The CORE 500 Digital Stethoscope is intended to be used by clinicians or lay users 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 or by lay users).

A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.

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 clinicians or lay users. 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. The device can be used in a professional healthcare facility and for home use.

CORE 500 features three auscultation modes for a 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

This FDA 510(k) summary for the Eko Health, Inc. CORE 500 Digital Stethoscope (K233609) describes the device's technical specifications and how it compares to a predicate device. Regarding acceptance criteria and detailed study results, the document provides a general overview rather than specific performance metrics.

Here's an analysis of the provided information concerning acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with corresponding reported device performance values for the CORE 500 Digital Stethoscope in the way one might expect for a clinical performance study. Instead, it lists the types of nonclinical testing performed and asserts that the device complies with standards or demonstrates performance.

Here's a summary of the reported performance without specific numerical acceptance criteria from the document:

Acceptance Criteria (Inferred from testing type)	Reported Device Performance
Biocompatibility (ISO 10993-1:2018)	Concluded that the CORE 500 Digital Stethoscope is biocompatible.
Electrical safety (IEC 60601-1-11, IEC 60601-2-47)	Demonstrated compliance with standards for safety.
Electromagnetic Compatibility (EMC) (IEC 60601-1-2)	Demonstrated compliance with standards for EMC.
Software Verification and Validation (FDA guidance for Content of Premarket Submissions for Device Software Functions)	Software is verified and validated.
Usability Testing (IEC 62366-1)	Intended users are able to achieve intended use with Instructions for Use.
Audio performance	Rigorous bench testing demonstrated product performance.
Electrical and mechanical function verification	Rigorous bench testing demonstrated product performance.
Heart rate measurement	Rigorous bench testing demonstrated product performance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not provide specific sample sizes for test sets, data provenance, or whether studies were retrospective or prospective. The performance data section focuses on nonclinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. The performance data is described as "nonclinical testing" and does not appear to involve expert-adjudicated ground truth as typically found in clinical studies assessing diagnostic accuracy.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided. As the document focuses on nonclinical performance, an adjudication method on a clinical test set is not described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device, the CORE 500 Digital Stethoscope, is primarily an electronic stethoscope for amplifying, filtering, and transferring body sounds and ECG waveforms, and displaying ECG and heart rate. It is not described as having an AI diagnostic interpretation component that would typically be evaluated in an MRMC study with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not explicitly state that a standalone (algorithm only) performance study was done for any specific AI functionality. The device displays ECG waveforms and heart rate, but the document does not describe it as having an autonomous diagnostic algorithm for complex conditions.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given that the performance data described is "nonclinical testing" (bench testing, biocompatibility, electrical safety, software V&V, usability), the concept of "ground truth" as it applies to clinical diagnostic accuracy (e.g., expert consensus, pathology) is not applicable or described in this section. The testing would have focused on meeting technical specifications and regulatory standards.

8. The sample size for the training set

The document does not mention a training set or its sample size. This type of information would typically be provided for devices involving machine learning or AI algorithms with extensive training phases, which is not the primary focus of the performance data in this submission.

9. How the ground truth for the training set was established

Since no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.

Summary of Device and Performance Context:

The K233609 submission for the CORE 500 Digital Stethoscope primarily focuses on demonstrating substantial equivalence to its predicate device (K230111) and a reference device (K200776), particularly for its expanded "Over-The-Counter Use" and inclusion of "lay users." The performance data provided are centered on foundational nonclinical tests to ensure safety, efficacy, and compliance with general device regulations and standards. It's not a submission for a novel diagnostic AI algorithm requiring extensive clinical performance studies with ground truth establishment by experts. The "nonclinical testing" confirms the device's technical functionality, biocompatibility, electrical safety, software validation, and usability for its intended purpose of amplifying, filtering, and transferring body sounds and ECG waveforms, and displaying basic heart rate and ECG.

Summary

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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: K233609

Trade/Device Name: CORE 500 Digital Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD, DPS Dated: November 8, 2023 Received: November 8, 2023

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 (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.

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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" (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 QS 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 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,

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

Submission Number (if known)

K233609

Device Name

CORE 500 Digital Stethoscope

Indications for Use (Describe)

A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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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 Huang, Ph.D. Director of Regulatory Affairs Eko Health, Inc. 2100 Powell Street, Suite 300 Emeryville, CA 94608

Date Prepared: November 9, 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

Primary Predicate: CORE 500 Digital Stethoscope (K230111) Reference Device: Eko CORE (K200776)

DEVICE DESCRIPTION

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INDICATIONS FOR USE

A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.

SUBSTANTIAL EQUIVALENCE

The CORE 500 Digital Stethoscope (CORE 500) has the same intended use, the same technological characteristics as its predicate device. The differences in user groups 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.

