(91 days)
Not Found
No
The description focuses on traditional signal processing techniques (Doppler ultrasound, Pulse Pressure Waveform Analysis) and calculations based on measured parameters. There is no mention of AI, ML, or related concepts.
No
The device is a monitoring system that provides real-time information about a patient's cardiac function and fluid status. It does not actively treat or ameliorate a disease or condition.
Yes
The device is designed to provide clinicians with "real-time information about a patient's left ventricular blood flow and key hemodynamic parameters" and can be "used by the managing clinician to evaluate and optimize hemodynamic performance." This indicates its role in assessing a patient's condition, which aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "medical instrument" that "combines Doppler measurement of blood flow with Pulse Pressure Waveform Analysis (PPWA)" and "employs esophageal Doppler monitoring (EDM) techniques using 4 MHz continuous wave ultrasound". This indicates the device includes hardware components for data acquisition (ultrasound transducer, pressure sensor interface) in addition to software for processing and display.
Based on the provided information, the CardioQ-EDM+ cardiac function and fluid status monitoring system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) outside the body. The CardioQ-EDM+ directly monitors physiological parameters within the patient's body using ultrasound and blood pressure signals.
- The intended use and device description clearly state that it monitors real-time information about a patient's left ventricular blood flow and hemodynamic parameters in vivo. It uses esophageal Doppler monitoring and analyzes blood pressure signals obtained from a vital signs monitor.
- There is no mention of analyzing biological samples.
Therefore, the CardioQ-EDM+ is a medical device used for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DPW, DPT, DSA
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 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.
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),
- Systemic Vascular Resistance Index (SVRI), .
- Mean Arterial Pressure (MAP) .
- Heart Rate (HR)
- Delivered Oxygen (DO2)
- Delivered Oxygen Index (DO2l)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
4 MHz Continuous Wave Doppler (CWD) ultrasound
Anatomical Site
descending thoracic aorta
Indicated Patient Age Range
For use in patients 59" (149 cm) or taller
Intended User / Care Setting
clinicians in the operating room, intensive care unit, emergency room or ward.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical Safety and Electromagnetic Compatibility: Testing has been conducted following IEC 60601 series of standards, which are FDA recognized voluntary consensus standards.
Acoustic Output Testing: Testing has been conducted following NEMA UD 2, which is a recognized voluntary consensus standard.
Bench Testing: Comparative bench testing of the CardioQ-EDM+ Cardiac Function and Fluid Status Monitoring System, using a CardioQ-EDM Cardiac Output and Fluid Status Monitoring System (K111542), is included. The results of this testing supports the conclusion that the two systems have substantially equivalent performance.
Animal Testing: No animal testing was conducted in support of this 510(k).
Clinical Testing: No clinical testing was conducted in support of this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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: 011 44 1243 523174 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.
1
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),
2
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 | |
| 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 | ||
| patients in the operating room, | ||
| intensive care unit, emergency room or | ||
| ward | 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. | ||
| Patient population | For use in patients | |
| 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 | |
| receives 4 MHz Continuous Wave | ||
| Doppler (CWD) ultrasound to measure | ||
