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510(k) Data Aggregation
K Number
K172457Device Name
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
Manufacturer
Deltex Medical Limited
Date Cleared
2018-06-28
(318 days)
Product Code
DPW
Regulation Number
870.2100Why did this record match?
Applicant Name (Manufacturer) :
Deltex Medical Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CardioQ-EDM series fluid management and cardiac output monitoring systems are designed to provide clinicians with real-time information about patients left ventricular blood flow and key hemodynamic parameters. The CardioQ-EDM series 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.
The CardioQ-EDM series monitors when used in Flow Monitoring Mode (esophageal Doppler) or Pressure Monitoring Mode (EDM+ only) are intended for use with adult and pediatric patients. When the CardioQ-EDM series monitors are used for High-Definition Impedance CardioGraphy with a PhysioFlow Q-Link module the intended use is for adult patients only.
Device Description
The CardioQ-EDM series are medical instruments designed to monitor cardiac function and fluid status. The CardioQ-EDM & EDM+ achieve this by combining Doppler measurements of the blood flow (4MHz continuous wave ultrasound) to monitor and quantify the blood flow in the descending thoracic aorta. In addition to this the CardioQ-EDM+ previously introduced as an upgrade to the EDM under (K132139) allows additional Pulse Pressure Waveform Analysis (PPWA) through arterial blood pressure based parameters slaved from a high-end monitor.
The CardioQ-EDM (K111542) & Cardio EDM+ (K132139) have now been introduced with the addition of a USB Hub accessory and software modifications that allow the CardioQ-EDM series monitors to display hemodynamic parameters from the coupled together hemodynamic impedance cardiography device.
The addition of USB Hub accessory and software modifications allow the CardioQ-EDM series monitors to become a non-invasive cardiac output measurement system which displays hemodynamic parameters, allowing analysis of a trans-thoracic impedance cardiography signal & cardiac output monitoring. The only addition to the CardioQ-EDM & CardioQ-EDM+ is the enabling of HD-ICG functionality through the USB Hub accessory introduction and software modifications to display the hemodynamic parameters from the coupled hemodynamic impedance cardiography device.
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K Number
K150347Device Name
Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+
Manufacturer
DELTEX MEDICAL LIMITED
Date Cleared
2015-07-24
(163 days)
Product Code
DPW
Regulation Number
870.2100Why did this record match?
Applicant Name (Manufacturer) :
DELTEX MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Deltex Medical CardioQ-EDM+ / Deltex Medical 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 Deltex Medical CardioQ-EDM+ / Deltex Medical 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 Description
The Deltex Medical CardioQ-EDM series are medical instruments designed to monitor cardiac function and fluid status. The CardioQ-EDM series combine Doppler measurement of the blood flow (4MHz continuous wave ultrasound) with Pulse Pressure Waveform Analysis (PPWA) to monitor and quantify the blood flow in the descending thoracic aorta and hence calculate other clinically significant information.
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K Number
K142932Device Name
Deltex Medical KDP72 Doppler Probe
Manufacturer
DELTEX MEDICAL LIMITED
Date Cleared
2015-01-22
(105 days)
Product Code
DPT
Regulation Number
870.2120Why did this record match?
Applicant Name (Manufacturer) :
DELTEX MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The probe is for use with the Deltex Medical CardioQ-EDM and CardioQ-EDM+ for Monitoring of cardiac output and fluid status. The probe is only approved for oral placement into the esophagus of a single anesthetized patient 15 years of age or younger, 50cm (20") to 170cm (67") in height.
Device Description
The Deltex Medical Ltd KDP72 Pediatric Doppler Probe is an oral extravascular blood flow probe designed to work with the CardioQ-EDM and CardioQ-EDM+ Systems (K111542 and K132139 respectively). It consists of a shaft, which is a spring reinforced silicone tube, with an electrical connector on the machine end and an ultrasonic transmitting and receiving tip on the patient end. The tip is fully covered and sealed to the shaft with a silicone rubber boot and by wires running through the shaft to the connector. Visual product identification is provided at the machine end and the device is provided single packed sterile for single patient use.
