Who is the manufacturer of CORE 500 Digital Stethoscope?

Eko Health, Inc. filed the 510(k) submission for CORE 500 Digital Stethoscope (K233609).

What is the FDA product code for CORE 500 Digital Stethoscope?

DQD. It is classified under 21 CFR 870.1875 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CORE 500 Digital Stethoscope?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CORE 500 Digital Stethoscope?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CORE 500 Digital Stethoscope

Q: What are the predicate devices for CORE 500 Digital Stethoscope?

CORE 500 Digital Stethoscope (K230111).

K233609 · Eko Health, Inc. · DQD · Mar 28, 2024 · Cardiovascular

Device Facts

Record ID	K233609
Device Name	CORE 500 Digital Stethoscope
Applicant	Eko Health, Inc.
Product Code	DQD · Cardiovascular
Decision Date	Mar 28, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1875
Device Class	Class 2
Attributes	Pediatric

Intended Use

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 Story

CORE 500 Digital Stethoscope is an electronic stethoscope with integrated electrodes for 3-lead ECG; consists of chestpiece, detachable earpiece, and mobile application (Eko App). Device captures body sounds via diaphragm and ECG via dry electrodes; transmits data via Bluetooth Low Energy (BLE) to mobile app. Features three auscultation modes (Cardiac, Pulmonary, Wide Band) to filter/enhance specific frequency ranges. Computes heart rate in real-time from phonocardiogram (PCG) data. Used in professional healthcare facilities or home settings by clinicians or lay users. Displays ECG waveforms and heart rate on device screen and app. Assists clinicians in physical assessment; lay users must consult professionals for clinical interpretation. Benefits include enhanced auscultation and integrated ECG monitoring.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including audio performance, electrical/mechanical function verification, heart rate measurement, biocompatibility (ISO 10993-1), electrical safety/EMC (IEC 60601-1-11, IEC 60601-2-47, IEC 60601-1-2), software verification/validation, and human factors usability testing (IEC 62366-1).

Technological Characteristics

Electronic stethoscope with 3 dry ECG electrodes. Audio bandwidth 20-2000 Hz; ECG frequency response 0.1-250 Hz. Connectivity: Bluetooth Low Energy (BLE). Power: 3.7V rechargeable lithium-ion battery. Interface: display, mode button, volume button, capacitive touch. Standards: ISO 10993-1 (biocompatibility), IEC 60601-1-11, IEC 60601-2-47, IEC 60601-1-2 (safety/EMC), IEC 62366-1 (usability).

Indications for Use

Indicated for adults and pediatric patients for electronic amplification, filtering, and transfer of body sounds and 3-lead ECG waveforms. Intended for use by clinicians or lay users. Lay users must consult a healthcare professional for interpretation or clinical action.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*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.

Predicate Devices

CORE 500 Digital Stethoscope (K230111)

Reference Devices

Eko CORE (K200776)

Related Devices

K201299 — HD Steth · Hd Medical, Inc. · Jul 10, 2020
K230111 — CORE 500 Digital Stethoscope · Eko Devices, Inc. · May 26, 2023
K123148 — PARACE MD EKOSCOPE IS100 · Parace, LLC · Nov 19, 2013
K050097 — TECHNO-SCOPE VISUAL STETHOSCOPE · Techtrade, LLC · Sep 30, 2005
K990809 — CADISCOPE ELECTRONIC STETHOSCOPE · Caditec AG · Jun 9, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font. 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. {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ # Indications for Use Submission Number (if known) K233609 Device Name CORE 500 Digital Stethoscope Indications for Use (Describe) 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 lav 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. 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) #### 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." {4}------------------------------------------------ ## 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 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. {5}------------------------------------------------ # INDICATIONS FOR USE 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. # 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 Digital Stethoscope | Predicate Device: CORE 500 Digital Stethoscope (K230111) | Reference Device: Eko CORE (K200776) | Comparison | |---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Device Classification Name | Electronic Stethoscope | Electronic Stethoscope | Electronic Stethoscope | Same | | Regulation Number | 21 CFR 870.1875 | 21 CFR 870.1875 | 21 CFR 870.1875 | Same | | Classification Product Code | DQD, DPS | DQD, DPS | DQD | Same as the predicate device | | Indications for Use | The CORE 500 Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds | The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead | The Eko CORE is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound | Same intended use as the predicate device, different user groups. The user | | Feature | Subject Device: CORE 500 Digital Stethoscope | Predicate Device: CORE 500 Digital Stethoscope (K230111) | Reference Device: Eko CORE (K200776) | Comparison | | | 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. | 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. | 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. | group difference does not raise different questions of safety and effectiveness | | Patient Population | Adults and pediatric patients | Adults and pediatric patients | Adults and pediatric patients | Same | | Prescribed | Over-the-Counter Use | Prescription Only | Over-the-Counter Use | The proposed OTC use is the same as the reference device | | Technological Characteristics Comparison | | | | | | Type of Data Acquired | Body sounds and ECG | Body sounds and ECG | Body sounds | Same as the predicate device | | Connectivity | Bluetooth Low | Bluetooth Low | Bluetooth | Same as the | | Feature | Subject Device: CORE 500 Digital Stethoscope | Predicate Device: CORE 500 Digital Stethoscope (K230111) | Reference Device: Eko CORE (K200776) | Comparison | | Energy (BLE) | Energy (BLE) | Energy (BLE) | | predicate device | | Battery Type | Rechargeable Lithium-ion, 3.7V | Rechargeable lithium-ion, 3.7V | Rechargeable 3.7 V Lithium-ion polymer cell | Same as the predicate device | | Audio Frequency Response Range | Bandwidth of 20 Hz - 2000 Hz | Bandwidth of 20 Hz - 2000 Hz | Bandwidth of 20 Hz - 2000 Hz | Same | | ECG Performance (ECG Frequency Response Range) | 0.1 - 250 Hz | 0.1 - 250 Hz | N/A | Same as the predicate device | | Mechanism of Action | User places the device on the body for auscultation. The device simultaneously captures ECG, and Audio data which is transmitted via Bluetooth to the Mobile application. | User places the device on the body for auscultation. The device simultaneously captures ECG, and Audio data which is transmitted via Bluetooth to the Mobile application. | User places the device on the body for auscultation. The device captures Audio data which is transmitted via Bluetooth to the Mobile application. | Same as the predicate device | | No. of ECG Electrodes | Three (3) dry electrodes | Three (3) dry electrodes | N/A | Same as the predicate device | | Hardware Interface | Display Mode Button Volume Button Capacitive touch | Display Mode Button Volume Button Capacitive touch | Volume Button | Same as the predicate device | | Software Interface | Mobile Application (Eko App) | Mobile Application (Eko App) | Mobile Application (Eko App) | Same | | Feature | Subject Device: CORE 500 Digital Stethoscope | Predicate Device: CORE 500 Digital Stethoscope (K230111) | Reference Device: Eko CORE (K200776) | Comparison | | Recording and Playback | Yes | Yes | Yes | Same | | Heart Rate Detection | PCG-based | PCG-based | N/A | Same as the predicate device | | Visualization of Sound and ECG Waveforms | Yes | Yes | N/A | Same as the predicate device | | Auscultation Mode | Cardiac Mode Pulmonary Mode Wide Band Mode | Cardiac Mode Pulmonary Mode Wide Band Mode | Cardiac Mode Pulmonary Mode Wide Band Mode | Same as the predicate device | Table 1 Substantial Equivalence Summary Comparison {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # 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. {9}------------------------------------------------ ## 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.