Feature	Subject Device:CORE 500 DigitalStethoscope	Predicate Device:CORE 500 DigitalStethoscope(K230111)	Reference Device:Eko CORE(K200776)	Comparison
DeviceClassificationName	ElectronicStethoscope	ElectronicStethoscope	ElectronicStethoscope	Same
RegulationNumber	21 CFR 870.1875	21 CFR 870.1875	21 CFR 870.1875	Same
ClassificationProduct Code	DQD, DPS	DQD, DPS	DQD	Same as thepredicatedevice
Indicationsfor Use	The CORE 500Digital Stethoscopeis intended to be usedby clinicians or layusers toelectronicallyamplify, filter, andtransfer body sounds	The CORE 500Digital Stethoscopeis intended to beused by clinicians toelectronicallyamplify, filter, andtransfer body soundsand three lead	The Eko CORE isan electronicstethoscope thatenablesamplification,filtering, andtransmission ofauscultation sound	Sameintended useas thepredicatedevice,different usergroups.The user
Feature	Subject Device:CORE 500 DigitalStethoscope	Predicate Device:CORE 500 DigitalStethoscope(K230111)	Reference Device:Eko CORE(K200776)	Comparison
	and three leadelectrocardiogram(ECG) waveforms.The CORE 500Digital Stethoscopealso displays ECGwaveforms and heartrate on the displayand accompanyingmobile application(when prescribed orused under the careof a clinician or bylay users).A lay user is notintended to interpretor take clinical actionbased on the deviceoutput withoutconsulting with aqualified healthcareprofessional.	electrocardiogram(ECG) waveforms.The CORE 500Digital Stethoscopealso displays ECGwaveforms and heartrate on the displayand accompanyingmobile application(when prescribed orused under the careof a clinician).The data offered bythe device is onlysignificant whenused in conjunctionwith clinicianevaluation as well asconsideration ofother relevant patientdata.	data (heart, lungs,bowel, arteries, andveins), whereby aclinician at onelocation on networkcan listen to theauscultation soundsof a patient on siteor at a differentlocation on thenetwork. EkoCORE is intendedfor use on pediatricand adult patients.The Eko CORE isintended to be usedby professionalusers in a clinicalenvironment or bylay users in anonclinicalenvironment. Thedevice is notintended forself-diagnosis.	groupdifferencedoes not raisedifferentquestions ofsafety andeffectiveness
PatientPopulation	Adults and pediatricpatients	Adults and pediatricpatients	Adults andpediatric patients	Same
Prescribed	Over-the-CounterUse	Prescription Only	Over-the-CounterUse	The proposedOTC use isthe same asthe referencedevice
Technological Characteristics Comparison
Type of DataAcquired	Body sounds andECG	Body sounds andECG	Body sounds	Same as thepredicatedevice
Connectivity	Bluetooth Low	Bluetooth Low	Bluetooth	Same as the
Feature	Subject Device:CORE 500 DigitalStethoscope	Predicate Device:CORE 500 DigitalStethoscope(K230111)	Reference Device:Eko CORE(K200776)	Comparison
Energy (BLE)	Energy (BLE)	Energy (BLE)		predicatedevice
Battery Type	RechargeableLithium-ion, 3.7V	Rechargeablelithium-ion, 3.7V	Rechargeable 3.7 VLithium-ionpolymer cell	Same as thepredicatedevice
AudioFrequencyResponseRange	Bandwidth of 20 Hz- 2000 Hz	Bandwidth of 20 Hz- 2000 Hz	Bandwidth of 20 Hz - 2000 Hz	Same
ECGPerformance(ECGFrequencyResponseRange)	0.1 - 250 Hz	0.1 - 250 Hz	N/A	Same as thepredicatedevice
Mechanismof Action	User places thedevice on the bodyfor auscultation. Thedevicesimultaneouslycaptures ECG, andAudio data which istransmitted viaBluetooth to theMobile application.	User places thedevice on the bodyfor auscultation. Thedevicesimultaneouslycaptures ECG, andAudio data which istransmitted viaBluetooth to theMobile application.	User places thedevice on the bodyfor auscultation.The device capturesAudio data which istransmitted viaBluetooth to theMobile application.	Same as thepredicatedevice
No. of ECGElectrodes	Three (3) dryelectrodes	Three (3) dryelectrodes	N/A	Same as thepredicatedevice
HardwareInterface	DisplayMode ButtonVolume ButtonCapacitive touch	DisplayMode ButtonVolume ButtonCapacitive touch	Volume Button	Same as thepredicatedevice
SoftwareInterface	Mobile Application(Eko App)	Mobile Application(Eko App)	Mobile Application(Eko App)	Same
Feature	Subject Device:CORE 500 DigitalStethoscope	Predicate Device:CORE 500 DigitalStethoscope(K230111)	Reference Device:Eko CORE(K200776)	Comparison
Recordingand Playback	Yes	Yes	Yes	Same
Heart RateDetection	PCG-based	PCG-based	N/A	Same as thepredicatedevice
Visualizationof Sound andECGWaveforms	Yes	Yes	N/A	Same as thepredicatedevice
AuscultationMode	Cardiac ModePulmonary ModeWide Band Mode	Cardiac ModePulmonary ModeWide Band Mode	Cardiac ModePulmonary ModeWide Band Mode	Same as thepredicatedevice

Table 1 Substantial Equivalence Summary Comparison

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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 60601-1-11, IEC 60601-2-47 standards for safety, IEC 60601-1-2 for electromagnetic compatibility.

Software Verification and Validation Testing

The software of the subject device is verified and validated according to the FDA guidance for the Content of Premarket Submissions for Device Software Functions.

Usability Testing

Human factors usability testing was conducted per IEC 62366-1 to evaluate that the intended users of the CORE 500 Digital Stethoscope are able to achieve its intended use with the help of the Instructions for Use.

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Nonclinical 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.