(174 days)
Yes
The device description explicitly states that the software uses "machine learning algorithms" and is a "machine learning based notification software which employs machine learning techniques". It also mentions the use of "deep neural network models" and "deep convolutional network models". Furthermore, the predicate device is listed as "Low Ejection Fraction AI ECG Algorithm".
No
The device is described as a software intended to aid clinicians in identifying individuals with LVEF
No
The device description explicitly states: "It is intended as the basis for further testing and is not intended to provide diagnostic quality output. As an integral part of a physical assessment, clinician's interpretations of this data can help identify previously undiagnosed left ventricular dysfunction in a patient." It is meant to aid identification, not provide a diagnosis.
Yes
The device is described as an "algorithm" and "software" that takes input from FDA-cleared Eko Stethoscopes (hardware) but the device itself is the software component that processes the data. The description focuses on the software's function and algorithms, not on any accompanying hardware.
Based on the provided information, the Eko Low Ejection Fraction Tool (ELEFT) 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.
- ELEFT's Input: ELEFT takes ECG and heart sounds as input. These are physiological signals recorded directly from the patient's body, not specimens taken from the body for laboratory analysis.
- ELEFT's Purpose: ELEFT is intended to aid clinicians in identifying individuals with low LVEF based on these physiological signals. It is explicitly stated that it is not a diagnosis and is intended as the basis for further testing.
Therefore, because ELEFT analyzes physiological signals from the body rather than specimens taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
No
The letter 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
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure This population includes, but is not limited to, patients with: coronary artery disease, diabetes mellitus; cardiomyopathy; hypertension; and obesity.
The interpretations of heart sounds and ECG offered by the software are meant only to assist healthcare providers in assessing Left Ventricular Eiection 40%).
Based on these two categories, 9.9% of recordings came from subjects with confirmed Low EF and 90.1% of recordings came from subjects with confirmed Normal EF. Of note, 307 recordings of the total 3,456 recordings were excluded from the performance analysis as a result of poor ECG quality.
Five sites within the US (n = 4) and India (n = 1) contributed data from 2,960 and 496 patients, respectively. The median age in the sample was 64 (IQR 52-73), and 44.3% (1,530) of patients were female. The majority of patients were White (2,011 [58.2%]), followed by Black or African American (748 [21.6%]), Asian (517 [15.0%]), American Indian or Alaska Native (28 [0.8%]), Other (147 [4.3]), and Native Hawaiian or Other Pacific Islander (5, 0.1%) and therefore representative of the intended use population.
In this sample, 307 records were excluded as a result of poor ECG quality, and a total of 341 cases of EF 40%). 3,456 recordings of which 307 were excluded due to poor ECG quality.
Key Results:
Sensitivity (Low EF Detection): 74.7% (95% CI: 69.4-79.6)
Specificity (Low EF Detection): 77.5% (95% CI: 75.9-79.0)
Positive Predictive Value (PPV): 25.7% (95%CI: 22.8-28.7)
Negative Predictive Value (NPV): 96.7% (95%CI: 95.9 to 97.4)
Subgroup Analyses:
Age: Specificity showed a slightly lower value for patients aged >70 years (70.7% [95%CI: 67.8-73.5]) compared to 31-50 (80.9% [95%CI: 77.3-84.3]) and 51-70 (81.1% [95%CI: 78.8-83.2]).
Biological sex: Specificity varied slightly (male: 73.6% [95% CI: 71.3-75.8] vs female: 81.8% [95% CI: 79.7-83.9]).
Body-Mass-Index (BMI): No significant differences were observed.
Race/ethnicity: No significant differences were observed.
Conduction disorders: Overall trend toward increased sensitivity but not significant. Specificity was lower for patients with these comorbidities.
Key Metrics
Sensitivity (Low EF Detection): 74.7% (95% CI: 69.4-79.6)
Specificity (Low EF Detection): 77.5% (95% CI: 75.9-79.0)
Positive Predictive Value (PPV): 25.7% (95%CI: 22.8-28.7)
Negative Predictive Value (NPV): 96.7% (95%CI: 95.9 to 97.4)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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March 28, 2024
Eko Health, Inc. Sam Huang Director of Regulatory Affairs 2100 Powell Street Suite 300 Emeryville, California 94608
Re: K233409
Trade/Device Name: Eko Low Ejection Fraction Tool (ELEFT) Regulation Number: 21 CFR 870.2380 Regulation Name: Cardiovascular Machine Learning-Based Notification Software Regulatory Class: Class II Product Code: OYE Dated: March 27, 2024 Received: March 27, 2024
Dear Sam Huang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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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 C. Browning -S
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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Eko Low Ejection Fraction Tool (ELEFT)
Indications for Use (Describe)
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure This population includes, but is not limited to, patients with: coronary artery disease, diabetes mellitus; cardiomyopathy; hypertension; and obesity.
