(332 days)
QNV
Not Found
Yes
The document explicitly mentions "the underlying dataset that AHI was trained on," which is a strong indicator of a machine learning approach.
No.
Explanation: The device is intended to assist in identifying patients showing signs of hemodynamic instability, but it explicitly states it is not intended to independently direct therapy. It provides a binary output to describe hemodynamic status and indicate instability, and its goal is to "enable identification" and "allow clinicians an opportunity to increase vigilance," not to treat or cure a disease.
Yes
The device identifies patients showing signs of hemodynamic instability by analyzing ECG waveforms and vital signs (blood pressure and heart rate), providing information for healthcare professionals to increase vigilance. This falls under the definition of a diagnostic device, as it aims to identify a condition (hemodynamic instability).
Yes
The device is explicitly described as "software as a medical device (SaMD)" and its function is solely based on analyzing ECG signals. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description clearly states that the AHI software analyzes Lead-II ECG signals, which are electrical signals measured on the body's surface, not a sample taken from the body (like blood, urine, or tissue).
- The intended use is for monitoring and identifying signs of hemodynamic instability based on physiological signals. This is a form of physiological monitoring and analysis, not an in vitro test performed on a biological specimen.
The device is a Software as a Medical Device (SaMD) that analyzes physiological data (ECG) to provide information about a patient's condition. This falls under the category of medical devices, but specifically not In Vitro Diagnostics.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The critical section 'Control Plan Authorized (PCCP) and relevant text' states "Not Found".
Intended Use / Indications for Use
The Analytic for Hemodynamic Instability (AHI) software is intended for use by healthcare professionals managing in-hospital patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG).
AHI provides a frequently undated binary output over time based on pattern analysis of a lead-II ECG waveform intended to describe a patient's hemodynamic status and indicate if a patient is showing signs of hemodynamic stability or instability. Signs of hemodynamic instability are defined as hypotension (systolic blood pressure
§ 870.2220 Adjunctive hemodynamic indicator with decision point.
(a)
Identification. An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software description, verification, and validation based on comprehensive hazard analysis and risk assessment must be provided, including:
(i) Full characterization of technical parameters of the software, including algorithm(s);
(ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications;
(iii) Specification of acceptable incoming sensor data quality control measures;
(iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on output accuracy; and
(v) The sensitivity, specificity, positive predictive value, and negative predictive value in both percentage and number form for clinically meaningful pre-specified time windows consistent with the device output.
(2) Scientific justification for the validity of the hemodynamic indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm must use an independent data set.
(3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated.
(4) Clinical data must support the intended use and include 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) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output represents the measure(s) that the device provides in an accurate and reproducible manner;
(iii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified;
(iv) Where continuous measurement variables are displayed, agreement of the output with the reference measure(s) must be assessed across the full measurement range; and
(v) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment.
(5) Labeling must include the following:
(i) The type of sensor data used, including specification of compatible sensors for data acquisition, and a clear description of what the device measures and outputs to the user;
(ii) Warnings identifying factors that may impact output results;
(iii) Guidance for interpretation of the outputs, including warning(s) specifying adjunctive use of the measurements;
(iv) Key assumptions made in the calculation and determination of measurements; and
(v) A summary of the clinical validation data, including details of the patient population studied (
e.g., age, gender, race/ethnicity), clinical study protocols, and device performance with confidence intervals for all intended use populations.
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DE NOVO CLASSIFICATION REQUEST FOR ANALYTIC FOR HEMODYNAMIC INSTABILITY (AHI)
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Adjunctive hemodynamic indicator with decision point. An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.
NEW REGULATION NUMBER: 21 CFR 870.2220
CLASSIFICATION: Class II
PRODUCT CODE: QNV
BACKGROUND
DEVICE NAME: Analytic for Hemodynamic Instability (AHI)
SUBMISSION NUMBER: DEN200022
DATE DE NOVO RECEIVED: April 3, 2020
SPONSOR INFORMATION:
Fifth Eye Inc. 110 Miller Avenue, Suite 300 Ann Arbor, MI 48104
INDICATIONS FOR USE
The Analytic for Hemodynamic Instability (AHI) software is intended for use by healthcare professionals managing in-hospital patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG).
AHI provides a frequently undated binary output over time based on pattern analysis of a lead-II ECG waveform intended to describe a patient's hemodynamic status and indicate if a patient is showing signs of hemodynamic stability or instability. Signs of hemodynamic instability are defined as hypotension (systolic blood pressure 85% |
| 1-Specificity | 15.1% | 97.5% UCB: 19.7% | 75% |
| Table 2: Primary Analysis of Windows-Based Primary Study Endpoints | |||
|---|---|---|---|
[1] Bootstrap confidence interval based on 100 samples with replacement from Primary Analysis Set patient data (note: not re-sampling windows within a patient). LCB = lower confidence bound: UCB = upper confidence bound: 1-specificity = false positiverate
[2] The null hypothesis is rejected and we constivity > 85% and 1-specificity 75%) if 2.5% LCB is > 85% and 97.5% UCB is 100 bpm).
