EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform

K160552 · Edwards Lifesciences, LLC · DXN · Jun 1, 2016 · Cardiovascular

Device Facts

• Record ID: K160552
• Device Name: EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

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 for use in patients with co- morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform and the ClearSightTM finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters. The EV1000 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.

Device Story

EV1000 Clinical Platform NI uses ClearSight finger cuffs to measure blood pressure and hemodynamic parameters non-invasively via Peñàz-Wesseling method; system includes monitor, pump-unit, wrist-worn pressure controller, and heart reference sensor. Device processes blood pressure waveforms to derive cardiac output and other hemodynamic metrics; provides clinician tools to trend parameters against goal-directed therapy protocols. Used in critical care and perioperative settings; operated by clinicians to guide fluid and hemodynamic management. Benefits include continuous, non-invasive monitoring for patients where invasive access is challenging or contraindicated.

Clinical Evidence

Evaluation of archived clinical data demonstrated substantial equivalence to predicate devices. Bench testing included side-by-side performance and functionality comparisons, mechanical and electrical testing, and software verification and validation.

Technological Characteristics

Non-invasive hemodynamic monitor using Peñàz-Wesseling method. Components: EV1000 monitor, pump-unit, wrist-worn pressure controller, heart reference sensor, ClearSight finger cuffs. Connectivity: Ethernet. Software-based analysis of blood pressure waveforms. Class II device.

Indications for Use

Indicated for patients >18 years requiring continuous assessment of cardiac function, fluid status, and vascular resistance; includes patients with co-morbidities where invasive measurements are difficult. Used for hemodynamic monitoring in perioperative goal-directed therapy. Oximetry monitoring indicated for adults and pediatrics when connected to Edwards oximetry catheter.

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

• EV1000 Clinical Platform (K131892)
• EV1000 Clinical Platform NI with ClearSight Finger Cuffs or ClearSight System (K140312)

Submission Summary (Full Text)

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

June 1, 2016

Edwards Lifesciences, LLC Tara Viviani Principle Project Manager, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K160552

Trade/Device Name: EV1000 Clinical Platform Non-Invasive (NI) and ClearSight Finger Cuffs or ClearSight System, EV1000 Clinical Platform Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer Regulatory Class: Class II Product Code: DXG, DSB, DXN Dated: May 25, 2016 Received: May 26, 2016

Dear Tara Viviani:

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 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

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

# Sincerely yours, Shawn W. Forrest -S 2016.06.01 17:45:37 -04'00'

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) K160552

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

Indications for Use (Describe)

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 for use in patients with co- morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform and the ClearSightTM finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

The EV1000 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.

Type of Use (Select one or both, as applicable)

| <span></span> | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|--------------------------------------------------------------------------------------|
| <span></span> | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## SECTION 5 – 510(k) SUMMARY

