Who is the manufacturer of EV1000 Clinical Platform NI, EV1000 Clinical Platform?

Edwards Lifesciences, LLC filed the 510(k) submission for EV1000 Clinical Platform NI, EV1000 Clinical Platform (K192058).

What is the FDA product code for EV1000 Clinical Platform NI, EV1000 Clinical Platform?

DXN. It is classified under 21 CFR 870.1130 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for EV1000 Clinical Platform NI, EV1000 Clinical Platform?

510(k) clearance (submission type: Special).

Does EV1000 Clinical Platform NI, EV1000 Clinical Platform use AI or machine learning?

Yes. EV1000 Clinical Platform NI, EV1000 Clinical Platform (K192058) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for EV1000 Clinical Platform NI, EV1000 Clinical Platform?

EV1000 Clinical Platform NI with ClearSight Finger Cuffs or ClearSight System (K160552); EV1000 Clinical Platform (K160552); Acumen Hypotension Prediction Index - EV1000 Clinical Platform (K183646).

Who can help prepare an FDA 510(k) submission like EV1000 Clinical Platform NI, EV1000 Clinical Platform?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like EV1000 Clinical Platform NI, EV1000 Clinical Platform get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

EV1000 Clinical Platform NI, EV1000 Clinical Platform

K192058 · Edwards Lifesciences, LLC · DXN · Aug 30, 2019 · Cardiovascular

Device Facts

Record ID	K192058
Device Name	EV1000 Clinical Platform NI, EV1000 Clinical Platform
Applicant	Edwards Lifesciences, LLC
Product Code	DXN · Cardiovascular
Decision Date	Aug 30, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1130
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

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 EV 1000 Clinical Platform and the ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

Device Story

EV1000 Clinical Platform monitors hemodynamic parameters in critical care settings. EV1000A uses invasive sensors (pressure transducers, FloTrac, VolumeView, oximetry catheters) to measure cardiac output, fluid volumes, and oximetry. EV1000NI uses non-invasive ClearSight finger cuffs and Peňàz-Wesseling method to derive blood pressure and hemodynamic parameters. Both systems include Acumen Hypotension Prediction Index (HPI), which analyzes hemodynamic data to predict likelihood of future hypotensive events (MAP < 65 mmHg) within 15 minutes. Output displayed on monitor for clinician review; provides physiological insight to support hemodynamic management. Device modifications include hardware ingress protection (power cord entry cover) and labeling updates to improve power adapter orientation and reduce fluid exposure risks.

Clinical Evidence

Bench testing only. No clinical data presented. Testing focused on design verification of hardware modifications (ingress protection) and labeling validation.

Technological Characteristics

System components: Monitor, Databox, Pump-Unit, Pressure Controller, Heart Reference Sensor, ClearSight Finger Cuffs. Sensing: Invasive pressure transducers/catheters (EV1000A) and non-invasive Peňàz-Wesseling method (EV1000NI). Connectivity: Ethernet. Hardware modifications: Power cord entry cover for liquid ingress reduction.

Indications for Use

Indicated for critical care patients (EV1000A) or adults >18 years (EV1000NI) requiring hemodynamic assessment, including cardiac function, fluid status, and vascular resistance. Used in surgical/nonsurgical settings for goal-directed therapy or when invasive 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 with ClearSight Finger Cuffs or ClearSight System (K160552)
EV1000 Clinical Platform (K160552)
Acumen Hypotension Prediction Index - EV1000 Clinical Platform (K183646)

