The EV1000 Clinical Platform NI and the ClearSightTM Finger Cuffs are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status, and vascular resistance needs continuous assessment. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. In addition, the non-invasive system is indicated for use in patients with co- morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform and the ClearSightTM finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

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. The EV1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. 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.

Device Description

The EV1000 Clinical Platform measures patient physiologic parameters in a minimally invasive manner 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 Clinical Platform consists of the EV1000 Monitor (Monitor), the EV1000 Databox (Databox), and an Ethernet cable to connect the Databox to the Monitor. It may be attached to the patient bedside, an IV pole or roll stand.
The EV1000 Clinical Platform NI with ClearSight Finger Cuffs is a non- invasive monitor that enables the continuous assessment of a patient's hemodynamic function based on the scientific method of Peñàz - Wesseling. The device measures continuous non-invasive blood pressure (Systolic, Diastolic, and Mean Arterial Pressure) and pulse rate. Cardiac Output and other hemodynamic parameters are derived from the blood pressure waveform.
The EV1000 NI consists of the EV1000 monitor (EV1000M), the EV1000 Pump-Unit (Pump-Unit), a Pressure Controller (PC2) that is worn on the wrist, a Heart Reference Sensor (HRS), and the ClearSight™ Finger Cuffs. It may be attached to the patient bedside, an IV pole or roll stand.

AI/ML Overview

This FDA 510(k) summary provides information for the EV1000 Clinical Platform NI with ClearSight™ Finger Cuffs or ClearSight™ System.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes the clinical study as demonstrating substantial equivalence to the predicate device. However, it does not explicitly list specific numerical acceptance criteria (e.g., accuracy thresholds, precision ranges) for individual hemodynamic parameters, nor does it provide a precise table of the device's reported performance against such criteria. The "Comparative Analysis" and "Functional/Safety Testing" sections state that the device's performance and functionality were compared to the predicate device, and the device was shown to be "safe, effective, and substantially equivalent."

Therefore, I cannot populate a table with specific numerical acceptance criteria and reported device performance from the provided text. The evaluation focused on substantial equivalence rather than meeting pre-defined numerical thresholds for accuracy or precision.

2. Sample Size and Data Provenance for the Test Set

Sample Size for the Test Set (Clinical Study): The document states that "an evaluation of archived clinical data demonstrated that the device is substantially equivalent to the cited predicate device." It also mentions "a clinical study" in the "Comparative Analysis" section. However, the exact sample size (number of patients or data points) for this clinical study or the evaluation of archived data is not specified in the provided text.
Data Provenance (e.g., country of origin, retrospective or prospective): The document refers to "archived clinical data," which implies a retrospective evaluation. The country of origin of this data is not specified.

3. Number of Experts and Their Qualifications for Ground Truth

The document does not mention the involvement of experts (e.g., radiologists) to establish ground truth for the test set. Instead, it refers to the device measuring blood pressure and deriving hemodynamic parameters based on the "scientific method of Peñàz - Wesseling" and comparison to a predicate device. This suggests that the "ground truth" or reference standard for comparison would likely be the measurements obtained from the predicate device or a clinical gold standard for blood pressure measurement, not expert consensus on image interpretation.

4. Adjudication Method for the Test Set

Since the establishment of ground truth by multiple experts is not mentioned, an adjudication method is not applicable and therefore not described in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is relevant for devices that involve human interpretation, such as AI for medical imaging. The EV1000 Clinical Platform NI with ClearSight™ Finger Cuffs is a hemodynamic monitoring device, not an imaging device that requires human interpretation in the same way. Therefore, an MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device based on the information provided. The study focused on device performance and functionality comparison with a predicate, not how human readers improve with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

The device described, the EV1000 Clinical Platform NI, is a continuous monitoring system that directly measures and derives physiological parameters. Its performance, as described, is its standalone performance without explicit human intervention in the real-time measurement or derivation of parameters. The "Functional/Safety Testing" included "software verification and validation, mechanical and electrical testing, and bench studies," which would assess its standalone operational accuracy. The evaluation of archived clinical data also represents a standalone assessment of the device's output against a reference. Therefore, yes, its performance described is essentially its standalone (algorithm only) performance.

7. Type of Ground Truth Used

The type of ground truth used for comparison during the "clinical study" and "evaluation of archived clinical data" was likely:

Measurements from the predicate device (K140312 – EV1000 Clinical Platform™ NI with ClearSight™ Finger Cuffs or ClearSight™ System).
A clinically established gold standard for blood pressure and hemodynamic parameter measurement, which the predicate device itself would have been compared against during its clearance. This could involve invasive arterial line measurements for blood pressure or other established methods for cardiac output and fluid volume assessment not explicitly detailed in this summary.

8. Sample Size for the Training Set

The document focuses on the evaluation of the device, which typically refers to testing its performance rather than training an AI model. While the device uses a "scientific method" (Peñàz - Wesseling) and derives parameters, there is no mention of an AI algorithm that was "trained" on a specific dataset as would be the case for machine learning devices. Therefore, a "training set" for an AI algorithm is not explicitly mentioned or applicable in the context presented.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI algorithm, the method for establishing its ground truth is not provided.

