eKuore Pro Series
Device Facts
| Record ID | K203007 |
|---|---|
| Device Name | eKuore Pro Series |
| Applicant | Chip Ideas Electronics S.L. |
| Product Code | DQD · Cardiovascular |
| Decision Date | Oct 30, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1875 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, Pediatric, 3rd-Party Reviewed |
Indications for Use
The eKuore Pro Series 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 Pro Series 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.
Device Story
Electronic stethoscope system comprising hardware device and mobile app; captures body sounds via MEMS microphone; filters and amplifies signals; creates WLAN access point for wireless transmission to smartphone/tablet. App displays real-time phonogram; records sounds (30-120s duration) as .wav files; allows playback, editing, and sharing. Used in clinical settings by healthcare professionals; eKuore Pro Amplified model provides additional gain for users with hearing difficulties. Output aids physical examination and diagnostic decision-making; enables remote review and documentation of cardiac, respiratory, and abdominal sounds.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including acoustic performance comparison against the predicate, electrical safety testing (AAMI ANSI ES 60601-1, IEC 60601-1-2), software validation (IEC 62304), and usability testing (AAMI ANSI IEC 62366).
Technological Characteristics
Materials: ABS body, epoxy/fiberglass membrane, PVC ring. Sensing: MEMS microphone. Energy: Lithium-Ion battery. Connectivity: Wi-Fi (WLAN access point) to mobile app. Dimensions: Modular chestpiece (S, M, L). Software: Mobile app for signal visualization/storage. Standards: AAMI ANSI ES 60601-1, IEC 60601-1-2, IEC 62304, AAMI ANSI IEC 62366, ISO 14971.
Indications for Use
Indicated for pediatric and adult patients undergoing physical assessment by healthcare professionals to record and analyze heart, lung, vascular, and abdominal sounds for diagnostic decision support.
Regulatory Classification
Identification
Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.
Special Controls
*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.
Predicate Devices
- 3M Littmann Electronic Stethoscope Model 3200 (K083903)
Submission Summary (Full Text)
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October 30, 2020
Chip Ideas Electronics S.L. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K203007
Trade/Device Name: eKuore Pro Series Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DOD Dated: September 28, 2020 Received: October 1, 2020
Dear Dave Yungvirt:
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
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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)
K203007
Device Name
eKuore Pro Series
#### Indications for Use (Describe)
The eKuore Pro Series 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 Pro Series 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 cardias, vascular, pulmonary or abdominal organ systems.
| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 20px;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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### Section 5 - 510(k) Summary
#### SUBMITTER
Submitter name: Submitter address:
Chip Ideas Electronics, S.L. C/ Alfarería 3 B. 46100 Burjasot, Valencia SPAIN
Registration Number: Owner Operator Number: 3017140534 10075275
Contact person: Phone: e-mail:
Bernardo Plaza Trillo +34 640742454 bernardo.plaza@ekuore.com
Date Prepared:
2020-10-26
#### DEVICE
Device Trade Name: Common Name: Regulation Name: Regulatory Class: Product Code: Regulation Number:
eKuore Pro Series ELECTRONIC STETHOSCOPE ELECTRONIC STETHOSCOPE Class II DQD 870.1875
#### PREDICATE DEVICE
Predicate Device (S): 3M Littmann Electronic Stethoscope Model 3200 (K083903)
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# Section 5 - 510(k) Summary
# 5.1 DEVICE DESCRIPTION
eKuore Pro Series is formed by eKuore Pro Series device and eKuore Pro App.
The eKuore Pro Series device introduce three different models:
- . eKuore Pro, the basic version of the stethoscope.
- eKuore Pro Amplified, that has a higher sound amplification designed for . people with hearing problems
The main purpose of eKuore Pro Series device is the detection and amplification of heart, lung, arteries, veins and internal sounds using selective frequency organ ranges. eKuore Pro and eKuore Pro Amplified creates a WLAN access point, to which the client is able to connect via Wi-Fi with smartphones and tablets, to send the data acquired during auscultation to the eKuore Pro App.
The design of eKuore Pro Series lets the user change the chestpiece attached between different sizes depend on the patient to be auscultated.
The main purpose of the eKuore Pro Series App is to get the acoustic signals from the eKuore Pro Series WLAN access point. Once the device is turn on, a new Wi-Fi signal could be detected by the smartphone/tablet, the signal name contains the last 6 digits of the serial number of the device for its identification.
After the connection, the eKuore Pro App displays the acoustic signal as a phonogram in real time, in the monitor screen there is a record button. When it is pressed the recording start, there is defined a record maximum duration of 30 seconds, it could be changed on the App configuration to 60. 90 or 120 seconds. To stop the record the recording button must be pressed again. Recordings are stored in *.wav file format in the internal memory of the connected smartphone/tablet, each recording is stored named with the date and time of the moment of the record.
eKuore Pro App has a management screen where it is possible to play, remove and edit a recording. Only the length and the name of the record file could be edited. Also, the eKuore Pro App lets the user share the records.