Related Devices

K203131 — EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform · Edwards Lifesciences, LLC · Jan 22, 2021
K193179 — EV1000 Clinical Platform · Edwards Lifesciences, LLC · Dec 17, 2019
K160552 — EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform · Edwards Lifesciences, LLC · Jun 1, 2016
K221833 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module · Edwards Lifesciences, LLC · Nov 7, 2022
K231248 — Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform · Edwards Lifesciencess, LLC · Sep 21, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. 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. 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 {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> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </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 with ClearSight™ Finger Cuffs or ClearSight System | EV1000 Clinical Platform™ | | Common Name | Non-Invasive Blood Pressure Measurement System | Cardiac Output / Oximetry Monitor | | Classification Name | Single-Function, Preprogrammed Diagnostic Computer (21 CFR 870.1435) System, Measurement, Blood- Pressure, Non-Invasive (21 CFR 870.1130) | Single-Function, Preprogrammed Diagnostic Computer (21 CFR 870.1435) | | Regulation Class / Product Code | Class II DXG, DXN | Class II DXG | | Primary Predicate Device(s) | K160552 - EV1000 Clinical Platform™ NI with ClearSight™ Finger Cuffs or ClearSight System (cleared 06/01/2016) | K160552 — EV1000 Clinical Platform™ (cleared 06/01/2016) | | Secondary Device(s) | Not applicable | K183646 - Acumen Hypotension Prediction Index - EV1000 Clinical Platform (Cleared 05/21/2019) | | EV1000 Clinical Platform (EV1000A) | | | | Device Description | The EV1000 Clinical Platform measures patient physiologic parameters in a minimally invasive manner when it is used as a system with various Edwards' components, including the Edwards pressure transducers, the FloTrac sensor, the components of the VolumeView System, oximetry catheters/sensors, and the corresponding accessories applied to the patient. The EV1000 Clinical Platform includes an Acumen Hypotension Prediction Index (HPI) feature, which is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure (MAP) < 65 mmHg for one minute in duration) within 15 minutes, where zero (0) indicates low likelihood and one hundred (100) indicates high likelihood. The Acumen Hypotension Prediction Index | | {4}------------------------------------------------ | HPI, should not be used exclusively to treat patients. A review of the patient's hemodynamics is recommended prior to initiating treatment. The EV1000 Clinical Platform consists of the EV1000 Monitor (Monitor), the EV1000 Databox (Databox), and an Ethernet cable to connect the Databox to the Monitor. It may be attached to the patient bedside, an IV pole or roll stand. | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Labeling changes (flag label and operator's manual) to reduce fluid exposure and correct power adapter orientation was implemented in the field. The operator's manual will also be updated to include the same information to further caution users of the importance of proper power adaptor orientation. | | EV1000 Clinical Platform NI (EV1000NI) | | The EV1000 Clinical Platform NI is a non-invasive monitor that enables the continuous assessment of a patient's hemodynamic function based on the scientific method of Peňàz – Wesseling. The device measures continuous non-invasive blood pressure (Systolic, Diastolic, and Mean Arterial Pressure) and pulse rate. Cardiac Output and other hemodynamic parameters are derived from the blood pressure waveform. | | The EV1000 NI consists of the EV1000 monitor (EV1000M), the EV1000 Pump-Unit (Pump-Unit), a Pressure Controller (PC2 or PC2K) that is worn on the wrist, a Heart Reference Sensor (HRS), and the ClearSightTM Finger 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- Unit and labeling updates related to a corrective action was made. The additional hardware for the EV1000NI Pump Unit consists of a power cord entry cover (ingress protector) that is used to reduce liquid ingress or other conductive contaminates from entering the AC inlet. | {5}------------------------------------------------ | | EV1000 Clinical Platform (EV1000A) | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 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. | | Indications for Use/Intended Use | 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 HPI feature 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 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 EV 1000 Clinical Platform and the ClearSightTM finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters. | | | EV1000 Clinical Platform (EV1000A) is identical to the predicate device with the exception of the labeling to indicate the correct positioning of the | | Comparative Analysis | power adaptor cord in necessary in order to reduce fluid exposure. | | | The EV1000 Clinical Platform NI (EV1000NI) has been modified by adding a power cord entry cover to the Pump Unit AC inlet in order to reduce liquid ingress. Design Verification testing for the EV1000NI Pump 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 made as the result of the change and for corrective action | | Functional/ Safety Testing | The EV1000 Clinical Platform (EV1000A) is identical in design to the predicate device. No design changes were made and the only change was the addition of a flag label to the power adaptor indicating the proper orientation. | | | The EV1000 Clinical Platform NI (EV1000NI) has successfully passed functional and bench studies to demonstrate that the device is substantially equivalent to the cited predicate device and the boot and bracket reduces the possibility of fluid ingress. | | Conclusion | The EV1000 Clinical Platform and the EV1000 Clinical Platform NI with ClearSight Finger cuffs have been shown to be safe and are substantially equivalent to the predicate devices for their intended use in hospitals and other appropriate clinical environments. | {6}------------------------------------------------