eKuore One electronic interface for stethoscope

K181882 · Chip Ideas Electronics S.L. · DQD · Mar 27, 2019 · Cardiovascular

Device Facts

• Record ID: K181882
• Device Name: eKuore One electronic interface for stethoscope
• Applicant: Chip Ideas Electronics S.L.
• Product Code: DQD · Cardiovascular
• Decision Date: Mar 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended 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.

Device Story

eKuore One is an electronic interface for acoustic stethoscopes; captures internal body sounds via a MEMS transducer; digitizes and transmits audio signals via USB OTG cable to a mobile application (eKuore ONE App). Used in clinical settings by healthcare professionals; device attaches to existing stethoscopes (e.g., Littmann Cardiology/Classic). App displays phonograms in real-time; allows 15-second recordings stored as .wav files on mobile devices. No signal processing occurs prior to display; app provides recording management (play, remove, edit metadata). Provides diagnostic decision support by enabling visualization and storage of auscultation sounds; benefits include objective documentation and potential for later review of cardiac, respiratory, and abdominal sounds.

Clinical Evidence

No clinical data. Bench testing only. Acoustic performance comparison against the predicate device confirmed similar signal acquisition accuracy and transmission characteristics. Compliance with AAMI ANSI 60601-1, IEC 60601-1-2, IEC 62304, AAMI ANSI IEC 62366, and ISO 14971 standards verified.

Technological Characteristics

Body material: ABS (Acrylonitrile Butadiene Styrene). Sensing: MEMS transducer. Frequency range: 20 Hz to 2 kHz. Connectivity: Wired USB OTG to mobile device (Android). Power: Provided by host smartphone/tablet. Form factor: Stethoscope attachment. Software: Mobile application for visualization and storage. Sterilization: Not intended to be sterilized.

Indications for Use

Indicated for pediatric and adult patients; used by healthcare professionals for diagnostic decision support during physical assessment; records 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

• Eko electronic Stethoscope System (K151319)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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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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# SUBMITTER

Submitter name: Chip Ideas Electronics, S.L. C/ Clariano 8, Entresuelo B. Submitter address: 46021 Valencia SPAIN

Contact person: Bernardo Plaza Trillo Phone: [phone] [e-mail] 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

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#### 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.

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| Equipment description | |
|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image: eKuore One main piece | eKuore One the main piece. Is the part<br>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<br>adaptors to the stethoscope.<br>The first pictogram is for attachment with<br>Littmann Cardiology stethoscopes<br>The second one is for attachment with<br>Littmann Classic stethoscopes |
| Image: eKuore One installed into the stethoscope and USB cable | eKuore One installed into the stethoscope<br>and USB cable to display the digital<br>sound to the mobile device. |
| Image: eKuore One real view of complete installation | eKuore One real view of complete<br>installation. |

