The EchoFlow BVM-1 is an ultrasonic Doppler system that can be used to measure blood flow velocities. It can be used either for measurement of vessels below the skin, or for intraoperative measurements. It is not intended for cardiac or fetal use. A 10 MHz probe is supplied. The unit maintains its specified accuracy even if the angle between the probe face and vessel axis is as much as ±15°, unlike conventional Doppler systems where the angle between the flow direction and the probe must be accurately known. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. The system will not detect any signals from vessels more than 15.5 mm from the probe.

Device Description

The EchoFlow velocity system is a computer-based ultrasonic Doppler blood velocity measuring system used to measure blood velocity in vessels beneath the skin. It can either be used for measurement on the surface of the skin, or for intraoperative measurements. A 10 MHz CW probe is used. When used intraoperatively, a sterile sheath covers the probe and 6 feet of cable coming from the probe. A unique feature of the system is that the angle between the probe and the axis of the blood vessel does not have to be known. An accuracy of 15% is maintained if this angle changes by as much as ±15°. This is done by using a unique probe that emits two beams at known angles with respect to each other, as explained in a later section. Thus, the system is well-adapted to measuring flow in blood vessels beneath the surface of the skin, where the exact angle of the axis of the blood vessel cannot be determined. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. It will not detect any signals at depths greater than 15.5 mm from the probe tip.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the EchoFlow Doppler Blood Velocity Meter BVM-1, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a formal, enumerated way with pass/fail thresholds. Instead, it describes performance characteristics the device is designed to achieve, which implicitly serve as the criteria for its intended functions. The reported device performance is presented as meeting these characteristics.

Acceptance Criteria (Implied from Intended Use/Description)	Reported Device Performance
Maintain accuracy even if the angle between the probe face and vessel axis changes by up to ±15°, without prior knowledge of the angle.	"An accuracy of 15% is maintained if this angle changes by as much as ±15°." (Page 1) "The unit maintains its specified accuracy even if the angle between the probe face and vessel axis is as much as ±15°, unlike conventional Doppler systems where the angle between the flow direction and the probe must be accurately known." (Page 2, 4, 5)
Detect large blood vessels at specific depths.	"The unit can detect large blood vessels at depths up to 12 mm..." (Page 2, 4, 5)
Detect small blood vessels at specific depths.	"...and small blood vessels at depths up to 10 mm in normal tissue." (Page 2, 4, 5)
Not detect signals beyond a certain depth.	"It will not detect any signals at depths greater than 15.5 mm from the probe tip." (Page 2) "The system will not detect any signals from vessels more than 15.5 mm from the probe." (Page 2, 4, 5)
Clinical Safety and Effectiveness	"The conclusions drawn from the non-clinical tests and clinical tests demonstrate that the device is as safe and effective, and performs as well or better than the legally marketed device identified in paragraph 3 [predicate devices]." (Page 3) (Supported by non-clinical tests: Electrical Safety, Doppler accuracy, Software validation, Depth penetration, Ultrasonic emissions tests; and clinical test: Clinical validation of the operation of the system in animals and a human.) (Page 2)

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

Test Set Sample Size: The document states that a "Clinical test" was performed for "Clinical validation of the operation of the system in animals and a human." However, specific sample sizes (number of animals, number of human subjects, number of measurements) for this test set are not provided.
Data Provenance: The document does not specify the country of origin for the data. The clinical test involved both "animals and a human," implying a combination of controlled laboratory/animal studies and a limited human study, though details are scarce. It is a prospective study, as it was conducted to validate the device's operation.

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

The document does not provide any information regarding the number of experts used, nor their qualifications, for establishing ground truth in the clinical test.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The submission focuses on demonstrating substantial equivalence to predicate devices through technical and clinical performance, not on comparing reader performance with and without AI assistance. The device is a measurement tool, not an interpretation tool that would involve human reader interpretation of images.

6. Standalone Performance Study:

Yes, a standalone performance assessment was conducted. The "Performance data" section (Page 2) details both "Non-clinical tests" and a "Clinical test." The non-clinical tests (Electrical Safety, Doppler accuracy, Software validation, Depth penetration, Ultrasonic emissions tests) are prime examples of a standalone evaluation of the algorithm/device's technical performance characteristics. The clinical test in animals and a human further validates the device's standalone operation in a biological context.

7. Type of Ground Truth Used:

For the non-clinical tests (e.g., Doppler accuracy, depth penetration), the ground truth would likely have been established using controlled physical phantoms, calibrated instruments, and known physical parameters (e.g., known flow velocities, known depths).
For the clinical test in animals and a human, the document doesn't explicitly state the ground truth. However, it can be inferred that the ground truth for "blood flow velocities" would likely come from established, independent, and accurate reference methods for measuring blood velocity (e.g., direct venipuncture with flow measurements, other established Doppler systems with known accuracy, or perhaps even direct observation/measurement in animal models if surgically accessible).

