TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO

K980906 · Transonic Systems, Inc. · MQS · Oct 6, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980906
• Device Name: TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO
• Applicant: Transonic Systems, Inc.
• Product Code: MQS · Gastroenterology, Urology
• Decision Date: Oct 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Indications for Use

The HD01-CO monitor is intended for use by trained medical personnel, for assessment of a patient's hemodynamic condition through estimation of cardiac output while undergoing hemodialysis treatment in a non-critical care setting. For use only by or on the order of a physician licensed by law to use or order the use of this device.

Device Story

Device measures cardiac output during hemodialysis using transit-time ultrasound dilution. System includes bench-top HD01 meter, two clip-on ultrasonic sensors (arterial/venous), and PC-based software. Operation: 10ml saline bolus injected into venous bubble trap for sensor calibration; 30ml saline bolus injected into venous line near patient for measurement. Bolus circulates through cardiopulmonary system; arterial sensor detects indicator dilution. Software integrates dilution curve using Stewart-Hamilton equations to calculate cardiac output. Used in clinical settings by trained medical personnel. Output displayed on PC; assists clinicians in hemodynamic assessment. Benefits include non-invasive monitoring without indwelling catheters through heart/lungs, reducing risks associated with traditional thermodilution methods.

Clinical Evidence

Bench testing and literature review provided. Bench accuracy ±5%, repeatability ±4%, cardiac output range 1-20 L/min. Clinical validation cited via 8 published studies (e.g., ASAIO Journal) comparing ultrasound dilution method to thermal methods. No new clinical trials conducted; reliance on established literature and bench performance data.

Technological Characteristics

Materials: plastic-encased ultrasonic sensors. Sensing: transit-time ultrasound. Energy: line-powered electronics. Connectivity: RS232 serial link to PC. Software: Windows-based application for signal processing and calculation. Standards: UL-544, IEC 601-1, 89/336/EEC. Ultrasound intensity levels 25-40 dB below CDRH limits.

Indications for Use

Indicated for patients undergoing hemodialysis treatment to assess hemodynamic condition via cardiac output estimation. For use by trained medical personnel under physician order in non-critical care settings.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Predicate Devices

• American Edwards Lab's COC-1 Thermodilution Cardiac Output Computer (K980906)

Submission Summary (Full Text)

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OCT 6 1998 Transonic Systems

### 1 OF 8 K980906

Section 2 - Summary Device Safety and Effectiveness

## 2. 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92, by:

| Contact Person: | Cornelis J. Drost, President<br>Transonic Systems, Inc.<br>34 Dutch Mill Road<br>Ithaca, NY 14850-9787, USA<br>Phone: [phone]<br>FAX: [phone]<br>Internet: www.transonic.com<br>E-Mail: [e-mail] |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

On:

March 10, 1998

# 2.1 Device Identification & Substantial Equivalency Claims

Table 2-1 summarizes the Device Identification and Substantial Equivalency Claims for the Transonic HD01-CO Cardiac Output Monitor.

| Trade name → | TRANSONIC HD01-CO<br>HEMODIALYSIS CARDIAC OUTPUT<br>MONITOR |
|-----------------------------------------------------|-------------------------------------------------------------------------|
| Common name → | Hemodialysis cardiac output monitor |
| Devices in this model family claimed → | Cardiac output monitor |
| Model Name → | HD01-CO |
| Legally marketed device<br>to which SE is claimed → | American Edwards Lab's COC-1<br>Thermodilution Cardiac Output Computer. |

# Table 2-1: Device Identification and Substantial Equivalency Claims

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Section 2 - Summary Device Safety and Effectiveness

#### 2.2 Device Description.

The HD01 family of devices use transit-time ultrasound principles to measure blood flow and to register sound velocity indicator dilution curves. Standard Stewart-Hamilton equations are employed for the various calculations. Portions of these technologies are covered under Transonic Systems' USA and worldwide patents and pending patents.

Image /page/1/Figure/5 description: This image shows a diagram of a hemodialysis machine. The diagram includes a patient connected to the machine via two tubes labeled A and V. The machine also includes a Transonic Hemodialysis Monitor, a laptop, flow and dilution clip-on sensors, and a dialyzer. The diagram shows the flow of blood from the patient through the machine and back to the patient.

