K Number

Device Name

EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System

Manufacturer

Edwards Lifesciences, LLC

Date Cleared

2018-11-30

(102 days)

Product Code

DXN DSB DXG

Regulation Number

870.1130

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K160552, K140312

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device that measures and derives hemodynamic parameters from blood pressure waveforms. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the physical components and the derivation of parameters from measured data, not on learning or adaptive algorithms.

Therapeutic

No
The device is used for continuous assessment and monitoring of hemodynamic parameters, which is for diagnostic and monitoring purposes, not for direct treatment or therapy.

Diagnostic

Yes

The device is indicated for continuous assessment of cardiac function, fluid status, and vascular resistance, and for monitoring hemodynamic parameters, which are activities directly related to diagnosing a patient's physiological state.

SaMD (Software as a Medical Device)

The device description explicitly lists multiple hardware components: the EV1000 monitor, EV1000 Pump-Unit, Pressure Controller, Heart Reference Sensor, and ClearSight™ Finger Cuffs. The 510(k) is specifically for a change in tubing material for one of these hardware components (EVHRS).

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use describes the device as monitoring hemodynamic parameters and blood pressure in patients. This involves measuring physiological signals directly from the patient's body.
Device Description: The device description details components like finger cuffs, a heart reference sensor, and a pump unit, all of which are used to interact with the patient's body to obtain measurements.
Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside of the body) to provide diagnostic information.

IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to monitor physiological parameters in vivo (within the body).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DXN, DSB, DXG

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

over 18 years of age

Intended User / Care Setting

hospitals and other appropriate clinical environments.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Functional/ Safety Testing: The Heart Reference Sensor (EVHRS), accessory to the subject device, EV1000 Clinical Platform NI and the ClearSight™ Finger Cuff are identical to the predicate device in terms of intended use/indications for use, and technology. To ensure that the material change to the EVHRS did not raise any new concerns of safety and effectiveness, and is substantially equivalent to the predicate device, biocompatibility was conducted in accordance to ISO 10993-10 and 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K160552, K140312

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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

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

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. Chun
Manager, Regulatory Affairs Program Management
Edwards Lifesciences
One Edwards Way
Irvine, CA 92614
Tel: (949) 250 – 2500
Fax: (949) 809 – 7303
Date Prepared	August 17, 2018
Trade Name	EV1000 Clinical Platform™ NI and the ClearSight™ Finger
Cuffs or ClearSight™ System
Common Name	Non-Invasive Blood Pressure Measurement System
Classification
Name	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 II
DXN, DSB, DXG
Primary Predicate
Device	K160552 – EV1000 Clinical Platform™ NI and the ClearSight™
Finger Cuffs or ClearSight™ System (cleared June 1, 2016).
Secondary
Predicate
(for Packaging
only)	K140312 – EV1000 Clinical Platform with ClearSight™t Finger
Cuff or ClearSight™ System (cleared June 13, 2014).
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.
Indications
for
Use/Intended Use	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 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.
Comparative
Analysis	The Heart Reference Sensor (EVHRS or may be referred to as
HRS), a component/accessory of the subject device, EV1000
Clinical Platform NI and the ClearSight™ Finger Cuffs (also
referred to as the EV1000NI, EV1000 Clinical Platform Non-
Invasive, or the ClearSight™ System cleared under K160552 on
June 01, 2016 and K140312 on June 13, 2014) has been modified
by 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 EV1000
Clinical Platform NI and the ClearSight Finger Cuffs.
Functional/ Safety
Testing	The Heart Reference Sensor (EVHRS), accessory to the subject
device, EV1000 Clinical Platform NI and the ClearSight™ Finger
Cuff are identical to the predicate device in terms of intended
use/indications for use, and technology. To ensure that the
material change to the EVHRS did not raise any new concerns of
safety and effectiveness, and is substantially equivalent to the
predicate device, biocompatibility was conducted in accordance
to ISO 10993-10 and 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.