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.

AI/ML Overview

This device is a Quantitative Flow Monitor, not an AI/ML device. Therefore, the requested information pertaining to AI/ML device studies (such as sample size for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable or cannot be extracted from the provided text.

The provided text describes a 510(k) premarket notification for the Quantix/OR™ Blood Flow Monitor, a medical device for measuring blood flow. The submission focuses on demonstrating substantial equivalence to predicate devices, which is the standard for 510(k) clearances. This type of submission typically relies on comparing technological characteristics and intended use, rather than detailed performance studies with acceptance criteria in the way an AI/ML device would.

Here's an analysis based on the information available in the text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format typically used for AI/ML device evaluation (e.g., sensitivity, specificity, AUC). The submission's core argument is substantial equivalence to predicate devices rather than meeting specific performance thresholds in a clinical study for a novel algorithm.

The "performance" is implicitly deemed equivalent to the predicate devices due to similar technological characteristics and intended use.

2. Sample Size Used for the Test Set and Data Provenance:
Not applicable as this is not an AI/ML device and no such test set is described.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable as this is not an AI/ML device.

4. Adjudication Method for the Test Set:
Not applicable as this is not an AI/ML device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is not an AI/ML device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as this is not an AI/ML device.

7. The type of ground truth used:
Not applicable in the context of an AI/ML device's ground truth. However, for a traditional medical device, ground truth for performance claims (if any were made beyond equivalence) would typically be established through recognized measurement standards or validated clinical methods. The document does not describe such studies for this device.

8. The sample size for the training set:
Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable as this is not an AI/ML device.

Summary

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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: +1 614-793-7500 Facsimile: +1 614-793-7520

1.8.2 Official Correspondent

Name:	Rodger A. Brown
Address:	425 Metro Place North
	Suite 300
	Dublin, Ohio 43017-1367 U.S.A
Telephone:	+1 614-822-8342
Facsimile:	+1 614-822-8343
E-mail:	rbrown@neoprobe.com

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 TMVessel Stabilizer
Common Name:	Blood Flowmeter
Classification Name:	Cardiovascular Blood Flowmeter, Class II,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

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 (301) 594-4646. 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" (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 (800) 638-2041 or (301) 443-6597 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

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).