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. Monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol enables consistent in the intended patient populations. 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 Edwards Lifesciences Acumen Hypotension Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or nonsurgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.

The EV1000 Clinical Platform NI and the ClearSight finger cuffs are indicated for patients over 18 years of age in which the balance between cardiac fluid status and vascular resistance needs continuous assessment. The EV 1000 Clinical Platform may be used for the monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol. In addition, the noninvasive system is in patients with comorbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform NI and the ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

Device Description

EV1000A:
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 includes an Acumen Hypotension Index (HPI) feature, which is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure (MAP) < 65 mmHg for one minute in duration) within 15 minutes, where zero (0) indicates low likelihood and one hundred (100) indicates high likelihood. The Acumen Hypotension Prediction Index, HPI, should not be used exclusively to treat patients. A review of the patient's hemodynamics is recommended prior to initiating treatment.

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.

No changes were made directly to the EV1000A system (i.e. Databox). However, since the monitor (EV1000M) is shared by the both platforms (EV1000N), the new software updates, Fluid Responsiveness Test feature, enhanced cybersecurity, and data download option to the EV1000NI impacted the EV1000A platform. Additionally, dP/dt, Eadyn, and PPV as key parameters, as well as minor updates to the graphic user interface to the key parameters and secondary screens were reflected in the operator's manual. All of these software changes reside in the EV1000 monitor.

EV1000NI:
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), a Pressure Controller (PC2K or PC2) that is worn on the wrist, a Heart Reference Sensor (HRS), and Edwards ClearSight finger cuffs (It may be attached to the patient bedside, an IV pole or roll stand.

Software modifications were made to support new features such as Fluid Response Interpretation. Blood Pressure Calibration, ClearSight Workflow Options, Focused Screens, enhanced error messaging/help screens, finger cuff brand recognition, enhanced cybersecurity updates, data download options, and Heart Reference Sensor (HRS) EEPROM update were included as part of this submission.

AI/ML Overview

The provided text does not contain specific acceptance criteria with numerical thresholds or detailed study results for device performance related to specific clinical metrics. Instead, it describes general verification and validation activities conducted for software modifications and system functionality.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with specific performance metrics and their corresponding reported values. It generally states that "All tests passed" and that the device "meet their predetermined design and performance specifications."

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

The document mentions "retrospective data analysis for algorithm and performance verification" but does not specify the sample size for this analysis nor the country of origin. It also does not explicitly state whether the test set was retrospective or prospective, though the mention of "retrospective data analysis" suggests a retrospective component.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

The document mentions "an assessment by clinicians of its usability and human factors considerations" for usability testing. However, it does not specify the number of experts used to establish ground truth for any of the performance verification, nor their qualifications.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. This type of study seems irrelevant given the device's function as a monitoring platform rather than an AI-assisted diagnostic tool for image interpretation.

6. Standalone (Algorithm Only) Performance Study:

The document mentions that "Measured and derived parameters were tested using a bench simulation" and "individual components were tested at a sub-system level" and "integrated as a system and verified for their safety and effectiveness." This implicitly describes standalone (algorithm-only) performance testing against simulations and individual component verification. However, it does not provide detailed numerical results or specific performance metrics from these standalone tests.

7. Type of Ground Truth Used:

The ground truth for the verification activities appears to be based on:

Predetermined design and performance specifications: The document states that the device "meet their predetermined design and performance specifications."
Bench simulation: Used for testing "measured and derived parameters."
Comparison to predicate devices: The submission aims to demonstrate substantial equivalence to predicate devices.

8. Sample Size for the Training Set:

The document does not mention a training set or its sample size. The submission focuses on software modifications and verification, and if any machine learning algorithms were involved (e.g., for the Acumen HPI feature which was previously cleared), the details of their training are not part of this specific submission summary. The Acumen HPI feature itself was cleared in a separate submission (K183646), and this submission for K203131 only notes minor updates to its display.

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

Since a training set is not mentioned in this document, the method for establishing its ground truth is not provided.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue. The logos are simple and professional, and they are easily recognizable.

