(205 days)
Yes
The device description explicitly states that the software uses "algorithms derived from machine learning".
No
The device provides decision support to clinicians and its interpretations are not diagnoses, indicating it does not directly treat or prevent a disease or condition.
Yes
This device is designed to "automatically detect murmurs that may be present, and the murmur timing and character" and to "classify them as innocent or structural", which falls under the scope of diagnostic capabilities by identifying or classifying disease. However, it also clarifies that the interpretations "are not diagnoses" and are intended for "decision support" for clinicians.
Yes
The device is described as "Eko Murmur Analysis Software (EMAS)" and is a cloud-based service that analyzes data uploaded via an API. It explicitly states it is designed to evaluate data from previously cleared hardware devices (Eko DUO and Eko CORE) but is itself a software service.
Based on the provided information, the Eko Murmur Analysis Software (EMAS) 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 obtain information for diagnostic or monitoring purposes.
- EMAS Function: The EMAS analyzes heart sounds and phonocardiograms (and ECG signals), which are physiological signals acquired from the body's surface, not specimens taken from within the body.
- Intended Use: The intended use clearly states that the software analyzes heart sounds and provides decision support to clinicians in their evaluation of patients' heart sounds. It does not involve the analysis of biological specimens.
Therefore, the EMAS falls under the category of a medical device that analyzes physiological signals, rather than an In Vitro Diagnostic device.
No
The input letter does not explicitly state that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The Eko Murmur Analysis Software (EMAS) is intended to provide decision support to clinicians in their evaluation of patients' heart sounds. The software analyzes heart sounds and phonocardiograms (and ECG signals, when available). The software will automatically detect murmurs that may be present, and the murmur timing and character, including S1, S2, innocent heart murmurs, structural heart murmurs, and the absence of a heart murmur.
The Eko Murmur Analysis Software is not intended as a sole means of diagnosis and is for use in environments where health care is provided by clinicians. The interpretations of heart sounds offered by the software are meant only to provide decision support to the clinician, who may use the result in conjunction with their own evaluation and clinical judgment. The interpretations are not diagnoses. The Eko Murmur Analysis Software is intended for use on pediatic and adult patients.
Product codes
DQD, DQC, DPS
Device Description
Eko Murmur Analysis Software (EMAS) is a cloud-based service that allows users to upload heart sound/phonocardiogram (PCG) and optional electrocardiogram (ECG) data via an application programming interface (API) for analysis. The software uses signal processing (such as waveform filtering), as well as algorithms derived from machine learning, to analyze the acquired data and generate clinical decision support output for clinicians. EMAS is designed to evaluate data derived by the company's two previously cleared devices, the Eko DUO (K170874) and Eko CORE (K151319, K200776). The heart sound data from those devices can be transmitted to the Eko Cloud using either the Eko mobile application or thirdparty applications that use a software development kit (SDK). The EMAS algorithm analyzes the heart sound data and outputs a JSON file with the algorithm results, which is passed down to the requesting application and displayed by the requesting application to the user in the humanreadable format.
The analysis will assess the signal quality of the phonocardiogram; detect heart murmurs and classify them as innocent or structural; determine the timing of S1 and S2 heart sounds; and distinguish between systolic and diastolic heart murmurs. As an integral part of a physical assessment, clinicians' interpretations of EMAS' output can help them rule in or rule out different pathological conditions in a patient.
The EMAS consists of the following algorithm components:
-
Signal Quality Detection Algorithm: .
This pre-processing algorithm accepts as input the PCG sound from the API controller (e.g., a mobile smartphone application). The algorithm is used to classify PCG recordings based on their signal quality as good or poor. -
Heart Sound Timing Algorithm: ● This algorithm detects the presence and timing of specific heart sounds including S1, S2, the systole region, and the diastole region.
-
Murmur Detection & Classification Algorithm: This algorithm is used to identify and classify heart sounds as having "No Murmur", an "Innocent Murmur" (i.e., not pathologic), or a "Structural Murmur" (i.e., pathologic).
