DELTEX MEDICAL CARDIOQ-EDM+

K132139 · Deltex Medical Limited · DPW · Oct 10, 2013 · Cardiovascular

Device Facts

• Record ID: K132139
• Device Name: DELTEX MEDICAL CARDIOQ-EDM+
• Applicant: Deltex Medical Limited
• Product Code: DPW · Cardiovascular
• Decision Date: Oct 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2100
• Device Class: Class 2

Intended Use

The CardioQ-EDM+ cardiac function and fluid status monitoring system is designed to provide clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters. The CardioQ-EDM+ beat-to-beat data on cardiovascular status can be used by the managing clinician to evaluate and optimize hemodynamic performance in anesthetized, sedated or conscious patients in the operating room, intensive care unit, emergency room or ward.

Device Story

CardioQ-EDM+ monitors cardiac function and fluid status via two modes: Flow Monitoring and Pressure Monitoring. Flow Monitoring uses an esophageal probe with 4 MHz continuous wave ultrasound to measure blood flow in the descending thoracic aorta; system processes signals to display velocity spectrum and derive hemodynamic parameters (e.g., Stroke Volume, Cardiac Output). Pressure Monitoring mode slaves arterial blood pressure signals from external vital signs monitors to calculate pressure-based hemodynamic parameters. Device is used in OR, ICU, ER, or ward by clinicians to evaluate and optimize hemodynamic performance. Output is displayed on a 10.4" TFT LCD screen, providing real-time beat-to-beat data to assist clinical decision-making regarding patient fluid status and cardiovascular performance.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Esophageal Doppler monitor; 4 MHz continuous wave ultrasound; 10.4" TFT LCD display (800x600); connectivity via patient interface cable and slaved arterial blood pressure input. Software algorithms perform Fast Fourier Transform (512 point) for spectral display and calculate hemodynamic parameters from Doppler and pressure inputs. Complies with IEC 60601 (electrical safety/EMC) and NEMA UD 2 (acoustic output).

Indications for Use

Indicated for monitoring cardiac function and fluid status in anesthetized, sedated, or conscious patients in clinical settings (OR, ICU, ER, ward). Contraindicated for patients with intra-aortic balloon pumping, severe coarctation of the aorta, pharyngo-esophago-gastric pathology, or severe bleeding diatheses.

Regulatory Classification

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.

Predicate Devices

• Deltex Medical CardioQ-EDM (K111542)

Submission Summary (Full Text)

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### 1.1.10 510(k) Summary

510(k) Summary (as required by 21 CFR 807.92 (c))

### Owner's Name:

Deltex Medical Terminus Road Chichester West Sussex POI9 8TX United Kingdom Tel: [phone] 011 44 1243 532534 Fax:

**OCT 1 0 2013**

### Classification:

| Proprietary Name: | Deltex Medical CardioQ-EDM+ |
|-----------------------|----------------------------------------|
| Common/Usual Name: | Esophageal Doppler Monitor |
| Classification Names: | Cardiovascular Blood Flowmeter |
| | Extravascular Blood Flow Probe |
| | Patient Transducer and electrode cable |
| Product Codes: | DPW, DPT, DSA |
| Regulation Numbers: | 21 CFR 870.2100, 870.2120, 870.2900 |

### Predicate Devices used to Demonstrate Substantial Equivalence:

The Deltex Medical CardioQ-EDM cleared on October 20, 2011 under 510(k) Number K 111542

### Description, including Intended Use:

The CardioQ-EDM+, is a medical instrument designed to monitor cardiac function and fluid status, providing clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters in anesthetized, sedated or conscious palients in the operating room. intensive care unit, emergency room or ward. In addition, the CardioQ-EDM+ includes a function to calculate arterial blood pressure based parameters from an output slaved from a vital signs monitor.

The CardioQ-EDM+ cardiac function and fluid status monitoring system is designed to provide clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters. The CardioQ-EDM+ beat-to-beat data on cardiovascular status can be used by the managing clinician to evaluate and optimize hemodynamic performance in anesthetized, sedated or conscious patients in the operating room, intensive care unit, emergency room or ward.

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# Comparison technological features:

The CardioQ-EDM+ has been designed by Deltex Medical as a modification to the CardioQ-EDM which received FDA clearance on October 20, 2011 under K111542. It uses the same product architecture but with the addition of the components, software algorithms, and display modifications that allow the CardioQ-EDM+ to calculate and display the hemodynamic parameters from the slaved pressure inputs.

