EV1000 Clinical Platform

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December 17, 2019 Edwards Lifesciences, LLC Jamie Byun Manager, Regulatory Affairs One Edwards Way Irvine, California 92614 Re: K193179 Trade/Device Name: EV1000 Clinical Platform Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DXG Dated: November 15, 2019 Received: November 18, 2019 Dear Jamie Byun: 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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Sincerely, Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K193179 Device Name EV1000 Clinical Platform ## Indications for Use (Describe) 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 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. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><span style="font-size:1.2em;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | | <div style="display:flex; align-items:center;"><span style="font-size:1.2em;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "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 | Jamie Byun | | | | Date Prepared | November 15, 2019 | | | | Trade Name | EV1000 Clinical Platform™ | | | | Common Name | Cardiac Output / Oximetry Monitor | | | | Classification Name | Single-Function, Preprogrammed Diagnostic Computer<br>(21 CFR 870.1435) | | | | Regulation Class /<br>Product Code | Class II<br>DXG | | | | Primary Predicate<br>Device(s) | K160552 - EV1000 Clinical Platform™ (cleared 06/01/2016) | | | | Reference Device(s) | K192058 – EV1000 Clinical Platforms: Special 510(k) Corrective Action<br>Being Effected | | | | Device Description | EV1000 Clinical Platform (EV1000A)<br>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>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,<br>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.<br>A design hardware change for the AC inlet related to a corrective action<br>was made. The additional hardware for the EV1000A power adaptor | | | {4}------------------------------------------------ | | prevent liquid ingress or other conductive contaminates from entering the<br>AC inlet. | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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. 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. | | | 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. | | Comparative<br>Analysis | EV1000 Clinical Platform (EV1000A) has been modified by adding a<br>Power Adapter Enclosure to the power adaptor in order to prevent liquid<br>ingress. Design verification testing for the EV1000A power adaptor with<br>the Power Adapter Enclosure was performed and a reduction in<br>occurrences of liquid ingress at the AC inlet was achieved. | | Functional/ Safety<br>Testing | The EV1000 Clinical Platform (EV1000A) has successfully passed<br>functional and bench studies to demonstrate that the device is substantially<br>equivalent to the cited predicate device and the Power Adapter Cover<br>reduces the possibility of fluid ingress. | | Conclusion | The EV1000 Clinical Platform (EV1000A) has been shown to be safe and<br>is substantially equivalent to the predicate device for its intended use in<br>hospitals and other appropriate clinical environments. |