Figure 2-1: System block diagram of the HD01 flow/dilution meter.

All Transonic HD01-series hemodialysis monitor devices consist of the following components (see Figure 2-1):

- HD01 Flow/Dilution meter ( or HD01 meter) - This is a bench-top, line-powered electronic measurement unit with a serial RS232 data output link, and connections for ultrasonic flow/dilution sensors. (See Figure 1-3, and Figure 1-3, and Figure 1-4 on pages 1-1 through 1-3.
- . Dual flow/dilution sensor - these are two plastic-encased ultrasonic sensors connected to the HD01 unit (see Figure 1-1 on page 1-1). One sensor is individually referred to as the "arterial sensor" and is clipped to the patient's arterial hemodialysis line, while the other (the "venous sensor") is clipped to the venous hemodialysis line.
- . Monitor software (also referred to as software) - This is computer software installed on an IBM-PC compatible computer running Windows or Windows 95. The software receives signal data produced by the HD01 meter and performs the various device function calculations (QA, QB, R%, and CO - see Table 1-1 on page 1-1).

The various HD01 devices differ in their indications for use through the supplied software routines. The following section discusses the software routines for Cardiac Output measurement.

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Transonic Systems

Section 2 - Summary Device Safety and Effectiveness

#### 2.3 Cardiac Output (CO) Measurement Technique

The Cardiac Output (CO) measurement technique requires the following HD01 sensor configuration and injectable indicator solution:

- ultrasonic dilution sensors clipped to the venous and arterial dialysis lines .
- . venous and arterial blood lines are connected as normal (not reversed) to the dialysis needles
- Body temperature (37°C) 0.9% saline solution .

The CO measurement starts by calibrating the venous indicator dilution sensor. This is done by injecting a 10 ml saline bolus into the venous bubble trap. Since all of the bolus volume passes through the venous sensor, the following equation determines that sensor's sensitivity to indicator dilution:

$$\mathcal{K} = \frac{\mathcal{V}_{\text{cat}}}{\mathcal{Q}_b \, ^\ast \mathcal{S}}$$

where:

| Vcal | = volume of calibration bolus injected (ml) |
|------|--------------------------------------------------|
| Qb | = mean dialysis blood flow (ml/min) |
| K | = concentration scaling factor (ppm/millivolt) |
| S | = area of ultrasonic dilution curve (volt - sec) |

Like the calibration, the actual CO measurement requires a saline injection into the venous dialysis line. The difference is that the measurement bolus is larger (30 ml), and it is injected at a location close to the patient. This bolus circulates through the cardiopulmonary system, a fraction of it returns to the arterial sensor, and the arterial sensor records the indicator dilution.

Finally, the HD01-CO software integrates the indicator dilution curve and calculates Cardiac Output from the following formula:

$$\mathcal{Q}_{co} = \frac{V_{meas}}{K S}$$

where:

$Q_{co}$ = cardiac output ( ml/min) = volume of injected bolus (ml saline) $V_{meas}$ = concentration scaling-factor (ppm/mv) K = area of dilution curve = 1 volt sec S

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#### Section 2 - Summary Device Safety and Effectiveness

## 2.4 Intended Uses of the HD01 Cardiac Output Monitor

The HD01-series monitors are intended for use by trained medical personnel, for assessment of a patient's hemodynamic condition through cardiac output determination while undergoing hemodialysis treatment

For use only by or on the order of a physician licensed by law to use or order the use of this device.

### Contraindications:

- The H4D dual flow/dilution sensor is for clip-on use only onto the dialysis tubing . specific to the flow sensor, and never on arteries or veins.
- Safe and effective use of these devices depend on correct application technique, . adequate precaution and readiness for emergencies.
- Caution: Federal law restricts this device to use by or on the order of a physician. .

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## 2.5 Summary of Technological Comparison with Predicate Device.

The Transonic HD01-CO Cardiac Output Monitoring device uses ultrasonic velocity measurements to measure indicator dilution.

