(257 days)
Not Found
No
The description focuses on digitalizing and displaying acoustic signals without mentioning any analytical or interpretive functions that would typically involve AI/ML. The data is displayed in real-time without processing, and recordings are simply stored and managed.
No.
The device is intended for diagnostic decision support by recording and processing sounds, not for treating or preventing diseases.
Yes
The device is described as "intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings." It records sounds from various organ systems for patients with suspected diseases.
No
The device description clearly states that the system is formed by both the "eKuore One device" and the "eKuore ONE App". The eKuore One device is described as having the main purpose of digitalizing auscultation sounds, indicating it is a hardware component. The app then receives the signal from this hardware device.
Based on the provided information, the eKuore One electronic interface for stethoscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The eKuore One is used to listen to sounds directly from the patient's body (heart, lungs, abdomen, etc.) during a physical examination. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for physical assessment and diagnostic decision support based on auscultation. This is a clinical examination technique, not an in vitro diagnostic test.
- The device description focuses on digitizing and displaying acoustic signals. It does not describe any analysis or testing of biological specimens.
Therefore, the eKuore One falls under the category of a medical device used for physical examination and diagnostic support, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The eKuore One 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 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
eKuore One is a system formed by eKuore One device and eKuore ONE App. The main purpose of eKuore One device is to digitalize auscultation sounds. The main purpose of eKuore ONE App is to get the acoustic signal from eKuore One device through point to point connection via USB OTG cable. The data transmission via the USB OTG cable provides high data integrity.
eKuore ONE App displays the acoustic signal as a phonogram in real time and allow user to make recordings for later use.
eKuore ONE App detects the eKuore One device automatically once the USB OTG cable is connected.
Once eKuore One device is detected, the application identifies the device and make a connection. Once connected, the application goes to the monitor screen where the phonogram is shown in real time, the data represented in the eKuore ONE App is not processes prior to display.
In the monitor screen, there is a record button. When pressed, it starts a recording with a duration of 15 seconds. Recordings are stored in * wav file format in the internal memory of the connected smartphone/tablet. At the end of the recording process, the application asks the user for a "PatientID" and "Position" only to conform the recording name. The idea is to help the user in the later handling of the recordings.
eKuore ONE App has a recording management screen where it is possible to play, remove and edit a recording. The edition is only for the "PatientID" and "Position". The audio data of one recording can't be modified either shared.
eKuore ONE App has an internal security process to remove any recording with incorrect name format or without the required duration.
Furthermore, eKuore ONE App has a tutorial to help the user and one "About App" screen where access to support is available.
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.
Hospitals
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 predicate device.
An acoustic performance comparison between eKuore One electronic interface for stethoscope and Eko Electronic Stethoscope System has been performed. Device signal acquisition accuracy and acoustic transmission disturbance has been evaluated and successfully, presenting both devices with similar acoustic characteristics.
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.
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 27, 2019
Chip Ideas Electronics S.L Bernardo Plaza Trillo Chief Operating Officer C/ Clariano 8. Entresuelo B Valencia, 46021 SPAIN
Re: K181882
Trade/Device Name: eKuore One electronic interface for stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: February 4, 2019 Received: February 8, 2019
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 vou, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shawn W. Forrest -S 2019.03.27 14:42:30 -04'00'
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K181882
Device Name
eKuore One electronic interface for stethoscope
Indications for Use (Describe)
The eKuore One 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 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
SUBMITTER
Submitter name: Chip Ideas Electronics, S.L. C/ Clariano 8, Entresuelo B. Submitter address: 46021 Valencia SPAIN
Contact person: Bernardo Plaza Trillo Phone: +34 640742454 bernardo.plaza@ekuore.com e-mail:
Date Prepared:
2018-03-16
DEVICE
| Device Trade Name: | eKuore One electronic interface for stethoscope |
|---|---|
| Common Name: | ELECTRONIC STETHOSCOPE |
| Regulation Name: | ELECTRONIC STETHOSCOPE |
| Regulatory Class: | Class II |
| Product Code: | DQD |
| Regulation Number: | 870.1875 |
PREDICATE DEVICE
Predicate Device (S):
Eko electronic Stethoscope System, K151319
4
l. DEVICE DESCRIPTION
eKuore One is a system formed by eKuore One device and eKuore ONE App. The main purpose of eKuore One device is to digitalize auscultation sounds. The main purpose of eKuore ONE App is to get the acoustic signal from eKuore One device through point to point connection via USB OTG cable. The data transmission via the USB OTG cable provides high data integrity.
eKuore ONE App displays the acoustic signal as a phonogram in real time and allow user to make recordings for later use.
eKuore ONE App detects the eKuore One device automatically once the USB OTG cable is connected.
