(29 days)
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.
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.
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.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes a 510(k) submission for modifications to existing devices (EV1000 Clinical Platform and EV1000 Clinical Platform NI) rather than a new device requiring extensive performance acceptance criteria for clinical efficacy. The primary purpose of this submission is a "Special 510(k) Corrective Action Being Effected" to address issues related to fluid exposure and power adapter orientation. Therefore, the acceptance criteria and performance reported are focused on the safety and functional integrity of these modifications.
| Acceptance Criterion | Device Performance (How the device meets the criterion) |
|---|---|
| EV1000 Clinical Platform (EV1000A): | |
| Proper power adapter orientation to reduce fluid exposure. | A flag label was added to the power adapter indicating the proper orientation. The device itself is "identical in design to the predicate device" with "no design changes" other than the labeling. |
| EV1000 Clinical Platform NI (EV1000NI): | |
| Reduction of liquid ingress at the Pump Unit AC inlet. | A power cord entry cover (ingress protector) was added to the Pump Unit AC inlet. "Design Verification testing" was performed, and it "achieved a reduction in occurrences of liquid ingress at the Pump Unit AC inlet." |
| Continued substantial equivalence to the predicate device after modifications. | Functional and bench studies were successfully passed, demonstrating that the modified device "is substantially equivalent to the cited predicate device." |
| Continued safety for intended use. | The device "has been shown to be safe" and substantially equivalent for its intended use. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not provide specific sample sizes for a "test set" in the context of clinical performance evaluation (e.g., patient numbers for diagnostic accuracy). Instead, it refers to "Design Verification testing" and "functional and bench studies" which are typically focused on engineering and safety validation, rather than clinical trials with patient cohorts.
- Sample Size for Test Set: Not explicitly stated in terms of patient numbers. The testing appears to be focused on bench and functional validation of the hardware changes.
- Data Provenance: Not specified, but given the nature of the modifications (hardware ingress protection, labeling), the testing would typically be conducted by the manufacturer in a controlled lab environment. There is no indication of clinical data from specific countries or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to the type of safety and functional testing described. The "ground truth" for the acceptance criteria outlined above would be established through engineering specifications, regulatory standards for ingress protection (e.g., IP ratings), and functional performance benchmarks, rather than expert clinical consensus.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert reviewers evaluate performance against a golden standard. For hardware and functional testing, the "adjudication" is based on objective measurements and compliance with engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not performed. The submission focuses on hardware modifications and labeling changes to address safety concerns, not on assessing reader performance or the clinical interpretation of the device's outputs.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. The EV1000 Clinical Platforms are medical monitoring devices that generate physiological parameters for clinicians. The "Acumen Hypotension Prediction Index" (HPI) feature is an algorithm that provides "additional quantitative information regarding the patient's physiological condition for reference only," explicitly stating "no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter." This indicates it's designed to be used with human interpretation, not as a standalone diagnostic or therapeutic tool. The current submission, however, is not about the HPI's performance but modifications to the physical device.
7. The Type of Ground Truth Used:
For the EV1000A, the "ground truth" for the corrected issue (power adapter orientation) is simply the correct physical orientation as defined by engineering and safety standards, communicated via labeling.
For the EV1000NI, the "ground truth" for the corrected issue (liquid ingress) would be objective measurements of liquid ingress (e.g., in milliliters or by visual inspection for presence of liquid) compared against a pre-defined acceptance threshold that demonstrates adequate protection, typically derived from engineering and safety standards (e.g., IEC 60601-1, IP ratings).
8. The Sample Size for the Training Set:
Not applicable. This submission is for modifications to existing cleared devices, not for the development or training of a new algorithm or AI model. The Acumen HPI, which does involve an algorithm, was part of a prior submission (K183646) and would have had its own training and validation data, but that is not the subject of this specific 510(k).
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set for this specific 510(k) submission.