-
Murmur Timing Algorithm:
This algorithm is used to identify in which regions of the heart cycle (systole vs diastole) a heart murmur occurs if either an "Innocent Murmur" or "Structural Murmur" is identified by the Murmur Detection and Classification Algorithm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
algorithms derived from machine learning
Input Imaging Modality
Not Found
Anatomical Site
Heart sounds
Indicated Patient Age Range
pediatric and adult patients.
Intended User / Care Setting
clinicians in environments where health care is provided by clinicians
Description of the training set, sample size, data source, and annotation protocol
No study subjects included in the training datasets were included in the test database.
Description of the test set, sample size, data source, and annotation protocol
The algorithms in this submission have been validated using retrospective analysis on a proprietary database. The database contains 2.380 unique heart sound recordings from 615 unique subjects. In the proprietary database, all heart sound recordings were collected using the Eko CORE (67.6%) or Eko DUO (32.4%) digital stethoscopes. The subject population was 42.6% female and had an age range of 0 to 95 years old, race was recorded in 45% of the subjects and out of that subset, 98% were white, 1.5% were African American and 0.7% were Asian. No complications or adverse events were experienced during the use of the EMAS device.
All recordings were annotated by multiple cardiologists in respect to their quality and the presence of any murmur. Of the recordings identified as being good signal by the expert cardiologists, 45.8% had a confirmed structural murmur and 54.2% had a confirmed no murmur or innocent murmur. Ground truth for murmur classification was obtained via pairing cardiologist annotations with gold standard echocardiogram. Additionally, 299 heart sound recordings were annotated by expert cardiologists to obtain the timing of the S1 and S2 sounds. Cardiologists were blinded to all subject demographic data and echocardiogram findings during annotation.
All algorithm testing was performed once the final EMAS version was locked.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Eko Murmur Analysis Software was the subject of software verification and validation testing, consistent with the principles outlined in FDA's General Principles of Software Validation: Final Guidance for Industry and FDA Staff issued May 11, 2005.
The algorithms in this submission have been validated using retrospective analysis on a proprietary database. The database contains 2.380 unique heart sound recordings from 615 unique subjects.
The lower bounds of the 95% confidence intervals of the primary predicate device are 72.9% and 74.9% for sensitivity and specificity, respectively. Through clinical validation, the lower bound of EMAS' calculated 95% confidence interval is found to be above 75.0%, thus demonstrating substantially equivalent performance (effectiveness) to the predicate device (eMurmur).
Given the data described above, the EMAS algorithm testing shows substantially equivalent performance to the predicate devices where applicable. Based on the clinical performance, the Eko Murmur Analysis Software has a safety and effectiveness profile that is similar to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Murmur Classification:
Sensitivity (%): 85.6 (95% CI: 82.6 - 88.7)
Specificity (%): 84.4 (95% CI: 81.3 - 87.5)
Heart Sound Timing:
S1 Detection:
Sensitivity (%): 96.2 (95% CI: 94.9 - 97.4)
PPV (%): 97.1 (95% CI: 96.3 - 98.0)
S2 Detection:
Sensitivity (%): 92.3 (95% CI: 90.3 - 94.3)
PPV (%): 94.3 (95% CI: 93.4 - 95.1)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
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June 29, 2022
Eko Devices, Inc. Sam Huang Director of Regulatory Affairs 1212 Broadway, Suite 100 Oakland, California 94612
Re: K213794
Trade/Device Name: Eko Murmur Analysis Software (EMAS) Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD, DQC, DPS Dated: Mav 28, 2022 Received: June 2, 2022
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 (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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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,
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
510(k) Number (if known) K213794
Device Name
Eko Murmur Analysis Software (EMAS)
Indications for Use (Describe)
The Eko Murmur Analysis Software (EMAS) is intended to provide decision support to clinicians in their evaluation of patients' heart sounds. The software analyzes heart sounds and phonocardiograms (and ECG signals, when available). The software will automatically detect murmurs that may be present, and the murmur timing and character, including S1, S2, innocent heart murmurs, structural heart murmurs, and the absence of a heart murmur.
