eKuore Pro 4T - REF EP0098

K212013 · Chip Ideas Electronics S.L. · DQD · Nov 10, 2021 · Cardiovascular

Device Facts

• Record ID: K212013
• Device Name: eKuore Pro 4T - REF EP0098
• Applicant: Chip Ideas Electronics S.L.
• Product Code: DQD · Cardiovascular
• Decision Date: Nov 10, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1875
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The eKuore Pro 4T 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 4T is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to compatible software. 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; captures body sounds via MEMS microphone; filters/amplifies signals; transmits audio via WLAN to compatible software using eKuore Pro 4T Engine Java library. Used in clinical settings by healthcare professionals. Device features interchangeable chestpieces (S, M, L) for patient size. Provides real-time auscultation audio; allows recording of heart, lung, vascular, and abdominal sounds. Enables diagnostic decision support by digitizing and transferring auscultation data to external platforms. Benefits include enhanced sound detection and remote audio streaming for clinical assessment.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (AAMI ANSI ES 60601-1), electromagnetic compatibility (IEC 60601-1-2), software validation (IEC 62304), usability (AAMI ANSI IEC 62366), and risk management (ISO 14971).

Technological Characteristics

Electronic stethoscope; MEMS microphone; ABS body; epoxy/fiberglass diaphragm with PVC ring. Connectivity: WLAN (IEEE 802.11bg, 2.4 GHz). Power: 1400 mAh Li-ion battery. Dimensions: 13x5x3 cm (without chestpiece). IP21 rating. Software: Java library for device management and audio streaming. Sterilization: Not intended to be sterilized.

Indications for Use

Indicated for pediatric and adult patients undergoing physical assessment by healthcare professionals to record and filter heart, cardiac murmur, bruit, respiratory, 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

• eKuore Pro Series (K203007)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

November 10, 2021

Chip Ideas Electronics S.L. Bernardo Plaza Regulatory Affairs Manager C/ Alfareria 3 B Burjasot, Valencia 46100 Spain

Re: K212013

Trade/Device Name: eKuore Pro 4T Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: October 1, 2021 Received: October 13, 2021

Dear Bernardo Plaza:

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

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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 ([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

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# Indications for Use

510(k) Number (if known) K212013

Device Name

eKuore Pro 4T

Indications for Use (Describe)

The eKuore Pro 4T 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 4T is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to compatible software.

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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### 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 [phone] [e-mail]

Date Prepared:

2021-10-14

### DEVICE

Device Trade Name: Common Name: Regulation Name: Regulatory Class: Product Code: Regulation Number: eKuore Pro 4T ELECTRONIC STETHOSCOPE ELECTRONIC STETHOSCOPE Class II DQD 870.1875

### PREDICATE DEVICE

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

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# Section 5 - 510(k) Summary

# 5.1 DEVICE DESCRIPTION

eKuore Pro 4T is formed by eKuore Pro 4T device and eKuore Pro 4T Engine.

- . eKuore Pro 4T allows use as standalone stethoscope and wireless audio transmission without smartphone to third party applications that uses eKuore Pro 4T Engine.
- eKuore Pro 4T Engine is a Java library that allows third party companies, . communicate with eKuore Pro 4T device.

The main purpose of eKuore Pro 4T device is the detection and amplification of heart, lung, arteries, veins and internal sounds using selective frequency organ ranges.

The design of eKuore Pro 4T lets the user change the chestpiece attached between different sizes depend on the patient to be auscultated.

eKuore Pro 4T Engine Java is a Java library (.jar file) that provides management functionalities for an eKuore Pro 4T device. It provides these functionalities:

- Stream auscultation audio from an eKuore Pro 4T device in real-time, ● through a WLAN.
- Get and set additional information about the connected device: ●
- o The battery level of the device
- The firmware version of the device o
- The serial number of the device o
- The volume level of the device o
- The filter currently being used in the auscultation O
- The hardware version of the device o
- Configure the connection (IP, SSID, password, and ports) of the eKuore Pro . 4T device with a router in a WLAN, allowing the device to autonomously reconnect to it when it is turned on again and stream audio.

