EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M by EDWARDS LIFESCIENCES, LLC.

The EV1000 Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs constant or intermittent assessment. The EV1000 Platform may be used in all settings in which critical care is provided.

Device Description

The EV1000 Platform consists of two components: a databox and a monitor. The databox is where all incoming signals are processed. It contains all the algorithms for parameter calculation. It is mounted to the patient bedside or to an IV pole. The databox has mounts so that pressure transducers, FloTrac sensors, and the VolumeView System can be attached to it. The databox has no graphical user interface. It connects, via an Ethernet cable, to the EV1000 monitor.

The EV1000 monitor is a panel PC with a touchscreen interface. It is connected to the databox by an Ethernet cable. It is intended to be mounted to an IV pole. The monitor does not process any data; its sole function is to act as a user and communication interface.

The EV1000 Platform, when connected to the VolumeView system, intermittently measures or calculates intermittent cardiac output, intermittent cardiac index. , intermittent stroke volume. intermittent stroke volume index, systemic vascular resistance, and systemic vascular resistance index.

When connected to a FloTrac sensor, the platform continuously measures or calculates arterial pressure cardiac output, stroke volume, stroke volume index, stroke volume variation, systemic vascular resistance, and systemic vascular resistance index.

AI/ML Overview

The provided FDA 510(k) summary for the EV1000 Platform focuses on its substantial equivalence to predicate devices based on functional and safety testing. It does not contain the kind of detailed information typically found in acceptance criteria and efficacy studies for AI/algorithm-based diagnostic devices, particularly regarding quantitative performance metrics, sample sizes for test/training sets, expert ground truth adjudication, or comparative effectiveness studies with human readers.

Here's why and what can be inferred:

Key Takeaway: The EV1000 Platform is a hardware monitoring system that calculates physiological parameters using algorithms. It is not an AI/ML diagnostic device in the modern sense that would typically have the requested data (e.g., diagnostic accuracy, sensitivity, specificity, or reader studies for image interpretation).

The document states: "It contains all the algorithms for parameter calculation." This implies that the algorithms perform calculations based on physiological signals, rather than interpreting complex data like medical images or making a diagnosis. Therefore, the "acceptance criteria" would likely be around the accuracy of these calculations compared to a known standard or the predicate devices, and functional safety.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance (from text)	Notes / Inferences
Functional/Safety Equivalence	"The EV1000 Platform has successfully undergone functional testing. This product has been shown to be equivalent to the predicate devices."	The specific functional tests and the quantitative metrics for "equivalence" are not detailed in this summary. It's a general statement that the device functions as intended and safely, similar to its predecessors.
Intended Use	"The EV1000 Platform is indicated for use primarily for critical care patients in which the balance between cardiac function, fluid status and vascular resistance needs constant or intermittent assessment. The EV1000 Platform may be used in all settings in which critical care is provided."	This describes the scope of application, not a performance metric.
Comparative Analysis	"The EV1000 Platform has been demonstrated to be as safe and effective as the predicate devices for their intended use."	Similar to functional/safety, this is a summary statement. The underlying data demonstrating "as safe and effective" is not provided.
Parameter Calculation (e.g., Cardiac Output, Stroke Volume)	Not explicitly stated in quantitative terms (e.g., accuracy, precision relative to a gold standard).	The document states it "measures or calculates intermittent cardiac output, intermittent cardiac index...". The acceptance criteria for these calculations would typically involve comparison against a reference method (e.g., thermodilution for cardiac output). However, these details are absent from the summary.

Detailed Breakdown of Other Requested Information:

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified in the provided text.
Data Provenance: Not specified. Given the nature of a medical device submission, it would likely involve clinical data, but its origin (e.g., country, specific hospitals) and whether it was retrospective or prospective are not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Number of Experts: Not applicable/not specified. For this type of device (physiological parameter calculation), "ground truth" would be established by reference methods or validated sensors, not by expert interpretation of data. If there were a need for expert review of device output for clinical acceptability, it is not mentioned.
Qualifications: Not applicable/not specified.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable/not specified. Adjudication methods (like 2+1, 3+1) are typically used when multiple human readers interpret complex data, such as medical images, to establish a consensus ground truth. Here, output parameters are calculated numbers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

MRMC Study: No, it was not done. MRMC studies are specifically designed to assess the diagnostic efficacy of a system (often AI-assisted) by comparing multiple human readers' performance with and without the system's help on multiple cases. This device is a physiological monitoring platform, not an image interpretation or diagnostic aid in that context.
Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

Standalone Study: The summary implies that the "functional testing" and "comparative analysis" against predicate devices would assess the algorithms within the system directly. However, the details of how this was done (e.g., comparison of calculated parameters against a gold standard or a reference device on a dataset) are not provided. It simply states the device "has been demonstrated to be as safe and effective."

