EV1000 Clinical Platform NI, EV1000 Clinical Platform

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August 30, 2019 Edwards Lifesciences, LLC Christine Chun Manager, Regulatory Affairs One Edwards Way Irvine, California 92614 Re: K192058 Trade/Device Name: EV1000 Clinical Platforms Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DSB, QAQ Dated: July 31, 2019 Received: August 1, 2019 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. 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You must comply with all the Act's {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K192058 Device Name EV1000 Clinical Platforms ## Indications for Use (Describe) EV1000 Clinical Platform (EV1000A): The EV 1000 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. The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen is intended for use in surgical or nonsurgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter. ## EV1000 Clinical Platform NI (EV1000NI): The EV 1000 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 EV 1000 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. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------|-------------------------------------------------------------------------| | <div> <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Department of Health and Hun Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | SECTION 5 - 510(K) SUMMARY | |----------------------------| |----------------------------| | EV1000™ Clinical Platform(s) Special 510(k) Corrective Action Being Effected | | | |------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | 510(k) Submitter | Edwards Lifesciences, LLC | | | Contact Person | Christine Chun, MBA | | | Date Prepared | July 31, 2019 | | | Trade Name | EV1000 Clinical Platform™ NI<br>with ClearSight™ Finger Cuffs<br>or ClearSight System | EV1000 Clinical Platform™ | | Common Name | Non-Invasive Blood<br>Pressure<br>Measurement System | Cardiac Output / Oximetry Monitor | | Classification Name | Single-Function, Preprogrammed<br>Diagnostic Computer (21 CFR<br>870.1435)<br>System, Measurement, Blood-<br>Pressure, Non-Invasive<br>(21 CFR 870.1130) | Single-Function,<br>Preprogrammed<br>Diagnostic Computer<br>(21 CFR 870.1435) | | Regulation Class /<br>Product Code | Class II<br>DXG, DXN | Class II<br>DXG | | Primary Predicate<br>Device(s) | K160552 - EV1000 Clinical<br>Platform™ NI with ClearSight™<br>Finger Cuffs or ClearSight<br>System (cleared 06/01/2016) | K160552 — EV1000 Clinical<br>Platform™ (cleared 06/01/2016) | | Secondary<br>Device(s) | Not applicable | K183646 - Acumen Hypotension<br>Prediction Index - EV1000 Clinical<br>Platform (Cleared 05/21/2019) | | EV1000 Clinical Platform (EV1000A) | | | | Device Description | The EV1000 Clinical Platform measures patient physiologic parameters in<br>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 patient.<br><br>The EV1000 Clinical Platform includes an Acumen Hypotension<br>Prediction Index (HPI) feature, which is an index related to the likelihood<br>of a patient experiencing a hypotensive event (defined as mean arterial<br>pressure (MAP) < 65 mmHg for one minute in duration) within 15<br>minutes, where zero (0) indicates low likelihood and one hundred (100)<br>indicates high likelihood. The Acumen Hypotension Prediction Index | | {4}------------------------------------------------ | HPI, should not be used exclusively to treat patients. A review of the<br>patient's hemodynamics is recommended prior to initiating treatment.<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. | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Labeling changes (flag label and operator's manual) to reduce fluid<br>exposure and correct power adapter orientation was implemented in the<br>field. The operator's manual will also be updated to include the same<br>information to further caution users of the importance of proper power<br>adaptor orientation. | | <b>EV1000 Clinical Platform NI (EV1000NI)</b> | | The EV1000 Clinical Platform NI is a non-invasive monitor that enables<br>the continuous assessment of a patient's hemodynamic function based on<br>the scientific method of Peňàz – Wesseling. The device measures<br>continuous non-invasive blood pressure (Systolic, Diastolic, and Mean<br>Arterial Pressure) and pulse rate. Cardiac Output and other hemodynamic<br>parameters are derived from the blood pressure waveform. | | The EV1000 NI consists of the EV1000 monitor (EV1000M), the EV1000<br>Pump-Unit (Pump-Unit), a Pressure Controller (PC2 or PC2K) that is worn<br>on the wrist, a Heart Reference Sensor (HRS), and the ClearSightTM Finger<br>Cuffs. It may be attached to the patient bedside, an IV pole or roll stand. | | A design hardware change for the power cord connection of the Pump-<br>Unit and labeling updates related to a corrective action was made. The<br>additional hardware for the EV1000NI Pump Unit consists of a power cord<br>entry cover (ingress protector) that is used to reduce liquid ingress or other<br>conductive contaminates from entering the AC inlet. | {5}------------------------------------------------ | | EV1000 Clinical Platform (EV1000A) | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 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. The<br>EV1000 Clinical Platform may be used for the monitoring of<br>hemodynamic parameters in conjunction with a perioperative goal directed<br>therapy protocol. Analysis of the thermodilution curve in terms of mean<br>transit time and the shape is used to determine intravascular and<br>extravascular fluid volumes. When connected to an Edwards oximetry<br>catheter, the monitor measures oximetry in adults and pediatrics. The<br>EV1000 Clinical Platform may be used in all settings in which critical care<br>is provided. | | Indications for<br>Use/Intended Use | The Edwards Lifesciences Acumen Hypotension Prediction Index feature<br>provides the clinician with physiological insight into a patient's likelihood<br>of future hypotensive events (defined as mean arterial pressure < 65 mmHg<br>for at least one minute in duration) and the associated hemodynamics. The<br>Acumen HPI feature is intended for use in surgical or nonsurgical patients<br>receiving advanced hemodynamic monitoring. The Acumen HPI feature is<br>considered to be additional quantitative information regarding the patient's<br>physiological condition for reference only and no therapeutic decisions<br>should be made based solely on the Hypotension Prediction Index (HPI)<br>parameter. | | | EV1000 Clinical Platform NI (EV1000NI) | | | | | | The EV1000 Clinical Platform NI and the ClearSightTM 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 monitoring<br>of hemodynamic parameters in conjunction with a perioperative goal<br>directed 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. The<br>EV 1000 Clinical Platform and the ClearSightTM finger cuffs noninvasively<br>measures blood pressure and associated hemodynamic parameters. | | | EV1000 Clinical Platform (EV1000A) is identical to the predicate device<br>with the exception of the labeling to indicate the correct positioning of the | | Comparative<br>Analysis | power adaptor cord in necessary in order to reduce fluid exposure. | | | The EV1000 Clinical Platform NI (EV1000NI) has been modified by<br>adding a power cord entry cover to the Pump Unit AC inlet in order to<br>reduce liquid ingress. Design Verification testing for the EV1000NI Pump<br>Unit was performed, and a reduction in occurrences of liquid ingress at the | | | Pump Unit AC inlet was achieved. In addition, labeling changes have been<br>made as the result of the change and for corrective action | | Functional/<br>Safety<br>Testing | The EV1000 Clinical Platform (EV1000A) is identical in design to the<br>predicate device. No design changes were made and the only change was<br>the addition of a flag label to the power adaptor indicating the proper<br>orientation. | | | The EV1000 Clinical Platform NI (EV1000NI) has successfully passed<br>functional and bench studies to demonstrate that the device is substantially<br>equivalent to the cited predicate device and the boot and bracket reduces<br>the possibility of fluid ingress. | | Conclusion | The EV1000 Clinical Platform and the EV1000 Clinical Platform NI with<br>ClearSight Finger cuffs have been shown to be safe and are substantially<br>equivalent to the predicate devices for their intended use in hospitals and<br>other appropriate clinical environments. | {6}------------------------------------------------