(331 days)
The EV1000 Clinical Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform may be used in all settings in which critical care is provided.
The EV1000 Clinical Platform consists of Databox and Monitor components, which can be mounted to an IV pole. The EV1000 Clinical Platform measures patient physiologic parameters when it is used as a system with various Edwards components, including the Edwards pressure transducers, the FloTrac sensor, the components of the VolumeView System, oximetry catheters/sensors, and the corresponding accessories applied to the patient.
The EV1000 Databox receives incoming signals from the patient through the connections provided by the accessories applied to the patient. The algorithms embedded in the Databox process the signals and provide parameter calculations.
The EV1000 Monitor is connected to the Databox via an ethernet cable. The Monitor is a touchscreen, panel PC with a graphical user interface (GUI). The Monitor displays the measured and calculated parameter values from the Databox.
The EV1000 Clinical Platform, when used with the VolumeView System, measures and/or calculates hemodynamic parameters such as: Manual-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume. Manual-calibrated intermittent parameters: cardiac output, cardiac index, extravascular lung water, extravascular lung water index, global ejection fraction, global end-diastolic volume, global end-diastolic volume index, intrathoracic blood volume, pulmonary vascular permeability index, stroke volume, stroke volume index, systemic vascular resistance, and systemic vascular resistance index.
When connected to a FloTrac sensor, the EV1000 Clinical Platform continuously measures/calculates auto-calibrated arterial pressure cardiac output, cardiac index, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, and systemic vascular resistance index.
When connected to Edwards oximetry sensors, the EV1000 Clinical Platform continuously measures/calculates oximetry parameters (specifically mixed venous oximetry (SvO2) and central venous oximetry (ScvO2).
Here's a breakdown of the acceptance criteria and the study information for the EV1000 Clinical Platform, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for the EV1000 Clinical Platform is a 510(k) summary and approval letter, not a detailed study report with specific acceptance criteria and quantitative performance metrics. Therefore, a direct table of numerical "acceptance criteria" and "reported device performance" as one might find for accuracy or precision claims is not available in the provided text.
Instead, the acceptance criteria here are broad statements related to safety, effectiveness, and substantial equivalence to a predicate device. The device performance is described in terms of having "successfully passed functional and performance testing."
Here's how we can infer and represent the information:
| Acceptance Criteria Category | General Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Overall Equivalence | Device must be safe, effective, and substantially equivalent to the predicate device (EV1000 Clinical Platform, K110597) for its intended use in critical care environments. | "The EV1000 Clinical Platform has been shown to be safe, effective, and substantially equivalent to the cited predicate device for its intended use in critical care environments." and "The EV1000 Clinical Platform has been shown to be safe, effective, and is substantially equivalent to the cited predicate device for its intended use in critical care environments." (from Conclusion) |
| Functional & Performance | Device must meet functional and performance requirements. | "The EV1000 Clinical Platform has successfully passed functional and performance testing, including software verification and validation, mechanical and electrical testing, bench studies, pre-clinical animal studies, comparison testing of clinical cases, and clinical utility." |
| Comparative Analysis | Performance and functionality of the device should be comparable to the predicate device. | "Verification and validation testing was conducted to compare the performance and functionality of the EV1000 Clinical Platform to the predicate device. This testing regimen included side-by-side bench and pre-clinical studies, and comparative analysis of clinical data." |
| Intended Use | The device should perform as intended for measuring/calculating hemodynamic parameters (e.g., cardiac output, stroke volume, SVR, EVLW, GEF, GEDVI, ITBV, PVPI, SVV, SvO2/ScvO2) accurately and continuously/intermittently, and for analysis of thermodilution curves to determine fluid volumes, in critical care patients. | The description of the device details its capabilities to measure/calculate these parameters, indicating it is designed to meet these functional aspects of its intended use. The conclusion states it is substantially equivalent "for its intended use in critical care environments," implying it fulfills these functions adequately. (No specific numerical performance data for these parameters is present in the summary, just the assertion of successful testing and equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The text mentions "comparison testing of clinical cases" and "comparative analysis of clinical data" but does not give a number of cases or patients.
- Data Provenance: Not explicitly stated regarding country of origin. The study included "bench studies, pre-clinical animal studies, comparison testing of clinical cases, and clinical utility." No indication if these were retrospective or prospective, or geographically where they were conducted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/Not stated. For a device like the EV1000 Clinical Platform, "ground truth" for its measurements (e.g., cardiac output, stroke volume) would typically be established by validated reference methods or the predicate device itself, not by a panel of human experts reviewing observational data.
- Qualifications of Experts: Not applicable/Not stated for the reason above.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not stated. Since the "ground truth" for this type of device is usually based on empirical measurements and comparison to a predicate, rather than subjective expert interpretation, an adjudication method for conflicting expert opinions is not relevant or described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. MRMC studies are typically used for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is measured. This device is a physiological monitoring platform, hence such a study design is not relevant here.
- Effect Size with AI vs. Without AI Assistance: Not applicable for the reasons above.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
- Standalone Study: Yes, implicitly. The nature of the device (a cardiac output/oximetry computer) means its core function is to autonomously process signals and calculate parameters. The "functional and performance testing" and "bench studies" inherently evaluate the algorithms' performance in a standalone manner, separate from human interpretation of raw signals. The comparison to the predicate device also assesses the algorithm's output. While not explicitly termed a "standalone study," the entire evaluation process focuses on the device's algorithmic and hardware performance.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the EV1000 Clinical Platform would be derived from:
- Validated Reference Methods: For quantitative physiological parameters, this would involve comparing the device's measurements to established, gold-standard methods (though these specific methods are not detailed in the summary).
