EV1000 Clinical Platform by Edwards Lifesciences, LLC

The EV 1000 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.

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 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.

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 includes an Acumen Hypotension Prediction 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. A design hardware change for the AC inlet related to a corrective action was made. The additional hardware for the EV1000A power adaptor prevent liquid ingress or other conductive contaminates from entering the AC inlet.

AI/ML Overview

This document is a 510(k) premarket notification for the Edwards Lifesciences EV1000 Clinical Platform. It describes a corrective action related to a hardware change in the AC inlet to prevent liquid ingress. The primary focus of the provided text is on demonstrating the safety and substantial equivalence of this modified device to a previously cleared predicate device, specifically regarding the hardware change.

Therefore, the study information requested (acceptance criteria related to device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training set details) is not detailed in this document. The document describes a design verification test for a hardware modification, not a clinical performance study of a device feature like the Acumen Hypotension Index (HPI).

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The document states that "a reduction in occurrences of liquid ingress at the AC inlet was achieved." This implies an acceptance criterion related to reducing liquid ingress, but specific quantitative targets (e.g., maximum ingress rate, number of failures allowed) are not provided.
Reported Device Performance: The document states that the device "successfully passed functional and bench studies to demonstrate that the device is substantially equivalent to the cited predicate device and the Power Adapter Cover reduces the possibility of fluid ingress." Again, specific quantitative performance metrics (e.g., exact reduction percentage, ingress test results) are not provided.

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

Sample Size: Not specified. The document mentions "functional and bench studies" but does not detail the number of units tested.
Data Provenance: Not specified, but given it's bench testing for a hardware modification, it would be laboratory data.

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

Not applicable for this type of hardware verification study. "Ground truth" in the context of device performance, specifically for preventing liquid ingress, would be determined by physical measurements and observations during bench testing, not expert consensus.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for interpreting clinical data or images, not for bench testing hardware modifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC study was not done. This document pertains to a hardware modification for liquid ingress prevention, not the clinical performance or AI features of the device. The "Acumen Hypotension Index (HPI) feature" is mentioned as part of the overall device, but this submission is not a study of its effectiveness. It's a special 510(k) for a corrective action related to a physical design change.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not explicitly stated, but not applicable. This document describes a hardware change, not an evaluation of an algorithm's standalone performance. While the HPI is an algorithm, its performance evaluation is not the subject of this specific submission.

7. The type of ground truth used:

For the liquid ingress test, the ground truth would be physical observation and measurement of liquid ingress during bench testing, as per relevant standards (e.g., IPX ratings).

8. The sample size for the training set:

Not applicable. This document describes verification testing for a hardware change, not an AI model's training.

9. How the ground truth for the training set was established:

Not applicable.

In summary, this 510(k) submission addresses a specific hardware modification for liquid ingress and demonstrates its safety and substantial equivalence through functional and bench studies. It does not contain the detailed clinical study information that would typically be provided for evaluating the performance of a diagnostic or predictive algorithm like the Acumen Hypotension Index. For such details, one would need to refer to separate 510(k)s or clinical trial reports specifically for those features.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

December 17, 2019

Edwards Lifesciences, LLC Jamie Byun Manager, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K193179

Trade/Device Name: EV1000 Clinical Platform Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DXG Dated: November 15, 2019 Received: November 18, 2019

Dear Jamie Byun:

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

{1}------------------------------------------------

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,

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K193179

Device Name 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)

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."

{3}------------------------------------------------

SECTION 5 - 510(K) SUMMARY
----------------------------	--

EV1000™ Clinical Platform(s) Special 510(k) Corrective Action Being Effected
510(k) Submitter	Edwards Lifesciences, LLC
Contact Person	Jamie Byun
Date Prepared	November 15, 2019
Trade Name	EV1000 Clinical Platform™
Common Name	Cardiac Output / Oximetry Monitor
Classification Name	Single-Function, Preprogrammed Diagnostic Computer(21 CFR 870.1435)
Regulation Class /Product Code	Class IIDXG
Primary PredicateDevice(s)	K160552 - EV1000 Clinical Platform™ (cleared 06/01/2016)
Reference Device(s)	K192058 – EV1000 Clinical Platforms: Special 510(k) Corrective ActionBeing Effected
Device Description	EV1000 Clinical Platform (EV1000A)The EV1000 Clinical Platform measures patient physiologic parameters ina 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 the patient.The EV1000 Clinical Platform includes an Acumen HypotensionPrediction Index (HPI) feature, which is an index related to the likelihoodof a patient experiencing a hypotensive event (defined as mean arterialpressure (MAP) < 65 mmHg for one minute in duration) within 15minutes, 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 thepatient'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 theDatabox to the Monitor. It may be attached to the patient bedside, an IVpole or roll stand.A design hardware change for the AC inlet related to a corrective actionwas made. The additional hardware for the EV1000A power adaptor

{4}------------------------------------------------

	prevent liquid ingress or other conductive contaminates from entering theAC inlet.
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. TheEV1000 Clinical Platform may be used for the monitoring ofhemodynamic parameters in conjunction with a perioperative goal directedtherapy protocol. Analysis of the thermodilution curve in terms of meantransit time and the shape is used to determine intravascular andextravascular fluid volumes. When connected to an Edwards oximetrycatheter, the monitor measures oximetry in adults and pediatrics. TheEV1000 Clinical Platform may be used in all settings in which critical careis provided.
	The Edwards Lifesciences Acumen Hypotension Prediction Index featureprovides the clinician with physiological insight into a patient's likelihoodof future hypotensive events (defined as mean arterial pressure < 65 mmHgfor at least one minute in duration) and the associated hemodynamics. TheAcumen HPI feature is intended for use in surgical or nonsurgical patientsreceiving advanced hemodynamic monitoring. The Acumen HPI feature isconsidered to be additional quantitative information regarding the patient'sphysiological condition for reference only and no therapeutic decisionsshould be made based solely on the Hypotension Prediction Index (HPI)parameter.
ComparativeAnalysis	EV1000 Clinical Platform (EV1000A) has been modified by adding aPower Adapter Enclosure to the power adaptor in order to prevent liquidingress. Design verification testing for the EV1000A power adaptor withthe Power Adapter Enclosure was performed and a reduction inoccurrences of liquid ingress at the AC inlet was achieved.
Functional/ SafetyTesting	The EV1000 Clinical Platform (EV1000A) has successfully passedfunctional and bench studies to demonstrate that the device is substantiallyequivalent to the cited predicate device and the Power Adapter Coverreduces the possibility of fluid ingress.
Conclusion	The EV1000 Clinical Platform (EV1000A) has been shown to be safe andis substantially equivalent to the predicate device for its intended use inhospitals and other appropriate clinical environments.

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).