| blood flow velocities in the descending | ||
| 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 | ||
| Interface Cable (PIC) to CardioQ-EDM | ||
| Monitor | same | |
| CardioQ-EDM Monitor processes the | ||
| signal and displays it as real-time | ||
| spectrum. to show the distribution of | ||
| red blood cell velocities over the entire | ||
| cardiac cycle | same | |
| Maximum velocity envelope is | ||
| continuously delineated and used to | ||
| calculate velocity-integral of the | ||
| waveform during systole | same | |
| Patient age, weight & height used with | ||
| velocity-integral to provide volumetric | ||
| flow data, including cardiac output, | ||
| 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 | |
| (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 | ||
| range (x-axis) | Full screen: 4.3 seconds Split screen: | |
| 1.4 seconds | same | |
| Velocity display scales (y-axis) | 50, 100, 200 cm/s | |
| 250 cm/s | same | |
| Doppler audio confirmation | Yes | same |
| Display | Color 10.4" TFT LCD screen (800 x | |
| 600 pixels) SVGA | same | |
| Ranges of directly measured | ||
| Doppler parameters | Peak Velocity (PV) 10 -- 250 cm/s | same |
| Heart Rate (HR) 20 - 360 bpm | same | |
| Flow time (systolic) (FT)* | ||
| 42 - 1500 ms | same | |
| *not displayed | ||
| (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) | ||
| 0.2 - 165 cm | same | |
| Mean Acceleration (MA) | ||
| 0.1 - 366 m/s² | same | |
| Minute Distance (MD) | ||
| 4 - 59400 cm | same | |
| Stroke Volume (SV) | ||
| 0 - 999 ml | same | |
| Cardiac Output (CO) | ||
| 0 - 99.9 L/min | same | |
| Cardiac Index (CI) | ||
| 0 - 99.9 L/min/m² | same | |
| Stroke Volume Index (SVI) | ||
| 0 - 99.9 L/m² | same | |
| Systemic Vascular Resistance (SVR) | ||
| 0 - 9999 dyne.sec/cm⁵ | same | |
| Systemic Vascular Resistance Index (SVRI) | ||
| 0 - 999 dyne.sec/cm⁵/m² | same | |
| Not Available | Stroke Volume Variation (SVV) | |
| 0-100 % | ||
| Not Available | Delivered Oxygen (DO₂) | |
| 0-8040 ml/min | ||
| Not Available | Delivered Oxygen Index (DO₂I) | |
| 0-3965 ml/min/m² | ||
| Ranges of pressure-based | ||
| calculated parameters | Not Available | Heart Rate (HR) 20 - 360 bpm |
| Not Available | Stroke Volume (SV) 0 - 999 ml | |
| Not Available | Stroke Volume Variation (SVV) | |
| 0-100 % | ||
| Not Available | Cardiac Output (CO) | |
| 0 - 99.9 L/min | ||
| Not Available | Cardiac Index (CI) | |
| 0 - 99.9 L/min/m² | ||
| Not Available | Stroke Volume Index (SVI) | |
| 0 - 99.9 L/m² | ||
| PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION | ||
| Deltex CardioQ-EDM (K111542) | ||
| Predicate Device | Deltex CardioQ-EDM+ | |
| Proposed Device | ||
| Not Available | Systemic Vascular Resistance | |
| (SVR) | ||
| $0-9999 dyne.sec/cm^{-5}$ | ||
| Not Available | Systemic Vascular Resistance | |
| Index (SVRI) | ||
| $0-999 dyne.sec/cm^{-5}/m^2$ | ||
| Not Available | Delivered Oxygen (DO₂) | |
| 0-8040 ml/min | ||
| Not Available | Delivered Oxygen Index (DO₂l) | |
| $0-3965 ml/min/m^2$ | ||
| Not Available | Systolic Pressure (Psys) | |
| 15-500 mmHg | ||
| Not Available | Diastolic Pressure (Pdia) | |
| 0-485 mmHg | ||
| Not Available | Mean Arterial Pressure (Pmap) | |
| 7.5-492.5 mmHg | ||
| Not Available | Pulse Pressure Variation (PPV) | |
| 0-100 % | ||
| Not Available | Blood Pressure (BP) | |
| 15/0 - 500/485 mmHg | ||
| Operating modes | Patient Data entry | same |
| Probe Focus | same | |
| Run Mode | same | |
| Controls & user interface | Control knob (function dependent on | |
| screen) | same | |
| Audio volume knob | ||
| 6 'soft' buttons (function dependent on | ||
| screen) | same | |
| Parameters displayed | Eight of the following can be displayed | |
| above the spectral display (access to all | ||
| with split screen): | same | |
| Doppler (Flow Monitoring Mode) | ||
| Peak Velocity (PV) | same | |
| Heart Rate (HR) | same | |
| Stroke Distance (SD) | same | |
| Mean Acceleration (MA) | same | |
| Stroke Volume (SV) | same | |
| Cardiac Output (CO) | same | |
| Minute Distance (MD) | same | |
