(29 days)
Yes
The device description explicitly mentions the "Acumen Hypotension Prediction Index (HPI) feature, which is an index related to the likelihood of a patient experiencing a hypotensive event". While it doesn't explicitly use the terms AI or ML, the concept of predicting a future physiological event based on current and potentially historical hemodynamic data strongly suggests the use of predictive modeling, which is a common application of machine learning. The description of the HPI as an "index" ranging from 0 to 100 further supports this interpretation, implying a calculated risk score derived from complex data analysis.
No
The device is described as a monitoring platform that assesses cardiac function, fluid status, and vascular resistance, and provides insight into the likelihood of future hypotensive events. It gathers quantitative information for reference, and explicitly states that "no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter" and "should not be used exclusively to treat patients." This indicates it is for diagnostic and monitoring purposes, not for direct treatment or therapy.
Yes
This device monitors hemodynamic parameters, determines intravascular and extravascular fluid volumes, measures oximetry, and provides insights into the likelihood of hypotensive events. All these functions involve assessing physiological parameters to provide information about a patient's health status, which falls under the definition of a diagnostic device.
No
The device description explicitly states that the EV1000 Clinical Platform consists of a Monitor, a Databox, and an Ethernet cable, which are hardware components. It also mentions a design hardware change for the AC inlet.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed 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 measures physiological parameters in vivo (within the living body) through minimally invasive means using sensors and catheters applied to the patient. It analyzes hemodynamic data and provides information about cardiac function, fluid status, vascular resistance, and the likelihood of hypotension.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient. The measurements are made directly on or within the patient's body.
Therefore, the EV1000 Clinical Platform falls under the category of a patient monitoring device, not an in vitro diagnostic device.
No
The provided text does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section explicitly states 'Not Found'.
Intended Use / Indications for 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
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).
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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
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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,
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
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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 ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| 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) |