The CardioQ-EDM+ combines Doppler measurement of blood flow with Pulse Pressure Waveform Analysis (PPWA). In "Flow Monitoring Mode" the system employs esophageal Doppler monitoring (EDM) techniques using 4 MHz continuous wave ultrasound to monitor and quantify the blood flow in the descending thoracic aorta. displaying this data as a maximum velocity curve, a velocity spectrum and derived measurements. Real-time information about cardiac function, in particular left ventricular flow, is displayed continuously.

From the maximum value in the velocity spectrum the following Doppler parameters are calculated: Stroke Distance (SD), Stroke Volume (SV), Stroke Volume Variation (SVV), Patient's heart rate (HR), Cardiac Output (CO), Peak Velocity (PV), Mean Acceleration (MA), Corrected Flow Time (FTc), Cardiac Index (Cl), Minute Distance (MD), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), Stroke Volume Index (SVI), Flow Time to Peak Velocity (FTp), Delivered Oxygen (DO2) and Delivered Oxygen index (DO2l).

For the CardioQ-EDM+, the newly added "Pressure Monitoring Mode" the system slaves the arterial blood pressure signal supplied by the hospital patient monitoring system to provide systolic and diastolic pressures and derived parameters.

The CardioQ-EDM+ uses these classical blood pressure measurements to calculate Stroke Volume (SV), Cardiac Output (CO), Stroke Volume Variation (SVV). Pulse Pressure Variation (PPV) and a small number of derived parameters (see below). The pressure derived stroke volume is calibrated from the CardioQ-EDM+'s Doppler ultrasound measurement of stroke volume ensuring consistency and allowing frequent recalibration.

From the Systolic and Diastolic pressures the following pressure-based parameters are calculated:

- . Cardiac Output (CO).
- . Cardiac Index (CI).
- Stroke Volume (SV), .
- Stroke Volume Index (SVI) .
- Stroke Volume Variation (SVV) .
- Pulse Pressure Variation (PPV) .
- Systemic Vascular Resistance (SVR),

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### K132139 page 3 of 8

- Systemic Vascular Resistance Index (SVRI), .
- Mean Arterial Pressure (MAP) .
- Heart Rate (HR) ◆
- Delivered Oxygen (DO2) ●
- Delivered Oxygen Index (DO2I) ●

The CardioQ-EDM+ monitor will be supplied with a Patient Interface Cable for connecting onto a Deltex Medical probe, but not a probe or Arterial Blood Pressure Interface Lead, which must be purchased separately.

A comparison of the technological features of the proposed CardioQ-EDM+ and the predicate CardioQ-EDM is presented in the table below:

| PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION | | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Deltex CardioQ-EDM (K111542) | Deltex CardioQ-EDM+ |
| | Predicate Device | Proposed Device |
| Device Classification | 21 CFR 870.2100, 870.2120, 870.2900 | 21 CFR 870.2100, 870.2120, 870.2900 |
| | Procode DPW, DPT, DSA | Procode DPW, DPT, DSA |
| Indications for use | The CardioQ-EDM cardiac function<br>and fluid status monitoring system is<br>designed to provide clinicians with<br>real-time information about a patient's<br>left ventricular blood flow and key<br>hemodynamic parameters. The<br>CardioQ-EDM's beat-to-beat data on<br>cardiovascular status can be used by the<br>managing clinician to evaluate and<br>optimize hemodynamic performance in<br>anesthetized, sedated or conscious<br>patients in the operating room,<br>intensive care unit, emergency room or<br>ward | The CardioQ-EDM+ cardiac function<br>and fluid status monitoring system is<br>designed to provide clinicians with<br>real-time information about a patient's<br>left ventricular blood flow and key<br>hemodynamic parameters. The<br>CardioQ-EDM+ beat-to-beat data on<br>cardiovascular status can be used by the<br>managing clinician to evaluate and<br>optimize hemodynamic performance in<br>anesthetized, sedated or conscious<br>patients in the operating room.<br>intensive care unit, emergency room or<br>ward. |
| Patient population | For use in patients<br>59" (149 cm) or taller | same |
| Patient status | Anesthetized/sedated patients/awake | same |
| Insertion route | Oral or Nasal | same |
| Contraindications | Intra-aortic balloon pumping | same |
| | Severe coarctation of the aorta | same |
| | Pharyngo-esophago-gastric pathology | same |
| | Severe bleeding diatheses | same |
| System design | Esophageal probe transmits and<br>receives 4 MHz Continuous Wave<br>Doppler (CWD) ultrasound to measure<br>blood flow velocities in the descending<br>thoracic aorta | same |
| PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION | | |
| | Deltex CardioQ-EDM (K111542) | Deltex CardioQ-EDM+ |
| | Predicate Device | Proposed Device |
| | Signals are returned via the Patient<br>Interface Cable (PIC) to CardioQ-EDM<br>Monitor | same |
| | CardioQ-EDM Monitor processes the<br>signal and displays it as real-time<br>spectrum. to show the distribution of<br>red blood cell velocities over the entire<br>cardiac cycle | same |
| | Maximum velocity envelope is<br>continuously delineated and used to<br>calculate velocity-integral of the<br>waveform during systole | same |
| | Patient age, weight & height used with<br>velocity-integral to provide volumetric<br>flow data, including cardiac output,<br>from 'nomogram' calculation | same |
| System Components | CardioQ-EDM Monitor | CardioQ-EDM+ Monitor |
| | Power cord | same |
| | Patient Interface Cable | same |
| | no probes included | same |
| | Not required | arterial blood pressure interface lead<br>(Not included) |
| Mode of operation | Continuous | same |
| Ultrasonic clutter rejection | 450 Hz & 900 Hz high-pass filters | same |
| Spectral Display | 512 point. Fast Fourier Transform | same |
| | Temporal resolution 6 ms | same |
| Velocity spectrum display time<br>range (x-axis) | Full screen: 4.3 seconds Split screen:<br>1.4 seconds | same |
| Velocity display scales (y-axis) | 50, 100, 200 cm/s<br>250 cm/s | same |
| Doppler audio confirmation | Yes | same |
| Display | Color 10.4" TFT LCD screen (800 x<br>600 pixels) SVGA | same |
| Ranges of directly measured<br>Doppler parameters | Peak Velocity (PV) 10 -- 250 cm/s | same |
| | Heart Rate (HR) 20 - 360 bpm | same |
| | Flow time (systolic) (FT)*<br>42 - 1500 ms | same |
| *not displayed<br>(see FTc below) | Flow time to peak (FTp) | same |
| | 6 - 750 ms | |
| PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION | | |
| | Deltex CardioQ-EDM (K111542) | Deltex CardioQ-EDM+ |
| | Predicate Device | Proposed Device |
| | 24 - 999 ms | |
| | Stroke Distance (SD)<br>0.2 - 165 cm | same |
| | Mean Acceleration (MA)<br>0.1 - 366 m/s² | same |
| | Minute Distance (MD)<br>4 - 59400 cm | same |
| | Stroke Volume (SV)<br>0 - 999 ml | same |
| | Cardiac Output (CO)<br>0 - 99.9 L/min | same |
| | Cardiac Index (CI)<br>0 - 99.9 L/min/m² | same |
| | Stroke Volume Index (SVI)<br>0 - 99.9 L/m² | same |
| | Systemic Vascular Resistance (SVR)<br>0 - 9999 dyne.sec/cm⁵ | same |
| | Systemic Vascular Resistance Index (SVRI)<br>0 - 999 dyne.sec/cm⁵/m² | same |
| | Not Available | Stroke Volume Variation (SVV)<br>0-100 % |
| | Not Available | Delivered Oxygen (DO₂)<br>0-8040 ml/min |
| | Not Available | Delivered Oxygen Index (DO₂I)<br>0-3965 ml/min/m² |
| Ranges of pressure-based<br>calculated parameters | Not Available | Heart Rate (HR) 20 - 360 bpm |
| | Not Available | Stroke Volume (SV) 0 - 999 ml |
| | Not Available | Stroke Volume Variation (SVV)<br>0-100 % |
| | Not Available | Cardiac Output (CO)<br>0 - 99.9 L/min |
| | Not Available | Cardiac Index (CI)<br>0 - 99.9 L/min/m² |
| | Not Available | Stroke Volume Index (SVI)<br>0 - 99.9 L/m² |
| PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION | | |
| | Deltex CardioQ-EDM (K111542)<br>Predicate Device | Deltex CardioQ-EDM+<br>Proposed Device |
| | Not Available | Systemic Vascular Resistance<br>(SVR)<br>$0-9999 dyne.sec/cm^{-5}$ |
| | Not Available | Systemic Vascular Resistance<br>Index (SVRI)<br>$0-999 dyne.sec/cm^{-5}/m^2$ |
| | Not Available | Delivered Oxygen (DO₂)<br>0-8040 ml/min |
| | Not Available | Delivered Oxygen Index (DO₂l)<br>$0-3965 ml/min/m^2$ |
| | Not Available | Systolic Pressure (Psys)<br>15-500 mmHg |
| | Not Available…