(140 days)
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.
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.
The provided text describes a 510(k) premarket notification for the Deltex Medical CardioQ-EDM Esophageal Doppler Monitor, aiming to demonstrate substantial equivalence to a predicate device (Deltex Medical CardioQ - K031706). Since it's a 510(k) submission, the "acceptance criteria" are implied by comparing the new device's performance to the legally marketed predicate device, rather than explicit numerical thresholds typically seen in AI/ML performance studies. The study described is a comparative bench study.
Here's the breakdown of the information requested based on the provided text, recognizing that it's a medical device submission focused on substantial equivalence rather than AI/ML performance:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, acceptance criteria are generally to demonstrate that the new device (CardioQ-EDM) performs as safely and effectively as the predicate device (CardioQ K031706). The "reported device performance" is the conclusion of the bench testing that substantial equivalence was achieved. Specific numerical acceptance criteria are not explicitly stated for individual device parameters, but rather the overall conclusion of comparable performance across all listed characteristics.
| Feature/Parameter | Acceptance Criteria (Implied - substantial equivalence to predicate) | Reported Device Performance (CardioQ-EDM) |
|---|---|---|
| Indications for Use | Same as predicate (with minor textural updates) | Same as predicate |
| Patient Population | Same as predicate | Same as predicate |
| Patient Status | Same as predicate | Same as predicate |
| Insertion Route | Oral or Nasal | Oral or Nasal (predicate was Oral, Nasal added later) |
| Contraindications | Same as predicate | Same as predicate |
| System Design | Same as predicate | Same as predicate |
| System Components | Functionally equivalent/improved as predicate | Updated components, modernized user interface |
| Mode of Operation | Same as predicate | Same as predicate |
| Ultrasonic Clutter Rejection | Same as predicate | Same as predicate |
| Spectral Display | Same as predicate | Same as predicate |
| Velocity Spectrum Display Time Range (x-axis) | Performance comparable to predicate | Full screen: 4.3 seconds (Predicate: 3.6 sec) Split screen: 1.4 seconds (Predicate: 1.4 sec) |
| Velocity Display Scales (y-axis) | Performance comparable to predicate | 50, 100, 200 cm/s, 250 cm/s (Predicate: 50, 100, 200 cm/s) |
| Doppler Audio Confirmation | Same as predicate | Same as predicate |
| Display | Performance comparable to predicate | Color 10.4" TFT LCD screen (800 x 600 pixels) (Predicate: 640 x 480 pixels) |
| Ranges of Directly Measured Parameters | Comparable to or improved from predicate | Peak Velocity (PV) 10 - 250 cm/s (Predicate: 10 - 220 cm/s) Other parameters same range |
| Ranges of Calculated Parameters | Same as predicate | Same as predicate |
| Operating Modes | Same as predicate | Same as predicate |
| Controls & User Interface | Performance and functionality comparable to predicate | Similar controls with updated implementation |
| Parameters Displayed | Performance comparable to predicate, with potential for improvement/increase of displayed parameters | Eight of listed parameters displayed (Predicate: Six) |
| Parameters Update Rate | Same as predicate | Same as predicate |
| Trend History | Performance comparable to or improved from predicate | Up to 240 hours/Unlimited (Predicate: Up to 48 hours) |
| Trend Temporal Resolution | Same as predicate | Same as predicate |
| Acoustic Output | Compliance with NEMA UD 2 | Compliant with NEMA UD 2 |
| Electrical Safety & EMC | Compliance with IEC 60601 series | Compliant with IEC 60601 series |
| Overall Performance | Substantially equivalent to predicate | Substantially equivalent performance achieved |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This was a bench testing study, therefore there is no "patient test set" in the traditional sense. The comparison was between the physical device (CardioQ-EDM) and the predicate device (CardioQ K031706) within a laboratory/bench environment. The text does not specify a "sample size" of individual tests or measurements, but rather refers to "Comparative bench testing of the CardioQ-EDM... using a CardioQ..."
- Data Provenance: The study was conducted by Deltex Medical Limited, based in the United Kingdom. The data is from bench testing, implicitly a prospective assessment of the new device's engineering and performance characteristics against the predicate's known specifications and performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. For this type of device (a diagnostic/monitoring tool) and study (bench testing for substantial equivalence), "expert ground truth" as understood in clinical evaluation or AI/ML performance is not relevant. The "ground truth" for the bench testing would be the engineering specifications and validated performance characteristics of the predicate device, against which the new device's measurements and functionalities were compared. This would be established by experts in device design, testing, and regulatory compliance, but not in the sense of clinical annotation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None. This concept is not applicable to bench testing where objective measurements and engineering specifications are compared. Discrepancies would be resolved through engineering re-evaluation or re-testing, not through a consensus-based adjudication of clinical observations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was NOT done. This submission is for a medical device (Esophageal Doppler Monitor), not an AI/ML diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant. The device measures physiological parameters, and its performance is assessed against directly measured physical quantities or established specifications.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable in the context of AI/ML algorithms. The CardioQ-EDM is a standalone medical device that provides direct measurements and calculated parameters. Its "standalone performance" refers to its ability to accurately measure and compute these physiological metrics as designed, compared to the predicate device. It's not an AI algorithm that processes data to generate a finding that a human then interprets or acts upon.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the bench testing was primarily the engineering specifications and established performance characteristics of the predicate device (CardioQ K031706), along with compliance with recognized consensus standards (IEC 60601 series for electrical safety/EMC, NEMA UD 2 for acoustic output). The goal was to show that the new device met or exceeded these, demonstrating substantial equivalence.