The Eko Murmur Analysis Software is not intended as a sole means of diagnosis and is for use in environments where health care is provided by clinicians. The interpretations of heart sounds offered by the software are meant only to provide decision support to the clinician, who may use the result in conjunction with their own evaluation and clinical judgment. The interpretations are not diagnoses. The Eko Murmur Analysis Software is intended for use on pediatic and adult patients.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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GENERAL INFORMATION
Applicant: Eko Devices, Inc. 1210 Broadway, Suite 100, Oakland, CA 94612 Phone: 844-356-3384
Contact Person: Sam Huang, Ph.D. Director of Regulatory Affairs Eko Devices, Inc. 1210 Broadway, Suite 100, Oakland, CA 94612
Date Prepared: Dec 03, 2021
DEVICE INFORMATION
Trade/Proprietary Name: Eko Murmur Analysis Software (EMAS) Regulation number: 21 CFR 870.1875 Classification Name: Electronic Stethoscope Regulatory Class: Class II Product Code: DOD, DOC, DPS
PREDICATE DEVICES
CSD Labs GmbH, eMurmur ID (K181988) Eko Devices, Inc., Eko Analysis Software (K192004)
DEVICE DESCRIPTION
Eko Murmur Analysis Software (EMAS) is a cloud-based service that allows users to upload heart sound/phonocardiogram (PCG) and optional electrocardiogram (ECG) data via an application programming interface (API) for analysis. The software uses signal processing (such as waveform filtering), as well as algorithms derived from machine learning, to analyze the acquired data and generate clinical decision support output for clinicians. EMAS is designed to evaluate data derived by the company's two previously cleared devices, the Eko DUO (K170874) and Eko CORE (K151319, K200776). The heart sound data from those devices can be transmitted to the Eko Cloud using either the Eko mobile application or thirdparty applications that use a software development kit (SDK). The EMAS algorithm analyzes the heart sound data and outputs a JSON file with the algorithm results, which is passed down to the requesting application and displayed by the requesting application to the user in the humanreadable format.
4
The analysis will assess the signal quality of the phonocardiogram; detect heart murmurs and classify them as innocent or structural; determine the timing of S1 and S2 heart sounds; and distinguish between systolic and diastolic heart murmurs. As an integral part of a physical assessment, clinicians' interpretations of EMAS' output can help them rule in or out different pathological conditions in a patient.
The EMAS consists of the following algorithm components:
-
Signal Quality Detection Algorithm: .
This pre-processing algorithm accepts as input the PCG sound from the API controller (e.g., a mobile smartphone application). The algorithm is used to classify PCG recordings based on their signal quality as good or poor. -
Heart Sound Timing Algorithm: ● This algorithm detects the presence and timing of specific heart sounds including S1, S2, the systole region, and the diastole region.
-
Murmur Detection & Classification Algorithm: This algorithm is used to identify and classify heart sounds as having "No Murmur", an "Innocent Murmur" (i.e., not pathologic), or a "Structural Murmur" (i.e., pathologic).
-
Murmur Timing Algorithm:
This algorithm is used to identify in which regions of the heart cycle (systole vs diastole) a heart murmur occurs if either an "Innocent Murmur" or "Structural Murmur" is identified by the Murmur Detection and Classification Algorithm.
INDICATIONS FOR USE
The Eko Murmur Analysis Software is intended to provide decision support to clinicians in their evaluation of patients' heart sounds. The software analyzes heart sounds and phonocardiograms (and ECG signals, when available). The software will automatically detect murmurs that may be present, and the murmur timing and character, including S1, S2, innocent heart murmurs, structural heart murmurs, and the absence of a heart murmur.
The Eko Murmur Analysis Software is not intended as a sole means of diagnosis and is for use in environments where health care is provided by clinicians. The interpretations of heart sounds offered by the software are meant only to provide decision support to the clinician, who may use the result in conjunction with their own evaluation and clinical judgment. The interpretations are not diagnoses. The Eko Murmur Analysis Software is intended for use on pediatric and adult patients.
