(12 days)
Not Found
No
The document describes a digital stethoscope for sound amplification, filtering, and transmission, with an accompanying app for data management. There is no mention of AI or ML being used for analysis, interpretation, or any other function.
No.
The device is an electronic stethoscope intended for amplification, filtering, and transmission of auscultation sound data, which is used for diagnostic purposes by allowing clinicians to listen to body sounds. It does not provide treatment or modify body function.
No
The device is an electronic stethoscope that amplifies, filters, and transmits sounds for auscultation. While it aids clinicians in listening to body sounds, the "Intended Use" section explicitly states, "The device is not intended for self-diagnosis," implying it does not directly provide a medical diagnosis itself.
No
The device description explicitly states it consists of two primary components: the CORE (an electronic attachment for an analog stethoscope) and the Eko App. The CORE is a hardware component that records audio, converts it to digital data, and transmits it.
Based on the provided information, the Eko CORE is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Eko CORE Function: The Eko CORE is an electronic stethoscope that captures and transmits sound data from within the body (heart, lungs, etc.). It is used for auscultation, which is the act of listening to internal sounds of the body. This is a form of in vivo (within the living body) examination.
- Intended Use: The intended use clearly states it's for listening to auscultation sound data. It does not mention any analysis of biological samples.
- Device Description: The description focuses on the capture, amplification, filtering, and transmission of sound. There is no mention of handling or analyzing biological specimens.
Therefore, the Eko CORE falls under the category of a medical device used for physical examination and data transmission, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DOD, DQD
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.
It 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, lungs, bowel, arteries, and veins.
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
professional users in a clinical environment or by lay users in a nonclinical environment.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Eko Electronic Stethoscope System (EESS)(K151319), Tyto Stethoscope (K181612) (OTC)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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). 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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)
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.
| 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
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.
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Intended Use / Indications for Use
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.
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 Electronic
Stethoscope System
(OTC) | Eko Electronic
Stethoscope System
(Rx) - K151319 | Tyto Stethoscope
(OTC)- K181612 |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | 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. | The Eko Electronic
Stethoscope System is
intended to be used as a
part of a physical
assessment of a patient
by healthcare
professionals for
diagnostic decision
support in clinical
settings. Eko is intended
for use on pediatric and
adult patients. It can
electronically amplify,
filter and transfer
sounds to the
accompanying mobile
application for storage
and sharing. It can used
to record heart sounds
and cardiac 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 Tyto Stethoscope is
an electronic
stethoscope that
enables transmission of
auscultation sound data,
whereby a
clinician at one location
on an IP network can
listen to the auscultation
sounds of a patient on
site or at a different
location
on the IP network with
the signal carried on an
IP connection between
the two locations. The
Tyto Stethoscope is
intended
to be used by
professional users in a
clinical environment or
by lay users in a
nonclinical
environment. The
device is for
medical diagnostics
purposes only. The
device is not intended
for 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 |
| Device
Classification | DQD: Electronic
stethoscope | DQD: Electronic
stethoscope | DQD: Electronic
stethoscope |
| Prescribed | OTC | Rx | OTC |
| Parameters | Eko Electronic
Stethoscope System
(OTC) | Eko Electronic
Stethoscope System
(Rx) - K151319 | Tyto Stethoscope
(OTC)- K181612 |
| Classification | Class II | Class II | Class II |
| Stethoscope
Type | Attachment to an
analog stethoscope
(Core) | Attachment to an analog
stethoscope (Core) | Stand-alone electronic
stethoscope |
| User Interface | On/Off Power button
Volume adjustment
LED status indicator
Mobile App | On/Off Power button
Volume adjustment
LED status indicator
Mobile App | On/Off Power button
Volume adjustment
LED screen
Mobile App |
| Analog/ Digital
Interoperability | Yes | Yes | No |
| Connectivity | Bluetooth® | Bluetooth® | Wi-Fi |
| Sound
Amplification | Yes | Yes | No |
| Record and
Playback
Sounds | Yes | Yes | Yes |
| Data Transfer
to Compatible
Computing
platform | Yes | Yes | Yes |
Table1. Comparison with Predicate Devices
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