eKuore One Wireless Electronic Interface for stethoscope

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November 24, 2020 Chip Ideas Electronics S.L Bernardo Trillo Regulatory Affairs Manager Calle Alfareria 3 B Burjasot, Valencia 46100 Spain Re: K201742 Trade/Device Name: eKuore One Wireless Electronic Interface for stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: October 26, 2020 Received: October 30, 2020 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). 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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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K201742 Device Name eKuore One Wireless electronic interface for stethoscope Indications for Use (Describe) The eKuore One Wireless electronic interface for stethoscope is intended to be used as a part of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore One Wireless 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. | 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 One Wireless Electronic Interface for Stethoscope 510(k) Premarket Notification ### Section 5 - 510(k) Summary ### SUBMITTER Submitter name: Submitter address: Chip Ideas Electronics, S.L. C/ Alfarería 3 B. 46100 Burjasot, Valencia. SPAIN Contact person: Phone: e-mail: Bernardo Plaza Trillo +34 640742454 bernardo.plaza@ekuore.com Date Prepared: November 23th, 2020 ### DEVICE Device Trade Name: eKuore One Wireless electronic interface for stethoscope ELECTRONIC STETHOSCOPE Common Name: ELECTRONIC STETHOSCOPE Requlation Name: Regulatory Class: Class II Product Code: DQD Regulation Number: 870.1875 ### PREDICATE DEVICE Predicate Device (S): Eko Electronic Stethoscope System, K151319 {4}------------------------------------------------ ### eKuore One Wireless Electronic Interface for Stethoscope 510(k) Premarket Notification ### Section 5 - 510(k) Summary ### l. DEVICE DESCRIPTION The equipment consists of a stethoscope attachment, which will let the sound flow through the stethoscope's tube, so the stethoscope can continue working as usual, and the sound will be collected by a little hole in the piece, where a microphone will be placed. Then, this piece will be covered by a plastic case. A Bluetooth module is placed for a wireless transition of the data to a mobile (Android/IOS) or tablet. The eKuore One Wireless electronic interface for stethoscope gets the power supply from an internal rechargeable battery. The application allows the user to visualize audio streaming received from the stethoscope. The connection is established between the smartphone application and the selected device, and after this event, the selected device starts to stream audio to the smartphone application. The application also allows the user to record the current audio streaming, storing it in the internal storage of the Android/iOS device. The recordings can be viewed, shared and deleted after that. The application does not store or collect any personal data of the users or patients. The only generated artifacts generated with the use of the application, the auscultations stored in the internal storage of the Android/iOS device, can only be identified by its name, which is a combination of the time and date when the auscultation was performed, which is insufficient to identify uniquely a patient or gets its personal information. #### II. INDICATIONS FOR USE The eKuore One Wireless electronic interface for stethoscope is indicated 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 Wireless is indicated 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}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "ekuore" in a sans-serif font. The letters are all lowercase and are a dark gray color. The word is centered in the image and takes up most of the space. Electronic Interface for Stethoscope 510(k) Premarket Notification ### Section 5 - 510(k) Summary ### lll. 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 One Wireless electronic interface for stethoscopes compared to the predicate device K181882 eKuore One electronic interface for stethoscope and the reference device K151319 Eko Electronic Stethoscope System: | Elements of<br>comparison | eKuore One Wireless<br>electronic interface for<br>stethoscope (Candidate<br>Device) | Eko electronic stethoscope<br>system.<br>(Reference device) | Comparison | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | Regulatory data | | | | | Regulatory Class | Class II | Class II | Identical to predicate<br>device | | Device<br>Classification<br>name | Electronic Stethoscope | Electronic Stethoscope | Identical to predicate<br>device | | Regulation<br>Number | 21 CFR 870.1875 | 21 CFR 870.1875 | Identical to predicate<br>device | | Classification<br>Product code | DQD | DQD | Identical to predicate<br>device | | Manufacturer | Chip Ideas Electronics,<br>S.L. | Eko Devices, Inc. | - | | FDA Clearance | Pending | K151319 | - | | USE | | | | | Intended use | The eKuore One Wireless<br>electronic interface for<br>stethoscope is intended to<br>be used as a part of a<br>physical assessment of a<br>patient by healthcare<br>professionals for<br>diagnostic decision<br>support in clinical settings.