Once eKuore One device is detected, the application identifies the device and make a connection. Once connected, the application goes to the monitor screen where the phonogram is shown in real time, the data represented in the eKuore ONE App is not processes prior to display.
In the monitor screen, there is a record button. When pressed, it starts a recording with a duration of 15 seconds. Recordings are stored in * wav file format in the internal memory of the connected smartphone/tablet. At the end of the recording process, the application asks the user for a "PatientID" and "Position" only to conform the recording name. The idea is to help the user in the later handling of the recordings.
eKuore ONE App has a recording management screen where it is possible to play, remove and edit a recording. The edition is only for the "PatientID" and "Position". The audio data of one recording can't be modified either shared.
eKuore ONE App has an internal security process to remove any recording with incorrect name format or without the required duration.
Furthermore, eKuore ONE App has a tutorial to help the user and one "About App" screen where access to support is available.
5
| Equipment description | |
|---|---|
| Image: eKuore One main piece | eKuore One the main piece. Is the part |
| which is attached to the stethoscope. | |
| Image: eKuore One main piece, internal view | eKuore One the main piece, internal view. |
| Image: eKuore One preparation into the tubing adaptors to the stethoscope | eKuore One preparation into the tubing |
| adaptors to the stethoscope. | |
| The first pictogram is for attachment with | |
| Littmann Cardiology stethoscopes | |
| The second one is for attachment with | |
| Littmann Classic stethoscopes | |
| Image: eKuore One installed into the stethoscope and USB cable | eKuore One installed into the stethoscope |
| and USB cable to display the digital | |
| sound to the mobile device. | |
| Image: eKuore One real view of complete installation | eKuore One real view of complete |
| installation. |
6
ll. INDICATIONS FOR USE
The eKuore One 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 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE lll. 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 electronic interface for stethoscopes compared to the predicate device K151319 Eko Electronic Stethoscope System:
| Elements of
comparison | eKuore One electronic
interface for
stethoscope
(Candidate Device) | Eko electronic
stethoscope system.
(Predicate device) | Comparison |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory data | | | |
| Regulatory Class | Class II | Class II | Identical to
predicate 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 |
| Product code | DQD | DQD | Identical to
predicate device |
| Manufacturer | Chip Ideas Electronics,
S.L. | Eko Devices, Inc. | - |
| FDA Clearance | Pending | 510(k) cleared:
K151319 | - |
| Elements of
comparison | eKuore One electronic
interface for
stethoscope
(Candidate Device) | Eko electronic
stethoscope system.
(Predicate device) | Comparison |
| USE | | | |
| Indications for use | The eKuore One
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 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. | 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 Indications for
Use statement for
the eKuore One is
identical to the
predicate device. |
| Characteristics | | | Comparison |
| Principles of operation | The device consists in a
microphone and some
electronics for their
digitalization and
codification to a
standard format, and
sending via USB cable
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
with the following
gaps:
Amplification vs
only
digitalization
RF transmission
(Bluetooth) vs
USB cable
IOS & Android
vs Android |
| Elements of
comparison | eKuore One electronic
interface for
stethoscope
(Candidate Device) | Eko electronic
stethoscope system.
