The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician).

The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.

Device Description

CORE 500 Digital Stethoscope (CORE 500) is an electronic stethoscope with integrated electrodes for electrocardiogram (ECG). The device consists of a chestpiece, detachable earpiece (Eko Earpiece) and a mobile application (Eko App) and is intended as a digital auscultation tool on patients requiring physical assessment by the health care providers. CORE 500 provides the ability to amplify, filter, and transfer body sounds with the chestpiece diaphragm, and three lead ECG through electrodes integrated around the chestpiece.

CORE 500 features three auscultation modes for better auscultation experience by filtering acoustic data and enhancing the primary frequency range of particular body sounds: Cardiac Mode for heart sounds. Pulmonary Mode for lung sounds, and Wide Band Mode for general auscultation. CORE 500 also detects and computes the heart rate in real-time based on the phonocardiogram (PCG) data.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided FDA 510(k) summary for the Eko CORE 500 Digital Stethoscope:

Note: The provided document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not detail a clinical study with specific acceptance criteria related to diagnostic performance involving human subjects and ground truth established by experts. The "acceptance criteria" discussed below are based on the non-clinical performance data provided.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an electronic stethoscope, the "acceptance criteria" are derived from the performance data provided to show equivalence and functionality. The document doesn't explicitly list pass/fail criteria with numerical thresholds in the same way a clinical trial might, but it states that "the CORE 500 Digital Stethoscope complies with" or "demonstrated compliance" with various standards and performance benchmarks.

Acceptance Criterion Type	Description of Criterion (Implicit)	Reported Device Performance
Biocompatibility	Device materials in contact with the body must be biocompatible.	Complies with ISO 10993-1:2018. The evaluation report concluded that the device is biocompatible.
Electrical Safety	Device must meet electrical safety standards.	Complies with IEC 60601-1.
EMC (Electromagnetic Compatibility)	Device must meet electromagnetic compatibility standards.	Complies with IEC 60601-1-2.
Software Verification & Validation	Software must be verified and validated.	Verified and validated according to FDA guidance.
Bench Testing (General Performance)	Differences between the subject and predicate devices do not raise new questions of safety and effectiveness.	Rigorous bench testing conducted to demonstrate product performance.
Audio Performance	Acoustic performance (amplification, filtering) must be adequate for intended use.	Testing conducted to verify audio performance. (Specific metrics not detailed in summary)
Electrical & Mechanical Function	Electrical and mechanical functions (e.g., buttons, display, connectivity) must operate as intended.	Testing conducted to verify electrical and mechanical function. (Specific metrics not detailed in summary)
Heart Rate Measurement	Heart rate detection must be accurate based on PCG data.	Testing conducted to verify heart rate measurement. (Specific metrics not detailed in summary)
ECG Frequency Range	While different from predicate (0.1-250 Hz vs 0.15-200 Hz), the wider range should not raise new safety/effectiveness questions.	Deemed acceptable as it "does not raise different questions of safety and effectiveness."
Number of ECG Electrodes	While different from predicate (3 dry electrodes vs 2 dry electrodes), the change should not raise new safety/effectiveness questions.	Deemed acceptable as it "does not raise different questions of safety and effectiveness."
Hardware Interface	While different from predicate (additional display, capacitive touch), the added features should not raise new safety/effectiveness questions.	Deemed acceptable as the "additional interfaces do not raise different questions of safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes non-clinical bench testing rather than a clinical study with a "test set" of patient data. Therefore, there is no patient sample size or provenance information in the sense of a clinical trial (e.g., country of origin, retrospective/prospective). The testing involved physical devices and simulated or controlled environments to assess performance properties.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

As this was non-clinical bench testing, no medical experts were explicitly used to establish "ground truth" for a patient test set. The tests focused on objective electrical, mechanical, and software performance criteria verified against technical standards and internal specifications, not diagnostic accuracy in a clinical context.

4. Adjudication Method for the Test Set

Since there was no patient test set requiring expert interpretation or diagnosis, there was no adjudication method (like 2+1 or 3+1) used.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical performance data for substantial equivalence, not a study assessing how human readers improve with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document pertains to the CORE 500 Digital Stethoscope hardware, which amplifies, filters, and transfers body sounds and ECG waveforms, and displays ECG waveforms and heart rate. While the device processes signals, it's a diagnostic tool, and the indications for use explicitly state: "The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data." This indicates that the device is intended for human-in-the-loop use. Therefore, a standalone algorithm-only performance assessment in a diagnostic context was not the focus of this submission. The "heart rate detection" is a standalone function of the device, but its diagnostic interpretation is with a clinician.

7. The Type of Ground Truth Used

For the non-clinical tests described:

Biocompatibility: Ground truth is established by adherence to ISO 10993-1:2018 standards and laboratory testing results.
Electrical Safety & EMC: Ground truth is established by compliance with IEC 60601-1 and IEC 60601-1-2 standards.
Software V&V: Ground truth is established by meeting FDA Guidance for Premarket Submissions for Software and internal software requirements.
Bench Testing (Audio, Electrical/Mechanical, Heart Rate): Ground truth is based on engineering specifications, established physical principles, and comparison to calibrated reference instruments/signals.

