(152 days)
No
The summary describes a device that electronically filters and transfers sounds, and allows for recording and visualization of audio streaming. There is no mention of AI, ML, or any form of automated analysis or interpretation of the sounds beyond basic filtering and transmission. The focus is on data acquisition and display, not intelligent processing.
No
Explanation: The device is intended for diagnostic decision support by electronically filtering and transferring sounds, and recording sounds for physical examination. It does not provide any form of therapy or treatment to the patient.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended to be used as a part of a patient by healthcare professionals for diagnostic decision support in clinical settings." It also mentions its use in identifying "suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems."
No
The device description explicitly details hardware components including a stethoscope attachment, microphone, plastic case, Bluetooth module, and internal rechargeable battery, in addition to the mobile software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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.
- Device Function: The eKuore One Wireless electronic interface for stethoscope is designed to electronically filter and transfer sounds from a stethoscope to a mobile application. It records and visualizes auscultation sounds (heart, lung, abdominal sounds) from the patient's body.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It works by capturing and processing sounds directly from the body surface.
Therefore, while it is a medical device used for diagnostic decision support, its function falls outside the scope of In Vitro Diagnostics. It is a device that aids in the physical examination and recording of physiological sounds.
N/A
Intended Use / Indications for Use
The eKuore One Wireless electronic interface for stethoscope is intended to be used as a part of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore One Wireless is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to the accompanying mobile software application.
It can be 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.
Product codes (comma separated list FDA assigned to the subject device)
DQD
Device Description
The equipment consists of a stethoscope attachment, which will let the sound flow through the stethoscope's tube, so the stethoscope can continue working as usual, and the sound will be collected by a little hole in the piece, where a microphone will be placed. Then, this piece will be covered by a plastic case. A Bluetooth module is placed for a wireless transition of the data to a mobile (Android/IOS) or tablet. The eKuore One Wireless electronic interface for stethoscope gets the power supply from an internal rechargeable battery.
The application allows the user to visualize audio streaming received from the stethoscope. The connection is established between the smartphone application and the selected device, and after this event, the selected device starts to stream audio to the smartphone application.
The application also allows the user to record the current audio streaming, storing it in the internal storage of the Android/iOS device. The recordings can be viewed, shared and deleted after that.
The application does not store or collect any personal data of the users or patients. The only generated artifacts generated with the use of the application, the auscultations stored in the internal storage of the Android/iOS device, can only be identified by its name, which is a combination of the time and date when the auscultation was performed, which is insufficient to identify uniquely a patient or gets its personal information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac, vascular, pulmonary or abdominal organ systems
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
healthcare professionals for diagnostic decision support in clinical settings.
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)
Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the subject device.
General requirements for basic safety standard requirements for medical electrical equipment test have been successfully completed following standard of IEC 60601-1:2008 and IEC 60601-1-2:2015
Integration verification and validation testing have been successfully completed following standard IEC 62304:2006/AC:2008
Usability testing requirements have been evaluated and successfully met standards ISO 62366:2008+A1:2015 and IEC 60601-1-6:2010.
Design and development included identification, evaluation and control of potential hazards as per standard ISO 14971:2012.
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.
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.
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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November 24, 2020
Chip Ideas Electronics S.L Bernardo Trillo Regulatory Affairs Manager Calle Alfareria 3 B Burjasot, Valencia 46100 Spain
Re: K201742
Trade/Device Name: eKuore One Wireless Electronic Interface for stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: October 26, 2020 Received: October 30, 2020
Dear Bernardo Trillo:
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,
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
2
Indications for Use
510(k) Number (if known) K201742
Device Name
eKuore One Wireless electronic interface for stethoscope
Indications for Use (Describe)
The eKuore One Wireless electronic interface for stethoscope is intended to be used as a part of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore One Wireless is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to the accompanying mobile software application.