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### eKuore Pro 4T 510(k) Premarket Notification

| Equipment description | |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image: eKuore Pro 4T main piece with the chestpiece attached | eKuore Pro 4T main piece with the chestpiece attached. |
| Image: Hand attaching chestpiece to eKuore Pro 4T | To use the eKure Pro 4T devices the chestpice must be attached and turn it on, as is shown in the pictogram.<br>There are three models of chestpiece depend on the patient to be auscultated. S, M or L from neonatal to adults patients. |
| Image: Healthcare professional, Integration-Information, Software Sistem | eKuore Pro 4T device is connected via Wi-Fi to software built using eKuore Pro 4T engine. |
| Image: eKuore Pro 4T product packaging | eKuore Pro 4T product packaging. |

# Section 5 – 510(k) Summary

Table 5.1 Equipment Description

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

| Characteristic | EP0002 | EP0099 | EP0098 |
|----------------|---------------------------|---------------------------|---------------------------|
| Form | Same for the three models | Same for the three models | Same for the three models |
| Design | Same for the three models | Same for the three models | Same for the three models |
| Material | Same for the three models | Same for the three models | Same for the three models |
| Function | For healthcare | For healthcare | For healthcare |

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# eKuore Pro 4T 510(k) Premarket Notification

# Section 5 - 510(k) Summary

| | professionals | professionals that needs<br>increased volume | professionals |
|--------------------------|-----------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Connectivity | Create an WLAN access<br>point | Create an WLAN access<br>point | It connects to an WLAN<br>access point Configurable<br>with eKuore Pro 4T Engine<br>Java library |
| Volume control /<br>gain | 5 steps, 2 dB of difference<br>between levels | 5 steps, 2 dB of difference<br>between levels with an<br>offset of +6db | 5 steps, 2 dB of difference<br>between levels |
| Energy Supply | | Same for the three models | |
| Software | Compatible with eKuore<br>Pro APP. | Compatible with eKuore<br>Pro APP. | No compatible with eKuore<br>Pro APP. Configurable with<br>eKuore Pro Engine Java<br>library |
| Firmware | eKuore Pro FW v1.10.07 | eKuore Pro FW v1.10.07 | eKP4T FW v1.0.4 |
| DSP configuration | v00.00.08 | v00.00.58 | v00.00.08 |
| Hardware | | Same for the three models | |

Table 5.2 - eKuore Pro models comparison table

The following table shows the technical characteristics of eKuore Pro 4T

| Weight without chestpiece | 85 gr |
|--------------------------------------------------------|--------------------------------------------------------------|
| Dimensions without chestpiece | 13cm x 5cm x 3cm (W x D x H) |
| Weight with chestpiece | 150 gr |
| Dimensions with chestpiece | 13cm x 5cm x 5cm (W x D x H) |
| Working temperature and humidity | 0 to +40 °C and +15 to +93% |
| Transportation and storage temperature and<br>humidity | -20 to +45°C and +15 to +93% |
| IP Rate | IP21 |
| Transmission frequency range | Beetween 2.412 GHz and 2.484 GHz |
| Modulation type | DSSS |
| Wireless quality of service | Device needs to be connected to wlan with at<br>least 705kbs |
| Wireless security | WLAN WPA2 encrypted networks preferred. |
| Input voltage during the load | 5V DC, 500 mA |
| Power | 2,5 W |

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## eKuore Pro 4T 510(k) Premarket Notification

## Section 5 - 510(k) Summary

| Battery | Rechargeable. 1400 mAh lithium polymer. Do<br>not replace by user |
|----------------------------|--------------------------------------------------------------------|
| USB Port | Do not connect while the device iss being used<br>with the patient |
| Wireless functions | Audio transmission |
| Wireless standard protocol | IEEE 802.11bg |
| Effective radiated power | 15dBm (32mW) |

Table 5.3 - eKuore Pro 4T technical characteristics

# 5.2 INDICATIONS FOR USE

The eKuore Pro 4T 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 4T is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to compatible software.

