The Quantix/OR is a dual-beam, angle-independent, pulse-wave Doppler ultrasound system used for intra-operative volume blood flow measurements, including blood flow velocity and volume blood flow. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix/OR 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.

AI/ML Overview

Since there is no study included in the provided text, I am unable to provide criteria from an efficacy study.

This document (K030357) is a 510(k) premarket notification for a medical device called Quantix/OR, a cardiovascular blood flowmeter. The purpose of a 510(k) is to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This process does not typically involve extensive clinical efficacy studies in the same way a Premarket Approval (PMA) would.

Therefore, the acceptance criteria are based on substantial equivalence to the predicate device, not on specific performance metrics established through an efficacy study. The "study" proving the device meets acceptance criteria is the 510(k) submission itself, which argues for substantial equivalence.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence, the "acceptance criteria" are not reported as specific performance thresholds, but rather as alignment with the predicate device. The "reported device performance" is implicitly that it functions similarly to the predicate.

Acceptance Criteria (Implied from 510(k) Process)	Reported Device Performance (Implied from Substantial Equivalence Claim)
Intended Use is the same as the predicate device	Intended for intra-operative examinations of blood flow measurements.
Technological Characteristics are substantially equivalent to the predicate device	Overall design, materials, mechanism of action, mode of operation, and performance characteristics are substantially equivalent to the predicate device (FlowGuard, K013803).

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) document does not describe an independent test set with a specific sample size for evaluating clinical performance. The substantial equivalence claim is based on comparing the new device's technological characteristics and intended use to a predicate device. This process generally relies on engineering and design comparisons, potentially bench testing, and comparisons of specifications, rather than a clinical "test set" in the traditional sense of an efficacy study.

Data Provenance: Not applicable in the context of this 510(k) submission, as it doesn't detail a clinical study with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. This 510(k) focuses on substantial equivalence to a predicate device, not on establishing ground truth for a novel claim via a clinical study with expert adjudication.

4. Adjudication Method for the Test Set

Not applicable. There is no described test set requiring expert adjudication in this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this 510(k) submission. The document focuses on demonstrating substantial equivalence to a predicate device, not on comparing performance with and without AI assistance or human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The Quantix/OR is described as a "dual-beam, angle-independent, pulse-wave Doppler ultrasound system used for intra-operative volume blood flow measurements." This implies it's a diagnostic device operated by a human, not an AI algorithm performing without human intervention. Therefore, a standalone algorithm-only performance study is not applicable and not described.

7. The Type of Ground Truth Used

Not applicable. The 510(k) primarily relies on the predicate device (FlowGuard, K013803) as the "standard" against which the new device's characteristics and performance are judged for substantial equivalence. There is no mention of pathology, outcomes data, or expert consensus being used as ground truth for a clinical performance evaluation in this document.

8. The Sample Size for the Training Set

Not applicable. The Quantix/OR is a Doppler ultrasound system, not an AI/machine learning algorithm that requires a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As the device is not an AI/machine learning algorithm, there is no training set mentioned or described.

Summary

{0}------------------------------------------------

SECTION 6 - SUMMARY OF SAFETY AND EFFECTIVENESS

K030357

(Premarket Notification [510(k)] Number)

1. Applicant

Cardiosonix Ltd. 3 Hatedhar Str. P.O.B. 3035. Raa'nana 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

Device Name

Device trade or proprietary name: Quantix/OR device Blood Flowmeter Common Name: Classification Name: Cardiovascular Blood Flowmeter, Class II, 870.2100

3. Predicate Devices

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

Device	Manufacturer	510(k) No.
FlowGuard	Biosonix Ltd./Cardiosonix Ltd.	K013803

{1}------------------------------------------------

4. Intended Use

The Quantix/OR device is intended for intra-operative examinations of blood flow measurements.

5. Description of the Device

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 device are substantially equivalent to the predicate devices cited above.

Signature

General Manager, Dr. Danny Manor

Jan. 27, 2003
Date

Date

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white seal. The seal is circular and contains an image of an eagle. The words "Department of Health & Human Services USA" are written around the edge of the seal.

AUG 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030357

Quantix/OR Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: 74 DPW Dated: June 22, 2003 Received: June 26, 2003

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 Amendments, or to devices that 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 requirements for annual registration, 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

{3}------------------------------------------------

Page 2 - Ms. Ahava Stein

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 mav 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 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 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office 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 premarket notification" (21 CFR 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 (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". If you have any questions regarding the content of this letter, please contact Kachi Enyinna at (301) 443-8262.

Sincerely yours,

Nolatter

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

Enclosures

{4}------------------------------------------------

Indications for Use Form Fill out one form for each ultrasound system and each transducer.

Mode of Operation
ClinicalApplication	A	B	C	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)				X
Pediatric
Small Organ(Specify)
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular
Laparoscopic
Musculo-SkeletalConventional
Muscolo-SkeletalSuperficial
Other (Specify)

Intended Use: Diagnostic blood flow measurements

Additional Comments: Intra-operative (Specify): For direct application to exposed blood vessel (miniature, sterilizable transducer)

(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) Indications for Use Form Fill out one form for each ultrasound system and each transducer.

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030357

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).