American Edwards Lab's COC-1 Thermodilution Cardiac Output Computer uses the same Stewart-Hamilton indicator dilution equations, but measures indicator dilution through blood temperature changes.

### 2.6 Safety

The HD01-series devices meet all requirements of:

- UL-544 & IEC 601-1 ●
- . The European Economic Council Directive 89/336/EEC (electromagnetic compatibility)
- . Ultrasound intensity levels applied by the H4D clip-on flow/dilution sensors are 25 to 40 dB below FDA CDRH maximum pre-amendment levels for "Fetal Doppler and Other" applications, and have passed FDA review under 510(k) #K960817

All procedures required to execute these measurements (saline injection, change in blood line connections) are standard clinical procedures in which hemodialysis nurses are well trained.

The HD01 procedures introduce no extra components into the hemodialysis circuit, and at no time is patient sterility compromised.

Image /page/4/Picture/13 description: The image shows a black and white abstract pattern. The pattern consists of small, irregular black shapes scattered across a white background. The shapes are concentrated in the upper portion of the image, with fewer shapes appearing towards the bottom.

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Transonic Systems

Section 2 - Summary Device Safety and Effectiveness

## 2.7 Effectiveness.

Table 2-2 lists printed publications that document the effectiveness of the HD01-CO cardiac output measurements, while Table 2-3 compares HD01-CO effectiveness with that of the predicate device. Appendix D contains copies of all these papers.

- 1. Krivitski, N.M., "Novel Method to Measure Access Flow During Hemodialysis by Ultrasound Dilution Technique," ASAIO Journal, Vol. 41, p. M741-M745, 1995.
- 2. Krivitski, N.M., "Cardiac Output Measurement in Extracorporeal Systems by Ultrasound Dilution," ASAIO Journal Abstracts, p. 82, 1994.
- 3. Nikiforov, U.V., Kisloukhine, V.V., Chaus, N.I., "Validation of a New Method to Measure Cardiac Output During Extracorporeal Detoxification," ASAIO Journal Vol. 42, No. 5, p. M903-M905, 1996.
- 4. Kisloukhine, V.V, Dean, D.A., "Validation of a Novel Ultrasound Dilution Method to Measure Cardiac Output During Hemodialysis," ASAIO Journal, Vol. 42, No. 5, p. M906-M907, 1996.
- J.J.. Glidden, D., Miranda, C.. "Access 5. Sands. Flow Measured during Hemodialysis," ASAIO Journal, Vol. 42, No. 5, p. M530-M532, 1996.
- 6. Depner, T.A., Eder, L.A., "Changes in Access Blood Flow and Appearance of Recirculation during Hemodialysis," XIIIth International Congress of Nephrology Abstracts, p. 570, 1995.
- 7. Chaus, N.I, Kislukhin, V.V., Dzemeshkevich, S.L., Zhidkov, I.L., "Comparison of Sound Velocity, Impedance, and Optical with Thermal Methods for Cardiac Output," FASEB Journal, Vol. 11, No. 3, Abstract #2872, 1997.
- 8. Depner, T.A. & Krivitski, N.M., "Influence of Access Blood Flow (AF) on Systemic Blood Flow in Hemodialysis Patients," JASN. Vol.8, p. 155A, 1997.

# Table 2-2: Cardiac Output Theory, Validation & Application Reports (Appendix D contains copies of all these papers)

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# Section 2 - Summary Device Safety and Effectiveness