SUBSTANTIAL EQUIVALENCE
Eko Murmur Analysis Software (EMAS) has the same intended use as the predicate devices for providing support to the physician in the evaluation of heart-related physiological data. Additionally, EMAS combines the indications of the predicate devices into a single product: algorithms to classify suspected murmurs as either innocent or structural, similar to that of the eMurmur ID; and algorithms that analyze heart sound data to identify the presence of suspected murmurs, similar to that of the Eko Analysis Software. Any differences in the Eko Murmur
5
Analysis Software's indication statement. i.e., omission of certain outputs and compatible device information, do not alter the intended diagnostic effect of the device.
Eko Murmur Analysis Software also has similar technological characteristics as the predicate devices in regard to it being a software-only analysis tool that analyzes and classifies heart sound data. EMAS's new technological characteristics, i.e., proprietary analysis algorithms, could affect its safety or effectiveness, but do not raise any different questions of safety or effectiveness, because they analyze the same data (input) to determine the same parameters (output) as those of the predicate devices. The performance testing data shown in this application demonstrate that the Eko Murmur Analysis Software is as safe and as effective as the predicate device(s).
A table comparing the key features of the subject and predicate devices is provided below.
| Parameters | Eko Murmur Analysis
Software | eMurmur ID
(Primary Predicate) | Eko Analysis
Software
(Secondary Predicate) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Number | K213794 | K181988 | K192004 |
| Indications for
Use | The Eko Murmur Analysis
Software is intended to
provide decision support
to clinicians in their
evaluation of patients'
heart sounds. The software
analyzes heart sounds and
phonocardiograms (and
ECG signals, when
available). The software
will automatically detect
murmurs that may be
present, and the murmur
timing and character,
including S1, S2, innocent
heart murmurs, structural
heart murmurs, and the
absence of a heart
murmur.
The Eko Murmur Analysis
Software is not intended
as a sole means of
diagnosis and is for use in | The eMurmur ID software
system is a decision
support device for the
healthcare provider (the
user) in the evaluation of
patient heart sounds.
eMurmur ID is used to
record, display, analyze,
and store the acoustic
signal of the heart,
recorded by means of an
electronic stethoscope. The
automated analysis will
identify specific heart
sounds that may be present,
including S1, S2,
physiological heart
murmurs, pathological
heart murmurs and absence
of a heart murmur.
eMurmur ID is indicated
for use in a setting where
auscultation would | The Eko Analysis
Software is intended to
provide support to the
physician in the
evaluation of patients'
heart sounds and
ECG's. The software
analyzes simultaneous
ECG and heart sounds.
The software will
detect the presence of
suspected murmurs in
the heart sounds. The
software also detects
the presence of atrial
fibrillation and normal
sinus rhythm from the
ECG signal. In
addition, it calculates
certain cardiac time
intervals such as heart
rate, ORS duration and
EMAT. The software
does not distinguish |
| Parameters | Eko Murmur Analysis
Software | eMurmur ID
(Primary Predicate) | Eko Analysis
Software
(Secondary Predicate) |
| environments where
health care is provided by
clinicians. The
interpretations of heart
sounds offered by the
software are meant only to
provide decision support
to the clinician, who may
use the result in
conjunction with their
own evaluation and
clinical judgment. The
interpretations are not
diagnoses. The Eko
Murmur Analysis
Software is intended for
use on pediatric and adult
patients. | typically be performed by a
healthcare provider. It is
not intended as a sole
means of diagnosis. The
heart sound interpretations
offered by eMurmur ID are
only significant when
considered in conjunction
with healthcare provider
over-read and including all
other relevant patient data. | between different kinds
of murmurs and does
not identify other
arrhythmias.
