(129 days)
No
The summary describes standard digital stethoscope and ECG functionalities, including amplification, filtering, heart rate detection, and different auscultation modes. There is no mention of AI, ML, or any related concepts like deep learning, neural networks, or algorithms that learn from data. The performance studies focus on bench testing of basic device functions.
No
The device is described as a diagnostic tool used by clinicians to amplify, filter, and transfer body sounds and ECG waveforms for assessment, not to provide treatment.
Yes
The device amplifies, filters, and transfers body sounds and ECG waveforms, displays ECG and heart rate data, and is used in conjunction with clinician evaluation for physical assessment. These functions directly contribute to gathering information for diagnosis.
No
The device description explicitly states it consists of a chestpiece, detachable earpiece, and a mobile application, indicating it includes hardware components (chestpiece and earpiece) in addition to the software.
Based on the provided information, the CORE 500 Digital Stethoscope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality.
- CORE 500 Function: The CORE 500 directly interacts with the patient's body to capture body sounds (auscultation) and electrical signals (ECG). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for amplifying, filtering, and transferring body sounds and ECG waveforms, and displaying these directly. It's a diagnostic tool used on the patient, not with patient samples.
Therefore, the CORE 500 falls under the category of a medical device used for direct patient assessment, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
DQD, DPS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults and pediatric patients.
Intended User / Care Setting
Clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Biocompatibility: Biological evaluations were conducted according to ISO 10993-1:2018. The evaluation report concluded that the CORE 500 Digital Stethoscope is biocompatible.
- Electrical safety and electromagnetic compatibility (EMC): Testing was conducted and demonstrated CORE 500 Digital Stethoscope complies with IEC 60601-1, IEC 60601-2-47, and IEC 60601-1-2.
- Software verification and validation testing: The software was verified and validated according to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- Bench testing: Rigorous bench testing was performed to demonstrate product performance and confirm that differences between the subject and predicate device do not raise different questions of safety and effectiveness. Testing included: Audio performance, Electrical and mechanical function verification, and Heart rate measurement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
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
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,
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 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.
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.
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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:
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3
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
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.
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INDICATIONS FOR USE
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.
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 Digital
Stethoscope | Predicate Device:
Eko Model E5 System
(EME5), Eko DUO
(K170874) | Reference Device:
Eko Analysis Software
(EAS)
(K192004) | Comparison |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Classification
Name | Electronic Stethoscope | Electronic Stethoscope | Cardiac Monitor | Same as the
predicate |
| Regulation
Number | 21 CFR 870.1875 | 21 CFR 870.1875 | 21 CFR 870.2300 | Same as the
predicate |
| Classification
Product Code | DQD, DPS | DQD, DPS | MWI, DQD, DPS | Same as the
predicate |
| Indications for
Use | 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 | The Eko Model E5 System is
intended to be used by
healthcare professionals to
electronically amplify, filter,
and transfer body sounds and
single-channel
electrocardiogram (ECG)
waveforms. The Eko Model E5
System also displays ECG
waveforms and
phonocardiogram waveforms on
the accompanying mobile
application for storage and
sharing (when prescribed or
used under the care of a
physician). It can be used to
record heart sounds and cardiac | 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 | Same intended
use and
indications for
use as the
predicate |
| | Subject Device:
CORE 500 Digital
Stethoscope | Predicate Device:
Eko Model E5 System
(EME5), Eko DUO
(K170874) | Reference Device:
Eko Analysis Software
(EAS)
(K192004) | Comparison |
| | device is only significant
when used in conjunction
with clinician evaluation as
well as consideration of
other relevant patient data. | murmurs, bruits, respiratory
sounds, and abdominal sounds
during physical examination in
normal patients or those with
suspected diseases of the
cardiac, vascular, pulmonary, or
abdominal organ systems. The
device can be used on adults
and pediatrics.