It can be 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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eKuore One Wireless Electronic Interface for Stethoscope 510(k) Premarket Notification
Section 5 - 510(k) Summary
SUBMITTER
Submitter name: Submitter address: Chip Ideas Electronics, S.L. C/ Alfarería 3 B. 46100 Burjasot, Valencia. SPAIN
Contact person: Phone: e-mail:
Bernardo Plaza Trillo +34 640742454 bernardo.plaza@ekuore.com
Date Prepared:
November 23th, 2020
DEVICE
Device Trade Name: eKuore One Wireless electronic interface for stethoscope ELECTRONIC STETHOSCOPE Common Name: ELECTRONIC STETHOSCOPE Requlation Name: Regulatory Class: Class II Product Code: DQD Regulation Number: 870.1875
PREDICATE DEVICE
Predicate Device (S):
Eko Electronic Stethoscope System, K151319
4
eKuore One Wireless Electronic Interface for Stethoscope 510(k) Premarket Notification
Section 5 - 510(k) Summary
l. DEVICE DESCRIPTION
The equipment consists of a stethoscope attachment, which will let the sound flow through the stethoscope's tube, so the stethoscope can continue working as usual, and the sound will be collected by a little hole in the piece, where a microphone will be placed. Then, this piece will be covered by a plastic case. A Bluetooth module is placed for a wireless transition of the data to a mobile (Android/IOS) or tablet. The eKuore One Wireless electronic interface for stethoscope gets the power supply
from an internal rechargeable battery.
The application allows the user to visualize audio streaming received from the stethoscope. The connection is established between the smartphone application and the selected device, and after this event, the selected device starts to stream audio to the smartphone application.
The application also allows the user to record the current audio streaming, storing it in the internal storage of the Android/iOS device. The recordings can be viewed, shared and deleted after that.
The application does not store or collect any personal data of the users or patients. The only generated artifacts generated with the use of the application, the auscultations stored in the internal storage of the Android/iOS device, can only be identified by its name, which is a combination of the time and date when the auscultation was performed, which is insufficient to identify uniquely a patient or gets its personal information.
II. INDICATIONS FOR USE
The eKuore One Wireless electronic interface for stethoscope is indicated to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore One Wireless is indicated for use on pediatric and adult patients. It can electronically filter and transfer sounds to the accompanying mobile software application.
It can be 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.
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Electronic Interface for Stethoscope 510(k) Premarket Notification
Section 5 - 510(k) Summary
lll. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The electronic stethoscopes are mainly used on auscultation in the detection of cardiac, respiratory sounds and check other internal organs. These types of devices are used to digitize the data of the auscultation into a mobile device.
In the establishment of substantial equivalence, eKuore One Wireless electronic interface for stethoscopes compared to the predicate device K181882 eKuore One electronic interface for stethoscope and the reference device K151319 Eko Electronic Stethoscope System:
| Elements of
comparison | eKuore One Wireless
electronic interface for
stethoscope (Candidate
Device) | Eko electronic stethoscope
system.
(Reference device) | Comparison |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Regulatory data | | | |
| Regulatory Class | Class II | Class II | Identical to predicate
device |
| Device
Classification
name | Electronic Stethoscope | Electronic Stethoscope | Identical to predicate
device |
| Regulation
Number | 21 CFR 870.1875 | 21 CFR 870.1875 | Identical to predicate
device |
| Classification
Product code | DQD | DQD | Identical to predicate
device |
| Manufacturer | Chip Ideas Electronics,
S.L. | Eko Devices, Inc. | - |
| FDA Clearance | Pending | K151319 | - |
| USE | | | |
| Intended use | The eKuore One Wireless
electronic interface for
stethoscope 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.
eKuore One Wireless is
indicated for use on
pediatric and adult
patients. It can
electronically filter and
transfer sounds to the
accompanying mobile | 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. | Similar to predicate
device.