It is not intended as a
sole means of
diagnosis. The
interpretations of heart
sounds and ECG
offered by the software
are only significant
when used in
conjunction with
physician over-read and
is for use on adults (>
18 years). | |
| Patient
Population | Adult and pediatric
patients | Adult and pediatric patients | Adult patients |
| Device
Classification | DQD, DQC, DPS | DQD, DQC | MWI, DQD, DPS |
| Prescribed | Prescription Only | Prescription Only | Prescription Only |
| Components | Software Only | Software Only | Software Only |
| Interface | Callable application
programming interface
(API) | N/A (Self-contained
software application) | Callable application
programming interface
(API) |
| Display | No primary display | No primary display | No primary display |
| Murmur
Detection | Yes | Yes | Yes |
| Murmur
Classification | Yes | Yes | No |
Table 1 Substantial Equivalence Summary Comparison
6
7
PERFORMANCE DATA - NONCLINICAL TESTING SUMMARY
The Eko Murmur Analysis Software was the subject of software verification and validation testing, consistent with the principles outlined in FDA's General Principles of Software Validation: Final Guidance for Industry and FDA Staff issued May 11, 2005.
PERFORMANCE DATA - CLINICAL TESTING SUMMARY
The algorithms in this submission have been validated using retrospective analysis on a proprietary database. The database contains 2.380 unique heart sound recordings from 615 unique subjects. In the proprietary database, all heart sound recordings were collected using the Eko CORE (67.6%) or Eko DUO (32.4%) digital stethoscopes. The subject population was 42.6% female and had an age range of 0 to 95 years old, race was recorded in 45% of the subjects and out of that subset, 98% were white, 1.5% were African American and 0.7% were Asian. No complications or adverse events were experienced during the use of the EMAS device.
All recordings were annotated by multiple cardiologists in respect to their quality and the presence of any murmur. Of the recordings identified as being good signal by the expert cardiologists, 45.8% had a confirmed structural murmur and 54,2% had a confirmed no murmur or innocent murmur. Ground truth for murmur classification was obtained via pairing cardiologist annotations with gold standard echocardiogram. Additionally, 299 heart sound recordings were annotated by expert cardiologists to obtain the timing of the S1 and S2 sounds. Cardiologists were blinded to all subject demographic data and echocardiogram findings during annotation.
No study subjects included in the training datasets were included in the test database. All algorithm testing was performed once the final EMAS version was locked.
The following tables demonstrate the results of the primary performance analyses (Murmur Classification and Heart Sound Timing).
Table 2 EMAS Murmur Classification Performance
| Sensitivity (%) | Specificity (%) | |
|---|---|---|
| Murmur Classification | 85.6 | |
| (95% CI: 82.6 - 88.7) | 84.4 | |
| (95% CI: 81.3 - 87.5) |
The lower bounds of the 95% confidence intervals of the primary predicate device are 72.9% and 74.9% for sensitivity and specificity, respectively. Through clinical validation, the lower bound of EMAS' calculated 95% confidence interval is found to be above 75.0%, thus demonstrating substantially equivalent performance (effectiveness) to the predicate device (eMurmur).
8
| Sensitivity (%) | PPV (%) | ||
|---|---|---|---|
| Heart Sound | |||
| Timing | S1 Detection | 96.2 | |
| (95% CI: 94.9 - 97.4) | 97.1 | ||
| (95% CI: 96.3 - 98.0) | |||
| S2 Detection | 92.3 | ||
| (95% CI: 90.3 - 94.3) | 94.3 | ||
| (95% CI: 93.4 - 95.1) |
Table 3 EMAS Heart Sound Timing Performance
Given the data described above, the EMAS algorithm testing shows substantially equivalent performance to the predicate devices where applicable. Based on the clinical performance, the Eko Murmur Analysis Software has a safety and effectiveness profile that is similar to the predicate devices.
CONCLUSIONS
The Eko Murmur Analysis Software is as safe and as effective as the predicate devices. The Eko Murmur Analysis Software has the same intended uses and similar indications, technological characteristics, and principles of operation as its primary predicate device. The minor differences in indications do not alter the intended diagnostic use of the device and do not raise different questions of safety and effectiveness when used as labeled. In addition, the minor technological differences between the Eko Murmur Analysis Software and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Eko Murmur Analysis Software is as safe and effective as the predicate devices. Thus, the Eko Murmur Analysis Software is substantially equivalent.