January 22, 2021

Edwards Lifesciences, LLC Christine Chun Manager, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K203131

Trade/Device Name: EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN, DXG, QAQ Dated: December 22, 2020 Received: December 23, 2020

Dear Christine Chun:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for LT Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203131

Device Name EV1000 Clinical Platform (EV1000A)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K203131

Device Name EV1000 Clinical Platform NI (EV1000NI)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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SECTION 5 — 510(k) SUMMARY

EV1000™ Clinical Platform(s) 510(k)
Submitter - 807.92(a)(1)
510(k)Submitter	Edwards Lifesciences, LLC
Contact Person	Christine J. Chun, MBA
	One Edwards Way
	Irvine, CA 92614
	christine chun@edwards.com
	(949) 250-2773
Date Prepared	October 16, 2020
Device Information - 807.92(a)(2)
Trade Name		EV1000 Clinical Platforms
	EV1000 Clinical Platform™ NI(EV1000NI)	EV1000 Clinical Platform (EV1000A)
Common Name	Non-Invasive Blood Pressure	Cardiac Output / Oximetry Monitor with
	Measurement System	Adjunctive Predictive Cardiovascular
		Indicator
Classification	Single-Function, Preprogrammed	Single-Function, Preprogrammed
Name	Diagnostic Computer	Diagnostic Computer
	(21 CFR 870.1435)	(21 CFR 870.1435)
	System, Measurement, Blood-	Adjunctive Predictive Cardiovascular
	Pressure, Non-Invasive	Indicator
	(21 CFR 870.1130)	(21 CFR 870.2210)
Regulation	Class II	Class II
Class / ProductCode	DXG, DXN	DXG, QAQ

Legally	Predicate Device - 807.92(a)(3)	EV1000 Clinical Platforms
Marketed	EV1000 Clinical Platform™ NI	EV1000 Clinical Platform (EV1000A)
Devices	(EV1000NI)
Primary	K160552 - EV1000 Clinical Platform™	K160552 – EV1000 Clinical Platform
Predicate	NI with ClearSight™ Finger Cuffs or	(cleared 06/01/2016)
Device(s)	ClearSight™ System (cleared
	06/01/2016)
Additional	K201446 - HemoSphere Advanced	K183646 - Acumen™ Hypotension
Predicate	Monitoring Platform, HemoSphere	Prediction Index (HPI) – EV1000
Device(s)	ClearSight Module (cleared 10/01/2020	Clinical Platform (cleared 05/21/2019)


	K190205 - HemoSphere Advanced	K190205 - HemoSphere Advanced
	Monitor, HemoSphere Tissue Oximetry	Monitor, HemoSphere Tissue Oximetry
	Module (cleared 08/29/2019)	Module (cleared 08/29/2019)

	K180881 - HemoSphere Advanced	K180881 - HemoSphere Advanced
	Monitor, HemoSphere Pressure Cable	Monitor, HemoSphere Pressure Cable
	(cleared 11/16/2018)	(cleared 11/16/2018)

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Device Description - 807.92(a)(4)

EV1000A:

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.

EV1000NI:

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.

Indications for Use/Intended Use - 807.92(a)(5)

EV1000 Clinical Platform (EV1000A):

No changes are being made to the indications for use as part of the 510(k) for EV1000A

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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 Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHq for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.

EV1000 Clinical Platform™ NI (EV1000NI):

No changes are being made to the indications for use as part of the 510(k) for EV1000NI

The EV1000 Clinical Platform NI and the ClearSight 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 noninvasive system is indicated for use in patients with comorbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform NI and the ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

