(95 days)
Yes
The device description explicitly mentions the "Acumen Hypotension Index (HPI) feature," which is described as an "index related to the likelihood of a patient experiencing a hypotensive event." While not explicitly stating "AI" or "ML," the concept of predicting a future physiological event based on current data strongly suggests the use of predictive algorithms, which are commonly implemented using ML techniques in medical devices. The predicate device K183646 is also for the Acumen Hypotension Prediction Index (HPI), further supporting this interpretation.
No.
The device is indicated for monitoring hemodynamic parameters and providing physiological insights, not for delivering therapy. It explicitly states that "no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter."
Yes
The device is used for "Monitoring of hemodynamic parameters" and "Analysis of the thermodilution curve in terms of mean transit time and the shape is used to determine intravascular and extravascular fluid volumes." It also "measures oximetry," "measures blood pressure and associated hemodynamic parameters," and provides "physiological insight into a patient's likelihood of future hypotensive events." These actions involve assessing physiological states and providing information about a patient's medical condition, which are functions of a diagnostic device.
No
The device description explicitly mentions hardware components such as the EV1000 Monitor, EV1000 Databox, Ethernet cable, EV1000 Pump-Unit, Pressure Controller, and Heart Reference Sensor. While software updates are mentioned, the device is clearly a system incorporating both hardware and software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is used for monitoring hemodynamic parameters in critical care patients. It measures physiological parameters directly from the patient (e.g., blood pressure, cardiac output, fluid volumes) using methods like thermodilution and non-invasive blood pressure measurement.
- Device Description: The device description details how the system interacts with the patient through sensors, catheters, and finger cuffs to obtain physiological data. It does not mention analyzing samples of human origin (like blood, urine, or tissue) outside of the body.
- Lack of IVD Characteristics: The description does not include any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or prognosis based on the analysis of biological samples.
The device is a patient monitoring system that measures physiological parameters in vivo (within the living body) or minimally invasively, rather than in vitro (in glass or outside the body) using biological samples.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device, nor does it reference section 515C(b)(1).
Intended Use / Indications for 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. Monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol enables consistent in the intended patient populations. 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
§ 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).
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January 22, 2021
Edwards Lifesciences, LLC Christine Chun Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K203131
Trade/Device Name: EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN, DXG, QAQ Dated: December 22, 2020 Received: December 23, 2020
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
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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,
for LT Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203131
Device Name EV1000 Clinical Platform (EV1000A)
Indications for Use (Describe)
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. Monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol enables consistent in the intended patient populations. 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 ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Indications for Use
510(k) Number (if known) K203131
Device Name EV1000 Clinical Platform NI (EV1000NI)
Indications for Use (Describe)
The EV1000 Clinical Platform NI and the ClearSight finger cuffs are indicated for patients over 18 years of age in which the balance between cardiac 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 noninvasive system is in patients with comorbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The EV1000 Clinical Platform NI 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 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."
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SECTION 5 — 510(k) SUMMARY
| EV1000™ Clinical Platform(s) 510(k) | ||
|---|---|---|
| Submitter - 807.92(a)(1) | ||
| 510(k) | ||
| Submitter | Edwards Lifesciences, LLC | |
| Contact Person | Christine J. Chun, MBA | |
| One Edwards Way | ||
| Irvine, CA 92614 | ||
| christine chun@edwards.com | ||
| (949) 250-2773 | ||
| Date Prepared | October 16, 2020 | |
| Device Information - 807.92(a)(2) | ||
| Trade Name | EV1000 Clinical Platforms | |
| EV1000 Clinical Platform™ NI | ||
| (EV1000NI) | EV1000 Clinical Platform (EV1000A) | |
| Common Name | Non-Invasive Blood Pressure | Cardiac Output / Oximetry Monitor with |
| Measurement System | Adjunctive Predictive Cardiovascular | |
| Indicator | ||
| Classification | Single-Function, Preprogrammed | Single-Function, Preprogrammed |
| Name | Diagnostic Computer | Diagnostic Computer |
| (21 CFR 870.1435) | (21 CFR 870.1435) | |
| System, Measurement, Blood- | Adjunctive Predictive Cardiovascular | |
| Pressure, Non-Invasive | Indicator | |
| (21 CFR 870.1130) | (21 CFR 870.2210) | |
| Regulation | Class II | Class II |
| Class / Product | ||
| Code | DXG, DXN | DXG, QAQ |
| Legally | Predicate Device - 807.92(a)(3) | EV1000 Clinical Platforms |
| Marketed | EV1000 Clinical Platform™ NI | EV1000 Clinical Platform (EV1000A) |
| Devices | (EV1000NI) | |
| Primary | K160552 - EV1000 Clinical Platform™ | K160552 – EV1000 Clinical Platform |
| Predicate | NI with ClearSight™ Finger Cuffs or | (cleared 06/01/2016) |
| Device(s) | ClearSight™ System (cleared | |
| 06/01/2016) | ||
| Additional | K201446 - HemoSphere Advanced | K183646 - Acumen™ Hypotension |
| Predicate | Monitoring Platform, HemoSphere | Prediction Index (HPI) – EV1000 |
| Device(s) | ClearSight Module (cleared 10/01/2020 | Clinical Platform (cleared 05/21/2019) |
| K190205 - HemoSphere Advanced | K190205 - HemoSphere Advanced | |
| Monitor, HemoSphere Tissue Oximetry | Monitor, HemoSphere Tissue Oximetry | |
| Module (cleared 08/29/2019) | Module (cleared 08/29/2019) | |
| K180881 - HemoSphere Advanced | K180881 - HemoSphere Advanced | |
| Monitor, HemoSphere Pressure Cable | Monitor, HemoSphere Pressure Cable | |
| (cleared 11/16/2018) | (cleared 11/16/2018) | |
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Device Description - 807.92(a)(4)
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 Index (HPI) feature, which is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure (MAP)