Furthermore, eKuore Pro App has a tutorial to help the user and one "About App" screen where access to support is available.
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### eKuore Pro Series 510(k) Premarket Notification
# Section 5 – 510(k) Summary
| Equipment description | |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image: eKuore Pro Series main piece with the chestpiece attached | eKuore Pro Series main piece with the<br>chestpiece attached. |
| Image: Hands using eKuore Pro Series | To use the eKure Pro Series devices the<br>chestpice must be attached and turn it on,<br>as is shown in the pictogram.<br>There are three models of chestpiece<br>depend on the patient to be auscultated.<br>S, M or L from neonatal to adults patients. |
| Image: eKuore Pro Series device connected to a smartphone | eKuore Pro Series device is connected<br>via Wi-Fi with eKuore Pro App installed in<br>the smartphone/tablet.<br>Then the ekuore Pro App shows the<br>phonogram in real time. |
| Image: eKuore Pro Series product packaging | eKuore Pro Series product packaging. |
Table 5.1 Equipment Description
The following table shows the difference and similarities of each model:
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### eKuore Pro Series 510(k) Premarket Notification
| Characterictic | EP0002 | EP0099 |
|-----------------------|-----------------------------------------------|----------------------------------------------------------------------|
| Form | Same for both models | Same for both models |
| Design | Same for both models | Same for both models |
| Material | Same for both models | Same for both models |
| Function | For healthcare professionals | For healthcare professionals that needs<br>increased volume |
| Connectivity | Create an WLAN access point | Create an WLAN access point |
| Volume control / gain | 5 steps, 2 dB of difference between<br>levels | 5 steps, 2 dB of difference between<br>levels with an offset of +6db |
| Energy Supply | Same for both models | Same for both models |
| Software | Compatible with eKuore Pro APP. | Compatible with eKuore Pro APP. |
| Firmware | eKuore Pro FW v1.10.07 | eKuore Pro FW v1.10.07 |
| DSP configuration | v00.00.08 | v00.00.58 |
| Hardware | Same for both models | Same for both models |
### Section 5 - 510(k) Summary
Table 5.2 - eKuore Pro Series models comparison table
# 5.2 INDICATIONS FOR USE
The eKuore Pro Series 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 Pro Series 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.
# 5.3 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 Pro Series compared to the predicate device K083903, 3M Littmann Electronic Stethoscope Model 320
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## eKuore Pro Series 510(k) Premarket Notification
# Section 5 - 510(k) Summary
| Elements of<br>comparison | eKuore Pro Series (New Device) | | 3M Littmann Electronic<br>Stethoscope Model 3200<br>(Predicate device) | Comparison |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | eKuore Pro | eKuore Pro Amplified | | |
| Regulatory Class | Class II | Class II | Class II | Identical to predicate device |
| Classification name | Electronic Stethoscope | Electronic Stethoscope | Electronic Stethoscope | Identical to predicate device |
| Regulation Number | 21 CFR 870.1875 | 21 CFR 870.1875 | 21 CFR 870.1875 | Identical to predicate device |
| Product code | DQD | DQD | DQD | Identical to predicate device |
| Manufacturer | Chip Ideas Electronics, SL. | Chip Ideas Electronics, SL. | 3M Company | - |
| FDA Clearance | Pending | Pending | 510(k) cleared: K083903 | - |
| Indications for use | The eKuore Pro Series is intended to<br>be used as a part of a physical<br>assessment of a patient by healthcare<br>professionals for diagnostic decision<br>support in clinical settings. eKuore<br>Pro Series is intended for use on<br>pediatric and adult patients. It can<br>electronically filter and transfer<br>sounds to the accompanying mobile<br>software application.<br>It can be used to record heart sounds<br>and cardiac murmurs, bruits,<br>respiratory sounds and abdominal<br>sounds during physical examination<br>in normal patients or those with<br>suspected diseases of the cardiac,<br>vascular, pulmonary or abdominal<br>organ systems. | The eKuore Pro Series is intended to<br>be used as a part of a physical<br>assessment of a patient by healthcare<br>professionals for diagnostic decision<br>support in clinical settings. eKuore<br>Pro Series is intended for use on<br>pediatric and adult patients. It can<br>electronically filter and transfer<br>sounds to the accompanying mobile<br>software application.<br>It can be used to record heart sounds<br>and cardiac murmurs, bruits,<br>respiratory sounds and abdominal<br>sounds during physical examination<br>in normal patients or those with<br>suspected diseases of the cardiac,<br>vascular, pulmonary or abdominal<br>organ systems. | The 3MTM Littmann® Electronic<br>stethoscope, Model 3200 is intended for<br>medical diagnostic purposes only. It may be<br>used for the detection and amplification of<br>sounds from the heart, lungs, arteries, veins,<br>and other internal organs with the use of a<br>selective frequency. It can be used on any<br>person undergoing a physical assessment | Similar to predicate device |