{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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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™ NIwith ClearSight™ Finger Cuffsor ClearSight System | EV1000 Clinical Platform™ |
| Common Name | Non-Invasive BloodPressureMeasurement System | Cardiac Output / Oximetry Monitor |
| Classification Name | Single-Function, PreprogrammedDiagnostic Computer (21 CFR870.1435)System, Measurement, Blood-Pressure, Non-Invasive(21 CFR 870.1130) | Single-Function,PreprogrammedDiagnostic Computer(21 CFR 870.1435) |
| Regulation Class /Product Code | Class IIDXG, DXN | Class IIDXG |
| Primary PredicateDevice(s) | K160552 - EV1000 ClinicalPlatform™ NI with ClearSight™Finger Cuffs or ClearSightSystem (cleared 06/01/2016) | K160552 — EV1000 ClinicalPlatform™ (cleared 06/01/2016) |
| SecondaryDevice(s) | Not applicable | K183646 - Acumen HypotensionPrediction Index - EV1000 ClinicalPlatform (Cleared 05/21/2019) |
| EV1000 Clinical Platform (EV1000A) | ||
| Device Description | The EV1000 Clinical Platform measures patient physiologic parameters ina minimally invasive manner when it is used as a system with variousEdwards' components, including the Edwards pressure transducers, theFloTrac sensor, the components of the VolumeView System, oximetrycatheters/sensors, and the corresponding accessories applied to the patient.The EV1000 Clinical Platform includes an Acumen HypotensionPrediction Index (HPI) feature, which is an index related to the likelihoodof a patient experiencing a hypotensive event (defined as mean arterialpressure (MAP) < 65 mmHg for one minute in duration) within 15minutes, 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 thepatient'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 theDatabox to the Monitor. It may be attached to the patient bedside, an IVpole or roll stand. |
|---|
| Labeling changes (flag label and operator's manual) to reduce fluidexposure and correct power adapter orientation was implemented in thefield. The operator's manual will also be updated to include the sameinformation to further caution users of the importance of proper poweradaptor orientation. |
| EV1000 Clinical Platform NI (EV1000NI) |
| The EV1000 Clinical Platform NI is a non-invasive monitor that enablesthe continuous assessment of a patient's hemodynamic function based onthe scientific method of Peňàz – Wesseling. The device measurescontinuous non-invasive blood pressure (Systolic, Diastolic, and MeanArterial Pressure) and pulse rate. Cardiac Output and other hemodynamicparameters are derived from the blood pressure waveform. |
| The EV1000 NI consists of the EV1000 monitor (EV1000M), the EV1000Pump-Unit (Pump-Unit), a Pressure Controller (PC2 or PC2K) that is wornon the wrist, a Heart Reference Sensor (HRS), and the ClearSightTM FingerCuffs. 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. Theadditional hardware for the EV1000NI Pump Unit consists of a power cordentry cover (ingress protector) that is used to reduce liquid ingress or otherconductive contaminates from entering the AC inlet. |
{5}------------------------------------------------
| EV1000 Clinical Platform (EV1000A) | |
|---|---|
| The EV1000 Clinical Platform is indicated for use primarily for criticalcare patients in which the balance between cardiac function, fluid statusand vascular resistance needs continuous or intermittent assessment. TheEV1000 Clinical Platform may be used for the monitoring ofhemodynamic parameters in conjunction with a perioperative goal directedtherapy protocol. Analysis of the thermodilution curve in terms of meantransit time and the shape is used to determine intravascular andextravascular fluid volumes. When connected to an Edwards oximetrycatheter, the monitor measures oximetry in adults and pediatrics. TheEV1000 Clinical Platform may be used in all settings in which critical careis provided. | |
| Indications forUse/Intended Use | The Edwards Lifesciences Acumen Hypotension Prediction Index featureprovides the clinician with physiological insight into a patient's likelihoodof future hypotensive events (defined as mean arterial pressure < 65 mmHgfor at least one minute in duration) and the associated hemodynamics. TheAcumen HPI feature is intended for use in surgical or nonsurgical patientsreceiving advanced hemodynamic monitoring. The Acumen HPI feature isconsidered to be additional quantitative information regarding the patient'sphysiological condition for reference only and no therapeutic decisionsshould 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 areindicated for patients over 18 years of age in which the balance betweencardiac function, fluid status, and vascular resistance needs continuousassessment. The EV1000 Clinical Platform may be used for the monitoringof hemodynamic parameters in conjunction with a perioperative goaldirected therapy protocol. In addition, the non-invasive system is indicatedfor use in patients with co- morbidities for which hemodynamicoptimization is desired and invasive measurements are difficult. TheEV 1000 Clinical Platform and the ClearSightTM finger cuffs noninvasivelymeasures blood pressure and associated hemodynamic parameters. | |
| EV1000 Clinical Platform (EV1000A) is identical to the predicate devicewith the exception of the labeling to indicate the correct positioning of the | |
| ComparativeAnalysis | power adaptor cord in necessary in order to reduce fluid exposure. |
| The EV1000 Clinical Platform NI (EV1000NI) has been modified byadding a power cord entry cover to the Pump Unit AC inlet in order toreduce liquid ingress. Design Verification testing for the EV1000NI PumpUnit was performed, and a reduction in occurrences of liquid ingress at the | |
| Pump Unit AC inlet was achieved. In addition, labeling changes have beenmade as the result of the change and for corrective action | |
| Functional/SafetyTesting | The EV1000 Clinical Platform (EV1000A) is identical in design to thepredicate device. No design changes were made and the only change wasthe addition of a flag label to the power adaptor indicating the properorientation. |
| The EV1000 Clinical Platform NI (EV1000NI) has successfully passedfunctional and bench studies to demonstrate that the device is substantiallyequivalent to the cited predicate device and the boot and bracket reducesthe possibility of fluid ingress. | |
| Conclusion | The EV1000 Clinical Platform and the EV1000 Clinical Platform NI withClearSight Finger cuffs have been shown to be safe and are substantiallyequivalent to the predicate devices for their intended use in hospitals andother appropriate clinical environments. |
{6}------------------------------------------------
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
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.(b)
Classification. Class II (performance standards).