The Eko CORE is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. Eko CORE is intended for use on pediatric and adult patients. The Eko CORE is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.

Device Description

The Eko CORE (OTC) is a digital stethoscope device designed for use by health care professionals as well as lay users in clinical or non-clinical environments. It enables physicians transition between traditional and digital auscultation. It can electronically amplify, filter and transfer sounds to the accompanying mobile application for storage and sharing or can transmit the data for telemedicine use. It also enables regular users to listen to their body sounds (lungs, heart, arteries, veins, Gastrointestinal tract, etc.) and record and share it with their physicians.

lt consists of two primary components: 1) The CORE: an electronic attachment for an analog stethoscope and 2) Eko App, and application that pairs with the CORE attachment.

. CORE is used to record audio in the stethoscope, convert it to digital data points, and transmit data to a mobile device via Bluetooth". It includes a volume adjustment button, an analog-to-digital power switch, and an LED light indicator.
. The app captures audio data from the CORE and provides data visualization, secure data storage, audio playback, and sharing features.

These features enable a healthcare professional to monitor patients, seek out second opinions from a specialist or use the device for telemedicine use.

AI/ML Overview

The Eko CORE is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins). It is intended for use on pediatric and adult patients by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a quantitative format for specific performance metrics (e.g., sensitivity, specificity for disease detection). Instead, the performance evaluation focuses on demonstrating that the Eko CORE is substantially equivalent to its predicate devices by showing it functions as intended and adheres to safety standards.

Acceptance Criteria (Implied by Substantial Equivalence Basis)	Reported Device Performance
Device functions as intended for its Indications for Use (amplification, filtering, transmission of auscultation sound data, use by professional and lay users).	Functional testing demonstrated the device functioned as intended in all instances. This includes the ability to attach to a standard analog stethoscope, featuring both digital and analog auscultation modes, connecting via Bluetooth to the Eko App for visualization, recording, and transfer of data, and including on/off power buttons and volume adjustment controls.
Device meets electrical safety standards.	Electrical safety testing was successfully conducted, complying with IEC 60601-1.
Device meets EMC (electromagnetic compatibility) safety standards.	EMC testing was successfully conducted, complying with IEC 60601-1-2.
Device meets wireless coexistence standards.	Wireless coexistence testing was successfully conducted.
Device is safe and effective for over-the-counter (OTC) use by lay users (as this is a new indication compared to the RX predicate).	Human factors testing for OTC use yielded passing results, indicating that lay users can safely and effectively operate the device.
Device maintains similar technological characteristics and performance to predicate devices (Eko Electronic Stethoscope System (K151319) and Tyto Stethoscope (K181612)).	The document states "The Eko CORE is a modified version of the previously-cleared predicate device and has very similar technological characteristics. Minor changes have been made, but the devices have the same overall operational and technological characteristics...Both devices have the same frequency range and have the same maximum sound level." Performance data demonstrated the Eko CORE is as safe and effective as the predicate device.

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

The document mentions "human factors testing," which is a type of test set, but does not specify the sample size used for this testing. It also does not directly state the country of origin or whether the data was retrospective or prospective for any of the performance tests. The context suggests that the testing was conducted by Eko Devices, Inc. likely in the US where it's seeking FDA clearance.

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

The document does not specify the number or qualifications of experts used to establish ground truth. For human factors testing, the "ground truth" would typically relate to the usability and comprehension of the device by representative users. For the functional and safety testing, the "ground truth" is adherence to technical specifications and regulatory standards.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method like 2+1 or 3+1. The performance data section refers to "bench verification," "software verification and validation," "electrical safety, EMC and wireless coexistence testing," and "human factors testing." These types of tests typically involve objective measurements against predefined standards rather than expert adjudication of qualitative outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and 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 Eko CORE is an electronic stethoscope intended for amplification, filtering, and transmission of sounds, not an AI-powered diagnostic tool in the sense of automatically interpreting sounds or assisting human readers with an AI model. Therefore, this type of study is not relevant to the described device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

The Eko CORE is a hardware device (an electronic stethoscope attachment) that works with an app. Its primary functions are amplification, filtering, and transmission of sound data. It's not described as having an "algorithm only" component that would perform diagnostic interpretations independently. The "performance data" described (bench, software, electrical, EMC, wireless, human factors) are for the device's functional integrity and safety, not for a standalone diagnostic algorithm. Therefore, a standalone performance study in the context of an "algorithm only" is not applicable or described.

7. The Type of Ground Truth Used:

The "ground truth" for the performance claims appears to be based on:

Technical Specifications and Regulatory Standards: For bench verification, software V&V, electrical safety (IEC 60601-1), and EMC safety (IEC 60601-1-2).
User Performance and Comprehension: For human factors testing related to OTC use, assessing if the device can be used safely and effectively by lay users.

8. The Sample Size for the Training Set:

The document does not mention any training set. This device is an electronic stethoscope, not an AI/ML diagnostic algorithm that would typically require a training set of data for model development. The performance testing described focuses on the device's functional and safety characteristics.

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

Since there is no mention of a training set or an AI/ML algorithm requiring one, this information is not applicable or provided in the document.