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 4T compared to the predicate device K203007, eKuore Pro Series:

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## eKuore Pro 4T 510(k) Premarket Notification

# Section 5 – 510(k) Summary

| Elements of<br>comparison | New Device | Predicate device | | Comparison |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| | eKuore Pro 4T | 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. | Chip Ideas Electronics, SL. | Identical to predicate device |
| FDA Clearance | K212013 Pending | K203007 | K203007 | - |
| Indications for use | The eKuore Pro Series is intended<br>to be used as a part of a physical<br>assessment of a patient by<br>healthcare professionals for<br>diagnostic decision support in<br>clinical settings. eKuore Pro Series<br>is intended for use on pediatric and<br>adult patients. It can electronically<br>filter and transfer sounds to<br>compatible software.<br>It can be used to record heart<br>sounds 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<br>to be used as a part of a physical<br>assessment of a patient by<br>healthcare professionals for<br>diagnostic decision support in<br>clinical settings. eKuore Pro Series<br>is intended for use on pediatric and<br>adult patients. It can electronically<br>filter and transfer sounds to<br>compatible software.<br>It can be used to record heart<br>sounds 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<br>to be used as a part of a physical<br>assessment of a patient by<br>healthcare professionals for<br>diagnostic decision support in<br>clinical settings. eKuore Pro Series<br>is intended for use on pediatric and<br>adult patients. It can electronically<br>filter and transfer sounds to<br>compatible software.<br>It can be used to record heart<br>sounds 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. | Identical to predicate device |
| Principles of operation | The device picks up sounds from a<br>patient's body. This sound is<br>filtered, amplified and sent it to the<br>user through earbuds, also it can be<br>sent via WiFi to eKuore Pro 4T | The device picks up sounds from a<br>patient's body. This sound is<br>filtered, amplified and sent it to the<br>user through earbuds, also it can be<br>sent via WiFi to compatible | The device picks up sounds from a<br>patient's body. This sound is<br>filtered, amplified + 6dB offset and<br>sent it to the user through earbuds,<br>also it can be sent via WiFi to | Similar to predicate device |
| Elements of<br>comparison | New Device | Predicate device | | Comparison |
| | eKuore Pro 4T | eKuore Pro | eKuore Pro Amplified | |
| | Engine Java. | smartphones and tablets. | compatible smartphones and<br>tablets. | |
| 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 | Health-care personnel with hearing<br>difficulties | Identical to predicate device |
| Target population | Pediatric and adult patients | Pediatric and adult patients | Pediatric and adult patients | Identical 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<br>of moisture on internal components.<br>Clean the stethoscope from patient<br>to 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<br>of moisture on internal components.<br>Clean the stethoscope from patient<br>to 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<br>of moisture on internal components.<br>Clean the stethoscope from patient<br>to patient | 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 eKuore<br>Pro 4T Engine Java | Wireless transmission to compatible<br>smartphones/ tablet via WiFi | Wireless transmission to compatible<br>smartphones/ tablet via WiFi | Similar to predicate device. |
| Energy Source | Lithium-Ion Battery | Lithium-Ion Battery | Lithium-Ion Battery | Identical to predicate device |
| System required | Platform compatible with Java VM | Android device and Apple, Inc | Android device and Apple, Inc | Different to predicate device |
| Hardware and<br>software platforms | Desktop or Mobile devices | Mobile devices or tables | Mobile devices or tables | Different to predicate device |
| Connections | Micro USB connector only to<br>charge the internal battery of the<br>device | Micro USB connector only to<br>charge the internal battery of the<br>device | Micro USB connector only to<br>charge the internal battery of the<br>device | Identical to predicate device |
| Elements of<br>comparison | New Device | Predicate device | | Comparison |
| comparison | eKuore Pro 4T | eKuore Pro | eKuore Pro Amplified | |
| 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) | • Heart (50-150 Hz)<br>• Lung (50-500 Hz)<br>• Extended (40-600 Hz)…