EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM

K140312 · Edwards Lifesciences, LLC · DXN · Jun 13, 2014 · Cardiovascular

Device Facts

• Record ID: K140312
• Device Name: EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended 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.

Device Story

Non-invasive hemodynamic monitor; utilizes Peňáz-Wesseling method to derive blood pressure and hemodynamic parameters from finger cuff signals. System components: monitor (touchscreen PC), pump-unit, wrist-worn pressure controller, and ClearSight finger cuffs. Pump-unit receives signals from finger cuffs and pressure controller; embedded algorithms process signals to calculate systolic, diastolic, mean arterial pressure, pulse rate, and cardiac output. Used in hospitals/clinical environments by healthcare providers. Output displayed on monitor GUI; assists clinicians in hemodynamic optimization and fluid management for patients where invasive monitoring is challenging.

Clinical Evidence

Clinical study and side-by-side bench testing conducted to compare performance and functionality against predicate device (ccNexfin). Results demonstrated the device is safe, effective, and substantially equivalent for intended use in hospital and clinical environments.

Technological Characteristics

Non-invasive blood pressure measurement system; utilizes Peňáz-Wesseling method. Components: touchscreen monitor, pump-unit, wrist-worn pressure controller, finger cuffs. Connectivity: Ethernet (monitor to pump), RS485 (pump to controller). Software-based signal processing for hemodynamic parameter derivation.

Indications for Use

Indicated for patients >18 years requiring continuous assessment of cardiac function, fluid status, and vascular resistance; indicated for patients with co-morbidities where hemodynamic optimization is desired and invasive measurements are difficult.

Regulatory Classification

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.

Predicate Devices

• ccNexfin Model 2 (K122381)
• EV1000 Clinical Platform (K110597)

Submission Summary (Full Text)

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

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 or<br>ClearSight™ System |
| Common Name | Non-Invasive Blood Pressure Measurement System |
| Classification<br>Name | System, Measurement, Blood-Pressure, Non-Invasive<br>(21 CFR 870.1130, Product Code DXN<br>Plethysmograph, Impedance<br>(21 CFR 870.2770, Product Code DSB) |
| Regulation<br>Class/Product<br>Code | Class II<br>DXN, DSB |
| Predicate Device(s) | ccNexfin Model 2 K122381 (cleared April 22, 2103)<br>EV1000 Clinical Platform K110597 (cleared June 14, 2011) |
| Device Description | The EV1000 Clinical Platform with ClearSight Finger Cuffs is a non-<br>invasive monitor that enables the continuous assessment of a patient's<br>hemodynamic function based on the scientific method of Peňáz -<br>Wesseling. The device measures continuous non-invasive blood<br>pressure (Systolic, Diastolic, and Mean Arterial Pressure) and pulse rate.<br>Cardiac Output and other hemodynamic parameters are derived from<br>the blood pressure waveform.<br>The EV1000 ClearSight™ System consists of a monitor, a pump-unit, a<br>pressure controller that is worn on the wrist, and ClearSight Finger cuffs.<br>The EV1000 Pump-unit receives incoming signals from the pressure<br>controller and the finger cuffs. The algorithms embedded in the Pump-<br>Unit and the pressure controller process signals from the finger cuffs and<br>provide parameter calculations.<br>The EV1000 Monitor is connected to the Pump-Unit via an Ethernet<br>cable, and the Pump-unit is connected to the pressure controller via a<br>RS485 port. The monitor is a touchscreen panel PC with a graphical<br>user interface (GUI). The monitor displays the measured and calculated<br>parameters from the Pump-Unit. |
| | |
| Indications for<br>Use/Intended Use | The EV1000 Clinical Platform and the ClearSight™ Finger Cuffs are<br>indicated for patients over 18 years of age in which the balance between.<br>cardiac function, fluid status, and vascular resistance needs continuous<br>assessment. In addition, the non-invasive system is indicated for use in<br>patients with co-morbidities for which hemodynamic optimization is<br>desired and invasive measurements are difficult. The EV1000 Clinical<br>Platform and the ClearSight™ finger cuffs noninvasively measures blood<br>pressure and associated hemodynamic parameters. |
| Comparative<br>Analysis | Verification and Validation testing was conducted to compare the<br>performance and functionality of the EV1000 Clinical Platform with<br>ClearSight Finger Cuffs to the predicate device. The testing included<br>side-by-side bench testing and a clinical study. The EV1000 Clinical<br>Platform with ClearSight Finger Cuffs was shown to be safe, effective,<br>and substantially equivalent to the predicate device (ccNexfin) for its<br>intended use in hospitals and other appropriate clinical environments. |
| Functional/ Safety<br>Testing | The EV1000 Clinical Platform with ClearSight Finger cuffs has<br>successfully passed functional and performance testing, including<br>software verification and validation, mechanical and electrical testing,<br>and bench studies. In addition, a clinical study demonstrated that the<br>device is substantially equivalent to the cited predicate device |
| Conclusion | The EV1000 Clinical Platform with ClearSight Finger cuffs has been<br>shown to be safe, effective, and is substantially equivalent to the<br>predicate ccNexfin for its intended use in hospitals and other appropriate<br>clinical environments. |

Edwards Lifesciences, LLC

:

、

- -

(

ﺳﺮ

.

28

.

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

ﺗ

·

## Edwards Lifesciences, LLC

ノ

.

י

-

:

29

介

(

ﺗ

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

## 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

. ' '

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

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 [phone] or [phone] 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 [phone] or [phone] 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

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

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