(Predicate device) | Comparison |
| 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
II/III
-Littmann 3M classic II | -Littmann 3M Cardiology
II/III
-WelchAllyn Harvey
Elite
-ADC601 lines of analog
stethoscopes | Similar to predicate
device |
| Prescription/OTC | Prescription use | Prescription use | Identical to
predicate device |
| Intended for Direct
Connection to Patient | NO | NO | Identical to
predicate device |
| Use environment | Hospitals | Hospitals | 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 |
| Technical
equivalence | | | |
| Sound track transfer
function | Yes | Yes | Identical to
predicate device |
| Signal transmission
for visualization | Wired transmission to
compatible
smartphones | Bluetooth transmission
to compatible
smartphones | Different from
predicate device |
| Energy Source | Provided by smartphone
via USB cable | Lithium Ion Battery | Different from
predicate device |
| System required | Android device | Android device and
Apple, Inc | Similar to predicate
device |
| Hardware and
software platforms | Mobile devices or tables | Mobile devices or
tablets | Identical to
predicate device |
| Connections | Micro USB conector to
communicate with the
mobile phone | Micro USB conector
only to charge internal
battery of the device | Different from
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 Trasnducer. 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 | Earbuds and 3.5mm
Jack when connected
with smartphone | Identical to
predicate device |
| Elements of
comparison | eKuore One electronic
interface for
stethoscope
(Candidate Device) | Eko electronic
stethoscope system
(Predicate device) | Comparison |
| 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: -10°C to
+40°C
Humidity range: 0% to
90% | The operating range is -
10°C to 40°C, and 0% to
90% relative humidity | Identical to
predicate device |
| Biological
Equivalence | | | |
| Materials | Body: ABS (Acrylonitrile
Butadiene Styrene) | Body: ABS (Acrylonitrile
Butadiene Styrene). | Identical to
predicate 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 | Not intended to be
sterilized | Not intended to be
sterilized | Identical to
predicate device |
7
8
9
Table 1. Substantial Equivalence Comparison - eKuore One electronic interface for stethoscope and Predicate Device K151319
As seen in the table above, most elements of comparison are identical between both proposed and predicate devices. The most relevant similarities of eKuore One electronic interface for stethoscope and Eko Electronic Stethoscope System include the following technological elements:
- . Compatible Stethoscopes: Both are designed to work with 3M Littmann Cardiology II/III stethoscopes. They may also work with many other brands models.
- . Digital signal processor: Both the eKuore One and Eko Core use the stethoscope attached to the device to filter internal organ sounds from the patient.
- . System configuration: Both are closed systems providing a mobile app software that displayed the signal from the internal organ sounds into a mobile device.
10
- . Frequency range The eKuore One and Eko Core use the same frequency range that is the place where the cardiac and pulmonary sounds are located.
- . Signal storage: The eKuore One and Eko Core allow recording auscultation sounds in the application software.
- . Hardware and software platform: The eKuore One and Eko Core are compatible with mobile devices software and they can be used on mobile and tablet app software.
The following technological differences exist between the subject and predicate devices:
-
· Principle of operation:
The eKuore One electronic digitalize the internal organ sounds and is intended to not alter the auscultation sounds captured by the stethoscope attached whilst the equivalent device Eko Core Electronic Stethoscope system amplify the organ sounds being able to alter the recording auscultation sounds -
· Signal transmission for visualization:
The eKuore One electronic interface for stethoscope not require enable Bluetooth pairing with the device to transmit sounds whereas the Eko Electronic Stethoscope system used Bluetooth to transmit signal sounds into a mobile device. -
Energy Source: .
The eKuore One obtain the energy source by smarthphone via USB cable whereas the Eko Core used Lithium Ion Battery. -
Connections: .
The connectios of eKuore One use a micro USB to communicate with the mobile phone while Eko Core need micro USB connector to charge internal battery of the device.
eKuore One electronic interface for stethoscope is a simpler variant of the Eko
11
electronic stethoscope system predicate design and with same indications for use. Technological differences as established above have been addressed in the different bench tests performed on the proposed device to provide data to support that they do not affect the safety and effectiveness of the device relative to the predicate. In conclusion eKuore One has similar intended uses as the predicate device and has very similar technological characteristics.
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 requirements for basic safety standard requirements for medical electrical equipment test have been successfully complete following standard of AAMI ANSI 60601-1:2005 and A1:2012 and IEC 60601-1-2 Edition 4: 2014-02
Integration verification and validation testing have been successfully complete following standard IEC 62304:2015.
Usability testing requirements have been evaluated and successfully met as per standards AAMI ANSI IEC 62366:2007.
Design and development included identification, evaluation and control of potential hazards as per standard ISO 14971:2007.
An acoustic performance comparison between eKuore One electronic interface for stethoscope and Eko Electronic Stethoscope System has been performed. Device signal acquisition accuracy and acoustic transmission disturbance has been evaluated and successfully, presenting both devices with similar acoustic characteristics.
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 predicate device.
IV. CONCLUSIONS
Based on the information provided in this premarket notification, Chip Ideas Electronics S.L., concludes that eKuore One electronic interface for stethoscope is substantially equivalent to the listed legally marketed predicate device.