The FlowGuard device is intended for non-invasive, peripheral vessel examinations and intraoperative examinations of blood flow measurements
Intended Use: Diagnostic blood flow measurements

Device Description

The FlowGuard is a dual-beam, angle-independent, pulse-wave Doppler ultrasound system used for non-invasive (peripheral vessel) and 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 FlowGuard 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

Here's an analysis of the provided text regarding the FlowGuard device:

Based on the provided text, the FlowGuard device cleared the 510(k) pathway by demonstrating substantial equivalence to predicate devices, rather than through a study proving it met specific performance acceptance criteria. The document is an FDA clearance letter and summary, which focuses on regulatory equivalence.

Therefore, much of the requested information about concrete acceptance criteria, study data, sample sizes, ground truth, and expert involvement for a performance study is not available in the provided text.

Here's a breakdown of what can be extracted and what is explicitly not present:

Acceptance Criteria and Device Performance

There are no explicit, quantitative acceptance criteria or performance values reported for the FlowGuard device in this document. The clearance is based on substantial equivalence.

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Not Explicitly Stated)
(e.g., Accuracy, Precision, Sensitivity, Specificity in blood flow measurement under specific conditions)	(No quantitative performance metrics are provided in this document)

Study Details (Not explicitly present for a performance study)

Sample size used for the test set and the data provenance: Not provided. The document does not describe a performance study with a test set. It mentions "non-invasive (peripheral vessel) and intra-operative volume blood flow measurements."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided, as no dedicated performance study is detailed where ground truth would be established.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
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. This device is a blood flowmeter, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an algorithm. This is a medical device for measurement. Its performance would be assessed intrinsically, but no such study is described here beyond "substantial equivalence."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
The sample size for the training set: Not applicable, as this is not an AI/machine learning device with a training set in the conventional sense.
How the ground truth for the training set was established: Not applicable.

Key Information from the Document:

Device Name: FlowGuard device: Blood Flowmeter
Intended Use: Non-invasive, peripheral vessel examinations and intraoperative examinations of blood flow measurements. Specifically, diagnostic blood flow measurements. For direct application to exposed blood vessel (miniature, sterilizable transducer).
Classification Name: Cardiovascular Blood Flowmeter, Class II, 870.2100.
Predicate Devices:
- Blood Flow Meter Model HD-4200 (Koven Technology, Inc., K892707)
- EchoFlow BVM-1 (EchoCath Inc., K990642)
- Dynemo 3000 (Sometec Inc., K972798)
Technological Characteristics: Dual-beam, angle-independent, pulse-wave Doppler ultrasound system. Measures blood flow velocity and volume blood flow. Calculates volume blood flow by deriving flow velocity from Doppler shift frequency and multiplying by the cross-sectional area of the blood vessel.
Basis for Clearance: Substantial equivalence to predicate devices in overall design, materials, mechanism of action, mode of operation, performance characteristics, and intended use.
Post-Clearance Requirement: The manufacturer is required to submit a "postclearance special report" containing complete information, including acoustic output measurements based on production line devices, as requested in Appendix G of the FDA's "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." This is a post-market requirement, not a pre-market performance study detail.

In summary, this document is a regulatory clearance letter focused on demonstrating substantial equivalence, not a detailed report of a performance study with specific acceptance criteria that the device met.

Summary

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SECTION 6 - SUMMARY OF SAFETY AND EFFECTIVENESS

FEB 1 3 2002

K013803

(Premarket Notification [510(k)] Number)

1. Applicant

Biosonix Ltd. 6 Haprachim Str. Kfar Malal, Hod Hasharon 45110 ISRAEL Tel: +972-9-7411740 Fax: +972-9-7421526

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: FlowGuard device : Blood Flowmeter Common Name: Cardiovascular Blood Flowmeter, Class II, 870.2100 Classification Name:

3. Predicate Devices

The FlowGuard device is substantially equivalent to a combination of the following devices:

Device	Manufacturer	510(k) No.
Blood Flow Meter Model HD-4200	Koven Technology, Inc.	K892707
EchoFlow BVM-1	EchoCath Inc.	K990642
Dynemo 3000	Sometec Inc.	K972798

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4. Intended Use

The FlowGuard device is intended for non-invasive, peripheral vessel examinations and intraoperative examinations of blood flow measurements

5. Description of the Device

Technological Characteristics Compared to Predicate Device 6.

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

General Manager, Dr. Danny Manor

29, 10,01

Date

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2002

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

Re: K013803 Trade Name: FlowGuard Device Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: DPW Dated: November 11, 2001 Received: November 15, 2001

Dear Mr. Stein:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your because of since is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate device marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate continered problem to may 20, 1978, 1998, 1998, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1 Amendincins, or to devices market Act (Act). You may, therefore, market the device, subject to I coordi I ood, Drag, and sions of the Act. The general controls provisions of the Act include the general controls pro risting of also isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for rms determination on our Device, as described in your premarket notification:

Transducer Model Number V1004

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Page 2 - Mr. Ahava M. 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 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 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 nredicate 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".

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Page 3 - Mr. Ahava M. Stein

If you have any questions regarding the content of this letter, please contact Kachi Enyinna at (301) 443-8262 ext. 162.

Sincerely yours,

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory 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.

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
Intra-operativeNeurological				X
Pediatric
Small Organ(Specify)
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular				X
Laparoscopic
Musculo-SkeletalConventional
Muscolo-SkeletalSuperficial					X
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 of Cardiovascular & Respiratory Devices
510(k) Number K013803

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).