DELTEX MEDICAL CARDIOQ EDM

K111542 · Deltex Medical Limited · DPW · Oct 20, 2011 · Cardiovascular

Device Facts

• Record ID: K111542
• Device Name: DELTEX MEDICAL CARDIOQ EDM
• Applicant: Deltex Medical Limited
• Product Code: DPW · Cardiovascular
• Decision Date: Oct 20, 2011
• 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'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 Story

CardioQ-EDM is an esophageal Doppler monitor for real-time hemodynamic assessment. System uses esophageal probe to transmit/receive 4 MHz continuous wave Doppler ultrasound; measures blood flow velocities in descending thoracic aorta. Signals processed to display real-time velocity spectrum; maximum velocity envelope delineated to calculate stroke volume, cardiac output, and other hemodynamic parameters using patient age, weight, and height via nomogram. Used in OR, ICU, ER, or ward by clinicians to evaluate/optimize hemodynamic performance. Provides beat-to-beat data; aids clinical decision-making regarding fluid status and cardiac function. Modernized version of predicate CardioQ (K031706) with updated components and user interface.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by comparative bench testing against predicate device (K031706) and adherence to recognized consensus standards for electrical safety (IEC 60601 series) and acoustic output (NEMA UD 2).

Technological Characteristics

Esophageal probe with 4 MHz Continuous Wave Doppler (CWD) ultrasound. Color 10.4" TFT LCD (800x600). Connectivity via Patient Interface Cable (PIC). High-pass filters (450 Hz/900 Hz) for clutter rejection. 512-point Fast Fourier Transform (6 ms temporal resolution). Parameters calculated via nomogram using patient demographics. Standalone monitor with roll stand/pole mount options.

Indications for Use

Indicated for patients 149 cm or taller, including anesthetized, sedated, or conscious patients, for monitoring left ventricular blood flow and hemodynamic parameters. Contraindicated for patients with intra-aortic balloon pumping, severe aortic coarctation, 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 (K031706)

Submission Summary (Full Text)

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OCT 2 0 2011

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Deltex Medical Limited: Premarket Notification for CardioQ-EDM Esophageal Doppler Monitor

#### 510(k) Summary 1.1.6

Deltex Medical Limited Terminus Road Chichester West Sussex, PO19 8TX, United Kingdom Telephone: [phone] Fax: [phone]

Image /page/0/Picture/5 description: The image shows the words "DELTEX MEDICAL" stacked on top of each other. To the left of the words is a black and white graphic that looks like a wave. The words are in all caps and are a simple font.

510(k) Summary

(as required by 21 CFR 807.92 (c))

#### Owner's Name:

Deltex Medical Terminus Road Chichester West Sussex PO19 8TX United Kingdom 011 44 1243 523174 Tel: [phone] Fax:

## Date Summary Prepared:

May 18, 2011

#### Classification:

The FDA has classified: Cardiovascular Blood Flowmeter (21 CFR 870.2100 Product ProCode DPW),

Extravascular Blood Flow Probe (21 CFR 870.2120, ProCode DPT),

Patient transducer and electrode cable (including connector) (21 CFR 870.2900, ProCode DSA) as a Class II Medical Device.

### Common/Usual Name:

Esophaqeal Doppler Monitor

### Proprietary Name:

Deltex Medical CardioQ-EDM

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# Predicate Devices used to Demonstrate Substantial Equivalence:

Deltex Medical CardioQ - K031706

# Description, including Intended Use:

The CardioQ-EDM system employs esophageal Doppler techniques using 4 MHz .ne caraloQ 2D. 0)-----------------------------------------------------------------------------------------------------------------------------------------------------------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.

| PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION | | |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| | Deltex CardioQ-EDM | Deltex CardioQ, K031706 |
| Indications for use | The CardioQ-EDM cardiac<br>function and fluid status<br>monitoring system is<br>designed to provide<br>clinicians with real-time<br>information about a<br>patient's left ventricular<br>blood flow and key<br>hemodynamic parameters.<br>The CardioQ-EDM's beat-to-<br>beat data on cardiovascular<br>status can be used by the<br>managing clinician to<br>evaluate and optimize<br>hemodynamic performance<br>in anesthetized, sedated or<br>conscious patients in the<br>operating room, intensive<br>care unit, emergency room<br>or ward | same,<br>but with minor textural<br>updates, see section 1.3 |
| Patient population | For use in patients<br>59″ (149 cm) or taller | same |
| Patient status | Anesthetized/sedated<br>patients/awake | same |
| Insertion route | Oral or Nasal | Oral in K031706<br>Nasal use probes added<br>later in K052989 |
| PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION | | |
| | Deltex CardioQ-EDM | Deltex CardioQ, K031706 |
| Contraindications | Intra-aortic balloon<br>pumping | same |
| | Severe coarctation of the<br>aorta | same |
| | Pharyngo-esophago-gastric<br>pathology | same |
| | Severe bleeding diatheses | same |
| System design | Esophageal probe transmits<br>and receives 4 MHz<br>Continuous Wave Doppler<br>(CWD) ultrasound to<br>measure blood flow<br>velocities in the descending<br>thoracic aorta | same |
| | Signals are returned via the<br>Patient Interface Cable<br>(PIC) to CardioQ-EDM<br>Monitor | same |
| | CardioQ-EDM Monitor<br>processes the signal and<br>displays it as real-time<br>spectrum, to show the<br>distribution of red blood cell<br>velocities over the entire<br>cardiac cycle | same |
| | Maximum velocity envelope<br>is continuously delineated<br>and used to calculate<br>velocity-integral of the<br>waveform during systole | same |
| | Patient age, weight & height<br>used with velocity-integral<br>to provide volumetric flow<br>data, including cardiac<br>output, from 'nomogram'<br>calculation | same |
| System Components | CardioQ-EDM Monitor | Components updated |
| | Power cord | same |
| PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION | | |
| | Deltex CardioQ-EDM | Deltex CardioQ, K031706 |
| | Patient Interface Cable<br>no probe included | same<br>probe included |
| Mode of operation | Continuous | same |
| Ultrasonic clutter rejection | 450 Hz & 900 Hz high-pass filters | same |
| Spectral Display | 512 point. Fast Fourier Transform<br>Temporal resolution 6 ms | same |
| Velocity spectrum display time range (x-axis) | Full screen: 4.3 seconds<br>Split screen: 1.4 seconds | Full screen: 3.6 seconds<br>Split screen: 1.4 seconds |
| Velocity display scales (y-axis) | 50, 100, 200 cm/s<br>250 cm/s | same<br>not available |
| Doppler audio confirmation | Yes | same |
| Display | Color 10.4" TFT LCD screen<br>(800 x 600 pixels) SVGA | same,<br>but (640 x 480 pixels) |
| Ranges of directly measured parameters | Peak Velocity (PV) 10 - 250 cm/s<br>Heart Rate (HR) 20 - 360 bpm<br>Flow time (systolic) (FT)* 42 - 1500 ms<br>Flow time to peak (FTp) 6 - 750 ms<br>Stroke Distance (SD) 0.2 - 165 cm<br>Mean Acceleration (MA) 0.1 - 366 m/s2<br>*not displayed (see FTc below) | Peak Velocity (PV) 10 - 220 cm/s<br>same<br>same<br>same<br>same<br>same |
| Ranges of calculated parameters | Stroke Volume (SV) 0 - 999 ml<br>Cardiac Output (CO) 0 - 99.9 L/min | same<br>same |
| PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION | | |
| | Deltex CardioQ-EDM | Deltex CardioQ, K031706 |
| | Corrected Flow Time (FTc)<br>24 - 999 ms | same |
| | Minute Distance (MD)<br>4 - 59400 cm | 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<br>Resistance (SVR)<br>0 - 9999 dyne.sec/cm-5 | same |
| | Systemic Vascular<br>Resistance Index (SVRI)<br>0 - 999 dyne.sec/cm-5 | same |
| Operating modes | Patient Data entry | same |
| | Probe Focus | same |
| | Run Mode | same |
| Controls & user interface | Control knob (function<br>dependent on screen) | same |
| | Audio volume knob<br>6 'soft' buttons (function<br>dependent on screen) | same |
| Parameters displayed | Eight of the following can<br>be displayed above the<br>spectral display (access to<br>all with split screen): | Six of the following can be<br>displayed above the<br>spectral display (access to<br>all with split screen): |
| | Peak Velocity (PV) | same |
| | Heart Rate (HR) | same |
| | Stroke Distance (SD)<br>Mean Acceleration (MA)<br>Stroke Volume (SV)<br>Cardiac Output (CO)<br>Minute Distance (MD)<br>Corrected Flow Time (FTc)<br>Flow Time to peak (FTp)<br>Cardiac Index (CI)<br>Stroke Volume Index (SVI) | same<br>same<br>same<br>same<br>same<br>same<br>same<br>same<br>same |
| PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION | | |
| | Deltex CardioQ-EDM | Deltex CardioQ, K031706 |
| | Systemic Vascular<br>Resistance (SVR) | same |
| | Systemic Vascular<br>Resistance Index (SVRI) | same |
| Parameters update rate | Every 1 to 20 heart beats | same |
| Trend history | Up to 240 hours/Unlimited | Up to 48 hours |
| Trend temporal<br>resolution | 30 seconds | same |
| Accessories | Roll Stand | CardioQ Pole Clamp<br>CardioQ Probe Holder |
| | Roll Stand Interface Kit | Screenshot Utility Package |
| | Probes and Probe<br>accessories: | |
| | Deltex Medical 240 Hour<br>Esophageal Doppler Probe<br>(DP240)<br>Deltex Medical 6 hour<br>Esophageal Doppler Probe<br>(I₂S)<br>Deltex Medical 24 hour<br>Esophageal Doppler Probe<br>(I₂P)<br>Deltex Medical 72 hour<br>Esophageal Doppler Probe<br>(I₂C) | |

# Technology Characteristics Compared to Predicate Devices:

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K111542 3/7

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111542 4/7

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111542 6/7

## 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.

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KH1542 7/7

#### Bench Testing:

Comparative bench testing of the CardioQ-EDM Cardiac Function and Fluid Status Monitoring System, using a CardioQ Cardiac Output and Fluid Status Monitoring System K031706, is included. This concludes that the two systems have substantially equivalent performance.

#### Animal Testing:

No animal testing is included.

#### Clinical Testing:

No clinical testing is included

#### Conclusion:

From a review of the non-clinical and clinical data, Deltex Medical Limited concludes that the CardioQ EDM is substantially equivalent in terms of safety, effectiveness and performance to the predicate device.

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Image /page/7/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure. The image is black and white.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 2 0 2011

Deltex Medical Ltd c/o Lawrence Brookfield Regulatory Affairs Manager Terminus Road Chichester West Sussex, PO19 8TX, United Kingdom

Re: K111542 Trade/Device Name: CardioQ-EDM Esophageal Doppler Monitor Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: DPW, DPT, DSA Dated: September 19, 2011 Received: September 20, 2011

Dear Mr. 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.

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.

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### Page 2 -- Mr. Brookfield

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

(Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 1.1.5 Indications for Use Statement

#### Indications for Use

K 111542 510(k) Number (if known):

Device Name:

CardioQ-EDM

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 sedated patients in the operating room, intensive care unit, emergency room or ward.

Prescription Use _ X__________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

Over-The-Counter Use

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

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