| | American Edwards COC-1 Thermodilution<br>Cardiac Output Computer with Swan Ganz<br>catheter | Transonic HD01-CO<br>with H4D sensor |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | For assessment of a patient's hemodynamic<br>condition through cardiac output<br>determination | For assessment of a patient's hemodynamic<br>condition through cardiac output determination<br>while undergoing hemodialysis |
| Contra-<br>indications | Not for use on patients with recurring sepsis,<br>patients with a hypercoagulable state, or (for<br>some catheters) patients sensitive to heparin | Clip-on sensors for use only on patient-<br>connected hemodialysis bloodlines, never on<br>arteries or veins. |
| Safety | | |
| Measurement<br>Method | The medical<br>community<br>raises<br>serious<br>concerns on a possible higher co-morbidity<br>when Swan-Ganz catheters are used. | Saline injection into HD venous line.<br>No separate indwelling devices: measurement<br>uses sensor clamped-on to hemodialysis line |
| Procedural<br>Dangers to<br>Patient | Inject saline directly into vena cava.<br>Sterile indwelling catheter must be entered<br>into a vein, passed through the heart (through<br>two heart valves) and into the pulmonary<br>artery | Measurement consists of procedures which are<br>standard in hemodialysis administration |
| Electrical | Input leakage current < 50 $\mu$ A<br>Patient leakage current < 10 $\mu$ A<br>Patient isolation > 2500V<br>10 $\mu$ A safety-trip electronics to protect<br>against thermal sensor insulation failure | Input leakage current < 50 $\mu$ A<br>Patient leakage current < 10 $\mu$ A<br>Patient isolation > 2500V<br>Double insulated sensor electronics, plus wall<br>of sterile tubing. |
| Ultrasonic | Not applicable | Ultrasonic irradiation level is 320 times lower<br>than CDRH permitted level for peripheral<br>vessel use. (Already FDA-cleared under 510(K)<br>#K960817) |
| Effectiveness | | |
| Bench Accuracy | In vitro: $\pm$ 3% (0-4 ℃), or $\pm$ 4% (19-25 ℃)<br>+ thermistor-related sensing errors | From all sources: $\pm$ 5 % |
| Bench | Computational variations: $\pm$ 3% | Computational variations: Negligible |
| Repeatability | Variations from all sources: Not Specified | Variations from all sources: $\pm$ 4% |
| <i>In Vivo</i> Accuracy | $\pm$ 20% (inferred from literature) | $\pm$ 20% |
| Cardiac Output<br>Measurement<br>Range | 0.1 to 20 L/min | 1 to 20 L/min |

Table 2-3: Comparisons between the HD01 devices and the predicate device

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K980906 - PAGE 8 OF 8

Transonic Systems

Section 2 - Summary Device Safety and Effectiveness

#### 2.7 Summary of Safety and Effectiveness.

The bench and clinical tests cited above demonstrate that, like the predicate devices, the HD01-CO device is safe and effective for its intended use.

Cornelia J. Frost

Cornelis J. Drost, President Transonic Systems Inc. 34 Dutch Mill Road Ithaca, NY 14850

March 10, 1998 Preparation date

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Image /page/8/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 6 1998

Mr. Cornelius J. Drost President Transonic Systems Inc. 34 Dutch Mill Road Ithaca, New York 14850-9787

" Re: K980906 Model HD01-CO Hemodialysis Monitor for Cardiac Output Dated: July 7, 1998 Received: July 8, 1998 Regulatory Class: II 21 CFR 876.5820/Procode: 78 MQS

Dear Mr. Drost:

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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Transonics Systems Inc. HD01-Series Hemodialysis Monitors, as described in your premarket notification:

| Device Model | Transducer Model Number |
|--------------|--------------------------|
| HD01-CO | H4D FLOW/DILUTION SENSOR |

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 for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation 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.

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 April 1995, "Format and Content of Diagnostic Ultrasound Special 510(k)." 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.

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Page 2 - Mr. Cornelis J. Drost

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] or at its Internet address "[e-mail]".

If you have any questions regarding the content of this letter, please contact Mr. Richard J. Williams at [phone].

Sincerely yours,

Jarind le. Seymon
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

Enclosures

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Page 1 of 1

## 510 (k) NUMBER (IF KNOWN) : K980906

DEVICE NAME: Transonic Hemodialysis Monitor, Cardiac Output, Model HD01-CO

## INDICATIONS FOR USE:

The HD01-CO monitor is intended for use by trained medical personnel, for assessment of a patient's hemodynamic condition through estimation of cardiac output while undergoing hemodialysis treatment in a non-critical care setting.

For use only by or on the order of a physician licensed by law to use or order the use of this device.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

Clifford C. Degnan

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