- Predicate Device Comparison: A significant part of the substantial equivalence claim relies on "side-by-side bench and pre-clinical studies, and comparative analysis of clinical data" against the EV1000 Clinical Platform, K110597 (the predicate). The measurements from the predicate device serve as the reference.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not stated. This summary describes a device that likely uses established physiological algorithms and signal processing, rather than a machine learning or AI model that requires a dedicated "training set" in the modern sense of deep learning. The algorithms are "embedded in the Databox." Therefore, there isn't a "training set" as one would discuss for, say, an image recognition AI. If any form of algorithm tuning or development data was used, it's not documented here.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable/Not stated for the same reasons as #8.
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SECTION 5 - 510(K) SUMMARY
| EV1000 CLINICAL PLATFORM 510(k) SUMMARY | |
|---|---|
| 510(k) Submitter | Edwards Lifesciences |
| Contact Person | Sally L. MaherOne Edwards WayIrvine, CA 92614-5686 |
| Date Prepared | May 16, 2014 |
| Trade Name | EV1000 Clinical Platform |
| Common Name | Cardiac Output/Oximetry Computer |
| ClassificationName | Single-Function, Preprogrammed Diagnostic Computer(21 CFR 870.1435, product code DXG) |
| RegulationClass/ ProductCode | Class II/DXG, DQE |
| Predicate Device | EV1000 Clinical Platform, K110597 (cleared 14 June 2011) |
| DeviceDescription | The EV1000 Clinical Platform consists of Databox and Monitorcomponents, which can be mounted to an IV pole. The EV1000 ClinicalPlatform measures patient physiologic parameters when it is used as asystem with various Edwards components, including the Edwards pressuretransducers, the FloTrac sensor, the components of the VolumeViewSystem, oximetry catheters/sensors, and the corresponding accessoriesapplied to the patient.The EV1000 Databox receives incoming signals from the patient throughthe connections provided by the accessories applied to the patient. Thealgorithms embedded in the Databox process the signals and provideparameter calculations.The EV1000 Monitor is connected to the Databox via an ethernet cable. TheMonitor is a touchscreen, panel PC with a graphical user interface (GUI).The Monitor displays the measured and calculated parameter values fromthe Databox.The EV1000 Clinical Platform, when used with the VolumeView System,measures and/or calculates hemodynamic parameters such as:Manual-calibrated continuous parameters: cardiac output, cardiacindex, stroke volume, stroke volume index, systemic vascularresistance, systemic vascular resistance index, and stroke volume |
| EV1000 CLINICAL PLATFORM 510(k) SUMMARY | |
| DeviceDescription,Continued | Manual-calibrated intermittent parameters: cardiac output , cardiac index, extravascular lung water, extravascular lung water index, global ejection fraction, global end-diastolic volume, global end-diastolic volume index, intrathoracic blood volume, pulmonary vascular permeability index, stroke volume, stroke volume index, systemic vascular resistance, and systemic vascular resistance index. |
| When connected to a FloTrac sensor, the EV1000 Clinical Platform continuously measures/calculates auto-calibrated arterial pressure cardiac output, cardiac index, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, and systemic vascular resistance index. | |
| When connected to Edwards oximetry sensors, the EV1000 Clinical Platform continuously measures/calculates oximetry parameters (specifically mixed venous oximetry (SvO2) and central venous oximetry (ScvO2). | |
| Indications forUse/ IntendedUse | The EV1000 Clinical Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform may be used in all settings in which critical care is provided. |
| ComparativeAnalysis | Verification and validation testing was conducted to compare the performance and functionality of the EV1000 Clinical Platform to the predicate device. This testing regimen included side-by-side bench and pre-clinical studies, and comparative analysis of clinical data. The EV1000 Clinical Platform has been shown to be safe, effective, and substantially equivalent to the cited predicate device for its intended use in critical care environments. |
| Functional/Safety Testing | The EV1000 Clinical Platform has successfully passed functional and performance testing, including software verification and validation, mechanical and electrical testing, bench studies, pre-clinical animal studies, comparison testing of clinical cases, and clinical utility. |
| Conclusion | The EV1000 Clinical Platform has been shown to be safe, effective, and is substantially equivalent to the cited predicate device for its intended use in critical care environments. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2014
Edwards Lifesciences LLC Mr. Stephen M. Enos Director, Regulatory Affairs One Edwards Way Irvine, CA 92614
Re: K131892
Trade Name: Edwards Lifesciences™ EV1000 Clinical Platform, Model EV 1000A Regulation Number: 21 CFR 870:1435 Regulation Name: Single-function, Preprogrammed Diagnostic Computer Regulatory Class: Class II (two) Product Code: DXG Dated: May 6, 2014 · Received: May 7, 2014
Dear Mr. Enos:
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
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Page 2 - Mr. Stephen M. Enos
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 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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/ReportalProblem/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.
FDA
for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131892
Device Name
Edwards Lifesciences™ EV 1000™ Clinical Platform
Indications for Use (Describe)
The EV1000 Clinical Platform is indicated for use primarily for crivents in which the balance between cardiac function, fluid status and vascular resistance needs continuous or intermittent assessment. Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular fluid volumes. When connected to an Edwards oximetry catheter, the monitor measures oximetry in adults and pediatrics. The EV1000 Clinical Platform may be used in all settings in which critical care is provided.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
THE THE FOR FOR FOR FOR FOR FDAIUSE ONEY SECURE . CALLER Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Date: 2014.05.22 11:25:37
FD
04:00'
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§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).