Summary

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April 6, 2020

Eko Devices, Inc. Arezou Azar Sr. Dir. Regulatory Affairs 1212 Broadway, Suite 100 Oakland, California 94612

Re: K200776

Trade/Device Name: Eko CORE Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DOD Dated: March 23, 2020 Received: March 25, 2020

Dear Arezou Azar:

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

LT 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

510(k) Number (if known) K200776

Device Name Eko CORE

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CER 801 Subpart D)	☑ Over-The-Counter Use (21 CER 801 Subpart C)

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510(k) SUMMARY

Eko Devices, Inc. Eko CORE

Submitter Name Eko Devices, Inc. and Address: 1212 Broadway, Suite 100 Oakland, CA 94612

Contact Person: Arezou Azar, PhD. Sr.Dir of Regulatory Affairs Email: arezou.azar@ekohealth.com Phone: 650-804-0285

Device Trade Name(s): Eko CORE Other Names Used: Eko Electronic Stethoscope System CORE by Eko Common or Usual Name: Electronic Stethoscope Classification Name: Electronic Stethoscope Regulatory Class: Class II Product Code: DQD, 870.1875 Predicate Devices: Eko Electronic Stethoscope System (EESS)(K151319), Eko Devices, Inc. Tyto Stethoscope (K181612) (OTC), Tyto Care Ltd.

Device Description

lt consists of two primary components: 1) The CORE: an electronic attachment for an analog stethoscope and 2) Eko App, and application that pairs with the CORE attachment.

. CORE is used to record audio in the stethoscope, convert it to digital data points, and transmit data to a mobile device via Bluetooth". It includes a volume adjustment button, an analog-to-digital power switch, and an LED light indicator.
. The app captures audio data from the CORE and provides data visualization, secure data storage, audio playback, and sharing features.

These features enable a healthcare professional to monitor patients, seek out second opinions from a specialist or use the device for telemedicine use.

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Intended Use / Indications for Use

Summary of Technological Characteristics

The Eko CORE is a modified version of the previously-cleared predicate device and has very similar technological characteristics. Minor changes have been made, but the devices have the same overall operational and technological characteristics. Both devices include the ability to attach to a standard analog stethoscope and feature both digital and analog auscultation modes. Additionally, both devices connect via Bluetooth to the Eko App for visualization, recording and transfer of data. Both devices included on/off power buttons and volume adjustment controls. Both devices have the same frequency range and have the same maximum sound level.

A table comparing the key features of the subject and predicate devices is provided below.

Performance Data

The device has undergone extensive bench verification, as well as software verification and validation. Electrical safety, EMC and wireless coexistence testing were also successfully conducted.

The OTC use of the device was assessed in human factors testing with passing results.

In all instances, the device functioned as intended. Based on the testing results, the device has a safety and effectiveness profile that is similar to the predicate device.

Conclusions

The Eko CORE is as safe and effective as the predicate devices. The Eko CORE has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not introduce a new intended use and do not raise different questions of safety and effectiveness when used as labeled. In addition, the minor technological differences between the Eko CORE

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and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Eko CORE is as safe and effective as the predicate device. Thus, the Eko CORE is substantially equivalent.

Parameters	Eko ElectronicStethoscope System(OTC)	Eko ElectronicStethoscope System(Rx) - K151319	Tyto Stethoscope(OTC)- K181612
Indications forUse	The Eko CORE is anelectronic stethoscopethat enablesamplification, filtering,and transmission ofauscultation sound data(heart, lungs, bowel,arteries, and veins),whereby a clinician atone location onnetwork can listen tothe auscultation soundsof a patient on site or ata different location onthe network. Eko COREis intended for use onpediatric and adultpatients. The Eko COREis intended to be usedby professional users ina clinical environmentor by lay users in anonclinicalenvironment. Thedevice is not intendedfor self-diagnosis.	The Eko ElectronicStethoscope System isintended to be used as apart of a physicalassessment of a patientby healthcareprofessionals fordiagnostic decisionsupport in clinicalsettings. Eko is intendedfor use on pediatric andadult patients. It canelectronically amplify,filter and transfersounds to theaccompanying mobileapplication for storageand sharing. It can usedto record heart soundsand cardiac murmurs,bruits, respiratorysounds and abdominalsounds during physicalexamination in normalpatients or those withsuspected diseases ofthe cardiac, vascular,pulmonary orabdominal organsystems.	The Tyto Stethoscope isan electronicstethoscope thatenables transmission ofauscultation sound data,whereby aclinician at one locationon an IP network canlisten to the auscultationsounds of a patient onsite or at a differentlocationon the IP network withthe signal carried on anIP connection betweenthe two locations. TheTyto Stethoscope isintendedto be used byprofessional users in aclinical environment orby lay users in anonclinicalenvironment. Thedevice is formedical diagnosticspurposes only. Thedevice is not intendedfor self-diagnosis.
Standards Met	IEC 60601-1	IEC 60601-1	IEC 60601-1
General Safety	IEC 60601-1-2	IEC 60601-1-2	IEC 60601-1-2
EMC Safety	IEC 60601-1-11		IEC 60601-1-11
DeviceClassification	DQD: Electronicstethoscope	DQD: Electronicstethoscope	DQD: Electronicstethoscope
Prescribed	OTC	Rx	OTC
Parameters	Eko ElectronicStethoscope System(OTC)	Eko ElectronicStethoscope System(Rx) - K151319	Tyto Stethoscope(OTC)- K181612
Classification	Class II	Class II	Class II
StethoscopeType	Attachment to ananalog stethoscope(Core)	Attachment to an analogstethoscope (Core)	Stand-alone electronicstethoscope
User Interface	On/Off Power buttonVolume adjustmentLED status indicatorMobile App	On/Off Power buttonVolume adjustmentLED status indicatorMobile App	On/Off Power buttonVolume adjustmentLED screenMobile App
Analog/ DigitalInteroperability	Yes	Yes	No
Connectivity	Bluetooth®	Bluetooth®	Wi-Fi
SoundAmplification	Yes	Yes	No
Record andPlaybackSounds	Yes	Yes	Yes
Data Transferto CompatibleComputingplatform	Yes	Yes	Yes

Table1. Comparison with Predicate Devices

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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.