The data offered by the device
is only significant when used in
conjunction with physician over
read as well as consideration of
other relevant patient data.
The device should not be used
on infants weighing less than
10kg. | certain cardiac time
intervals such as heart
rate, QRS duration and
EMAT. The software does
not distinguish 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 | Adults and pediatric patients | Adults and pediatric patients | Adults (> 18 years) | Same as the
predicate |
| Prescribed | Prescription Only | Prescription Only | Prescription Only | Same as the
predicate |
| Technological Characteristics Comparison | | | | |
| | Subject Device:
CORE 500 Digital
Stethoscope | Predicate Device:
Eko Model E5 System
(EME5), Eko DUO
(K170874) | Reference Device:
Eko Analysis Software
(EAS)
(K192004) | Comparison |
| Type of Data
Acquired | Body sounds and ECG | Body sounds and ECG | N/A as EAS is a
standalone software | Same as the
predicate |
| Connectivity | Bluetooth Low Energy
(BLE) | Bluetooth Low Energy (BLE) | N/A as EAS is a
standalone software | Same as the
predicate |
| Battery Type | Rechargeable Lithium-ion,
3.7V | Rechargeable lithium-ion, 3.7V | N/A as EAS is a
standalone software | Same as the
predicate |
| Audio
Frequency
Range | 20 Hz - 2000 Hz | 20 Hz - 2000 Hz | N/A as EAS is a
standalone software | Same as the
predicate |
| ECG
Frequency
Range | 0.1 - 250 Hz | 0.15 - 200 Hz | N/A as EAS is a
standalone software | Similar to the
predicate.
The subject
device has wider
frequency range
that does not raise
different
questions of
safety and
effectiveness |
| Mechanism of
Action | User places the device on
the body for auscultation.
The device simultaneously
captures ECG, and Audio
data which is transmitted via | User places the device on the
body for auscultation. The
device simultaneously captures
ECG, and Audio data which is
transmitted via Bluetooth to the | N/A as EAS is a
standalone software | Same as the
predicate |
| | Subject Device:
CORE 500 Digital
Stethoscope | Predicate Device:
Eko Model E5 System
(EME5), Eko DUO
(K170874) | Reference Device:
Eko Analysis Software
(EAS)
(K192004) | Comparison |
| | Bluetooth to the Mobile
application. | Mobile application. | | |
| No. of ECG
Electrodes | Three (3) dry electrodes | Two (2) dry electrodes | N/A as EAS is a
standalone software | Different.
The technology
characteristic
difference does
not raise different
questions of
safety and
effectiveness |
| Hardware
Interface | Display
Mode Button
Volume Button
Capacitive touch | Mode Button
Volume Button | N/A as EAS is a
standalone software | Similar to the
predicate.
The additional
interfaces do not
raise different
questions of
safety and
effectiveness |
| Software
Interface | Mobile Application (Eko
App) | Mobile Application (Eko App) | N/A as EAS is a
standalone software | Same as the
predicate |
| Recording and
Playback | Yes | Yes | N/A as EAS is a
standalone software | Same as the
predicate |
| Heart Rate
Detection | PCG-based | N/A | ECG-based and/or PCG-
based | Similar to
the reference |
| | Subject Device:
CORE 500 Digital
Stethoscope | Predicate Device:
Eko Model E5 System
(EME5), Eko DUO
(K170874) | Reference Device:
Eko Analysis Software
(EAS)
(K192004) | Comparison |
| | | | | device |
| Visualization of
Sound and
ECG
Waveforms | Yes | Yes | N/A as EAS is a
standalone software | Same as the
predicate |
| Auscultation
Mode | Cardiac Mode
Pulmonary Mode
Wide Band Mode | Diaphragm Mode
Pulmonary Mode
Bell Mode | N/A as EAS is a
standalone software | Similar to the
predicate.
The filter setting
difference does
not raise different
questions of
safety and
effectiveness |
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9
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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.