The EV1000 Clinical Platform 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. 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 ClearSight™ finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

Device Description

The EV1000 Clinical Platform 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 Peňáz - 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 ClearSight™ System consists of a monitor, a pump-unit, a pressure controller that is worn on the wrist, and ClearSight Finger cuffs. The EV1000 Pump-unit receives incoming signals from the pressure controller and the finger cuffs. The algorithms embedded in the Pump- Unit and the pressure controller process signals from the finger cuffs and provide parameter calculations. The EV1000 Monitor is connected to the Pump-Unit via an Ethernet cable, and the Pump-unit is connected to the pressure controller via a RS485 port. The monitor is a touchscreen panel PC with a graphical user interface (GUI). The monitor displays the measured and calculated parameters from the Pump-Unit.

AI/ML Overview

The provided text describes the EV1000 Clinical Platform with ClearSight™ Finger Cuffs, a non-invasive blood pressure measurement system. The submission focuses on demonstrating substantial equivalence to a predicate device through verification and validation testing, including a clinical study.

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

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

The document does not explicitly state numerical acceptance criteria in a dedicated table format. Instead, it describes meeting acceptance criteria through a comparison to a predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance
Safety	Shown to be safe
Effectiveness	Shown to be effective
Substantial Equivalence	Shown to be substantially equivalent to the predicate device (ccNexfin) for its intended use
Performance and Functionality	Demonstrated to be comparable to the predicate device through side-by-side bench testing and a clinical study
Functional/Performance Testing	Successfully passed (including software verification & validation, mechanical & electrical testing, bench studies)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "a clinical study" was conducted. However, it does not specify the sample size used for this clinical study (test set). It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications. Given that the device measures physiological parameters (blood pressure), ground truth would likely be established through a reference measurement method, rather than expert interpretation of images/data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method for the test set.

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

The document describes a comparative effectiveness study, but it is not an MRMC study comparing human readers with and without AI assistance. This device is a non-invasive blood pressure monitor, not an AI-assisted diagnostic tool for human readers. The comparative effectiveness study focuses on the device's performance against a predicate device. Therefore, there is no mention of an effect size related to human reader improvement with AI.

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

The device itself is a standalone non-invasive blood pressure monitor that measures and calculates parameters. The "clinical study" would inherently assess the performance of this device in a standalone manner against a reference method or predicate device. The document states "a clinical study demonstrated that the device is substantially equivalent to the cited predicate device." This implies standalone performance was assessed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

While not explicitly stated, for a non-invasive blood pressure monitor, the "ground truth" in a clinical study would typically be established by simultaneous measurements from a reference invasive blood pressure monitoring system (e.g., arterial line) or another highly accurate, validated non-invasive method. The document does not specify the exact method used for ground truth.

8. The sample size for the training set

This document describes a medical device seeking 510(k) clearance, not an AI/Machine Learning model that undergoes explicit "training." Therefore, there is no concept of a training set sample size as it would apply to AI. The device's algorithms are embedded and validated through testing, not iterative training on a large dataset in the AI sense.

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

As described in point 8, there isn't a "training set" in the context of an AI model for this device. The device's underlying scientific method (Peňáz - Wesseling) and embedded algorithms are based on established physiological principles and likely validated through extensive engineering and clinical testing, not ground truth labeling for a training set.

Summary

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Traditional 510(k) – EV1000 Clinical Platform and ClearSight™ Finger Cuffs

Image /page/0/Picture/1 description: The image shows a date and a tracking number. The date is "JUN 13 2014". The tracking number is "K140312". The text is black and the background is white.