Summary

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

June 1, 2016

Edwards Lifesciences, LLC Tara Viviani Principle Project Manager, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K160552

Trade/Device Name: EV1000 Clinical Platform Non-Invasive (NI) and ClearSight Finger Cuffs or ClearSight System, EV1000 Clinical Platform Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer Regulatory Class: Class II Product Code: DXG, DSB, DXN Dated: May 25, 2016 Received: May 26, 2016

Dear Tara Viviani:

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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, Shawn W. Forrest -S 2016.06.01 17:45:37 -04'00'

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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Indications for Use

510(k) Number (if known) K160552

Device Name EV1000 Clinical Platform Non-Invasive NI and ClearSightTM Finger Cuffs or ClearSight™ System EV1000 Clinical Platform

Indications for Use (Describe)

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)

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SECTION 5 – 510(k) SUMMARY

EV1000™ Clinical Platform(s) 510(k)
510(k) Submitter	Edwards Lifesciences, LLC
Contact Person	Tara M. Viviani, RACOne Edwards WayM/S JAM B3Irvine, CA 92614tara viviani@edwards.com(949) 250-4030
Date Prepared	February 26, 2016
Trade Name	EV1000 Clinical Platform™	EV1000 Clinical Platform™ NI withClearSight™ Finger Cuffs orClearSight™ System
Common Name	Cardiac Output / Oximetry Monitor	Non-Invasive Blood PressureMeasurement System
ClassificationName	Single-Function,Preprogrammed DiagnosticComputer(21 CFR 870.1435)	Single-Function, PreprogrammedDiagnostic Computer(21 CFR 870.1435)System, Measurement, Blood-Pressure, Non-Invasive(21 CFR 870.1130)Plethysmograph, Impedance(21 CFR 870.2770)
Regulation Class /Product Code	Class IIDXG	Class IIDXG, DXN, DSB
Predicate Device(s)	K131892 – EV1000 ClinicalPlatform (cleared 05/22/2014)	K140312 – EV1000 ClinicalPlatform™ NI with ClearSight™Finger Cuffs or ClearSight™ System(cleared 06/13/2014)
Device Description	The EV1000 Clinical Platform measures patient physiologic parametersin a minimally invasive manner when it is used as a system with variousEdwards' components, including the Edwards pressure transducers, theFloTrac sensor, the components of the VolumeView System, oximetrycatheters/sensors, and the corresponding accessories applied to thepatient.The EV1000 Clinical Platform consists of the EV1000 Monitor (Monitor),the EV1000 Databox (Databox), and an Ethernet cable to connect theDatabox to the Monitor. It may be attached to the patient bedside, an IVpole or roll stand.The EV1000 Clinical Platform NI with ClearSight Finger Cuffs is a non-invasive monitor that enables the continuous assessment of a patient'shemodynamic function based on the scientific method of Peñàz -Wesseling. The device measures continuous non-invasive blood
	pressure (Systolic, Diastolic, and Mean Arterial Pressure) and pulse rate.Cardiac Output and other hemodynamic parameters are derived fromthe blood pressure waveform.
	The EV1000 NI consists of the EV1000 monitor (EV1000M), the EV1000Pump-Unit (Pump-Unit), a Pressure Controller (PC2) that is worn on thewrist, a Heart Reference Sensor (HRS), and the ClearSight™ FingerCuffs. It may be attached to the patient bedside, an IV pole or roll stand.
Indications forUse/Intended Use	The EV1000 Clinical Platform is indicated for use primarily for criticalcare patients in which the balance between cardiac function, fluid statusand vascular resistance needs continuous or intermittent assessment.The EV1000 Clinical Platform may be used for the monitoring ofhemodynamic parameters in conjunction with a perioperative goaldirected therapy protocol. Analysis of the thermodilution curve in termsof mean transit time and the shape is used to determine intravascularand extravascular fluid volumes. When connected to an Edwardsoximetry catheter, the monitor measures oximetry in adults andpediatrics. The EV1000 Clinical Platform may be used in all settings inwhich critical care is provided.
	The EV1000 Clinical Platform NI and the ClearSight™ Finger Cuffs areindicated for patients over 18 years of age in which the balance betweencardiac function, fluid status, and vascular resistance needs continuousassessment. The EV1000 Clinical Platform may be used for themonitoring of hemodynamic parameters in conjunction with aperioperative goal directed therapy protocol. In addition, the non-invasive system is indicated for use in patients with co-morbidities forwhich hemodynamic optimization is desired and invasive measurementsare difficult. The EV1000 Clinical Platform and the ClearSight™ fingercuffs noninvasively measures blood pressure and associatedhemodynamic parameters.
ComparativeAnalysis	Verification and Validation testing was conducted to compare theperformance and functionality of the EV1000 Clinical Platform and theEV1000 Clinical Platform with ClearSight Finger Cuffs to the predicatedevice. The testing included side-by-side bench testing and a clinicalstudy. The EV1000 Clinical Platform(s) were shown to be safe,effective, and substantially equivalent to the predicate device for itsintended use in hospitals and other appropriate clinical environments.
	The EV1000 Clinical Platform(s) use the same technology as thepredicate devices with the added feature of providing a tool for theclinician to trend monitored parameters and compare them forcompliance to a Goal Directed Therapy protocol. The trending featuresare Goal Directed Therapy protocol agnostic and may be used withreported parameters commonly used in Goal Directed Therapy.
Functional/ SafetyTesting	The EV1000 Clinical Platform and the EV1000 Clinical Platform NI withClearSight Finger cuffs have successfully passed functional andperformance testing, including software verification and validation,
	mechanical and electrical testing, and bench studies. In addition, anevaluation of archived clinical data demonstrated that the device issubstantially equivalent to the cited predicate device
Conclusion	The EV1000 Clinical Platform and the EV1000 Clinical Platform NI withClearSight Finger cuffs have been shown to be safe, effective, and aresubstantially equivalent to the predicate devices for their intended use inhospitals and other appropriate clinical environments.

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Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).