(140 days)
Not Found
Yes
The device description mentions "pattern analysis" of ECG waveforms and "analyzes heart rate variability (HRV) and ECG morphology features" to categorize hemodynamic status and predict future instability. While not explicitly stating "AI" or "ML," these descriptions strongly suggest the use of algorithmic pattern recognition and feature analysis, which are common techniques in machine learning applied to physiological data. The predictive indicator (AHI-PI) further supports this, as it utilizes past AHI outputs to predict future events, a typical application of predictive modeling often employing ML.
No.
The device is intended to provide insights into a patient's hemodynamic status and likelihood of future hemodynamic instability, but it is explicitly stated that it is "not intended to independently direct therapy."
Yes
The device is intended to describe a patient's hemodynamic status and indicate if a patient is showing signs of hemodynamic stability or instability, and to provide physiological insight into a patient's likelihood of a future episode of HI. This involves analyzing ECG waveforms and providing risk indicators, which are diagnostic in nature.
Yes
The device description explicitly states that the AHI System is a "multiparameter system designed to meet clinicians' need to identify patient hemodynamic status and predict patient hemodynamic instability episodes using two analytics." It then describes these analytics (AHI and AHI-PI) as utilizing data from an existing ECG and processing that data to provide outputs and indicators. There is no mention of any hardware component being part of the submitted device itself; it relies on data from existing medical devices (ECG).
Based on the provided information, 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 AHI System analyzes physiological signals (ECG waveforms) directly from the patient's body to assess hemodynamic status and predict future instability. It does not process samples taken from the body.
- Intended Use: The intended use clearly states it's for "healthcare professionals managing patients... receiving continuous physiological monitoring with electrocardiography (ECG) in hospitals." This describes a direct patient monitoring application, not laboratory testing of samples.
- Device Description: The description focuses on analyzing "data from a single existing lead of a non-invasive electrocardiograph (ECG)" and "AHI outputs from up to the most recent 30 minutes of ECG data." This confirms the input is physiological data, not biological samples.
Therefore, the AHI System falls under the category of a physiological monitoring device rather than an in vitro diagnostic device.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The AHI System is intended for use by healthcare professionals managing patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG) in hospitals.
AHI provides a frequently updated 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 (HI) 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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December 3, 2021
Fifth Eye Inc. % Donna-Bea Tillman Senior Consultant Biologics Consulting Group 1555 King Street. Suite 300 Alexandria, Virginia 22314
Re: K212219
Trade/Device Name: AHI System Regulation Number: 21 CFR 870.2220 Regulation Name: Adjunctive hemodynamic indicator with decision point Regulatory Class: Class II Product Code: QNV, QNL Dated: November 3, 2021 Received: November 4, 2021
Dear Donna-Bea Tillman:
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.
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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 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 (QS) 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.
for
LCDR 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
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Indications for Use
510(k) Number (if known) K212219
Device Name AHI System
Indications for Use (Describe)
The AHI System is intended for use by healthcare professionals managing patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG) in hospitals.
AHI provides a frequently updated 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 (HI) are defined as hypotension (systolic blood pressure 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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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for the AHI System is provided below.
1. SUBMITTER
| Applicant: | Fifth Eye Inc.
110 Miller Avenue, Suite 300
Ann Arbor, MI 48104 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jen Baird
Chief Executive Officer
Fifth Eye Inc.
734.260.4800
jbaird@fiftheye.com |
| Submission Correspondent: | Donna-Bea Tillman, Ph.D.
Senior Consultant
Biologics Consulting
1555 King St, Suite 300
Alexandria, VA 22314
410.531.6542
dtillman@biologicsconsulting.com |
| Date Prepared: | November 2, 2021 |
2. DEVICE
| Device Trade Name: | AHI System |
|---|---|
| Device Common Name: | Hemodynamic Indicator |
| Classification Name | 21 CFR 870.2220 Adjunctive Hemodynamic |
| Indicator with Decision Point | |
| Regulatory Class: | II |
| Primary Product Code: | QNV |
| Subsequent Product Code: | QNL |
3. PREDICATE DEVICE
Predicate Device: Analytic for Hemodynamic Instability (AHI) - DEN200022 Secondary Predicate Device: CLEWICU System (ClewICUServer And ClewICUnitor) -K200717
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DEVICE DESCRIPTION 4.
The AHI System is a multiparameter system designed to meet clinicians' need to identify patient hemodynamic status and predict patient hemodynamic instability episodes using two analytics:
-
Analytic for Hemodynamic Instability (AHI) (as granted in DEN200022): Utilizing data from a single existing lead of a non-invasive electrocardiograph (ECG), AHI analyzes heart rate variability (HRV) and ECG morphology features to rapidly detect signs of hemodynamic stability or instability and categorize each window of data as either "AHI Stable" or "AHI Unstable." Time trending of AHI outputs is also provided.
-
Analytic for Hemodynamic Instability Predictive Indicator (AHI-PI): Utilizing AHI outputs from up to the most recent 30 minutes of ECG data, AHI-PI indicates the likelihood of a future episode of hemodynamic instability, defined as ten continuous minutes or more where signs of hemodynamic instability are present.
INTENDED USE/INDICATIONS FOR USE 5.
The AHI System is intended for use by healthcare professionals managing patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG) in hospitals.
AHI provides a frequently updated 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 (HI) are defined as hypotension (systolic blood pressure