Predicate device also
amplify sound. |
| Elements of
comparison | eKuore One Wireless
electronic interface for
stethoscope (Candidate
Device) | Eko electronic stethoscope
system.
(Reference device) | Comparison |
| | software application.
It can be 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. | 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. | |
| | Characteristics | | |
| Principles of
operation | The device consists in a
microphone and some
electronics for their
digitalization and
codification to a standard
format, and sending via
wireless (Bluetooth) to
smartphones and tablets. | Dispositive introduced in an
acoustic stethoscope and
gives sound amplification and
audio transmission to a
smartphone via Bluetooth that
allows the user to open and
playback sounds in a mobile
application on compatible iOS
smartphones and tablets. | Similar to predicate
device. Both acquire
and transmit sound to a
mobile app. |
| Clinical conditions | Human body sounds
related | Human body sounds related | Identical to predicate
device |
| Use | Electronic stethoscope | Electronic stethoscope | Identical to predicate
device |
| Compatibility | -Littmann 3M Cardiology
III/IV
-Littmann 3M classic II/III | -Littmann 3M Cardiology II/III
-Welch Allyn Harvey Elite
-ADC601 lines of analog
stethoscopes | Similar to predicate
device.
Both devices are
compatible with
stethoscopes Littmann
3M Cardiology III |
| Prescription/OTC | Prescription use | Prescription use | Identical to predicate
device |
| Intended for Direct
Connection to
Patient | No | No | Identical to predicate
device |
| Use environment | Clinical | Clinical | Identical to predicate
device |
| Type of users | Health-care personnel | Health-care personnel | Identical to predicate
device |
| Target population | All types of patients | All types of patients | Identical to predicate
device |
| Cleaning &
Maintenance | Before clean eKuore One
Wireless, please detach it | The stethoscope and CORE
should be cleaned between | Identical to predicate
device |
| Elements of
comparison | eKuore One Wireless
electronic interface for
stethoscope (Candidate
Device) | Eko electronic stethoscope
system.
(Reference device) | Comparison |
| | of the stethoscope. It can
be easily cleaned by
suing an alcohol wipe.
Cleaning of stethoscope
should be done between
each patient use. Is not
necessary to clean
eKuore One Wireless for
each use with the same
patient. | eachpatient use. All cleaning
instructions pertaining to the
originalstethoscope apply.
Under normal conditions it is
unnecessary to remove
CORE fromthe stethoscope
tubing for cleaning. All
external parts of thehardware
can be cleaned with 70%
isopropyl alcohol wipes. | |
| Technical equivalence | | | |
| Sound track
transfer function | Yes | Yes | Identical to predicate
device |
| Signal
transmission for
visualization | Bluetooth transmission to
compatible
smartphones/tablets | Bluetooth transmission to
compatible
smartphones/tablets | Identical to predicate
device |
| Energy Source | Rechargeable Lithium Ion
Battery | Rechargeable Lithium Ion
Battery | Identical to predicate
device |
| System required | Android and iOS | Android and iOS | Identical to predicate
device |
| Hardware and
software platforms | Mobile devices or tablets | Mobile devices or tablets | Identical to predicate
device |
| Connections | Micro USB connector only
to charge internal battery
of the device | Micro USB connector only to
charge internal battery of the
device | Identical to predicate
device |
| Frequency range | 20 Hz to 2 KHz | 20 Hz to 2 kHz | Identical to predicate
device |
| Signal Input
Method | Sound was collected via a
Transducer. MEMS | Sound waves collected via a
Transducer. Electro micro-
phone | Identical to predicate
device |
| Audio Output
Method | Earbuds and 3.5mm Jack
when connected with
smartphone/tablets | Earbuds and 3.5mm Jack
when connected with
smartphone/tablets | Identical to predicate
device |
| Signal Storage | Allows signal storage
depending on technical
features (capacity,...) of
connected device
(smartphone or tablet). | Allows signal storage
depending on technical
features (capacity,...) of
connected device
(smartphone or tablet). | Identical to predicate
device |
| Performance
requirements | Temp range: -20℃ to
+45℃
Humidity range: 0% to
90% | The operating range is 10℃
to 40℃, and 0% to 90%
relative humidity | Similar to predicate
device. |
| Biological Equivalence | | | |
| Materials | •Cover: ABS and EPDM | Body: ABS (Acrylonitrile | Similar to predicate |
| Elements of
comparison | eKuore One Wireless
electronic interface for
stethoscope (Candidate
Device) | Eko electronic stethoscope
system.