7. The Type of Ground Truth Used:

Ground Truth: For a device calculating physiological parameters, the ground truth would typically be established by:
- Reference Methods: Such as thermodilution for cardiac output, or direct arterial line measurements for arterial pressure, using independently validated instruments.
- Predicate Device Comparison: Performance relative to the legally marketed predicate devices would be a primary comparison point for demonstrating substantial equivalence.
- The specific type of ground truth used to validate the accuracy of the calculated parameters is not detailed in this 510(k) summary.

8. The Sample Size for the Training Set:

Training Set Sample Size: Not specified. This device calculates parameters using algorithms, meaning it's likely based on established physiological models and signal processing rather than machine learning algorithms that require a "training set" in the common sense (i.e., for learning from annotated data). If machine learning was used, the training set size would be crucial, but it's not mentioned.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth for Training Set: Not applicable/not specified. As above, this device's algorithms are likely model-based, not learned from a large annotated training set. If there were development data, its ground truth establishment is not described.

In summary: The provided 510(k) summary for the EV1000 Platform is for a physiological monitoring device that calculates parameters. The information it contains aligns with demonstrating "substantial equivalence" based on functional and safety testing compared to predicate devices, rather than the detailed performance metrics and study designs (like MRMC or reader studies) typically associated with modern AI/ML diagnostic tools focused on pattern recognition or complex data interpretation. The summary lacks the granularity for the acceptance criteria and study details that would be present for an AI product.

Summary

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DEC - 7 2010

100709

510(k) Summarv

Submitter: Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614-5686
Contact Person: Patricia A. Milbank Vice President, RA/CA
Date Prepared: November 29, 2010
Trade name: EV1000 Platform
Classification Name: Single-function, Preprogrammed Diagnostic Computer (21 CFR 870.1435)
Predicate Devices: Edwards Lifesciences Vigileo Arterial Pressure Cardiac Output/Oximetry Monitor; cleared under K082308 Pulsion PICCO-2 Monitor, cleared under K072735

Device Description: The EV1000 Platform consists of two components: a databox and a monitor. The databox is where all incoming signals are processed. It contains all the algorithms for parameter calculation. It is mounted to the patient bedside or to an IV pole. The databox has mounts so that pressure transducers, FloTrac sensors, and the VolumeView System can be attached to it. The databox has no graphical user interface. It connects, via an Ethernet cable, to the EV1000 monitor.

The EV1000 monitor is a panel PC with a touchscreen interface. It is connected to the databox by an Ethernet cable. It is intended to be mounted to an IV pole. The monitor does not process any data; its sole function is to act as a user and communication interface.

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510(k) Summary

Intended Use:	The EV1000 Platform is indicated for use primarily for criticalcare patients in which the balance between cardiac function, fluidstatus and vascular resistance needs constant or intermittentassessment. The EV1000 Platform may be used in all settings inwhich critical care is provided.
ComparativeAnalysis:	The EV1000 Platform has been demonstrated to be as safe andeffective as the predicate devices for their intended use.
Functional/SafetyTesting:	The EV1000 Platform has successfully undergone functionaltesting. This product has been shown to be equivalent to thepredicate devices.
Conclusion:	The proposed EV 1000 Platform is substantially equivalent to thepredicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines representing the body and wings.

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

Edwards Lifesciences, LLC c/o Ms. Patricia Milbank, J.D. Vice President, RA/CA, Critical Care One Edwards Way Irvine, CA 92614

DEC - 7 2010

Re: K100709

Trade/Device Name: EV 1000 Platform Regulatory Number: 21 CFR 870.1435 Regulation Name: Single-function, Preprogrammed Diagnostic Computer Regulatory Class: II (two) Product Code: DXG Dated: November 19, 2010 Received: November 22, 2010

Dear Ms. Milbank:

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 - Ms. Patricia Milbank, 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

summa R. Richner

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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K100709

Indications for Use Statement

DEC - 7 2010

510(k) Number (if known):

Device Name: EV1000 Platform

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Vihinen

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510(k) Number_KLL02209

Regulation Number and Section

§ 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).