ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.

K211779 · Chip Ideas Electronics S.L. · DQD · May 26, 2022 · Cardiovascular

Device Facts

• Record ID: K211779
• Device Name: ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.
• Applicant: Chip Ideas Electronics S.L.
• Product Code: DQD · Cardiovascular
• Decision Date: May 26, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The eKuore Stethoscope Touch 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. The eKuore Stethoscope Touch is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to a compatible 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 device, mobile app, and Android engine. Collects body sounds via microphone transducer; digitizes, amplifies, and encodes signals; transmits via Bluetooth/WiFi to compatible smartphones, tablets, or third-party software. Features interchangeable chestpieces (S, M, L) for patient size. Used in clinical settings by healthcare professionals. App displays phonogram in real-time; allows recording (max 30s), storage (*.wav), playback, and editing. ES002 model includes OLED touchscreen and hearing aid compatibility. ES003 enables third-party integration via Android library. Provides diagnostic decision support by allowing clinicians to visualize and store auscultation data, facilitating remote or longitudinal assessment of cardiac, vascular, pulmonary, and abdominal conditions.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including acoustic performance comparison against the predicate, electrical safety (AAMI ANSI ES 60601-1, IEC 60601-1-2), software verification/validation (IEC 62304), usability testing (AAMI ANSI IEC 62366), and risk management (ISO 14971).

Technological Characteristics

Materials: ABS/PMMA body, AISI 303 stainless steel chestpiece base, PVC membrane/ring. Sensing: Electret microphone transducer. Frequency response: 40Hz-8KHz (ES002). Connectivity: Bluetooth, WiFi (ES003), USB-C audio output. Power: 1400mAH LiPo battery. Form factor: Handheld with interchangeable chestpieces. Software: Embedded firmware and mobile application. Sterilization: Not intended to be sterilized.

Indications for Use

Indicated for pediatric and adult patients for physical assessment and diagnostic decision support by healthcare professionals. Used to record heart, cardiac murmur, bruit, respiratory, and abdominal sounds in normal patients or those with suspected cardiac, vascular, pulmonary, or abdominal disease.

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

• eKuore Pro Series (K203007)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 26, 2022

Chip Ideas Electronics S.L. Bernardo Trillo Regulatory Affairs Manager Calle Alfareria 3 B Burjasot, Valencia 46100 Spain

Re: K211779

Trade/Device Name: eKuore Stethoscope Touch Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DOD Dated: May 25, 2021 Received: December 13, 2022

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

{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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K211779

Device Name eKuore Stethoscope Touch

#### Indications for Use (Describe)

The eKuore Stethoscope Touch is intended to be used as a part of a physical assessment of a patient by healtheare professionals for diagnostic decision support in clinical settings.

The eKuore Stethoscope Touch is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to a compatible software application.

It can be used to record heart sounds and cardiac murmurs, bruits, 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# ekuore

# eKuore Stethoscope Touch

510(k) Premarket Notification

# Section 5 - 510(k) Summary

#### SUBMITTER

Chip Ideas Electronics, S.L. Submitter name: Submitter address: C/ Alfarería 3 B. 46100 Burjasot, Valencia SPAIN

Registration Number: Owner Operator Number:

3017140534 10075275

Contact person: Phone: e-mail:

Bernardo Plaza Trillo [phone] [e-mail]

Date Prepared:

2022-01-11

# DEVICE

Device Trade Name: Common Name: Regulation Name: Regulatory Class: Product Code: Regulation Number: eKuore Stethoscope Touch ELECTRONIC STETHOSCOPE ELECTRONIC STETHOSCOPE Class II DQD 870.1875

# PREDICATE DEVICE

eKuore Pro Series (K203007) Predicate Device (S):

{4}------------------------------------------------

# ekuore

# eKuore Stethoscope Touch

510(k) Premarket Notification

# Section 5 - 510(k) Summary

# 5.1 DEVICE DESCRIPTION

eKuore Stethoscope Touch is formed by eKuore Stethoscope Touch device, eKuore Medical Devices App and eKuore Touch Android Engine.

The eKuore Stethoscope Touch device introduces three different models:

- . ES001 is the basic version of the electronic stethoscope for general purposes.
- . ES002 is an electronic stethoscope designed for people with hearing problems and enable hearing aids connection.
- ES003 is an electronic stethoscope that can connect to third-party software ● using an Android Library.

The primary purpose of the eKuore Stethoscope Touch device is to detect and amplify heart, lung, arteries, veins, and internal sounds using selective frequency organ ranges.