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#### 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<br>comparison | eKuore One electronic<br>interface for<br>stethoscope<br>(Candidate Device) | Eko electronic<br>stethoscope system.<br>(Predicate device) | Comparison |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory data | | | |
| Regulatory Class | Class II | Class II | Identical to<br>predicate device |
| Classification name | Electronic Stethoscope | Electronic Stethoscope | Identical to<br>predicate device |
| Regulation Number | 21 CFR 870.1875 | 21 CFR 870.1875 | Identical to<br>predicate device |
| Product code | DQD | DQD | Identical to<br>predicate device |
| Manufacturer | Chip Ideas Electronics,<br>S.L. | Eko Devices, Inc. | - |
| FDA Clearance | Pending | 510(k) cleared:<br>K151319 | - |
| Elements of<br>comparison | eKuore One electronic<br>interface for<br>stethoscope<br>(Candidate Device) | Eko electronic<br>stethoscope system.<br>(Predicate device) | Comparison |
| USE | | | |
| Indications for use | The eKuore One<br>electronic interface for<br>stethoscope is intended<br>to be used as a part of a<br>physical assessment of<br>a patient by healthcare<br>professionals for<br>diagnostic decision<br>support in clinical<br>settings. eKuore One is<br>intended for use on<br>pediatric and adult<br>patients. It can<br>electronically filter and<br>transfer sounds to the<br>accompanying mobile<br>software application.<br><br>It can be used to record<br>heart sounds and<br>cardiac murmurs, bruits,<br>respiratory sounds and<br>abdominal sounds<br>during physical<br>examination in normal<br>patients or those with<br>suspected diseases of<br>the cardiac, vascular,<br>pulmonary or abdominal<br>organ systems. | The Eko Electronic<br>Stethoscope System is<br>intended to be used as a<br>part of a physical<br>assessment of a patient<br>by healthcare<br>professionals for<br>diagnostic decision<br>support in clinical<br>settings. Eko is intended<br>for use on pediatric and<br>adult patients. It can<br>electronically amplify,<br>filter and transfer sounds<br>to the accompanying<br>mobile application for<br>storage and sharing.<br><br>It can used to record<br>heart sounds and<br>cardiac murmurs, bruits,<br>respiratory sounds and<br>abdominal sounds<br>during physical<br>examination in normal<br>patients or those with<br>suspected diseases of<br>the cardiac, vascular,<br>pulmonary or abdominal<br>organ systems. | The Indications for<br>Use statement for<br>the eKuore One is<br>identical to the<br>predicate device. |
| Characteristics | | | Comparison |
| Principles of operation | The device consists in a<br>microphone and some<br>electronics for their<br>digitalization and<br>codification to a<br>standard format, and<br>sending via USB cable<br>to smartphones and<br>tablets. | Dispositive introduced in<br>an acoustic stethoscope<br>and gives sound<br>amplification and audio<br>transmission to a<br>smartphone via<br>Bluetooth that allows the<br>user to open and<br>playback sounds in a<br>mobile application on<br>compatible iOS<br>smartphones and<br>tablets. | Similar to predicate<br>device<br>with the following<br>gaps:<br>Amplification vs<br>only<br>digitalization<br>RF transmission<br>(Bluetooth) vs<br>USB cable<br>IOS & Android<br>vs Android |
| Elements of<br>comparison | eKuore One electronic<br>interface for<br>stethoscope<br>(Candidate Device) | Eko electronic<br>stethoscope system.<br>(Predicate device) | Comparison |
| Clinical conditions | Human body sounds<br>related | Human body sounds<br>related | Identical to<br>predicate device |
| Use | Electronic stethoscope | Electronic stethoscope | Identical to<br>predicate device |
| Compatibility | -Littmann 3M Cardiology<br>II/III<br>-Littmann 3M classic II | -Littmann 3M Cardiology<br>II/III<br>-WelchAllyn Harvey<br>Elite<br>-ADC601 lines of analog<br>stethoscopes | Similar to predicate<br>device |
| Prescription/OTC | Prescription use | Prescription use | Identical to<br>predicate device |
| Intended for Direct<br>Connection to Patient | NO | NO | Identical to<br>predicate device |
| Use environment | Hospitals | Hospitals | Identical to<br>predicate device |
| Type of users | Health-care personnel | Health-care personnel | Identical to<br>predicate device |
| Target population | All types of patients | All types of patients | Identical to<br>predicate device |
| Technical<br>equivalence | | | |
| Sound track transfer<br>function | Yes | Yes | Identical to<br>predicate device |
| Signal transmission<br>for visualization | Wired transmission to<br>compatible<br>smartphones | Bluetooth transmission<br>to compatible<br>smartphones | Different from<br>predicate device |
| Energy Source | Provided by smartphone<br>via USB cable | Lithium Ion Battery | Different from<br>predicate device |
| System required | Android device | Android device and<br>Apple, Inc | Similar to predicate<br>device |
| Hardware and<br>software platforms | Mobile devices or tables | Mobile devices or<br>tablets | Identical to<br>predicate device |
| Connections | Micro USB conector to<br>communicate with the<br>mobile phone | Micro USB conector<br>only to charge internal<br>battery of the device | Different from<br>predicate device |
| Frequency range | 20 Hz to 2 KHz | 20 Hz to 2 kHz | Identical to<br>predicate device |
| Signal Input Method | Sound was collected via<br>a Trasnducer. MEMS | Sound waves collected<br>via a Transducer.<br>Electro micro-phone | Identical to<br>predicate device |
| Audio Output Method | Earbuds and 3.5mm<br>Jack when connected<br>with smartphone | Earbuds and 3.5mm<br>Jack when connected<br>with smartphone | Identical to<br>predicate device |
| Elements of<br>comparison | eKuore One electronic<br>interface for<br>stethoscope<br>(Candidate Device) | Eko electronic<br>stethoscope system<br>(Predicate device) | Comparison |
| Signal Storage | Allows signal storage<br>depending on technical<br>features (capacity,...) of<br>connected device<br>(smartphone or tablet). | Allows signal storage<br>depending on technical<br>features (capacity,...) of<br>connected device<br>(smartphone or tablet). | Identical to<br>predicate device |
| Performance<br>requirements | Temp range: -10°C to<br>+40°C<br>Humidity range: 0% to<br>90% | The operating range is -<br>10°C to 40°C, and 0% to<br>90% relative humidity | Identical to<br>predicate device |
| Biological<br>Equivalence | | | |
| Materials | Body: ABS (Acrylonitrile<br>Butadiene Styrene) | Body: ABS (Acrylonitrile<br>Butadiene Styrene). | Identical to<br>predicate device |
| Contact with human<br>tissues or body fluids | Does not contact<br>patient's body. Attached<br>stethoscope does. | Does not contact<br>patient's body. Attached<br>stethoscope does. | Identical to<br>predicate device |
| Sterility | Not intended to be<br>sterilized | Not intended to be<br>sterilized | Identical to<br>predicate device |

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### 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 softwar…