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 or use in patients with comorbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV 1000 Clinical Platform and the ClearSightTM Finger Cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

Device Description

The EV1000 Clinical Platform NI and the ClearSight™ Finger Cuffs is a non-invasive system that continuously measures 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 Clinical Platform NI and the ClearSight™ Finger Cuffs 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 (EVHRS or also referred to as HRS), and the ClearSight™ Finger Cuffs. EV1000M may be attached to the patient bedside, an IV pole or roll stand. The subject of this 510(k) is a change of the tubing material and its establishment of shelf life for the EVHRS, a component of the subject device, EV1000 Clinical Platform NI and the ClearSight Finger Cuff.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the EV1000 Clinical Platform™ NI and the ClearSight™ Finger Cuffs or ClearSight™ System. The submission, K182245, is seeking substantial equivalence to a previously cleared device (K160552) for a change in tubing material and shelf life of a component, the Heart Reference Sensor (EVHRS).

Based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria related to its performance as a blood pressure measurement system after the material change. The provided text primarily focuses on demonstrating substantial equivalence for engineering/material changes, not clinical performance changes.

Therefore, many of the requested details cannot be extracted from this document because they pertain to a performance study for a medical device AI/software, not a material change to an existing device component.

However, I can extract the following:

1. A table of acceptance criteria and the reported device performance:

The document states: "functional testing was conducted to show performance is not affected. The EVHRS has been shown to be substantially equivalent to the predicate device for its intended use in hospitals and other appropriate clinical environments. The Heart Reference Sensor (EVHRS) accessory to the subject device, EV1000 Clinical Platform NI and the ClearSight™ Finger cuffs have successfully passed functional and performance testing, including mechanical, shelf life, biocompatibility, and bench studies, demonstrating that the subject device is substantially equivalent to the predicate device."

This implies that the acceptance criteria for this specific 510(k) (K182245) related to the change in tubing material were that the performance characteristics of the device, as measured by functional, mechanical, shelf life, biocompatibility, and bench studies, remained equivalent to the predicate device. However, specific numerical acceptance criteria or reported performance data are NOT provided in this document. It only states that the tests were "successfully passed."

Acceptance Criteria (Implied)	Reported Device Performance
Performance is not affected by tubing material change	"functional and performance testing, including mechanical, shelf life, biocompatibility, and bench studies, demonstrating that the subject device is substantially equivalent to the predicate device."
Biocompatibility in accordance to ISO 10993-10	"biocompatibility was conducted in accordance to ISO 10993-10"
Maintains shelf life	"establishment of shelf life" and "shelf life...successfully passed"

The remaining questions (2-9) cannot be answered from the provided text as they relate to clinical performance studies, particularly for AI/software, which are not the subject of this specific 510(k) submission. This 510(k) (K182245) is for a material change and shelf-life establishment of a component (EVHRS), not the initial clinical validation of the blood pressure measurement capabilities of the EV1000 system. The clinical performance and ground truth for the overall device would have been established during the clearance of the predicate device (K160552 and K140312).

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA (U.S. Food & Drug Administration) logo.

November 30, 2018

Edwards Lifesciences, LLC Christine Chun Manager, Regulatory Affairs Program Management One Edwards Wav Irvine, California 92614

Re: K182245

Trade/Device Name: EV1000 Clinical Platform™ NI and the ClearSight™ Finger Cuffs or ClearSight™ System Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DSB, DXG Dated: August 17, 2018 Received: August 20, 2018

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 C. Browning -S5

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) K182245

Device Name

EV1000 Clinical Platform™ NI and the ClearSight™ Finger Cuffs or ClearSight™ System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CER 801 Subnart D)	Over-The-Counter Use (21 CER 801 Subnart C)

