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

K182245 · Edwards Lifesciences, LLC · DXN · Nov 30, 2018 · Cardiovascular

Device Facts

• Record ID: K182245
• Device Name: EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

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 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 Story

Non-invasive hemodynamic monitoring system; measures blood pressure (systolic, diastolic, mean arterial) and pulse rate; derives cardiac output and other hemodynamic parameters from blood pressure waveform. System components: EV1000 monitor, pump-unit, wrist-worn pressure controller, heart reference sensor (EVHRS), and finger cuffs. Used in hospital/clinical environments by healthcare professionals. Provides continuous hemodynamic data to assist in clinical decision-making for fluid management and hemodynamic optimization. Subject device modification involves changing internal tubing material of the heart reference sensor from PVC to medical-grade polyurethane and establishing shelf life.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included biocompatibility (ISO 10993-10), mechanical testing, and shelf-life studies to validate the material change in the Heart Reference Sensor.

Technological Characteristics

Non-invasive hemodynamic monitoring system. Components: EV1000 monitor, pump-unit, wrist-worn pressure controller, heart reference sensor, and finger cuffs. Tubing material: medical-grade polyurethane. Sterilization: not specified. Connectivity: bedside, IV pole, or roll stand mounting. Software/algorithm: unchanged from predicate.

Indications for Use

Indicated for patients >18 years requiring continuous assessment of cardiac function, fluid status, and vascular resistance; suitable for perioperative goal-directed therapy or patients with comorbidities where invasive hemodynamic monitoring is 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

• EV1000 Clinical Platform™ NI and the ClearSight™ Finger Cuffs or ClearSight™ System (K160552)
• EV1000 Clinical Platform with ClearSight™ Finger Cuff or ClearSight™ System (K140312)

Submission Summary (Full Text)

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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 ([e-mail]) 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)

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.

| 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<br>Manager, Regulatory Affairs Program Management<br>Edwards Lifesciences<br>One Edwards Way<br>Irvine, CA 92614<br>Tel: (949) 250 – 2500<br>Fax: (949) 809 – 7303 |
| Date Prepared | August 17, 2018 |
| Trade Name | EV1000 Clinical Platform™ NI and the ClearSight™ Finger<br>Cuffs or ClearSight™ System |
| Common Name | Non-Invasive Blood Pressure Measurement System |
| Classification<br>Name | System, Measurement, Blood-Pressure, Non-Invasive<br>(21 CFR 870.1130)<br>Plethysmograph, Impedance<br>(21 CFR 870.2770)<br>Single-Function, Preprogrammed Diagnostic Computer<br>(21 CFR 870.1435) |
| Regulation Class /<br>Product Code | Class II<br>DXN, DSB, DXG |
| Primary Predicate<br>Device | K160552 – EV1000 Clinical Platform™ NI and the ClearSight™<br>Finger Cuffs or ClearSight™ System (cleared June 1, 2016). |
| Secondary<br>Predicate<br>(for Packaging<br>only) | K140312 – EV1000 Clinical Platform with ClearSight™t Finger<br>Cuff or ClearSight™ System (cleared June 13, 2014). |
| Device Description | The EV1000 Clinical Platform NI and the ClearSight™ Finger<br>Cuffs is a non-invasive system that continuously measures blood<br>pressure (Systolic, Diastolic, and Mean Arterial Pressure) and<br>pulse rate. Cardiac Output and other hemodynamic parameters<br>are derived from the blood pressure waveform.<br>The EV1000 Clinical Platform NI and the ClearSight™ Finger<br>Cuffs consists of the EV1000 monitor (EV1000M), the EV1000<br>Pump-Unit (Pump-Unit), a Pressure Controller (PC2) that is worn<br>on the wrist, a Heart Reference Sensor (EVHRS or also referred<br>to as HRS), and the ClearSight™ Finger Cuffs. EV1000M may<br>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<br>its establishment of shelf life for the EVHRS, a component of the<br>subject device, EV1000 Clinical Platform NI and the ClearSight<br>Finger Cuff. |
| Indications<br>for<br>Use/Intended Use | The EV1000 Clinical Platform NI and the ClearSight™ Finger<br>Cuffs are indicated for patients over 18 years of age in which the<br>balance between cardiac function, fluid status, and vascular<br>resistance needs continuous assessment. The EV1000 Clinical<br>Platform may be used for the monitoring of hemodynamic<br>parameters in conjunction with a perioperative goal directed<br>therapy protocol. In addition, the non-invasive system is indicated<br>for use in patients with co- morbidities for which hemodynamic<br>optimization is desired and invasive measurements are difficult.<br>The EV1000 Clinical Platform and the ClearSight™ Finger Cuffs<br>noninvasively measures blood pressure and associated<br>hemodynamic parameters. |
| Comparative<br>Analysis | The Heart Reference Sensor (EVHRS or may be referred to as<br>HRS), a component/accessory of the subject device, EV1000<br>Clinical Platform NI and the ClearSight™ Finger Cuffs (also<br>referred to as the EV1000NI, EV1000 Clinical Platform Non-<br>Invasive, or the ClearSight™ System cleared under K160552 on<br>June 01, 2016 and K140312 on June 13, 2014) has been modified<br>by changing the inner tubing material from polyvinyl chloride<br>(PVC) to an medical grade polyurethane plastic tubing material.<br>No other changes have been made to the software, algorithm,<br>hardware, and packaging or any other portion of the EV1000<br>Clinical Platform NI and the ClearSight Finger Cuffs. |
| Functional/ Safety<br>Testing | The Heart Reference Sensor (EVHRS), accessory to the subject<br>device, EV1000 Clinical Platform NI and the ClearSight™ Finger<br>Cuff are identical to the predicate device in terms of intended<br>use/indications for use, and technology. To ensure that the<br>material change to the EVHRS did not raise any new concerns of<br>safety and effectiveness, and is substantially equivalent to the<br>predicate device, biocompatibility was conducted in accordance<br>to ISO 10993-10 and functional testing was conducted to show<br>performance is not affected. The EVHRS has been shown to be<br>substantially equivalent to the predicate device for its intended<br>use in hospitals and other appropriate clinical environments.<br>The Heart Reference Sensor (EVHRS) accessory to the subject<br>device, EV1000 Clinical Platform NI and the ClearSight™ Finger<br>cuffs have successfully passed functional and performance<br>testing, including mechanical, shelf life, biocompatibility, and<br>bench studies, demonstrating that the subject device is<br>substantially equivalent to the predicate device. |

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