8. The Sample Size for the Training Set

The document describes premarket notification for a hardware device (digital stethoscope) with integrated capabilities. It does not mention machine learning or AI algorithms requiring a "training set" in the context of diagnostic interpretation (e.g., for automated murmur detection or arrhythmia classification). While heart rate detection is mentioned, the details of its underlying algorithm training are not provided. No specific "training set" size is part of this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

Since no explicit "training set" for a diagnostic AI algorithm is described as part of this submission, the method for establishing its ground truth is not applicable here.

Summary

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May 26, 2023

Eko Devices, Inc. Sam Huang, Ph.D. Director of Regulatory Affairs 1212 Broadway, Suite 100 Oakland, California 94612

Re: K230111

Trade/Device Name: CORE 500 Digital Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II Product Code: DQD Dated: January 13, 2023 Received: January 17, 2023

Dear Sam Huang, Ph.D .:

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

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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,

Robert T. Kazmierski -S

for

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.

510(k) Number (if known) K230111

Device Name CORE 500 Digital Stethoscope

Indications for Use (Describe)

The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.

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)

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."

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GENERAL INFORMATION

Applicant: Eko Devices, Inc. 1212 Broadway, Suite 100 Oakland, CA 94612 Phone: 844-356-3384

Contact Person: Sam Huang, Ph.D. Director of Regulatory Affairs Eko Devices, Inc. 1212 Broadway, Suite 100 Oakland, CA 94612

Date Prepared: January 13, 2023

DEVICE INFORMATION

Trade/Proprietary Name: CORE 500 Digital Stethoscope Regulation number: 21 CFR 870.1875 Device Classification Name: Electronic Stethoscope Regulatory Class: Class II Product Code: DQD, DPS

PREDICATE DEVICE

Predicate Device: Eko Model E5 System (EME5), Eko DUO (K170874) Reference Device: Eko Analysis Software (EAS) (K192004)

DEVICE DESCRIPTION

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INDICATIONS FOR USE

The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.

SUBSTANTIAL EQUIVALENCE

The CORE 500 Digital Stethoscope (CORE 500) is substantially equivalent to its predicate devices with regard to the intended use and the indications for use. Any differences in technological characteristics do not raise new questions on safety or effectiveness compared to the predicate device. A substantial equivalence comparison table between the subject device and the predicate device is provided below.

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Table 1 Substantial Equivalence Summary Comparison

