(29 days)
K183646 - Acumen Hypotension Prediction Index - EV1000 Clinical Platform
Yes
The device description explicitly mentions the "Acumen Hypotension Prediction Index (HPI) feature" which is described as an "index related to the likelihood of a patient experiencing a hypotensive event". The reference to K183646, "Acumen Hypotension Prediction Index", further supports that this feature is a key component and likely utilizes AI/ML to predict future events based on physiological data.
No.
The device is indicated for monitoring and assessment of hemodynamic parameters, and while it provides insights into physiological conditions (like the Hypotension Prediction Index), it explicitly states that "no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter" and "The Acumen Hypotension Prediction Index HPI, should not be used exclusively to treat patients." This indicates it's a diagnostic/monitoring tool, not a therapeutic one that actively treats or modifies patient physiology.
Yes
Explanation: The device is indicated for monitoring hemodynamic parameters, assessing fluid status, and predicting hypotensive events, all of which involve diagnosing or assessing medical conditions.
No
The device description explicitly mentions hardware components such as the EV1000 Monitor, EV1000 Databox, Ethernet cable, EV1000 Pump-Unit, Pressure Controller, Heart Reference Sensor, and ClearSight Finger Cuffs. It also describes hardware changes and ingress protection, indicating it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The EV1000 Clinical Platform and its variations are described as monitoring devices that measure physiological parameters directly from the patient (e.g., blood pressure, cardiac function, fluid status, oximetry). They do not perform tests on samples in vitro (outside the body).
- Intended Use: The intended use focuses on continuous or intermittent assessment of hemodynamic parameters in critical care patients, monitoring blood pressure, and providing an index related to the likelihood of hypotension. These are all direct patient measurements and assessments.
- Device Description: The description details how the device connects to the patient via sensors, catheters, and finger cuffs to obtain physiological data. There is no mention of analyzing biological samples.
Therefore, the EV1000 Clinical Platform is a patient monitoring device, not an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for 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
§ 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).
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 ☑ 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™ 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) 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 |