There is no universally accepted definition of hemodynamic instability. For AHI, the definition is based on medial literature references in which hemodynamic instability can be defined as one or more out-of-range vital sign measurements represented by clinical features of circulatory shock and advanced heart failure. Hemodynamic instability is associated with the development of potentially life-threatening shock. It has been clinically recognized that a combination of hypotension and tachycardia can ensue in any type of shock.
- . The user manual describes that the AHI provides a binary output every 2 minutes from a rolling 5-minute window of ECG data showing either AHI Unstable (red bar) or AHI Stable (green bar). If AHI is not able to produce an analytic output, a user may obtain further information based upon the following scenarios: Noisy (gray bar)
- Missing data (black bar) ●
- Prior to initialization of patient (no bar)
Image /page/11/Figure/5 description: The image shows a timeline from 0 to 20 minutes, with markers at each 5-minute interval. There are three AHI outputs labeled 1, 2, and 3, each corresponding to a different time window. Window 1 starts at 0 minutes and extends to AHI Output 1 at 5 minutes, Window 2 starts at 0 minutes and extends to AHI Output 2 at 10 minutes, and Window 3 starts at 0 minutes and extends to AHI Output 3 at 10 minutes.
The manual describes the interpretation of each of the outputs as follows:
AHI Stable (green bar) - The AHI output is indicating to the healthcare professional that the patient is showing signs of hemodynamic stability, specifically no combination of hypotension (systolic blood pressure 100 bpm), in their 5-minute ECG-II signal. The interpretation of a red AHI output is to increase clinical vigilance on that patient and review patient hemodynamics in the context of other available clinical information to identify any potential causes for hemodynamic instability and intervene if appropriate. AHI is intended for use by healthcare professionals as additional information regarding the patient's physiological condition for reference only and no diagnostic or therapeutic decisions should be made based solely on AHI's output.
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Missing (black bar) - A black bar indicates that an AHI output could not be generated for patients on ECG monitoring due to missing data in the 5-minute window. Potential causes include a patient being removed from ECG monitoring for transport or discharge, patient with poor electrode contact, patient associated with more than one ECG monitor, or problem with the ECG monitor or network.
Noisy (gray bar) - In order to increase the accuracy of AHI, each 5-minute window of patient ECG data is pre-qualified. If the pre-qualification of the ECG window detects heart rate, heart rate variability, or waveform morphology outside of the validated analytic inputs, the window is described as noisy and is represented with a gray bar. Noisy windows (gray bars) do not indicate patient status. Patient deterioration should be detected via the normal course of care using the full clinical context information available to the healthcare professional. Every 2 minutes, each rolling 5-minute window of ECG data is pre-qualified independently.
Prior to initialization of patient (no bar) - AHI will not display an output bar in the following conditions:
- AHI is Initializing upon the start of a new patient. The first output will be displayed ● when the first AHI output is calculated, typically within 5 to 7 minutes
- Time period to the left of the first AHI output ●
- Duplicate MRN, a patient is registered in two ECG monitors ●
Further description is provided in the user manual of how trends of outputs should be interpreted:
How many red AHI outputs indicate that I should intervene?
Each AHI output is based on analysis of a specific 5-minute window of ECG data. AHI outputs are based on a "point-in-time" pattern analysis and are not cumulative, so while more red AHI outputs indicate that AHI is repeatedly identifying concerning patterns, there is no specific number of red bars that indicate required intervention. The interpretation of a red AHI bar is to increase clinical vigilance on that patient and review patient hemodynamics in the context of other available clinical information to identify any potential causes for the identified signs of hemodynamic instability (hypotension and tachycardia) and intervene if appropriate. AHI is intended for use by healthcare professionals as additional information regarding the patient's physiological condition for reference only and no diagnostic or therapeutic decisions should be made based solely on AHI's output.
If the patient's AHI output was GREEN and goes to RED. do I need to increase vicillance?
The most recent red AHI output is indicating to the healthcare professional that the patient is showing signs of hemodynamic instability (hypotension and tachycardia) in their 5-minute ECG-II signal. The interpretation of a red AHI bar is to increase clinical vigilance on that patient and review patient hemodynamics in the context of other
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available clinical information to identify any potential causes for the signs of hemodynamic instability (hypotension and tachycardia) and intervene if appropriate. AHI is intended for use by healthcare professionals as additional information regarding the patient's physiological condition for reference only and no diagnostic or therapeutic decisions should be made based solely on AHI's output.
If the patient's AHI output was RED and goes to GREEN, should I decrease vigilance?