The design of eKuore Stethoscope Touch lets the user change the chestpiece attached between different sizes depending on the patient to be auscultated.

The primary purpose of the eKuore Medical Devices App is to get the acoustic signals from the eKuore Stethoscope Touch device. Once the device is turned on, the smartphone/tablet could detect a Bluetooth device.

After the connection, the eKuore Medical Devices App displays the acoustic signal as a phonogram in real-time, on the monitor screen, there is a record button. When it is pressed, the recording start, a record maximum duration of 30 seconds is defined. 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 Medical Devices 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 Medical Devices App lets the user share the records.

eKuore Touch Android Engine enable third party companies to connect eKuore Stethoscope Touch model ES003 to obtain the audio from the device and use it in their own software. Audio is transmitted without modifications or processing.

{5}------------------------------------------------

# ekuore

# eKuore Stethoscope Touch

510(k) Premarket Notification

Image /page/5/Figure/4 description: The image shows an eKuore Stethoscope Touch device with the chestpiece attached. According to the text, there are three models of chestpieces that depend on the patient to be auscultated. The models are S, M, or L from neonatal to adults patients. The image is labeled with the title "Equipment description".

# Section 5 – 510(k) Summary

Table 5.1 Equipment Description

The following table shows the difference and similarities of each model:

| Specification | ES001 | ES002 | ES003 | Note: |
|----------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Model | ES001 | ES002 | ES003 | |
| Basic UDI-DI | 8437021515ES001T9 | 8437021515ES002TB | 8437021515ES003TD | |
| Dimensions | | 132*55*35mm | | |
| Screen | | 1,54 OLED with resistive touchscreen | | |
| Device lifetime from<br>the date of<br>manufacture | | 10 years | | Manufacturing date included in labeling |
| Frequency<br>response | | 20Hz to 8KHz | | |
| Signal to Noise<br>Ratio | | 62.5dB | | |
| Data representation | | 16-24 bits | | |
| Environmental<br>range | | Temperature: 10°C to +40°C<br>Humidity: 0-90% | | |
| Maximum audio<br>delay | | 50ms | | |
| Internal memory | | Up to 10 recordings | | |
| Battery | 1400mAH rechargeable LiPo Battery | 1400mAH rechargeable LiPo Battery | 1400mAH rechargeable LiPo Battery | |
| Functionalities: | USB-C audio output<br>3 selective filters<br>Android and iOS<br>compatible | USB-C audio output<br>3 selective filters<br>Bluetooth audio<br>devices compatible | USB-C audio output<br>3 selective filters<br>Compatible with<br>eKuore ES Android<br>Engine library | |
| GMDN | | 13754 | | |
| Weight | | 75g | | |
| Power supply | | | | EN 60601-1 compliant |
| Battery charger | | | | Not included. Use USB-C cable provided with a 5V DC charger |
| Data interface | USB-C Audio | USB-C Audio | USB-C Audio | |
| Wireless<br>communication | Bluetooth | Bluetooth | Bluetooth/WiFi | ES001 Bluetooth for app communication.<br>ES002 Bluetooth for |

Rev 02

{6}------------------------------------------------

# eKuore Stethoscope Touch

510(k) Premarket Notification

| | | | Section 5 - 510(k) Summary |
|--|--|--|----------------------------|
|--|--|--|----------------------------|

| Specification | ES001 | ES002 | ES003 | Note: |
|-------------------|-----------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------|
| Use combined with | iOS / Android App<br>Interchangeable<br>chestpieces | A2DP Bluetooth<br>receivers<br>Interchangeable<br>chestpieces | Android Engine library<br>Interchangeable<br>chestpieces | the audio stream.<br>ES0003 Bluetooth and<br>WiFi for the audio<br>stream |
| Manufacturer | CHIP IDEAS ELECTRONICS SL | | | |

Table 5.2 - Comparison table of eKuore Stethoscope Touch models

# 5.2 INDICATIONS FOR USE

The eKuore Stethoscope Touch 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.

The eKuore Stethoscope Touch is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to a compatible 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 to detect 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 or computers.

In the establishment of substantial equivalence, eKuore Stethoscope Touch compared to the predicate device (K203007) eKuore Pro Series.

eKuore Stethoscope Touch is the evolution of CHIP IDEAS ELECTRONICS SL, electronic stethoscopes.