| Corrected Flow Time (FTc) | same | |
| Flow Time to peak (FTp) | same | |
| PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION | ||
| Deltex CardioQ-EDM (K111542) | ||
| Predicate Device | Deltex CardioQ-EDM+ | |
| Proposed Device | ||
| Cardiac Index (CI) | same | |
| Stroke Volume Index (SVI) | same | |
| Systemic Vascular Resistance (SVR) | same | |
| Systemic Vascular Resistance Index | ||
| (SVRI) | same | |
| Pressure (Pressure Monitoring Mode) | same | |
| Not Available | Heart Rate (HR) | |
| Not Available | Stroke Volume (SV) | |
| Not Available | Stroke Volume Variation (SVV) | |
| Not Available | Cardiac Output (CO) | |
| Not Available | Cardiac Index (CI) | |
| Not Available | Stroke Volume Index (SVI) | |
| Not Available | Systemic Vascular Resistance (SVR) | |
| Not Available | Systemic Vascular Resistance Index | |
| (SVRI) | ||
| Not Available | Delivered Oxygen (DO₂) | |
| Not Available | Delivered Oxygen Index (DO₂1) | |
| Not Available | Systolic Pressure (Psys) | |
| Not Available | Diastolic Pressure (Pdia) | |
| Not Available | Mean Arterial Pressure (MAP) | |
| Not Available | Pulse Pressure Variation (PPV) | |
| Not Available | Blood Pressure (BP) | |
| Parameters update rate | Every 1 to 20 heart beats | same |
| Trend history | Up to 240 hours/Unlimited | up to 48 hours |
| Trend temporal resolution | 30 seconds | same |
| Accessories | Roll Stand | same |
| Roll Stand Interface Kit | same | |
| Probes and Probe accessories: | ||
| Deltex Medical 240 Hour Esophageal | ||
| Doppler Probe (DP240) | ||
| Deltex Medical 6 hour Esophageal | ||
| Doppler Probe (I₂S) | ||
| Deltex Medical 24 hour Esophageal | ||
| Doppler Probe (I₂P) | ||
| Deltex Medical 72 hour Esophageal | ||
| Doppler Probe (I₂C) | same |
Table TI - Technology Characteristics of New Device Compared to Predicate Device
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6
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Summary of Clinical and Non-Clinical Data:
Electrical Safety and Electromagnetic Compatibility:
Testing has been conducted following IEC 60601 series of standards, which are FDA recognized voluntary consensus standards.
Acoustic Output Testing:
Testing has been conducted following NEMA UD 2, which is a recognized voluntary consensus standard.
Bench Testing:
Comparative bench testing of the CardioQ-EDM+ Cardiac Function and Fluid Status Monitoring System, using a CardioQ-EDM Cardiac Output and Fluid Status Monitoring System (K111542), is included. The results of this testing supports the conclusion that the two systems have substantially equivalent performance.
Animal Testing:
No animal testing was conducted in support of this 510(k).
Clinical Testing:
No clinical testing was conducted in support of this 510(k).
Conclusions:
Based on the testing completed and the comparisons with predicate device, the CardioQ-EDM+ does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
8
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Image /page/8/Picture/3 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person reaching out, which is the official symbol of HHS.
October 10, 2013
Deltex Medical, Ltd. Lawrence Brookfield Regulatory Affairs Manager Terminus Road Chichester West Sussex PO19 8TX United Kingdom
Re: K132139
Trade/Device Name: Deltex Medical Cardiog-EDM+ Regulation Number: 21 CFR 870.2100 Regulation Name: Esophageal Doppler Monitor Regulatory Class: Class II Product Code: DPW Dated: July 9, 2013 Received: July 12, 2013
Dear Lawrence Brookfield :
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems
9
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(QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Feli Aguel Felipe Aguel
Bram D. Zuckerman, M.D. for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
K132139
1
Indications for Use Statement 1.1.9 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): To Be Assigned
CardioQ-EDM+ Device Name:
Indications For 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Felipe Aguel
2013.10.10 16
-04'00'
2013.10.10 16:42:46
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