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K Number
K132139Device Name
DELTEX MEDICAL CARDIOQ-EDM+
Manufacturer
DELTEX MEDICAL LIMITED
Date Cleared
2013-10-10
(91 days)
Product Code
DPW
Regulation Number
870.2100Why did this record match?
Applicant Name (Manufacturer) :
DELTEX MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
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 patients 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+ 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. 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. The pressure derived stroke volume is calibrated from the CardioQ-EDM+'s Doppler ultrasound measurement of stroke volume ensuring consistency and allowing frequent recalibration.
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K Number
K111542Device Name
DELTEX MEDICAL CARDIOQ EDM
Manufacturer
DELTEX MEDICAL LIMITED
Date Cleared
2011-10-20
(140 days)
Product Code
DPW, DPT, DSA
Regulation Number
870.2100Why did this record match?
Applicant Name (Manufacturer) :
DELTEX MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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's 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 sedated patients in the operating room, intensive care unit, emergency room or ward.
Device Description
The CardioQ-EDM system employs esophageal Doppler techniques using 4 MHz continuous thoracic aorta, displaying this data as a maximum velocity curve, a descriting there is derived measurements. Thus, real-time information about verouty opesant in particular left ventricular flow, is displayed continuously. This is the same as for the predicate CardioQ K031706. CardioQ-EDM is an enhancement of the CardioQ K031706; obsolete The components have been replaced and an improved/modernized user interface created, by utilizing the full capabilities of the new components.
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K Number
K073593Device Name
I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016
Manufacturer
DELTEX MEDICAL LIMITED
Date Cleared
2009-01-29
(405 days)
Product Code
DPT
Regulation Number
870.2120Why did this record match?
Applicant Name (Manufacturer) :
DELTEX MEDICAL LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The I2 probe is for use with the Deltex Medical CardioQ for the monitoring of cardiac output and fluid status. The I₂ is only approved for oral or nasal placement into the esophagus of a single patient 16 years of age or older. The probe may be placed orally or nasally in sedated or anesthetized patients. The probe must be placed nasally in awake patients.
Device Description
Esophageal probe for measuring blood flow in the descending aorta. Sterile. For single use only. Overall length 89 cm (35"). Shaft construction Spring enclosed in silicone rubber. Shaft color Clear (non-pigmented) shaft. Shaft flexibility (N) 0.095. Main shaft diameter 14 FG (~4.8 mm). Distal tip diameter 19FG (~6.3 mm). Maximum Usage time (hours) 6, 24 or 72. Main shaft wall thickness 0.03" (~0.7mm). Marks in the shaft The probe shaft has three depth markers at 35, 40 and 45 cm. Color of transducer head "clear" (non-pigmented). Color of the molded connector "white" (pigmented). Color of the shaft "clear" (non-pigmented). Connection to the monitor non-reversible connector with ROM to identify probe type. Doppler transducer / Central frequency 4MHz. Doppler transducer / Global maximum output 195 mW/cm². Doppler transducer / Mechanical index 0.039. Spring wire 0.030" (0.76 mm) diameter to BS5216 HS3, Pre-galvanized. Spring length 550mm (+/- 25 mm). Spring internal diameter 1.80/2.00 mm. Spring external diameter 3.30/3.50 mm. Spring pitch The spring has fewer turns per unit of length (it has a larger pitch than DP 240). ROM memory This ROM memory is characteristic for the particular probe. Mode of operation Esophageal probe transmits and receives 4 MHz Continuous Wave Doppler (CWD) ultrasound from the probe tip at a fixed angle to the descending aorta, by excitation of a piezo-electric transducer. The ultrasound is reflected by the red blood cells and is received by a separate transducer in the probe tip. Signals are returned via the Patient Interface Cable (PIC) to CardioQ Monitor. This permits to measure blood flow velocities in the descending thoracic aorta. Compatible Monitor CardioQ monitor. Rx Status Rx. Physicians Caution included in labeling Yes.
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