SECTION 5 -- 510(k) SUMMARY

EV1000™ Clinical Platform with ClearSight™ Finger Cuffs 510(k)
510(k) Submitter	Edwards Lifesciences, LLC
Contact Person	Renate A. MacLaren, Ph.D.
Date Prepared	February 6, 2014
Trade Name	EV1000 Clinical Platform™ with ClearSight™ Finger Cuffs orClearSight™ System
Common Name	Non-Invasive Blood Pressure Measurement System
ClassificationName	System, Measurement, Blood-Pressure, Non-Invasive(21 CFR 870.1130, Product Code DXNPlethysmograph, Impedance(21 CFR 870.2770, Product Code DSB)
RegulationClass/ProductCode	Class IIDXN, DSB
Predicate Device(s)	ccNexfin Model 2 K122381 (cleared April 22, 2103)EV1000 Clinical Platform K110597 (cleared June 14, 2011)
Device Description	The EV1000 Clinical Platform 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 Peňáz -Wesseling. The device measures continuous non-invasive bloodpressure (Systolic, Diastolic, and Mean Arterial Pressure) and pulse rate.Cardiac Output and other hemodynamic parameters are derived fromthe blood pressure waveform.The EV1000 ClearSight™ System consists of a monitor, a pump-unit, apressure controller that is worn on the wrist, and ClearSight Finger cuffs.The EV1000 Pump-unit receives incoming signals from the pressurecontroller and the finger cuffs. The algorithms embedded in the Pump-Unit and the pressure controller process signals from the finger cuffs andprovide parameter calculations.The EV1000 Monitor is connected to the Pump-Unit via an Ethernetcable, and the Pump-unit is connected to the pressure controller via aRS485 port. The monitor is a touchscreen panel PC with a graphicaluser interface (GUI). The monitor displays the measured and calculatedparameters from the Pump-Unit.

Indications forUse/Intended Use	The EV1000 Clinical Platform and the ClearSight™ Finger Cuffs areindicated for patients over 18 years of age in which the balance between.cardiac function, fluid status, and vascular resistance needs continuousassessment. In addition, the non-invasive system is indicated for use inpatients with co-morbidities for which hemodynamic optimization isdesired and invasive measurements are difficult. The EV1000 ClinicalPlatform and the ClearSight™ finger cuffs noninvasively measures bloodpressure and associated hemodynamic parameters.
ComparativeAnalysis	Verification and Validation testing was conducted to compare theperformance and functionality of the EV1000 Clinical Platform withClearSight Finger Cuffs to the predicate device. The testing includedside-by-side bench testing and a clinical study. The EV1000 ClinicalPlatform with ClearSight Finger Cuffs was shown to be safe, effective,and substantially equivalent to the predicate device (ccNexfin) for itsintended use in hospitals and other appropriate clinical environments.
Functional/ SafetyTesting	The EV1000 Clinical Platform with ClearSight Finger cuffs hassuccessfully passed functional and performance testing, includingsoftware verification and validation, mechanical and electrical testing,and bench studies. In addition, a clinical study demonstrated that thedevice is substantially equivalent to the cited predicate device
Conclusion	The EV1000 Clinical Platform with ClearSight Finger cuffs has beenshown to be safe, effective, and is substantially equivalent to thepredicate ccNexfin for its intended use in hospitals and other appropriateclinical environments.

Edwards Lifesciences, LLC

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 13, 2014

Edwards Lifesciences, LLC Renate Maclaren, Ph.D. Senior Manager, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K140312

Trade/Device Name: EV1000 Clinical Platform with Clearsight finger cuff or Clearsight system Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Monitoring Device Regulatory Class: Class II Product Code: DXN, DSB Dated: May 9, 2014 Received: May 12, 2014

Dear Dr. Maclaren,

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

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Page 2 - Renate Maclaren, Ph.D.

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Arthur Stein

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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Traditional 510(k) ~ EV1000 Clinical Platform and ClearSight™ Finger Cuffs

INDICATIONS FOR USE STATEMENT

Indications for Use

K140312 510(k) Number (if known):

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

Indications For Use:

The EV1000 Clinical Platform 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. 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 ClearSight™ finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Date:
2014.06.13
09:38:02 -04'00'

Edwards Lifesciences, LLC

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).