(536 days)
Not Found
Yes
The description explicitly states that the HPI uses "a data-driven model developed from retrospective analysis of an arterial waveform database". This is a clear indication of a machine learning approach.
No
The device provides "additional quantitative information regarding the patient's physiological condition for reference only" and states "no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter." It is for monitoring, not therapy.
Yes
The device provides "physiological insight into a patient's likelihood of future hypotensive events" and provides "additional quantitative information regarding the patient's physiological condition for reference only," which aligns with the definition of a diagnostic device that detects, diagnoses, or monitors a disease or condition.
No
The device description explicitly states that the software runs on the Edwards Lifesciences EV1000 Platform and is paired with the FloTrac IQ extravascular blood pressure transducer and a radial arterial catheter. These are hardware components necessary for the device's function.
Based on the provided information, the Edwards Lifesciences Acumen Hypotension Prediction Index (HPI) feature is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Acumen HPI Function: The Acumen HPI feature analyzes physiological data (arterial pressure waveforms) collected directly from the patient's body via an arterial catheter and transducer. It does not process or analyze specimens taken from the body.
- Intended Use: The intended use clearly states it provides "physiological insight into a patient's likelihood of future hypotensive events" and is for use in "operating room (OR) patients receiving advanced hemodynamic monitoring." This is real-time monitoring and analysis of in-vivo physiological signals, not in-vitro analysis of specimens.
Therefore, the Acumen HPI feature falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The Edwards Lifesciences Acumen Hypotension Prediction Index (HPI) feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure
§ 870.2210 Adjunctive predictive cardiovascular indicator.
(a)
Identification. The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must be provided, including:
(i) A full characterization of the software technical parameters, including algorithms;
(ii) A description of the expected impact of all applicable sensor acquisition hardware characteristics and associated hardware specifications;
(iii) A description of sensor data quality control measures;
(iv) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy;
(v) A description of the expected time to patient status or clinical event for all expected outputs, accounting for differences in patient condition and environment; and
(vi) The sensitivity, specificity, positive predictive value, and negative predictive value in both percentage and number form.
(2) A scientific justification for the validity of the predictive cardiovascular indicator algorithm(s) must be provided. This justification must include verification of the algorithm calculations and validation using an independent data set.
(3) A human factors and usability engineering assessment must be provided that evaluates the risk of misinterpretation of device output.
(4) A clinical data assessment must be provided. This assessment must fulfill the following:
(i) The assessment must include a summary of the clinical data used, including source, patient demographics, and any techniques used for annotating and separating the data.
(ii) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified.
(iii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment.
(iv) The assessment must evaluate how the device output correlates with the predicted event or status.
(5) Labeling must include:
(i) A description of what the device measures and outputs to the user;
(ii) Warnings identifying sensor acquisition factors that may impact measurement results;
(iii) Guidance for interpretation of the measurements, including a statement that the output is adjunctive to other physical vital sign parameters and patient information;
(iv) A specific time or a range of times before the predicted patient status or clinical event occurs, accounting for differences in patient condition and environment;
(v) Key assumptions made during calculation of the output;
(vi) The type(s) of sensor data used, including specification of compatible sensors for data acquisition;
(vii) The expected performance of the device for all intended use populations and environments; and
(viii) Relevant characteristics of the patients studied in the clinical validation (including age, gender, race or ethnicity, and patient condition) and a summary of validation results.
0
DE NOVO CLASSIFICATION REQUEST FOR ACUMEN HYPOTENSION PREDICTION INDEX FEATURE SOFTWARE
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Adjunctive predictive cardiovascular indicator. The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
NEW REGULATION NUMBER: 21 CFR 870.2210
CLASSIFICATION: II
PRODUCT CODE: QAQ
BACKGROUND
DEVICE NAME: Acumen Hypotension Prediction Index (HPI) Feature Software
SUBMISSION NUMBER: DEN160044
DATE OF DE NOVO: September 26, 2016
Edwards Lifesciences LLC CONTACT: One Edwards Way Irvine, CA 92614
INDICATIONS FOR USE
The Edwards Lifesciences Acumen Hypotension Prediction Index (HPI) feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure 85 | Red (Flashing) | High Priority
Alarm Tone | Patient has a high likelihood of experiencing a hypotensive event within 15 minutes | Check patient hemodynamics using the secondary screen and other primary screen parameters in order to investigate the potential cause of the high likelihood of hypotension in order to inform a potential course of action |
| HPI > 85 and persists for
2 continuous readings
(40 seconds) | Red (Flashing)
Popup | High Priority
Alarm Tone | Patient has a high likelihood of experiencing a hypotensive event within 15 minutes | Check patient hemodynamics using the secondary screen and other primary screen parameters in order to investigate the potential cause of the high likelihood of hypotension in order to inform a potential course of action
Acknowledge popup by chosen method |
| HPI = 100 | Red (Flashing)
Popup | High Priority
Alarm Tone | Patient is hypotensive | Check patient hemodynamics using the secondary screen and other primary screen parameters in order to investigate the potential cause of the hypotension in order to inform a potential course of action
Acknowledge popup by chosen method |
Table 16-2 HPI Value Graphical and Audible Display Elements
Note: If HPI is displayed in the Information Bar, the graphical display element changes will not change color nor alarm Instead, the user will only be notified when HP exceeds 85 for consecutive updates by displaying the HPJ High Alert Popup
"The Hypotension Prediction Index, HPI, should not be used exclusively to treat the patients. A review of the patient's hemodynamics is recommended prior to initiating treatment."
"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."
-
d. A specific time or a range of times before the predicted patient status or clinical event occurs, accounting for differences in patient condition and environment;
"Patient has a high likelihood of experiencing a hypotensive event within 15 minutes" -
e. Key assumptions made during calculation of the output;
"The HPI parameter uses data from the first ten minutes of monitoring to establish a 'base value'. Device performance during these first ten minutes may differ as a result."
9
- The type(s) of sensor data used, including specification of compatible sensors for data f. acquisition;
"Acumen Hypotension Prediction Index (HPI) software, when active and when using a FloTrac IQ sensor, connected to a radial arterial catheter, provides the clinician with information regarding the likelihood of a patient trending toward a hypotensive vent, defined as mean arterial pressure (MAP)