Comparative Analysis – 807.92(a)(6)
TechnicalCharacteristics(Similarity)	EV1000 Clinical Platform ™ NI(EV1000NI)Non-Invasive ClearSighttechnology:	EV1000 Clinical Platform (EV1000A)Minimally Invasive Technology:
	The technological characteristics of thepredicate and subject devices areidentical.	The technological characteristics of thepredicate and subject devices areidentical.
The purpose of this Traditional 510(k) submission is to obtain clearance of EV1000™ ClinicalPlatform (EV1000A) and EV1000™ Clinical Platform NI (EV100NI) with software modifications toincorporate the following new and modified features:
	EV1000 ™ Clinical Platform NI(EV100NI)	EV1000 ™ Clinical Platform(EV1000A)
TechnicalCharacteristics(Differences)	New Features:•Fluid Responsiveness Test screen•Manual Blood Pressure (BP)Calibration•ClearSight Workflow Options•Focused Screens	New Features:•Fluid Responsiveness Test screen(Passive Leg Raise and Fluid Bolus)
Modified Features:	Modified Features:
•Optimization/Bug FixesBeat Detection EnhancementsStaircase Improvements•Enhanced error messaging/helpscreens• System identification of appropriatefinger cuffs when connected to theEV1000NI platform•Heart Reference Sensor (HRS)EEPROM manufacturing date update•Cybersecurity•De-Identity Option in Data download•Flexible Alarm Standards Option (forChina only, not subject of this 510(k))	•"Mini-Trends" and PPV added to HPIsecondary screen•Existing PPV, Eadyn and dP/dt wereadded to the key parameter menu•Algorithm library (APCO) was updatedfor dP/dt, Eadyn, and PPV calculations•Cybersecurity•De-Identity Option in Data download•Flexible Alarm Standards Option (forChina only, not subject of this 510(k))
Performance Data – 807.92(b)
The following verification activities were performed in support of a substantial equivalencedetermination for the modifications being made as part of this submission.
NonclinicalTest807.92(b)(1)	Software Verification
	The EV1000 Clinical Platforms (EV1000A and EV1000NI) are considered assoftware of Moderate Level of Concern.
	Software verification was performed per FDA's Guidance for Industry and FDAStaff, "Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices". Software on each of the individual modules wastested at a sub-system level to ensure the safety of the device. All tests passed.
	System
	Verification and Validation testing was conducted to compare the performanceand functionality of the EV1000 Clinical Platforms (EV1000A and EV1000NI).Thetesting included side-by-side bench testing and a retrospective data analysis foralgorithm and performance verification.
	Completion of all verification and validation activities demonstrated that thesubject devices meet their predetermined design and performancespecifications. Verification activities performed confirmed that the differences inthe design and materials used did not adversely affect the safety andeffectiveness of the subject device.
	Measured and derived parameters were tested using a bench simulation.Additionally, individual components were tested at a system level to verify thesafety of these modules. They were also integrated as a system and verified fortheir safety and effectiveness. All tests passed.
	Therefore, the EV1000 Clinical Platforms were shown to be substantiallyequivalent to the predicate devices for its intended use in hospitals and otherappropriate clinical environments.
Usability
System validation of the EV1000 Clinical Platforms (EV1000A and EV1000NI) included an assessment by clinicians of its usability and human factors considerations. Usability tests for the new and modified features were performed and met all acceptance criteria. Therefore, the usability test was deemed as passed and the EV1000 Clinical Platforms met its intended use related to its primary operating function and did not create any confusion or use errors that could lead to unsafe conditions of use. The EV1000 Clinical Platforms remain in compliance with AAMI/ANSI/IEC 62366.
Electrical Safety and Electromagnetic Compatibility (EMC)
EV1000A
Modifications do not require hardware changes to the EV1000A databox. Therefore, the EV1000A remains in compliance with Electrical Safety and Electromagnetic Compatibility (EMC) that have been previously reviewed and cleared by FDA in K160552.
EV1000NI
Confirmatory testing for EMC and Electrical Safety were performed as a result of minor changes made to the Heart Reference Sensor (HRS) and Pressure Controller (PC2K) components of the EV1000NI Platform to demonstrate equivalence to the predicate device. No other components were updated and therefore, these components remains in compliance with the IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366-1, IEC 60601-2-34, IEC 60601-2-57 and IEC 60601-2-49 that have been previously reviewed and cleared by the FDA in K160552. All tests passed.
Clinical Test807.92(b)(2)	A clinical study was not necessary to demonstrate equivalence to the predicate device.
Conclusion807.92(b)(3)	Completion of all non-clinical activities demonstrated that the subject devices meet their predetermined design and performance specifications.
	The EV1000 Clinical Platform(s) have been shown to be substantially equivalent to the predicate devices for their intended use in hospitals 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).