| Principles of operation | The device picks up sounds from a<br>patient's body. This sound is filtered,<br>amplified and sent it to the user<br>through earbuds, also it can be sent | The device picks up sounds from a<br>patient's body. This sound is filtered,<br>amplified + 6dB offset and sent it to<br>the user through earbuds, also it can | Model 3200 electronic stethoscope picks up<br>sounds, such as heart and lung sounds, from<br>a patient's body. After amplification and<br>filtering, the sounds are sent to the user | Similar to predicate device |
| Elements of<br>comparison | eKuore Pro Series (New Device) | | 3M Littmann Electronic | Comparison |
| | eKuore Pro | eKuore Pro Amplified | Stethoscope Model 3200<br>(Predicate device) | |
| | via WiFi to compatible smartphones<br>and tablets. | be sent via WiFi to compatible<br>smartphones and tablets. | through a binaural headset. Also, can be<br>sent via Bluetooth to compatible devices. | |
| Clinical conditions | Human body sounds related | Human body sounds related | Human body sounds related | Identical to predicate device |
| Use | Electronic stethoscope | Electronic stethoscope | Electronic stethoscope | Identical to predicate device |
| Prescription/O.T.C. | Prescription use | Prescription use | Prescription use | Identical to predicate device |
| Intended for Direct<br>Connection to Patient | YES | YES | YES | Identical to predicate device |
| Use environment | Clinical settings | Clinical settings | Clinical settings | Identical to predicate device |
| Type of users | Health-care personnel | Health-care personnel with hearing<br>difficulties | Health-care personnel | Similar to predicate device.<br>eKuore Pro Amplified is<br>designed for Health-care<br>personnel with hearing<br>difficulties due to increased<br>amplification |
| Target population | Pediatric and adult patients | Pediatric and adult patients | Adult, pediatric and infants | Similar to predicate device |
| Cleaning &<br>Maintenance | When the power supply is off, the<br>entire plastic surface can be cleaned<br>sliding an alcohol pad. Excess fluid<br>during cleaning can cause leakage of<br>moisture on internal components.<br>Clean the stethoscope from patient to<br>patient. | When the power supply is off, the<br>entire plastic surface can be cleaned<br>sliding an alcohol pad. Excess fluid<br>during cleaning can cause leakage of<br>moisture on internal components.<br>Clean the stethoscope from patient to<br>patient | Cleaning of stethoscope should be done<br>between each patient use.<br>Cleaning the Chestpiece<br>Under normal conditions, it is unnecessary<br>to remove the diaphragm for cleaning. The<br>diaphragm can easily be cleaned by using<br>an alcohol wipe. | Identical to predicate device |
| Technical equivalence | | | | |
| Sound track transfer<br>function | Yes | Yes | Yes | Identical to predicate device |
| Signal transmission<br>for visualization | Wireless transmission to compatible<br>smartphones/ tablet via WiFi | Wireless transmission to compatible<br>smartphones/ tablet via WiFi | Wireless transmission to compatible<br>smartphones/tablets via Bluetooth | Similar to predicate device. |
| Energy Source | Lithium-Ion Battery | Lithium-Ion Battery | AA Alkaline, Lithium or NiMH battery | Similar to predicate device. |
| System required | Android device and Apple, Inc | Android device and Apple, Inc | PC/Mac | Different to predicate device |
| Hardware and | Mobile devices or tables | Mobile devices or tables | PC/Mac | Different to predicate device |
| Elements of | eKuore Pro Series (New Device) | | 3M Littmann Electronic | Comparison |
| comparison | eKuore Pro | eKuore Pro Amplified | Stethoscope Model 3200<br>(Predicate device) | |
| software platforms | | | | |
| Connections | Micro USB connector only to charge<br>the internal battery of the device | Micro USB connector only to charge<br>the internal battery of the device | None | Different to predicate device |
| Filter frequency range | • Heart (50-150 Hz)<br>• Lung (50-500 Hz)<br>• Extended (40-600 Hz) | • Heart (50-150 Hz)<br>• Lung (50-500 Hz)<br>• Extended (40-600 Hz) | • Bell (20-200 Hz)<br>• Diaphragm (100-500 Hz)<br>• Extended Range (50-500 Hz) | Similar to predicate device |
| Wireless data<br>transmission | Audio | Audio | Audio | Identical to predicate device |
| Signal Input Method | Sound waves collected via a<br>Transducer. Microelectro-mechanical<br>microphone | Sound waves collected via a<br>Transducer. Microelectro-mechanical<br>microphone…
