The Model HD-800 Tubing Blood Flow Meter is indicated for the measurement of volume blood flow through extracorporeal tubing during the performance of hemodialysis and cardiopulmonary bypass procedures.

Device Description

The subject device is a compact, continuous-wave Doppler ultrasound blood velocity detector equipped with four interchangeable clamp-on transducers for attachment to extracorporeal tubing. All transducers operate at a nominal frequency of 2.5 MHz and vary according to the internal diameter of the tubing in use and the volume flow range to be measured. Operation: The system provides an LCD display of mean volume blood flow through the insonated tubing in liters per minute or millliliters per minute averaged over the last three seconds and updated every 0.6 second. Volume flow is calculated by deriving flow velocity from the Doppler shift frequency using the standard formula and then multiplying the velocity by the diameter of the tubing in use. Audible and LED alarms are provided for disconnection of the transducer, excessive bubbles. flow exceeding measurement limits, cessation of flow exceeding 1 second or insufficient flow to permit measurement, and low battery power. 15 volts DC. By AC adaptor or ten 1.5V AA batteries, as preferred.

AI/ML Overview

The provided text describes the Koven Technology Inc. Model HD-800 Tubing Blood Flow Meter. Here's an analysis of its acceptance criteria and the study performed:

Acceptance Criteria and Reported Device Performance

The device's performance data is primarily focused on its measurement accuracy.

Acceptance Criterion	Reported Device Performance
Measurement Accuracy	Maximum variance of 0.06 liters per minute compared to an electromagnetic flowmeter
Doppler Sensitivity	Evaluated by determining the signal-to-noise ratio at minimum flow rates (specific value not provided)
Bubble Detection Capability	Determined using a flow phantom (specific details/values not provided)
Acoustic Output	Measured according to established standards and guidelines (specific values not provided)

Study Details

The information provided describes a performance study conducted to evaluate the device.

Sample Size used for the test set and Data Provenance:
- Sample Size: Not explicitly stated. The study mentions "simultaneous comparison of values obtained with the subject device and an electromagnetic flowmeter using a flow phantom in which pig blood is pumped through vinyl chloride tubing at known flow rates." This implies a series of measurements, but the number of measurements or data points is not quantified.
- Data Provenance: The study was conducted using a "flow phantom" with "pig blood" and "vinyl chloride tubing." This indicates a laboratory, in vitro (or ex vivo if the pig blood was fresh) setting rather than human data. It is a prospective study design as the testing was specifically performed for this evaluation.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. The ground truth for flow measurement was established by using an "electromagnetic flowmeter" as the reference standard and "known flow rates" in the flow phantom. This is a technical, rather than expert-driven, ground truth.
Adjudication method for the test set: Not applicable. The ground truth was based on a reference instrument and known flow rates, not on human interpretation or adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a measurement instrument, not an AI-assisted diagnostic tool requiring human reader studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the performance data presented is for the standalone device, as it focuses on the device's accuracy in measuring flow in a phantom. There is no human-in-the-loop aspect described for this particular performance evaluation.
The type of ground truth used:
- Measurement Accuracy: An "electromagnetic flowmeter" served as the reference standard, and "known flow rates" were established in the flow phantom. This is a technical reference standard/physical measurement ground truth.
- Doppler Sensitivity & Bubble Detection: These capabilities were also evaluated using a "flow phantom," implying specific technical criteria were used as ground truth (e.g., whether bubbles were detected, what the signal-to-noise ratio was).
The sample size for the training set: Not applicable. This device is a physical instrument, not a machine learning model that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary

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510(k) SUMMARY

MODEL HD-800 TUBING BLOOD FLOW METER

1. COMPANY INFORMATION. Name: Koven Technology Inc. Address: 300 Brookes Drive, Suite 105, Hazelwood, MO 63042. Phone: (314) 731-0008 Contact: Paul G. Koven, President
1. DEVICE IDENTIFICATION. Trade Name: Model HD-800 Tubing Blood Flow Meter. Common Name: Doppler Blood Flow Detector. Classification Name: Cardiovascular Blood Flowmeter, 74-DPW.
1. PREDICATE DEVICE. Transonic Systems Inc., Transonic Flowmeter--Models HT107. HT207, and 311-- K872048, SE decision 6/21/88.
1. DEVICE DESCRIPTION. General: The subject device is a compact, continuous-wave Doppler ultrasound blood velocity detector equipped with four interchangeable clamp-on transducers for attachment to extracorporeal tubing. All transducers operate at a nominal frequency of 2.5 MHz and vary according to the internal diameter of the tubing in use and the volume flow range to be measured. Operation: The system provides an LCD display of mean volume blood flow through the insonated tubing in liters per minute or millliliters per minute averaged over the last three seconds and updated every 0.6 second. Volume flow is calculated by deriving flow velocity from the Doppler shift frequency using the standard formula and then multiplying the velocity by the diameter of the tubing in use. Audible and LED alarms are provided for disconnection of the transducer, excessive bubbles. flow exceeding measurement limits, cessation of flow exceeding 1 second or insufficient flow to permit measurement, and low battery power. 15 volts DC. By AC adaptor or ten 1.5V AA batteries, as preferred.
1. INTENDED USES. The Model MD-800 is intended for the measurement of volume blood flow through extracorporeal tubing during the performance of hemodialysis and cardiopulmonary bypass procedures.
1. COMPARISON WITH PREDICATE DEVICE. Both devices are Doppler ultrasound systems designed to measure volume blood flow. The only significant differences are that the predicate device is supplied with a more extensive variety of ultrasound transducers and is recommended for intraoperative use as well as extracorporeal volume blood flow measurement. Also, the predicate device is AC rather than DC powered.
1. PERFORMANCE DATA. Measurement accuracy was evaluated by means of simultaneous comparison of values obtained with the subject device and an electromagnetic flowmeter using a flow phantom in which pig blood is pumped through vinyl chloride tubing at known flow rates. The maximum variance was 0.06 liters per minute. Doppler sensitivity was evaluated by determining the signal-to-noise ratio at minimum flow rates. Bubble detection capability was also determined using a flow phantom. Acoustic output was measured according to established standards and guidelines and reported following Track 1.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of a stylized human figure.

NOV 24 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Paul G. Koven President Koven Technology Incorporated 300 Brookes Drive Suite 105 Hazelwood, MO 60342-2746

Re: K982986 Model HD-800 Tubing Blood Flow Meter Regulatory Class: II/21 CFR 870.2100/21 CFR 870.2120 Product Code: 74 DPW/74 DPT August 17, 1998 Dated: August 26, 1998 Received:

Dear Mr. Koven:

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 leqally 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 followinq transducers intended for use with the Model HD-800 Tubing Blood Flow Meter, as described in your premarket notification:

Transducer Model Number

T-0110-1/4 T-0110-3/8 T-0110-1/2 T-0110-1/4 TO

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 Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 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 - Paul G. Koven

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 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 and additionally 809.10 for in vitro diagnostic devices), 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 Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree 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 Paul M. Gammell, Ph.D. at (301) 594-1212.

Sincerely yours,

for Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _K982986

Device Name: Model HD-800 Tubing Blood Flow Meter

The Model HD-800 Tubing Blood Flow Meter Indications For Use: is indicated for the measurement of volume blood flow through extracorporeal tubing during the performance of hemodialysis and cardiopulmonary bypass procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David b. Seggern
(Division Sign-Off)

Division of Reproductive, Andominal, ENT, and Radiological Device 510(k) Number

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Formal 1-2-96)

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Fill out one form for each ultrasound system and each transducer

510(k) Number (if known) _ K 9 8 2 9 8 6

Device Name: HD-800 Jubing Blood Flow Meter

Transducer : System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
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

Additional Comments:__________________________________________________________________________________________________________________________________________________________

(PLEASE QO NOT WHITE BELOW THIS UNE . CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seymour

(Division Sien-Off) 1 Division of Reproductive, Abdomina and Radiological I 510(k) Numb

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Fill out one form for each ultrasound system and each transducer

K 982986 510(k) Number (if known) j

HD-800 Tubing Blood Flow Meter Device Name: __

Transducer : : _______________________________________________________________________________________________________________________________________________________________

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
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

Additional Comments:____* Extracorporeal Use On1y

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Gmin h. Sejser

Prescription Use (Per 21 CFR 801.109)

ductive, Abdomina

510(k) Number K98

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Fill out one form for each ultrasound system and each transducer

510(k) Number (if known)

Device Name: _ HD-800_Iubing Blood_Flow_Meter_________________________________________________________________________________________________________________________________

Transducer : _ T-0110-3/8

Intended Use: Diagnostic uttrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
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

Additional Comments:* Extracorporeal Use Only

(PLEASE DO NOT WRITE BELOW THIS UNE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. leymon

(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982986
00027

K982986

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Fill out one form for each ultrasound system and each transducer

510(k) Number (if known)

K 982986

HD-800 Tubing Blood Flow Meter Device Name:

Transducer :

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
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

Additional Comments: * Extracorporeal Use Only

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Sezer

(Division Sign-Off) Division of Reproductive, Abdominal, EN 0029 and Radiological I 510(k) Number

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K982986

Fill out one form for each ultrasound system and each transducer

510(k) Number (if known) K982966

HD-800 Tubing Blood Flow Meter Device Name:

T-0110-1/4T0 (Medisys) Transducer :

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Intended Use: Diagnostic ultrasound imaging of

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular *					N
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix EAdditional Comments:__________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation

David C. Jesson

n of Teproductive, Abdominal, ENT

510(k) Number K9829860002

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).