(Reference device) | Comparison |
| | (ethylene propylene diene
monomer)
•Pushbutton: PMMA
(para-Methoxy-N-
methylamphetamine)
•Gasket: EPDM | Butadiene Styrene). | device |
| Contact with
human tissues or
body fluids | Does not contact patient's
body. Attached
stethoscope does. | Does not contact patient's
body. Attached stethoscope
does. | Identical to predicate
device |
| Sterility | Sterility considerations
are not applicable | Sterility considerations are
not applicable | Identical to predicate
device |
6
e a
eKuore One Wireless
Electronic Interface for Stethoscope 510(k) Premarket Notification
Section 5 – 510(k) Summary
7
Electronic Interface for Stethoscope 510(k) Premarket Notification
Section 5 – 510(k) Summary
8
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Electronic Interface for Stethoscope 510(k) Premarket Notification
Section 5 - 510(k) Summary
Table 05-1. Substantial Equivalence Comparison - eKuore One Wireless electronic interface for stethoscope and Predicate Device EKo Electronic Stethoscope System K151319
Information provided in these 510(k) submissions shows that eKuore One Wireless Electronic Interface for Stethoscope is substantially equivalent to the predicate device Eko Electronic Stethoscope System cleared under K151319 in terms of intended use. indications for use, compatibility, and technological characteristics. There are no new questions of safety or effectiveness.
Summary discussion of non-clinical data:
The proposed device has been designed, developed, tested, verified and validated according to documented procedures and specific protocols in line with the following FDA guidance documents:
- Guidance for the Content of Premarket Submissions for Software -Contained in Medical Devices.
- General Principles of Software Validation -
- Guidance for Premarket Submissions for Management of Cybersecurity in Medical Devices
- Postmarket Management of Cybersecurity in Medical Devices -
- -Radio Frequency Wireless Technology in Medical Devices
General requirements for basic safety standard requirements for medical electrical equipment test have been successfully completed following standard of IEC 60601-1:2008 and IEC 60601-1-2:2015
Integration verification and validation testing have been successfully completed following standard IEC 62304:2006/AC:2008
Usability testing requirements have been evaluated and successfully met standards
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Electronic Interface for Stethoscope 510(k) Premarket Notification
Section 5 - 510(k) Summary
ISO 62366:2008+A1:2015 and IEC 60601-1-6:2010. Design and development included identification, evaluation and control of potential hazards as per standard ISO 14971:2012.
Summary discussion of clinical data:
Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the subject device.
IV. CONCLUSIONS
We believe the intended use, indication for use, principle of operation and technical characteristics of the eKuore One Wireless electronic interface for stethoscope are the same as the intended use, indication for use, principle of operation and technical characteristics of the predicate device.
We did not use new technology in this system, so those differences between our system and its predicate do not affect the safety and performance.
- General information of the propose and predicate device are the same. -
- -Intended use and indication/principle of operations of the propose device and predicate device are the same.
- There are minimum differences in the technological characteristics of the propose device and the predicate device.
Based on the information provided in this premarket notification, Chip Ideas Electronics S.L., concludes that eKuore One Wireless electronic interface for stethoscope does not suppose any new or increased risk compared with the predicate device, we conclude that eKuore One Wireless is substantially equivalent to the listed legally marketed predicate device.