| EV1000™ Clinical Platform(s) 510(k) | | |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter | Edwards Lifesciences, LLC | |
| Contact Person | Tara M. Viviani, RAC<br>One Edwards Way<br>M/S JAM B3<br>Irvine, CA 92614<br>tara [e-mail]<br>[phone] | |
| Date Prepared | February 26, 2016 | |
| Trade Name | EV1000 Clinical Platform™ | EV1000 Clinical Platform™ NI with<br>ClearSight™ Finger Cuffs or<br>ClearSight™ System |
| Common Name | Cardiac Output / Oximetry Monitor | Non-Invasive Blood Pressure<br>Measurement System |
| Classification<br>Name | Single-Function,<br>Preprogrammed Diagnostic<br>Computer<br>(21 CFR 870.1435) | Single-Function, Preprogrammed<br>Diagnostic Computer<br>(21 CFR 870.1435)<br>System, Measurement, Blood-<br>Pressure, Non-Invasive<br>(21 CFR 870.1130)<br>Plethysmograph, Impedance<br>(21 CFR 870.2770) |
| Regulation Class /<br>Product Code | Class II<br>DXG | Class II<br>DXG, DXN, DSB |
| Predicate Device(s) | K131892 – EV1000 Clinical<br>Platform (cleared 05/22/2014) | K140312 – EV1000 Clinical<br>Platform™ NI with ClearSight™<br>Finger Cuffs or ClearSight™ System<br>(cleared 06/13/2014) |
| Device Description | The EV1000 Clinical Platform measures patient physiologic parameters<br>in a minimally invasive manner when it is used as a system with various<br>Edwards' components, including the Edwards pressure transducers, the<br>FloTrac sensor, the components of the VolumeView System, oximetry<br>catheters/sensors, and the corresponding accessories applied to the<br>patient.<br>The EV1000 Clinical Platform consists of the EV1000 Monitor (Monitor),<br>the EV1000 Databox (Databox), and an Ethernet cable to connect the<br>Databox to the Monitor. It may be attached to the patient bedside, an IV<br>pole or roll stand.<br>The EV1000 Clinical Platform NI 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 Peñàz -<br>Wesseling. The device measures continuous non-invasive blood | |
| | 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. | |
| | The EV1000 NI consists of the EV1000 monitor (EV1000M), the EV1000<br>Pump-Unit (Pump-Unit), a Pressure Controller (PC2) that is worn on the<br>wrist, a Heart Reference Sensor (HRS), and the ClearSight™ Finger<br>Cuffs. It may be attached to the patient bedside, an IV pole or roll stand. | |
| Indications for<br>Use/Intended Use | The EV1000 Clinical Platform is indicated for use primarily for critical<br>care patients in which the balance between cardiac function, fluid status<br>and vascular resistance needs continuous or intermittent assessment.<br>The EV1000 Clinical Platform may be used for the monitoring of<br>hemodynamic parameters in conjunction with a perioperative goal<br>directed therapy protocol. Analysis of the thermodilution curve in terms<br>of mean transit time and the shape is used to determine intravascular<br>and extravascular fluid volumes. When connected to an Edwards<br>oximetry catheter, the monitor measures oximetry in adults and<br>pediatrics. The EV1000 Clinical Platform may be used in all settings in<br>which critical care is provided. | |
| | The EV1000 Clinical Platform NI 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. The EV1000 Clinical Platform may be used for the<br>monitoring of hemodynamic parameters in conjunction with a<br>perioperative goal directed therapy protocol. In addition, the non-<br>invasive system is indicated for use in patients with co-morbidities for<br>which hemodynamic optimization is desired and invasive measurements<br>are difficult. The EV1000 Clinical Platform and the ClearSight™ finger<br>cuffs noninvasively measures blood pressure and associated<br>hemodynamic parameters. | |
| Comparative<br>Analysis | Verification and Validation testing was conducted to compare the<br>performance and functionality of the EV1000 Clinical Platform and the<br>EV1000 Clinical Platform with ClearSight Finger Cuffs to the predicate<br>device. The testing included side-by-side bench testing and a clinical<br>study. The EV1000 Clinical Platform(s) were shown to be safe,<br>effective, and substantially equivalent to the predicate device for its<br>intended use in hospitals and other appropriate clinical environments. | |
| | The EV1000 Clinical Platform(s) use the same technology as the<br>predicate devices with the added feature of providing a tool for the<br>clinician to trend monitored parameters and compare them for<br>compliance to a Goal Directed Therapy protocol. The trending features<br>are Goal Directed Therapy protocol agnostic and may be used with<br>reported parameters commonly used in Goal Directed Therapy. | |
| Functional/ Safety<br>Testing | The EV1000 Clinical Platform and the EV1000 Clinical Platform NI with<br>ClearSight Finger cuffs have successfully passed functional and<br>performance testing, including software verification and validation, | |
| | mechanical and electrical testing, and bench studies. In addition, an<br>evaluation of archived clinical data demonstrated that the device is<br>substantially equivalent to the cited predicate device | |
| Conclusion | The EV1000 Clinical Platform and the EV1000 Clinical Platform NI with<br>ClearSight Finger cuffs have been shown to be safe, effective, and are<br>substantially equivalent to the predicate devices for their intended use in<br>hospitals and other appropriate clinical environments. | |

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