(79 days)
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 <90 mmHg or mean arterial pressure (MAP) <70 mmHq) combined with tachycardia (heart rate ≥ 100 bpm).
AHI-PI provides the clinician with physiological insight into a patient's likelihood of a future episode of HI. An episode of HI is defined as 10 continuous minutes or more where HI is present.
The goal of this adjunctive monitoring method is to enable identification of patients who are showing HI or are likely to experience a future episode of HI, and to allow clinicians an opportunity to increase vigilance. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
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:1. Analytic for Hemodynamic Instability (AHI): Utilizing data from a single existing lead of a non-invasive electrocardiograph (ECG), AH analyzes heart rate variability (HRV) and ECG morphology features to rapidly detect signs of hemodynamic stability 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 (AH-P); Utilizing AH outputs from up to the most recent 30 minutes of EG data, AH-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.
The provided text details the FDA clearance for the AHI System (v 2.2.0) and references a previous version (K212219) as the predicate device. However, the document primarily focuses on regulatory approval and equivalence, not on a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, expert qualifications, or ground truth establishment.
Therefore, many of the requested details about the study proving the device meets acceptance criteria are not present in the provided text. The text only vaguely refers to "Software: Software verification and validation testing were conducted and documentation was provided... Testing was conducted to ensure the AHI System works as designed." This is insufficient to populate the requested table and further study details.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not include a table of acceptance criteria or reported device performance metrics such as sensitivity, specificity, or AUC for the AHI System (v 2.2.0) or its predicate. It only states the device "works as designed" following software V&V.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for any test set or the provenance (e.g., country of origin, retrospective/prospective) of the data.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The provided text does not mention the number or qualifications of experts used to establish ground truth for any test set.
4. Adjudication Method for the Test Set
The provided text does not describe any adjudication method (e.g., 2+1, 3+1, none) for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate that an MRMC comparative effectiveness study was done, nor does it provide any effect size for human reader improvement with or without AI assistance.
6. Standalone Performance Study
While the device's function (AHI and AHI-PI) is described as "pattern analysis of a lead-II ECG waveform" to indicate hemodynamic status and predict instability, the document does not provide the results of a standalone (algorithm only) performance study with specific metrics. It states "Testing was conducted to ensure the AHI System works as designed," which is a high-level statement without data.
7. Type of Ground Truth Used for the Test Set
The "Signs of hemodynamic instability (HI)" are defined within the Indications for Use as "hypotension (systolic blood pressure <90 mmHg or mean arterial pressure (MAP) <70 mmHg) combined with tachycardia (heart rate ≥ 100 bpm)." This operational definition of HI serves as the clinical definition/outcome data that the AHI system aims to detect or predict. It's likely this definition would form the basis of the ground truth if a study were conducted, but the document does not explicitly state how this ground truth was used or established in a specific test set or if it was verified by experts.
8. Sample Size for the Training Set
The provided text does not specify the sample size for any training set used for the algorithm.
9. How the Ground Truth for the Training Set Was Established
The provided text does not explain how the ground truth for any training set was established.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
July 14, 2022
Fifth Eye Inc. % Donna-Bea Tillman Senior Consultant Biologics Consulting 1555 King Street. Suite 300 Alexandria, Virginia 22314
Re: K221203
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: June 17, 2022 Received: June 21, 2022
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.
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
{1}------------------------------------------------
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,
LCDR 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
{2}------------------------------------------------
Indications for Use
Submission Number (if known)
Device Name
AHI System (v 2.2.0)
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 <90 mmHg or mean arterial pressure (MAP) <70 mmHq) combined with tachycardia (heart rate ≥ 100 bpm).
AHI-PI provides the clinician with physiological insight into a patient's likelihood of a future episode of HI. An episode of HI is defined as 10 continuous minutes or more where HI is present.
The goal of this adjunctive monitoring method is to enable identification of patients who are showing HI or are likely to experience a future episode of HI, and to allow clinicians an opportunity to increase vigilance. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Type of Use (Select one or both, as applicable)
< Prescription Use (Part 21 CFR 801 Subpart D)
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."
{3}------------------------------------------------
510(k) Summary
Prepared on: 2022-06-14
Contact Details
| Applicant Name | Fifth Eye Inc. |
|---|---|
| Applicant Address | 110 Miller Avenue, Suite 300 Ann Arbor MI 48104 United States |
| Applicant Contact Telephone | 734-260-4800 |
| Applicant Contact | Ms. Jennifer Baird |
| Applicant Contact Email | jbaird@fiftheye.com |
| Correspondent Name | Biologics Consulting |
| Correspondent Address | 1555 King Street, Suite 300 Alexandria VA 22314 United States |
| Correspondent Contact Telephone | (410) 531- 6542 |
| Correspondent Contact | Dr. Donna-Bea Tillman |
| Correspondent Contact Email | dtillman@biologicsconsulting.com |
21 CFR 807.92(a)(2)
| Device Trade Name | AHI System (v 2.2.0) |
|---|---|
| Common Name | Adjunctive hemodynamic indicator with decision point |
| Classification Name | Adjunctive Hemodynamic Indicator With Decision Point |
| Regulation Number | 870.2220 |
| Product Code | QNV |
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K212219 | AHI System | QNV |
21 CFR 807.92(a)(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:1. Analytic for Hemodynamic Instability (AHI): Utilizing data from a single existing lead of a non-invasive electrocardiograph (ECG), AH analyzes heart rate variability (HRV) and ECG morphology features to rapidly detect signs of hemodynamic stability 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 (AH-P); Utilizing AH outputs from up to the most recent 30 minutes of EG data, AH-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.
{4}------------------------------------------------
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-ll ECG waveform intended to describe a patient's hemodynamic status and indicate if a patient is showing stability or instability or instability. Signs of hemodynamic instability (HI) are defined as hypotension (systolic blood pressure <90 mmHq or mean arterial pressure (MAP) <70 mmHg) combined with tachycardia (heart rate ≥ 100 bpm).
AHI-Pl provides the clinician with physiological insight into a patient's likelihood of a future episode of HI is defined as 10 continuous minutes or more where HI is present.
The goal of this adjunctive monitoring method is to enable identification of patients who are showing Hl or are likely to experience a future episode of H, and to allow clinicians an opportunity to increase vigilance. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Indications for Use Comparison
The subject device and predicate device have identical indications for use statements.
Technological Comparison
Technological Characteristics: The subject device have very similar technological characteristics. The only difference is a minor modification to the user interface to allow users to contraindicate only the whom contraindications apply, rather than having to proactively assert "not contraindicated" on all patients.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Software: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a moderate level of concern. Testing was conducted to ensure the AH System works as designed.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
§ 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.