The interpretations of heart sounds and ECG offered by the software are meant only to assist healthcare providers in assessing Left Ventricular Eiection ≤ 40%, who may use the result in conjunction with their own evaluation and clinical judgment. It is not a diagnosis or for monitoring of patients diagnosed with heart failure. This software is for use on adults (18 years and older).
Type of Use (Select one or both, as applicable)
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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GENERAL INFORMATION
Applicant: Eko Health, Inc. 2100 Powell Street, Suite 300, Emeryville, CA 94608 Phone: 844-356-3384
Contact Person: Sam H. Huang, Ph.D. Director of Regulatory Affairs Eko Health, Inc.
Date Prepared: March 25th, 2024
DEVICE INFORMATION
Trade/Proprietary Name: Eko Low Ejection Fraction Tool (ELEFT) Regulation number: 21 CFR 870.2380 Regulation Name: Cardiovascular machine learning-based notification software Regulatory Class: Class II Product Code: QYE
PREDICATE DEVICES
- Low Ejection Fraction AI ECG Algorithm (K232699) .
DEVICE DESCRIPTION
Eko Low Ejection Fraction Tool (ELEFT) is an algorithm that is intended to aid clinicians to identify individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds from patients at risk for heart failure. The software uses signal processing as well as machine learning algorithms, to analyze the electrocardiogram (ECG) and heart sound/phonocardiogram (PCG) recording signals generated by FDA-cleared Eko Stethoscopes and saved as .WAV file recordings in the Eko Cloud. ELEFT is a machine learning based notification software which employs machine learning techniques to suggest the likelihood of LVEF 40%).
Based on these two categories, 9.9% of recordings came from subjects with confirmed Low EF and 90.1% of recordings came from subjects with confirmed Normal EF. Of note, 307 recordings of the total 3,456 recordings were excluded from the performance analysis as a result of poor ECG quality.
The following table (Table 2) demonstrates the results of the primary performance analysis (Low EF Detection):
| Sensitivity (%) | Specificity (%) | |
|---|---|---|
| Low EF Detection | 74.7 | |
| (95% CI: 69.4-79.6) | 77.5 | |
| (95% CI: 75.9-79.0) |
Table 2: Clinical Performance of ELEFT.
Additional analysis of validation data supports the safety and effectiveness of the device in the intended use population, including patients at risk of heart failure not diagnosed with coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.
In addition to the above performance data, the below summarizes the patient demographics for the
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training and test sets as well as subgroup analyses to demonstrate generalizability, safety and effectiveness of the tool across patient populations.
Summary-Level Descriptions of Patient Demographics for Training Dataset
Eight sites within the US (n = 7) and India (n = 1) contributed training data from 1,515 and 337 patients, respectively. The median age in the training dataset was 66 (IQR 51-75). 51.3% (951) of patients were male and 45.7% (847) were female, while gender was unknown for the remaining 2.9% (54). The majority of patients were White (1,089 [58.8%]), followed by Black or African American (65 [3.5%]), Asian (423 [22.9%]), American Indian or Alaska Native (2 [0.1%]), Other (24 [1.3%]), Native Hawaiian or Other Pacific Islander (3 [0.2%]), and Unknown (246 [13.3%]). A total of 201 cases of EF 70
years. While no significant differences in sensitivity were
observed among the age groups, the specificity of tests for
patients aged >70 years (70.7% [95%CI: 67.8-73.5]) showed a
slightly lower value compared to those performed on patients
aged 31-50 (80.9% [95%CI: 77.3-84.3]) and 51-70 (81.1%
[95%CI: 78.8-83.2]). Elderly patients are more likely to have
several cardiac comorbidities, potentially resulting in higher
rates of false positives. |
| Biological sex | Specificity varied slightly across biological sex (male:
73.6% [95% CI: 71.3-75.8] vs female: 81.8% [95% CI:
79.7-83.9]. However, this may not reflect a true difference, as
the values may be confounded by the higher prevalence of
cardiac comorbidities in the male subgroup (15.6% vs. 11.5%). |
| Body-Mass-Index (BMI) | BMI was stratified into six categories: =40 kg/m2. No significant differences were
observed. |
| Race/ethnicity | No significant differences were observed. |
| Conduction disorders | In patients with pacemakers or cardiac comorbidities (e.g.,
atrial fibrillation, left bundle branch block, wide QRS complex
[>120ms]), there was an overall trend toward increased
sensitivity, however this was not significant. Specificity,
conversely, was lower for patients with the above
comorbidities. These comorbidities are known to cause
variations in ECG morphology, resulting in higher rates of false
positives in these subgroups. |
Table 3: Clinical Performance in Pre-Specified Subgroup Analyses
CONCLUSIONS
The Eko Low Ejection Fraction Tool (ELEFT) has the same intended use and similar technological characteristics as the Anumana Low Ejection Fraction AI-ECG Algorithm . Differences in technological characteristics have been evaluated through performance testing has shown that the minor technological differences between ELEFT and the predicate device raise no new issues of safety or effectiveness. Bench and clinical data demonstrate that the ELEFT is substantially equivalent to the Anumana Low Ejection Fraction AI-ECG Algorithm .