(104 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 a 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:
• Auto-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume variation;
• Manual-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume variation; and,
• 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 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.
Acceptance Criteria and Study for EV1000 Clinical Platform
This document describes the acceptance criteria and the study performed to demonstrate that the EV1000 Clinical Platform meets these criteria, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria in a table format. Instead, it describes a comprehensive testing regimen designed to demonstrate the device's "safety and effectiveness and substantial equivalence to the cited predicate devices." The performance reported is that the EV1000 Clinical Platform has been shown to be safe and effective and substantially equivalent to the cited predicate devices for their intended use.
The comparative analysis and functional/safety testing sections indicate that the device met the performance and functionality of the predicate devices. Therefore, the implicit acceptance criteria are that the EV1000 Clinical Platform performs comparably to its predicate devices in terms of functionality and safety without introducing new questions of safety or effectiveness.
Implicit Acceptance Criteria and Reported Device Performance:
| Parameter/Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Performance and Functionality | Equivalent to predicate devices (K100709, K082308, K072735) | Demonstrated through head-to-head bench and pre-clinical studies, and comparative analysis of archived and new clinical data. |
| Safety and Effectiveness | No new questions of safety or effectiveness compared to predicate devices | Demonstrated through functional/performance testing, software V&V, mechanical/electrical testing, bench/pre-clinical studies, simulated comparisons, and clinical study. |
| Intended Use | Suitable for use in OR and ICU environments for critical care patients requiring continuous/intermittent assessment | Demonstrated through testing and found substantially equivalent to predicate devices for their intended use. |
| Hemodynamic Parameter Measurement | Accurate measurement/calculation of listed parameters (CO, CI, SV, SVI, SVR, SVRI, SVV, EVLW, EVLWI, GEF, GEDV, GEDVI, ITBV, PVPI) | Device measures/calculates these parameters. Implicitly, these measurements are comparable to predicate devices. |
| Oximetry Parameter Measurement | Accurate measurement/calculation of oximetry parameters in adults and pediatrics | Device measures/calculates oximetry parameters. Implicitly, these measurements are comparable to predicate devices. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document states:
- Archived clinical data: This implies retrospective data.
- Clinical data obtained during a multi-center clinical trial: This implies prospective data.
- The country of origin is not specified, but Edwards Lifesciences LLC is based in Irvine, CA.
However, specific sample sizes for the test sets used in the comparative analysis, bench studies, pre-clinical studies, or multi-center clinical trial are not provided in the summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. The document does not mention the use of experts to establish ground truth for the test set. Given the nature of the device (measuring physiological parameters), ground truth would typically be established by established medical measurement methods or reference devices, not expert consensus in the traditional sense of image interpretation.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. As mentioned above, for physiological parameter measurements, ground truth is usually established by comparison to reference methods rather than human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is relevant for devices involving human interpretation of clinical data (e.g., imaging devices). The EV1000 Clinical Platform measures and calculates physiological parameters directly. Therefore, a MRMC comparative effectiveness study was not conducted as it is not applicable to this type of device. The study involved comparing the device's measurements against predicate devices or established methods, not assessing human reader improvement with AI assistance.
6. Standalone (Algorithm Only) Performance
The device itself is an algorithm-driven platform for measuring and calculating physiological parameters. The entire study described, which includes head-to-head bench and pre-clinical studies, and comparative analysis of clinical data, is essentially a standalone performance assessment of the EV1000 Clinical Platform's algorithms and hardware in measuring these parameters. It doesn't involve a human-in-the-loop scenario where a human is assisting the algorithm's output for diagnosis or interpretation. The device provides information to human clinicians.
7. Type of Ground Truth Used
Based on the description of device functionality and the testing methods, the ground truth would likely be established through:
- Reference physiological measurements: Comparing the device's output to measurements obtained from established, validated methods or "gold standard" devices for hemodynamic and oximetry parameters.
- Pathology/Outcomes data: While not explicitly stated, clinical outcomes or direct physiological measurements taken during procedures would serve as the ultimate ground truth for validating the accuracy and clinical utility of the measured parameters.
- Predicate device comparison: The study explicitly mentions "head-to-head bench and pre-clinical studies, and comparative analysis of archived clinical data and clinical data obtained during a multi-center clinical trial of the EV1000 Clinical Platform" against predicate devices. This implies the predicate devices' performance serves as a form of "ground truth" or reference for evaluating substantial equivalence.
8. Sample Size for the Training Set
The document does not specify a sample size for any training set. The EV1000 Clinical Platform is a measurement device with embedded algorithms, not a machine learning "AI" device as typically understood that undergoes a distinct training phase on a large dataset. Its algorithms are likely based on established physiological models and signal processing, rather than being "trained" in the machine learning sense. The "comparative analysis" refers to testing the device's performance, not training it.
9. How the Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" in the context of machine learning is not indicated for this device. Therefore, this information is not applicable and not provided in the summary. The algorithms' inherent accuracy would be based on underlying scientific principles and engineering design, with performance validated through the testing described.