Rev 02

{7}------------------------------------------------

# Section 5 - 510(k) Summary

| Elements of<br>comparison | eKuore Stethoscope Touch (Candidate Device) | | | eKuore Pro Series (Predicate Device) | Comparison |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| comparison | ES001 | ES002 | ES003 | | |
| Regulatory data | | | | | |
| Regulatory<br>Class | | Class II | | Class II | Identical to predicate device |
| Classification<br>name | | Electronic Stethoscope | | Electronic Stethoscope | Identical to predicate device |
| Regulation<br>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, SL. | | Chip Ideas Electronics, SL. | Identical to predicate device |
| FDA Clearance | | K211779 Pending | | K203007 | - |
| | | | | USE | |
| Indications for<br>use | The eKuore Stethoscope Touch is intended to be used as a<br>part of a physical assessment of a patient by healthcare<br>professionals for diagnostic decision support in clinical<br>settings.<br><br>The eKuore Stethoscope Touch is intended for use on<br>pediatric and adult patients. It can electronically filter and<br>transfer sounds to a compatible software application.<br><br>It can be used to record heart sounds and cardiac murmurs,<br>bruits, respiratory sounds, and abdominal sounds during<br>physical examination in normal patients or those with<br>suspected diseases of the cardiac, vascular, pulmonary or<br>abdominal organ systems. | | | The eKuore Pro Series is intended to be<br>used as a part of a physical assessment of<br>a patient by healthcare professionals for<br>diagnostic decision support in clinical<br>settings. eKuore Pro Series is intended for<br>use on pediatric and adult patients. It can<br>electronically filter and transfer sounds to<br>the accompanying mobile software<br>application.<br><br>It can be used to record heart sounds and<br>cardiac murmurs, bruits, respiratory sounds<br>and abdominal sounds during physical<br>examination in normal patients or those<br>with suspected diseases of the cardiac,<br>vascular, pulmonary or abdominal organ<br>systems. | Similar to predicate device with the following<br>gap:<br>Predicate Device: connects only to mobile<br>apps.<br>Canidate device can connects to mobile apps<br>but also other devices. |
| CHARACTERISTICS | | | | | |
| Principles of<br>operation | The device consists in a microphone and some electronics for<br>their digitalization, amplification, and codification to a standard<br>format, and sending using wireless technology to compatible<br>devices and software. | | | The device consists in a microphone and<br>some electronics for their digitalization,<br>amplification, and codification to a standard<br>format, and sending via WiFi to | Similar to predicate device<br>with the following gaps:<br>WiFi transmission vs WiFi and Bluetooth<br>transmission |
| Elements of<br>comparison | eKuore Stethoscope Touch (Candidate Device) | | | eKuore Pro Series (Predicate Device) | Comparison |
| | ES001 | ES002 | ES003 | | |
| Clinical<br>conditions | Human body sounds related | | | Human body sounds related | Identical to predicate device |
| Use | Electronic stethoscope | | | Electronic stethoscope | Identical to predicate device |
| Compatibility | Android and iOS<br>devices | Bluetooth<br>receivers | Third party<br>Android projects | Android and iOS devices | Predicate device is an electronic stethoscope<br>that can send audio to iOS and Android<br>devices, candidate device can also transfer<br>sound to other compatible systems. |
| Prescription/O.T<br>.C. | Prescription use | | | Prescription use | Identical to predicate device |
| Intended for<br>Direct<br>Connection to<br>Patient | YES | | | YES | Identical to predicate device |
| Use<br>environment | Clinical settings | | | Clinical settings | Identical to predicate device |
| Type of users | Healthcare<br>personnel | Healthcare<br>personnel with<br>hearing aids | Healthcare<br>personnel | Healthcare personnel | Similar to predicate device. ES002 is designed<br>to transfer sound to Bluetooth hearing aids |
| Target<br>population | All types of patients | | | All types of patients | Identical to predicate device |
| TECHNICAL EQUIVALENCE | | | | | |
| Sound track<br>transfer<br>function | Yes | | | Yes | Identical to predicate device |
| Signal<br>transmission for<br>visualization | Wireless transmission to compatible systems via WiFi and<br>Bluetooth | | | Wireless transmission to compatible<br>smartphones/tablet via WiFi | Different from predicate device, candidate<br>device can also transfer sound using Bluetooth<br>connectivity |
| Device control | 1.4' touch screen | | | Touching buttons | Different to predicate device. |
| Energy Source | Lithium-Ion Battery | | | Lithium-Ion Battery | Identical to predicate device |
| System required | Android and iOS | Bluetooth | Third party | Android and iOS devices | Predicate device can send audio to iOS and |
| Elements of<br>comparison | eKuore Stethoscope Touch (Candidate Device) | | | eKuore Pro Series (Predicate Device) | Comparison |
| | ES001 | ES002…