The most recent green AHI output is indicating to the healthcare professional that the patient is showing signs of stable hemodynamic status (no combination of hypotension and tachycardia) in their 5-minute ECG-II signal, indicating that they should maintain the normal course of care in treating the patient. AHI is an adjunct to and is not intended to replace other sources of clinical information. Healthcare professionals should rely on other clinical measures to make decisions about care.
Should I order a medical intervention based solely on an AHI Unstable (red) output?
AHI is intended for use by healthcare professionals as additional information regarding the patient's physiological condition for reference only and no diagnostic or therapeutic decisions should be made based solely on AHI's output. The interpretation of a red AHI bar is to increase clinical vigilance on that patient and review patient hemodynamics in the context of other available clinical information to identify any potential causes for signs of hemodynamic instability (hypotension and tachycardia) and intervene if appropriate.
How will patients deteriorating for non-hemodynamic reasons be detected by AHI?
Patient deterioration for causes that do not lead to signs of hemodynamic instability hypotension and tachycardia) will not be detected by AHI. Such patient deterioration should be detected via the normal course of care using the full clinical context information available to the healthcare professional. This is outside of the intended use of AHI . AHI is an adjunct to and is not intended to replace other sources of clinical information.
How often does AHI indicate "AHI Unstable" when the patient is actually stable?
Based on the windows-level analysis in the clinical validation study, this question represents the False Positive Rate of AHI. It will be captured in the Specificity value within the Clinical Validation portion of the Instructions for Use.
How often does AHI indicate "AHI Stable" when the patient is actually unstable?
Based on the windows-level analysis in the clinical validation study, this question represents the False Negative Rate of AHI. It will be captured in the Sensitivity value within the Clinical Validation portion of the Instructions for Use.
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- (iv) Key assumptions made in the calculation and determination of measurements.
There is no universally accepted definition of hemodynamic instability. For AHI, the definition is based on medical literature references in which hemodynamic instability can be defined as one or more out-or-range vital sign measurements represented by clinical features of circulatory shock and advanced heart failure.
AHI is an adjunct to and is not intended to replace ECG monitoring and is not intended for arrhythmia alarm notification. Since AHI is not indicated for use under conditions of sustained atrial or ventricular arrhythmia, clinicians should consider any arrhythmia alarms provided directly by their ECG monitoring system when interpreting AHI outputs.
AHI uses the continuous waveform produced from Lead-II of a standard application of the electrocardiogram (ECG) monitor. AHI depends on the quality of the data captured. Follow the ECG monitor manufacturer's instructions when prepping the patient and placing electrodes. Be sure the patient is associated with the proper ECG monitor.
Designed to detect if a patient is showing signs of hemodynamic stability as represented by the hemodynamic variables of heart rate and blood pressure, the AHI display does not address all potential physiologic conditions and no diagnostic or therapeutic decisions should be made based solely on AHI's output. See Indications for Use.
Follow ECG monitor manufacturer's standards for electrode placement.
Before a new patient's outputs are displayed in the AHI user interface, the user must affirm that the patient does not meet any of the contraindicated criteria by clicking on the "Start AHI Monitoring" button to begin display of AHI outputs for that patient. If one of the contraindicated criteria applies, the user should click the "Contraindicate" button which will prevent the display of AHI outputs for that patient.
Each AHI output is based on analysis of a specific 5-minute window of ECG data. AHI outputs are based on a "point-in-time" pattern analysis and are not cumulative, so while more red AHI outputs indicate that AHI is repeatedly identifying concerning patterns, there is no specific number of red bars that indicate required intervention.
Patient deterioration for causes that do not lead to signs of hemodynamic instability (hypotension and tachycardia) will not be detected by AHI. Such patient deterioration should be detected via the normal course of care using the full clinical context information available to the healthcare professional. This is outside of the intended use of AHI. AHI is an adjunct to and is not intended to replace other sources of clinical information.
- (v) The performance of the device for all presented parameters, for all intended use populations, with appropriate confidence intervals, and the supporting evidence for this performance: and
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Table 2 Primary Analysis of Windows-Based Primary Endpoints. Primary Analysis Set.
| Windows-Based
Performance Measure | Observed | 95% one-sided
confidence interval [1] | Acceptable
Threshold [2] |
|--------------------------------------|----------|------------------------------------------|-----------------------------|
| Sensitivity | 95.6% | 2.5% LCB: 88.9% | >85% |
| 1-Specificity | 15.1% | 97.5% UCB: 19.7% | 75% |
[1] Bootstrap confidence interval based on 100 samples with replacement from Primary Analysis Set patient data (note: not re-sampling within a patient). LCB = lower confidence bound; UCB = upper confidence bound; 1-specificity = false positive fraction.
[2] The null hypothesis is rejected and we conclude that sensitivity > 85% and 1-specificity 75%) if 2.5% LCB is > 85% and 97.5% UCB is