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5. 510(k) Summary
| EV1000 CLINICAL PLATFORM 510(k) SUMMARY | |
|---|---|
| Submitter: | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614-5686 |
| Contact Person: | Marguerite Thomlinson, Sr. Manager, Regulatory AffairsEdwards Lifesciences, LLC, Critical CarePhone: (949) 756-4386Fax: (949) 809-5676 |
| Date Prepared: | March 1, 2011 |
| Trade name: | EV1000 Clinical Platform |
| ClassificationName: | Single-Function, Preprogrammed Diagnostic Computer(21 CFR 870.1435) |
| PredicateDevices: | • K100709, Edwards Lifesciences LLC, EV1000 Platform• K082308, Edwards Lifesciences LLC, Vigileo ArterialPressure Cardiac Output/Oximetry Monitor• K072735, Pulsion Medical Systems, PiCCO-2 |
| DeviceDescription: | The EV1000 Clinical Platform consists of a Databox andMonitor components, which can be mounted to an IV pole. TheEV1000 Clinical Platform measures patient physiologicparameters when it is used as a system with various Edwardscomponents, including the Edwards pressure transducers, theFloTrac sensor, the components of the VolumeView System,oximetry catheters/sensors, and the corresponding accessoriesapplied to the patient.The EV1000 Databox receives incoming signals from the patientthrough 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 anethernet cable. The Monitor is a touchscreen, panel PC with agraphical user interface (GUI). The Monitor displays themeasured and calculated parameter values from the Databox.The EV1000 Clinical Platform, when used with theVolumeView System, measures and/or calculates hemodynamicparameters such as: |
| EV1000 CLINICAL PLATFORM 510(k) SUMMARY | |
| • | Auto-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume variation; |
| • | Manual-calibrated continuous parameters: cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, and stroke volume variation; and, |
| • | 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 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. | |
| Indications for Use/ Intended Use | 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. |
| EV1000 CLINICAL PLATFORM 510(k) SUMMARY | |
| ComparativeAnalysis: | Verification and validation testing was conducted to comparethe performance and functionality of the EV1000 ClinicalPlatform to the predicate devices. This testing regimen includedhead-to-head bench and pre-clinical studies, and comparativeanalysis of archived clinical data and clinical data obtainedduring a multi-center clinical trial of the EV1000 ClinicalPlatform. The EV1000 Clinical Platform has been shown to besafe and effective and substantially equivalent to the citedpredicate devices for their intended use in the OR and ICUenvironments. |
| Functional/Safety Testing: | The EV1000 Clinical Platform has successfully undergonefunctional and performance testing, including softwareverification and validation, mechanical and electrical testing,bench studies, pre-clinical animal studies, simulated comparisontesting of archived clinical cases, clinical usability and humanfactor assessment and a multi-center clinical study. The EV1000Clinical Platform has been shown to be safe and effective andsubstantially equivalent to the cited predicate devices for theirintended use in the OR and ICU environments. |
| Conclusion: | The proposed EV1000 Clinical Platform is safe and effectiveand is substantially equivalent to the predicate devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird with three wing-like strokes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Edwards Lifesciences, LLC Edwards Enescions Thomlinson, J.D. c/o Ms. Marguethe Thommers)
Sr. Manager of Regulatory Affairs, Critical Care One Edwards Way Irvine, CA 92614
JUN 1 4 2011
K110597 Re: K110597
Trade/Device Name: EV1000 Clinical Platform
Trade/Device School Co., 01 CFR 870 1435 Trade/Device Name: 21 CFR 870.1435 Regulatory Number: 21 CFR 870.1435
Regulation Name: Single-function, Preprogrammed Diagnostic Computer
Single-Single-Sunction, Hunce) Regulatory Class: II (two) Product Code: DXG Dated: May 13, 2011 Received: May 16, 2011
Dear Ms. Thomlinson:
Deal interest We have reviewed your Section 510(k) premarket notifically equivalent (for the indications)
referenced above and have determined the device is substantially equivales of the we nave and have determined the devices is substantially cqurvalisms.
for use stated in the enclosure) to legally marketed predicate devices market din interstate for use stated in the encloser to tegally marketed prodical Device arminents, or to
for use stated in the enclosed in accordent date of the Fedical Device of Duris, or BMA for use stated in according in accordines with the provisions of the Federal Food, Drux).
commerce prior o May 28, 1976, the encordines with the provisions of the Pederal Foo comments in to may 20, 2011 accordance with the provisions of the Peach of PMA).
devices that have been require approval of a premarket approval one of Act. The Act. The A devices market the device, subject to the general ontrols provisions of the Act. The Act. The Act. The Act. The Act. The Act. The and Cosments ( the Act the Act include requirements for annual registration, listing of
general controls provisions of the Act include requirements for annual misbranding an I ou film, woreated include requirements for ammun registered, whiles against misbranding and
devices, good manufacturing practice, labeling, and prohibitions against misbran adulteration.
adulteration:
If your device is classified (see above) into either class III (PMA), etc.
If your device and liting al controls . Existing major regulations affective and If your device is classified (see above) into either class II (Special Collicols) of Children)
it may be subject to additions. Existing major regulations affecting your devi If your device is externed in the States on the St. In additions article for the may be
it may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may
foun found in the Code of Federal Regulations, Title 21, Farst 800 to College of Register.
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Page 2 - Ms. Marguerite Thomlinson, J.D.
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/ResourcesforYou/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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K110597
Indications for Use 4.
510(k) Number (if known):
EV1000 Clinical Platform Device Name:
Indications for Use:
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.
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 Device Evaluation (ODE)
ﻟﻤ
Division of Cardiovascular Devices
510(k) Number K110597
§ 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).