(136 days)
No
The summary describes signal processing (amplification, filtering, heart rate detection based on PCG) but does not mention AI or ML algorithms for interpretation or analysis beyond basic signal processing.
No
The device is used to amplify, filter, and transfer body sounds and ECG waveforms for assessment, but it is not intended to interpret or take clinical action for treatment.
No.
The device is intended to amplify, filter, and transfer body sounds and ECG waveforms. While it displays ECG and heart rate, the "Intended Use" specifically states that a "lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional," indicating it is not a standalone diagnostic device for lay users. For clinicians, it serves as a "digital auscultation tool" for physical assessment, supporting diagnosis rather than performing it independently.
No
The device description explicitly states that the device consists of a chestpiece, detachable earpiece, and a mobile application, indicating the presence of hardware components beyond just 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 derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- CORE 500 Function: The CORE 500 Digital Stethoscope directly interacts with the patient's body to capture body sounds and ECG waveforms. It does not analyze samples taken from the body.
- Intended Use: The intended use describes amplifying, filtering, and transferring body sounds and ECG waveforms, and displaying them. This is a direct measurement of physiological signals, not an analysis of a biological specimen.
Therefore, the CORE 500 Digital Stethoscope falls under the category of a medical device that interacts directly with the patient, rather than an IVD device that analyzes samples.
N/A
Intended Use / 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.
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 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.
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 or lay users, professional healthcare facility and for home use.
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)
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.
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CORE 500 Digital Stethoscope (K230111)
Reference Device(s)
Eko CORE (K200776)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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)
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)
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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.