The Accuflo™ Electromagnetic Flow System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. The device will function in circuits utilizing centrifugal pump heads as well as circuits utilizing roller pumps. There are no other intended uses for the device. The equivalent device, the Bioprobe, is primarily used with centrifugal pumps.

Device Description

The Accuflo™ Electromagnetic Flow Monitoring System is composed of three (3) components, a monitor display unit, a transducer and a sterile flow-through probe.

AI/ML Overview

The provided document is a 510(k) summary for the Accuflo™ Electromagnetic Flow Monitoring System, asserting its substantial equivalence to a predicate device, the Biomedicus Bioprobe Electromagnetic Flow System. It does not contain information about a study proving the device meets specific acceptance criteria in the manner of a clinical trial or performance study report. Instead, the "acceptance criteria" appear to be implicit in the comparison table demonstrating similarity to the predicate device. The "reported device performance" refers to the accuracy claim made for the Accuflo™ system within this comparison.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Predicate: Bioprobe System)	Reported Device Performance (Accuflo™ System)
Components	3	3
Separate Monitor	Yes	Yes
Digital Display	Yes	Yes
Zero Offset Control	Yes	Yes
Electromagnetic Transducer	Yes	Yes
Electromagnets	1	2
Disposable Flow Probe	Yes	Yes
Construction	Insert Injection Molded	Insert Injection Molded
Electrodes	3 pairs in a row	3 in a row
Inside Diameter	3/8"	3/8"
Material	Polycarbonate	Polycarbonate
Sterilization	Ethylene Oxide	Ethylene Oxide
Accuracy	Accurate within 300 ml	Accurate within 50 ml

Note: The accuracy claim for the Accuflo™ system (within 50 ml) is presented as an improvement over the predicate device (within 300 ml), not as an "acceptance criterion" that was met in a separate study with a predefined threshold. The "acceptance criteria" here are inferred from the characteristics of the predicate device for demonstrating substantial equivalence.

Regarding a "study that proves the device meets the acceptance criteria":

The document does not describe a study in the traditional sense that would prove the Accuflo™ system meets its own stated accuracy of "within 50 ml" through specific testing methodologies. The accuracy claim is stated as a characteristic within the comparison table, implying it is inherent to the design and operation, potentially demonstrated through internal testing that is not detailed here.

The entire 510(k) submission itself serves as the "study" demonstrating that the Accuflo™ system is substantially equivalent to the predicate device based on design, components, materials, and intended use, with the improved accuracy noted as a difference that does not raise new questions of safety or effectiveness.

Therefore, the following information is largely not available in the provided text:

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

Not provided. The document is a 510(k) summary, not a detailed study report. It does not mention sample sizes, test sets, or data provenance for performance testing.

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)

Not applicable. This type of ground truth establishment is typically for diagnostic imaging or similar devices, not for an electromagnetic flow monitoring system where accuracy would be determined by physical measurements against a known standard.

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

Not applicable. This refers to clinical or diagnostic adjudication processes, which are not relevant to the type of device described.

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. This is a medical imaging study type, not relevant to a flow monitoring system. The device does not involve "human readers" or "AI assistance" in this context.

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

Not explicitly stated as a formal study. The device itself is "standalone" in its function of measuring flow, but the document doesn't describe a specific "standalone performance study" with detailed methodology.

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

Not explicitly stated. For a flow monitoring device, ground truth for accuracy would typically be established by in vitro testing against precisely known flow rates using calibrated equipment. This detail is not provided.

8. The sample size for the training set

Not applicable/Not provided. This is relevant for machine learning models. The Accuflo™ system is a measurement device, not an AI/ML system.

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

Not applicable/Not provided. As above, not relevant for this type of device.

Summary

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510(k) SUMMARY

Accuflo™ Electromagnetic Flow Monitoring System

The Accuflo™ Electromagnetic Flow Monitoring System is composed of three (3) components, a monitor display unit, a transducer and a sterile flow-through probe. The system is substantially equivalent to the Biomedicus Bioprobe Electromagnetic Flow System which is marketed by Medtronic, Inc.

TABLE OF COMPARISON:

APR - 8 1998

CHARACTERISTIC	ACCUFLO™ SYSTEM	BIOPROBE SYSTEM
Components	3	3
Separate Monitor	Yes	Yes
Digital Display	Yes	Yes
Zero Offset Control	Yes	Yes
Electromagnetic Transducer	Yes	Yes
Electromagnets	2	1
Disposable Flow Probe	Yes	Yes
Construction	Insert Injection Molded	Insert Injection Molded
Electrodes	3 in a row	3 pairs in a row
Inside Diameter	3/8"	3/8"
Material	Polycarbonate	Polycarbonate
Sterilization	Ethylene Oxide	Ethylene Oxide
Accuracy	Accurate within 50 ml	Accurate within 300 ml

DISCUSSION OF SIMILARITIES AND DIFFERENCES:

The use of a single electromagnet in the Bioprobe System compromises the uniformity of field within the flow-through cell. To compensate for this, two pair of electrodes are used to pick up the signal on opposite sides of the probe wall. The use of two electromagnets in the Accuflo™ System enhances the uniformity of the field within the probe so that a single electrode pair can be used to pick up the signal with improved accuracy. The Biomedicus Bioprobe System is sold as an integral part of the Biomedicus Pump Console. The Accuflo™ System is a free standing system permitting expanded utilization of this more accurate flow measurement in non centrifugal, i.e., Roller Pump, pump systems. All remaining differences are cosmetic only.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

H. David Shockley, Jr. President Official Correspondent International Biophysics Corporation 4020 S. Industrial Drive, Suite 160 Austin, TX 78744

APR - 8 1998

K963703 Re : Accuflo™ Electromagnetic Flow Monitoring System Regulatory Class: II (Two) Product Code: DPT Dated: January 8, 1998 Received: January 12, 1998

Dear Mr. Shockley:

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 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 Regulation (QS) for Medical Devices: General regulation (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 - Mr. H. David Shockley, Jr.

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" (21 CFR 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/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, 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): K963703

Device Name: Accuflo_Monitoring_System

Indications For Use:

INTENDED USE

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular, Respiratory
Division of Cardiovascular, Respiratory, and Neurological Devices 1963703 510(k) Number_

Prescription Use_C_C_ (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.2120 Extravascular blood flow probe.

(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).