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SECTION 5 – 510(k) SUMMARY

EV1000™ Clinical Platform NI and the ClearSight™ Finger Cuffs
510(k) Submitter	Edwards Lifesciences, LLC
Contact Person	Christine J. ChunManager, Regulatory Affairs Program ManagementEdwards LifesciencesOne Edwards WayIrvine, CA 92614Tel: (949) 250 – 2500Fax: (949) 809 – 7303
Date Prepared	August 17, 2018
Trade Name	EV1000 Clinical Platform™ NI and the ClearSight™ FingerCuffs or ClearSight™ System
Common Name	Non-Invasive Blood Pressure Measurement System
ClassificationName	System, Measurement, Blood-Pressure, Non-Invasive(21 CFR 870.1130)Plethysmograph, Impedance(21 CFR 870.2770)Single-Function, Preprogrammed Diagnostic Computer(21 CFR 870.1435)
Regulation Class /Product Code	Class IIDXN, DSB, DXG
Primary PredicateDevice	K160552 – EV1000 Clinical Platform™ NI and the ClearSight™Finger Cuffs or ClearSight™ System (cleared June 1, 2016).
SecondaryPredicate(for Packagingonly)	K140312 – EV1000 Clinical Platform with ClearSight™t FingerCuff or ClearSight™ System (cleared June 13, 2014).
Device Description	The EV1000 Clinical Platform NI and the ClearSight™ FingerCuffs is a non-invasive system that continuously measures bloodpressure (Systolic, Diastolic, and Mean Arterial Pressure) andpulse rate. Cardiac Output and other hemodynamic parametersare derived from the blood pressure waveform.The EV1000 Clinical Platform NI and the ClearSight™ FingerCuffs consists of the EV1000 monitor (EV1000M), the EV1000Pump-Unit (Pump-Unit), a Pressure Controller (PC2) that is wornon the wrist, a Heart Reference Sensor (EVHRS or also referredto as HRS), and the ClearSight™ Finger Cuffs. EV1000M maybe attached to the patient bedside, an IV pole or roll stand.
	The subject of this 510(k) is a change of the tubing material andits establishment of shelf life for the EVHRS, a component of thesubject device, EV1000 Clinical Platform NI and the ClearSightFinger Cuff.
IndicationsforUse/Intended Use	The EV1000 Clinical Platform NI and the ClearSight™ FingerCuffs are indicated for patients over 18 years of age in which thebalance between cardiac function, fluid status, and vascularresistance needs continuous assessment. The EV1000 ClinicalPlatform may be used for the monitoring of hemodynamicparameters in conjunction with a perioperative goal directedtherapy protocol. In addition, the non-invasive system is indicatedfor use in patients with co- morbidities for which hemodynamicoptimization is desired and invasive measurements are difficult.The EV1000 Clinical Platform and the ClearSight™ Finger Cuffsnoninvasively measures blood pressure and associatedhemodynamic parameters.
ComparativeAnalysis	The Heart Reference Sensor (EVHRS or may be referred to asHRS), a component/accessory of the subject device, EV1000Clinical Platform NI and the ClearSight™ Finger Cuffs (alsoreferred to as the EV1000NI, EV1000 Clinical Platform Non-Invasive, or the ClearSight™ System cleared under K160552 onJune 01, 2016 and K140312 on June 13, 2014) has been modifiedby changing the inner tubing material from polyvinyl chloride(PVC) to an medical grade polyurethane plastic tubing material.No other changes have been made to the software, algorithm,hardware, and packaging or any other portion of the EV1000Clinical Platform NI and the ClearSight Finger Cuffs.
Functional/ SafetyTesting	The Heart Reference Sensor (EVHRS), accessory to the subjectdevice, EV1000 Clinical Platform NI and the ClearSight™ FingerCuff are identical to the predicate device in terms of intendeduse/indications for use, and technology. To ensure that thematerial change to the EVHRS did not raise any new concerns ofsafety and effectiveness, and is substantially equivalent to thepredicate device, biocompatibility was conducted in accordanceto ISO 10993-10 and functional testing was conducted to showperformance is not affected. The EVHRS has been shown to besubstantially equivalent to the predicate device for its intendeduse in hospitals and other appropriate clinical environments.The Heart Reference Sensor (EVHRS) accessory to the subjectdevice, EV1000 Clinical Platform NI and the ClearSight™ Fingercuffs have successfully passed functional and performancetesting, including mechanical, shelf life, biocompatibility, andbench studies, demonstrating that the subject device issubstantially equivalent to the predicate device.

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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).