	Subject Device:CORE 500 DigitalStethoscope	Predicate Device:Eko Model E5 System(EME5), Eko DUO(K170874)	Reference Device:Eko Analysis Software(EAS)(K192004)	Comparison
DeviceClassificationName	Electronic Stethoscope	Electronic Stethoscope	Cardiac Monitor	Same as thepredicate
RegulationNumber	21 CFR 870.1875	21 CFR 870.1875	21 CFR 870.2300	Same as thepredicate
ClassificationProduct Code	DQD, DPS	DQD, DPS	MWI, DQD, DPS	Same as thepredicate
Indications forUse	The CORE 500 DigitalStethoscope is intended to beused by clinicians toelectronically amplify, filter,and transfer body soundsand three leadelectrocardiogram (ECG)waveforms. The CORE 500Digital Stethoscope alsodisplays ECG waveformsand heart rate on the displayand accompanying mobileapplication (when prescribedor used under the care of aclinician).The data offered by the	The Eko Model E5 System isintended to be used byhealthcare professionals toelectronically amplify, filter,and transfer body sounds andsingle-channelelectrocardiogram (ECG)waveforms. The Eko Model E5System also displays ECGwaveforms andphonocardiogram waveforms onthe accompanying mobileapplication for storage andsharing (when prescribed orused under the care of aphysician). It can be used torecord heart sounds and cardiac	The Eko AnalysisSoftware is intended toprovide support to thephysician in the evaluationof patients' heart soundsand ECG's. The softwareanalyzes simultaneousECG and heart sounds.The software will detectthe presence of suspectedmurmurs in the heartsounds. The software alsodetects the presence ofatrial fibrillation andnormal sinus rhythm fromthe ECG signal. Inaddition, it calculates	Same intendeduse andindications foruse as thepredicate
	Subject Device:CORE 500 DigitalStethoscope	Predicate Device:Eko Model E5 System(EME5), Eko DUO(K170874)	Reference Device:Eko Analysis Software(EAS)(K192004)	Comparison
	device is only significantwhen used in conjunctionwith clinician evaluation aswell as consideration ofother relevant patient data.	murmurs, bruits, respiratorysounds, and abdominal soundsduring physical examination innormal patients or those withsuspected diseases of thecardiac, vascular, pulmonary, orabdominal organ systems. Thedevice can be used on adultsand pediatrics.The data offered by the deviceis only significant when used inconjunction with physician overread as well as consideration ofother relevant patient data.The device should not be usedon infants weighing less than10kg.	certain cardiac timeintervals such as heartrate, QRS duration andEMAT. The software doesnot distinguish betweendifferent kinds of murmursand does not identify otherarrhythmias.It is not intended as a solemeans of diagnosis. Theinterpretations of heartsounds and ECG offeredby the software are onlysignificant when used inconjunction with physicianover-read and is for use onadults (> 18 years).
PatientPopulation	Adults and pediatric patients	Adults and pediatric patients	Adults (> 18 years)	Same as thepredicate
Prescribed	Prescription Only	Prescription Only	Prescription Only	Same as thepredicate
Technological Characteristics Comparison
	Subject Device:CORE 500 DigitalStethoscope	Predicate Device:Eko Model E5 System(EME5), Eko DUO(K170874)	Reference Device:Eko Analysis Software(EAS)(K192004)	Comparison
Type of DataAcquired	Body sounds and ECG	Body sounds and ECG	N/A as EAS is astandalone software	Same as thepredicate
Connectivity	Bluetooth Low Energy(BLE)	Bluetooth Low Energy (BLE)	N/A as EAS is astandalone software	Same as thepredicate
Battery Type	Rechargeable Lithium-ion,3.7V	Rechargeable lithium-ion, 3.7V	N/A as EAS is astandalone software	Same as thepredicate
AudioFrequencyRange	20 Hz - 2000 Hz	20 Hz - 2000 Hz	N/A as EAS is astandalone software	Same as thepredicate
ECGFrequencyRange	0.1 - 250 Hz	0.15 - 200 Hz	N/A as EAS is astandalone software	Similar to thepredicate.The subjectdevice has widerfrequency rangethat does not raisedifferentquestions ofsafety andeffectiveness
Mechanism ofAction	User places the device onthe body for auscultation.The device simultaneouslycaptures ECG, and Audiodata which is transmitted via	User places the device on thebody for auscultation. Thedevice simultaneously capturesECG, and Audio data which istransmitted via Bluetooth to the	N/A as EAS is astandalone software	Same as thepredicate
	Subject Device:CORE 500 DigitalStethoscope	Predicate Device:Eko Model E5 System(EME5), Eko DUO(K170874)	Reference Device:Eko Analysis Software(EAS)(K192004)	Comparison
	Bluetooth to the Mobileapplication.	Mobile application.
No. of ECGElectrodes	Three (3) dry electrodes	Two (2) dry electrodes	N/A as EAS is astandalone software	Different.The technologycharacteristicdifference doesnot raise differentquestions ofsafety andeffectiveness
HardwareInterface	DisplayMode ButtonVolume ButtonCapacitive touch	Mode ButtonVolume Button	N/A as EAS is astandalone software	Similar to thepredicate.The additionalinterfaces do notraise differentquestions ofsafety andeffectiveness
SoftwareInterface	Mobile Application (EkoApp)	Mobile Application (Eko App)	N/A as EAS is astandalone software	Same as thepredicate
Recording andPlayback	Yes	Yes	N/A as EAS is astandalone software	Same as thepredicate
Heart RateDetection	PCG-based	N/A	ECG-based and/or PCG-based	Similar tothe reference
	Subject Device:CORE 500 DigitalStethoscope	Predicate Device:Eko Model E5 System(EME5), Eko DUO(K170874)	Reference Device:Eko Analysis Software(EAS)(K192004)	Comparison
				device
Visualization ofSound andECGWaveforms	Yes	Yes	N/A as EAS is astandalone software	Same as thepredicate
AuscultationMode	Cardiac ModePulmonary ModeWide Band Mode	Diaphragm ModePulmonary ModeBell Mode	N/A as EAS is astandalone software	Similar to thepredicate.The filter settingdifference doesnot raise differentquestions ofsafety andeffectiveness

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PERFORMANCE DATA - NONCLINICAL TESTING SUMMARY

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility

Biological evaluations were conducted with the CORE 500 Digital Stethoscope according to ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The evaluation report concluded that the CORE 500 Digital Stethoscope is biocompatible.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted and demonstrated CORE 500 Digital Stethoscope complies with IEC 60601-1. IEC 60601-2-47 standard for safety, IEC 60601-1-2 for electromagnetic compatibility.

Software verification and validation testing

The software of this device is verified and validated according to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

Bench testing

The CORE 500 Digital Stethoscope has gone through rigorous bench testing to demonstrate the product performance, and confirmed that differences between the subject and predicate device do not raise different questions of safety and effectiveness. The testing includes the following:

· Audio performance
Electrical and mechanical function verification, and
Heart rate measurement

CONCLUSIONS

The indications for use, technological characteristics and performance testing support that the proposed device, the CORE 500 Digital Stethoscope is substantially equivalent, and as safe and effective as the predicate device, and raises no new issues of safety or effectiveness.

Regulation Number and Section

§ 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.