8. Sample Size for the Training Set:

The document does not provide any information about a separate "training set" or its sample size. This is a medical device, not an AI/machine learning algorithm that typically undergoes a distinct training phase with a dedicated dataset. The "development" or "design" of the device (including its unique diffractive transducer and velocity measurement algorithms) would have involved engineering and calibration efforts, but these are not referred to as statistical "training sets" in this context.

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

As a dedicated "training set" is not mentioned, information on how its ground truth was established is not provided. The device likely underwent extensive engineering design, simulations, and experimental validation against known physical principles and calibrated setups, rather than machine learning-style training with a distinct ground truth dataset.

Summary

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K990642

EchoCath Inc. 510(k) Submission EchoFlow Doppler Blood Velocity Meter 510(k) Summary

(1) Submitters name, address, telephone number, contact person, and date of preparation

Name: EchoCath Inc. Address: PO Box 7224 Princeton, NJ 08543 Telephone Number: 609-987-8400 Contact person:

Dr. George H. Myers Medsys Inc 377 Route 17 Hasbrouck Heights NJ 07604

201-727-1703 fax: 201-727-1708

Date of preparation: September 2, 1999

(2) Names

Trade name: EchoFlow Doppler Blood Velocity Meter BVM-1 Common Name: Doppler ultrasonic blood-flow measuring system Classification Name: Flowmeter, blood, ultrasonic, w/wo calibration, and Transducer, Ultrasonic

(3) Predicate devices:

Ultramed Ultraplex, K861378
Zertl K921377, P/Meter

(4) Description

A unique feature of the system is that the angle between the probe and the axis of the blood vessel does not have to be known. An accuracy of 15% is maintained if this

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angle changes by as much as ±15°. This is done by using a unique probe that emits two beams at known angles with respect to each other, as explained in a later section. Thus, the system is well-adapted to measuring flow in blood vessels beneath the surface of the skin, where the exact angle of the axis of the blood vessel cannot be determined. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. It will not detect any signals at depths greater than 15.5 mm from the probe tip.

(5) Intended Use

The EchoFlow BVM-1 is an ultrasonic Doppler system that can be used to measure blood flow velocities in blood vessels. It can be used either for measurement of vessels below the skin, or for intraoperative measurements. It is not intended for cardiac or fetal use. A 10 MHz probe is supplied. The unit maintains its specified accuracy even if the angle between the probe face and vessel axis is as much as ±15°, unlike conventional Doppler systems where the angle between the flow direction and the probe must be accurately known. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. The system will not detect any signals from vessels more than 15.5 mm from the probe.

(6) Comparison to Predicate Devices

(a) The EchoFlow system has the same intended use, method of application, and clinical utility as the predicate devices. It differs from them in that it has a special transducer (the "diffractive transducer") which makes it unnecessary to know the angle between the direction of blood flow and the plane of the transducer.

(b) Performance data

(1) Non-clinical tests:

Electrical Safety Doppler accuracy Software validation Depth penetration Ultrasonic emissions tests

(2) Clinical test

Clinical validation of the operation of the system in animals and a human.

(3) Conclusions

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The conclusions drawn from the non-clinical tests and clinical tests demonstrate that the device is as safe and effective, and performs as well or better than the legally marketed device identified in paragraph 3.

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EchoCath Inc. September 2, 1999

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Diagnostic Ultrasound Indications for Use Form

Page 1 of 2

510(k) Number: K990642

Device Name: EchoFlow Doppler Blood Velocity Meter BVM-1

Indications For Use:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)					N
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular					N
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

(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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Diagnostic Ultrasound Indications for Use Form

Page 2 of 2

510(k) Number: K990642

Device Name: IOP10 Transducer for EchoFlow Doppler Blood Velocity Meter BVM-1

Indications For Use:

The IOP10 transducer for the EchoFlow BVM-1 is intended to be used with that unit to measure blood flow velocities. It can be used either for measurement of vessels below the skin, or for intraoperative measurements. It is not intended for cardiac or fetal use. A 10 MHz probe is supplied. The unit maintains its specified accuracy even if the angle between the probe face and vessel axis is as much as ±15°, unlike conventional Doppler systems where the angle between the flow direction and the probe must be accurately known. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. The system will not detect any signals from vessels more than 15.5 mm from the probe.

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)					N
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular					N
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

(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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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 1999

David Vilkomerson, Ph.D. Executive Vice President EchoCath, Inc. P.O. Box 7224 08543-7224 Princeton, NJ

Re: K990642 EchoFlow™ Doppler Blood Velocity Meter Requlatory Class: II (two) Product Code: 74CAS and 74JOP February 23, 1999 Dated: Received: July 2, 1999

Dear Dr. Vilkomerson:

We have reviewed your Section 510(k) 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - David Vilkomerson, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahah, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K990642

Diagnostic Ultrasound Indications for Use Form

Device Name: EchoFlow Doppler Blood Velocity Meter BVM-1

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bera K. Kemper a

Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number k 990642

Regulation Number and Section

§ 870.2880 Ultrasonic transducer.

(a)
Identification. An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.(b)
Classification. Class II (performance standards).