8. The sample size for the training set
- Not applicable. This submission is for a medical device that does not use machine learning algorithms, thus there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth established for it.
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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: +44 1243 774837 Fax: +44 1243 532534
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: 011 44 1243 532534 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 cardiacfunction and fluid statusmonitoring system isdesigned to provideclinicians with real-timeinformation about apatient's left ventricularblood flow and keyhemodynamic parameters.The CardioQ-EDM's beat-to-beat data on cardiovascularstatus can be used by themanaging clinician toevaluate and optimizehemodynamic performancein anesthetized, sedated orconscious patients in theoperating room, intensivecare unit, emergency roomor ward | same,but with minor texturalupdates, see section 1.3 |
| Patient population | For use in patients59″ (149 cm) or taller | same |
| Patient status | Anesthetized/sedatedpatients/awake | same |
| Insertion route | Oral or Nasal | Oral in K031706Nasal use probes addedlater in K052989 |
| PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION | ||
| Deltex CardioQ-EDM | Deltex CardioQ, K031706 | |
| Contraindications | Intra-aortic balloonpumping | same |
| Severe coarctation of theaorta | same | |
| Pharyngo-esophago-gastricpathology | same | |
| Severe bleeding diatheses | same | |
| System design | Esophageal probe transmitsand receives 4 MHzContinuous Wave Doppler(CWD) ultrasound tomeasure blood flowvelocities in the descendingthoracic aorta | same |
| Signals are returned via thePatient Interface Cable(PIC) to CardioQ-EDMMonitor | same | |
| CardioQ-EDM Monitorprocesses the signal anddisplays it as real-timespectrum, to show thedistribution of red blood cellvelocities over the entirecardiac cycle | same | |
| Maximum velocity envelopeis continuously delineatedand used to calculatevelocity-integral of thewaveform during systole | same | |
| Patient age, weight & heightused with velocity-integralto provide volumetric flowdata, including cardiacoutput, from 'nomogram'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 Cableno probe included | sameprobe included | |
| Mode of operation | Continuous | same |
| Ultrasonic clutter rejection | 450 Hz & 900 Hz high-pass filters | same |
| Spectral Display | 512 point. Fast Fourier TransformTemporal resolution 6 ms | same |
| Velocity spectrum display time range (x-axis) | Full screen: 4.3 secondsSplit screen: 1.4 seconds | Full screen: 3.6 secondsSplit screen: 1.4 seconds |
| Velocity display scales (y-axis) | 50, 100, 200 cm/s250 cm/s | samenot available |
| Doppler audio confirmation | Yes | same |
| Display | Color 10.4" TFT LCD screen(800 x 600 pixels) SVGA | same,but (640 x 480 pixels) |
| Ranges of directly measured parameters | Peak Velocity (PV) 10 - 250 cm/sHeart Rate (HR) 20 - 360 bpmFlow time (systolic) (FT)* 42 - 1500 msFlow time to peak (FTp) 6 - 750 msStroke Distance (SD) 0.2 - 165 cmMean Acceleration (MA) 0.1 - 366 m/s2*not displayed (see FTc below) | Peak Velocity (PV) 10 - 220 cm/ssamesamesamesamesame |
| Ranges of calculated parameters | Stroke Volume (SV) 0 - 999 mlCardiac Output (CO) 0 - 99.9 L/min | samesame |
| PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION | ||
| Deltex CardioQ-EDM | Deltex CardioQ, K031706 | |
| Corrected Flow Time (FTc)24 - 999 ms | same | |
| Minute Distance (MD)4 - 59400 cm | same | |
| Cardiac Index (CI)0 - 99.9 L/min/m² | same | |
| Stroke Volume Index (SVI)0 - 99.9 L/m² | same | |
| Systemic VascularResistance (SVR)0 - 9999 dyne.sec/cm-5 | same | |
| Systemic VascularResistance Index (SVRI)0 - 999 dyne.sec/cm-5 | same | |
| Operating modes | Patient Data entry | same |
| Probe Focus | same | |
| Run Mode | same | |
| Controls & user interface | Control knob (functiondependent on screen) | same |
| Audio volume knob6 'soft' buttons (functiondependent on screen) | same | |
| Parameters displayed | Eight of the following canbe displayed above thespectral display (access toall with split screen): | Six of the following can bedisplayed above thespectral display (access toall with split screen): |
| Peak Velocity (PV) | same | |
| Heart Rate (HR) | same | |
| Stroke Distance (SD)Mean Acceleration (MA)Stroke Volume (SV)Cardiac Output (CO)Minute Distance (MD)Corrected Flow Time (FTc)Flow Time to peak (FTp)Cardiac Index (CI)Stroke Volume Index (SVI) | samesamesamesamesamesamesamesamesame | |
| PREDICATE DEVICE COMPARISON-GENERAL SYSTEM DESCRIPTION | ||
| Deltex CardioQ-EDM | Deltex CardioQ, K031706 | |
| Systemic VascularResistance (SVR) | same | |
| Systemic VascularResistance 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 temporalresolution | 30 seconds | same |
| Accessories | Roll Stand | CardioQ Pole ClampCardioQ Probe Holder |
| Roll Stand Interface Kit | Screenshot Utility Package | |
| Probes and Probeaccessories: | ||
| Deltex Medical 240 HourEsophageal Doppler Probe(DP240)Deltex Medical 6 hourEsophageal Doppler Probe(I₂S)Deltex Medical 24 hourEsophageal Doppler Probe(I₂P)Deltex Medical 72 hourEsophageal Doppler Probe(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 (800) 638-2041 or (301) 796-7100 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
Page 1 of 1 510(k) Number K111542
Page 25 of 160
§ 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).