Who is the manufacturer of EV1000 Clinical Platform?

Edwards Lifesciences, LLC filed the 510(k) submission for EV1000 Clinical Platform (K193179).

What is the FDA product code for EV1000 Clinical Platform?

DXG. It is classified under 21 CFR 870.1435 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for EV1000 Clinical Platform?

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

What are the predicate devices for EV1000 Clinical Platform?

EV1000 Clinical Platform (K160552).

Who can help prepare an FDA 510(k) submission like 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.

EV1000 Clinical Platform

K193179 · Edwards Lifesciences, LLC · DXG · Dec 17, 2019 · Cardiovascular

Device Facts

Record ID	K193179
Device Name	EV1000 Clinical Platform
Applicant	Edwards Lifesciences, LLC
Product Code	DXG · Cardiovascular
Decision Date	Dec 17, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1435
Device Class	Class 2
Attributes	Pediatric

Intended Use

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.

Device Story

EV1000 Clinical Platform monitors hemodynamic parameters; inputs include data from Edwards pressure transducers, FloTrac sensors, VolumeView system components, and oximetry catheters. System comprises EV1000 Monitor, Databox, and Ethernet cable; used in critical care settings by clinicians. Features Acumen Hypotension Prediction Index (HPI) to estimate likelihood of future hypotensive events (MAP < 65 mmHg for 1 min) within 15 minutes; HPI scale 0-100. Output provides physiological insight for reference; clinicians use data to support hemodynamic management. Corrective action added power adapter enclosure to prevent liquid ingress at AC inlet. Benefits include continuous hemodynamic monitoring and early warning of potential hypotension to assist clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data presented. Functional and bench studies demonstrated that the modified device (with power adapter enclosure) is substantially equivalent to the predicate and effectively reduces the possibility of fluid ingress.

Technological Characteristics

System includes monitor, databox, and sensors. Features Acumen HPI algorithm. Hardware modification: added power adapter enclosure to AC inlet to prevent liquid ingress. Connectivity via Ethernet. Class II device.

Indications for Use

Indicated for critical care patients (adults and pediatrics) requiring continuous or intermittent assessment of cardiac function, fluid status, and vascular resistance; includes surgical and nonsurgical patients receiving advanced hemodynamic monitoring.

Regulatory Classification

Identification

A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

Predicate Devices

EV1000 Clinical Platform (K160552)

Reference Devices

EV1000 Clinical Platforms: Special 510(k) Corrective Action Being Effected (K192058)

Related Devices

K203131 — EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform · Edwards Lifesciences, LLC · Jan 22, 2021
K192058 — EV1000 Clinical Platform NI, EV1000 Clinical Platform · Edwards Lifesciences, LLC · Aug 30, 2019
K231248 — Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform · Edwards Lifesciencess, LLC · Sep 21, 2023
DEN160044 — Acumen Hypotension Prediction Index (HPI) Feature Software · Edwards Lifesciences, LLC · Mar 16, 2018
K221833 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module · Edwards Lifesciences, LLC · Nov 7, 2022

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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. 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. 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 mediation-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 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;">☒ Prescription Use (Part 21 CFR 801 Subpart D)</div> | | <div style="display:flex; align-items:center;">☐ 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 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 (21 CFR 870.1435) | | | | Regulation Class / Product Code | Class II DXG | | | | Primary Predicate Device(s) | K160552 - EV1000 Clinical Platform™ (cleared 06/01/2016) | | | | Reference Device(s) | K192058 – EV1000 Clinical Platforms: Special 510(k) Corrective Action Being Effected | | | | Device Description | EV1000 Clinical Platform (EV1000A) 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, 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. A design hardware change for the AC inlet related to a corrective action was made. The additional hardware for the EV1000A power adaptor | | | {4}------------------------------------------------ | | prevent liquid ingress or other conductive contaminates from entering the AC inlet. | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use/Intended Use | 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. | | | 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. | | Comparative Analysis | EV1000 Clinical Platform (EV1000A) has been modified by adding a Power Adapter Enclosure to the power adaptor in order to prevent liquid ingress. Design verification testing for the EV1000A power adaptor with the Power Adapter Enclosure was performed and a reduction in occurrences of liquid ingress at the AC inlet was achieved. | | Functional/ Safety Testing | The EV1000 Clinical Platform (EV1000A) has successfully passed functional and bench studies to demonstrate that the device is substantially equivalent to the cited predicate device and the Power Adapter Cover reduces the possibility of fluid ingress. | | Conclusion | The EV1000 Clinical Platform (EV1000A) has been shown to be safe and is substantially equivalent to the predicate device for its intended use in hospitals and other appropriate clinical environments. |