acceptance criteria (e.g., minimum accuracy, precision, or sensitivity/specificity targets) for its performance. It also does not include the results of any performance studies against such criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be provided: The document does not describe any specific test set or clinical study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Cannot be provided: No test set or ground truth establishment is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Cannot be provided: No adjudication method is mentioned as no test set evaluation is detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable / Cannot be provided: This device is a blood flowmeter, not an AI-assisted diagnostic imaging device that involves human readers interpreting cases. Therefore, an MRMC study as described would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Cannot be provided: This document does not describe any standalone performance studies. The device itself is a blood flowmeter for intraoperative use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Cannot be provided: No specific ground truth methodology is mentioned as no performance study is detailed.

8. The sample size for the training set

Cannot be provided: This document does not describe a training set, as it is a 510(k) for a medical device (blood flowmeter), not an AI/machine learning algorithm that typically requires a training set.

9. How the ground truth for the training set was established

Cannot be provided: As there's no mention of a training set, there's no information on how its ground truth might have been established.

Summary regarding the provided text:

The provided document is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a predicate device. It defines the device, its intended use, and its technological characteristics. It does not include the detailed technical performance studies, acceptance criteria, or clinical trial data that would contain the information requested in the prompt. Such detailed performance data is typically found in accompanying technical documentation, internal reports, or other sections of a more comprehensive regulatory submission, but not in this summary form.

Summary

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SECTION 6 - SUMMARY OF SAFETY AND EFFECTIVENESS

JUN - 7 2004

KD41180

(Premarket Notification [510(k)] Number)

Applicant

Cardiosonix Ltd. Beit Milenium 3 Hatidhar Str. Rananna, 43654 ISRAEL Tel: +972-9-7766444 Fax: +972-9-7766445

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: +972-9-767 0002 Fax: +972-9-766 8534

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

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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (201) 597 1039. 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 (800) 638-2041 or at (301) 443-6597 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 (301) 443-8262.

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)

(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

ClinicalApplication	A	B	C	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(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:__________________________________________________________________________________________________________________________________________________________

(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)

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

3 of 3

Regulation Number and Section

§ 870.2100 Cardiovascular blood flowmeter.

(a)
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.(b)
Classification. Class II (performance standards).