<br>eKuore One Wireless is<br>indicated for use on<br>pediatric and adult<br>patients. It can<br>electronically filter and<br>transfer sounds to the<br>accompanying mobile | The Eko Electronic<br>Stethoscope System is<br>intended to be used as a part<br>of a physical assessment of a<br>patient by healthcare<br>professionals for diagnostic<br>decision support in clinical<br>settings. Eko is intended for<br>use on pediatric and adult<br>patients. It can electronically<br>amplify, filter and transfer<br>sounds to the accompanying<br>mobile application for storage<br>and sharing. | Similar to predicate<br>device.<br>Predicate device also<br>amplify sound. | | Elements of<br>comparison | eKuore One Wireless<br>electronic interface for<br>stethoscope (Candidate<br>Device) | Eko electronic stethoscope<br>system.<br>(Reference device) | Comparison | | | software application.<br>It can be used to record<br>heart sounds and cardiac<br>murmurs, bruits,<br>respiratory sounds and<br>abdominal sounds during<br>physical examination in<br>normal patients or those<br>with suspected diseases<br>of the cardiac, vascular,<br>pulmonary or abdominal<br>organ systems. | It can used to record heart<br>sounds and cardiac murmurs,<br>bruits, respiratory sounds and<br>abdominal sounds during<br>physical examination in<br>normal patients or those with<br>suspected diseases of the<br>cardiac, vascular, pulmonary<br>or abdominal organ systems. | | | | Characteristics | | | | Principles of<br>operation | The device consists in a<br>microphone and some<br>electronics for their<br>digitalization and<br>codification to a standard<br>format, and sending via<br>wireless (Bluetooth) to<br>smartphones and tablets. | Dispositive introduced in an<br>acoustic stethoscope and<br>gives sound amplification and<br>audio transmission to a<br>smartphone via Bluetooth that<br>allows the user to open and<br>playback sounds in a mobile<br>application on compatible iOS<br>smartphones and tablets. | Similar to predicate<br>device. Both acquire<br>and transmit sound to a<br>mobile app. | | Clinical conditions | Human body sounds<br>related | Human body sounds related | Identical to predicate<br>device | | Use | Electronic stethoscope | Electronic stethoscope | Identical to predicate<br>device | | Compatibility | -Littmann 3M Cardiology<br>III/IV<br>-Littmann 3M classic II/III | -Littmann 3M Cardiology II/III<br>-Welch Allyn Harvey Elite<br>-ADC601 lines of analog<br>stethoscopes | Similar to predicate<br>device.<br>Both devices are<br>compatible with<br>stethoscopes Littmann<br>3M Cardiology III | | Prescription/OTC | Prescription use | Prescription use | Identical to predicate<br>device | | Intended for Direct<br>Connection to<br>Patient | No | No | Identical to predicate<br>device | | Use environment | Clinical | Clinical | Identical to predicate<br>device | | Type of users | Health-care personnel | Health-care personnel | Identical to predicate<br>device | | Target population | All types of patients | All types of patients | Identical to predicate<br>device | | Cleaning &<br>Maintenance | Before clean eKuore One<br>Wireless, please detach it | The stethoscope and CORE<br>should be cleaned between | Identical to predicate<br>device | | Elements of<br>comparison | eKuore One Wireless<br>electronic interface for<br>stethoscope (Candidate<br>Device) | Eko electronic stethoscope<br>system.<br>(Reference device) | Comparison | | | of the stethoscope. It can<br>be easily cleaned by<br>suing an alcohol wipe.<br>Cleaning of stethoscope<br>should be done between<br>each patient use. Is not<br>necessary to clean<br>eKuore One Wireless for<br>each use with the same<br>patient. | eachpatient use. All cleaning<br>instructions pertaining to the<br>originalstethoscope apply.<br>Under normal conditions it is<br>unnecessary to remove<br>CORE fromthe stethoscope<br>tubing for cleaning. All<br>external parts of thehardware<br>can be cleaned with 70%<br>isopropyl alcohol wipes. | | | Technical equivalence | | | | | Sound track<br>transfer function | Yes | Yes | Identical to predicate<br>device | | Signal<br>transmission for<br>visualization | Bluetooth transmission to<br>compatible<br>smartphones/tablets | Bluetooth transmission to<br>compatible<br>smartphones/tablets | Identical to predicate<br>device | | Energy Source | Rechargeable Lithium Ion<br>Battery | Rechargeable Lithium Ion<br>Battery | Identical to predicate<br>device | | System required | Android and iOS | Android and iOS | Identical to predicate<br>device | | Hardware and<br>software platforms | Mobile devices or tablets | Mobile devices or tablets | Identical to predicate<br>device | | Connections | Micro USB connector only<br>to charge internal battery<br>of the device | Micro USB connector only to<br>charge internal battery of the<br>device | Identical to predicate<br>device | | Frequency range | 20 Hz to 2 KHz | 20 Hz to 2 kHz | Identical to predicate<br>device | | Signal Input<br>Method | Sound was collected via a<br>Transducer. MEMS | Sound waves collected via a<br>Transducer. Electro micro-<br>phone | Identical to predicate<br>device | | Audio Output<br>Method | Earbuds and 3.5mm Jack<br>when connected with<br>smartphone/tablets | Earbuds and 3.5mm Jack<br>when connected with<br>smartphone/tablets | Identical to predicate<br>device | | 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 predicate<br>device | | Performance<br>requirements | Temp range: -20℃ to<br>+45℃<br>Humidity range: 0% to<br>90% | The operating range is 10℃<br>to 40℃, and 0% to 90%<br>relative humidity | Similar to predicate<br>device. | | Biological Equivalence | | | | | Materials | •Cover: ABS and EPDM | Body: ABS (Acrylonitrile | Similar to predicate | | Elements of<br>comparison | eKuore One Wireless<br>electronic interface for<br>stethoscope (Candidate<br>Device) | Eko electronic stethoscope<br>system.<br>(Reference device) | Comparison | | | (ethylene propylene diene<br>monomer)<br>•Pushbutton: PMMA<br>(para-Methoxy-N-<br>methylamphetamine)<br>•Gasket: EPDM | Butadiene Styrene). | device | | Contact with<br>human tissues or<br>body fluids | Does not contact patient's<br>body. Attached<br>stethoscope does. | Does not contact patient's<br>body. Attached stethoscope<br>does. | Identical to predicate<br>device | | Sterility | Sterility considerations<br>are not applicable | Sterility considerations are<br>not applicable | Identical to predicate<br>device | {6}------------------------------------------------ # e a ### eKuore One Wireless Electronic Interface for Stethoscope 510(k) Premarket Notification # Section 5 – 510(k) Summary {7}------------------------------------------------ Electronic Interface for Stethoscope 510(k) Premarket Notification ## Section 5 – 510(k) Summary {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the word "ekuore" in a sans-serif font. The letters are all lowercase and are a dark gray color. The word is centered in the image and is the only element present. Electronic Interface for Stethoscope 510(k) Premarket Notification ### Section 5 - 510(k) Summary Table 05-1. Substantial Equivalence Comparison - eKuore One Wireless electronic interface for stethoscope and Predicate Device EKo Electronic Stethoscope System K151319 Information provided in these 510(k) submissions shows that eKuore One Wireless Electronic Interface for Stethoscope is substantially equivalent to the predicate device Eko Electronic Stethoscope System cleared under K151319 in terms of intended use. indications for use, compatibility, and technological characteristics. There are no new questions of safety or effectiveness. ### Summary discussion of non-clinical data: The proposed device has been designed, developed, tested, verified and validated according to documented procedures and specific protocols in line with the following FDA guidance documents: - Guidance for the Content of Premarket Submissions for Software -Contained in Medical Devices. - General Principles of Software Validation - - Guidance for Premarket Submissions for Management of Cybersecurity in Medical Devices - Postmarket Management of Cybersecurity in Medical Devices - - -Radio Frequency Wireless Technology in Medical Devices General requirements for basic safety standard requirements for medical electrical equipment test have been successfully completed following standard of IEC 60601-1:2008 and IEC 60601-1-2:2015 Integration verification and validation testing have been successfully completed following standard IEC 62304:2006/AC:2008 Usability testing requirements have been evaluated and successfully met standards {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the word "ekuore" in a sans-serif font. The letters are all lowercase and are a dark gray color. The word is centered and takes up most of the frame. Electronic Interface for Stethoscope 510(k) Premarket Notification ### Section 5 - 510(k) Summary ISO 62366:2008+A1:2015 and IEC 60601-1-6:2010. Design and development included identification, evaluation and control of potential hazards as per standard ISO 14971:2012. ### Summary discussion of clinical data: Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the subject device. #### IV. CONCLUSIONS We believe the intended use, indication for use, principle of operation and technical characteristics of the eKuore One Wireless electronic interface for stethoscope are the same as the intended use, indication for use, principle of operation and technical characteristics of the predicate device. We did not use new technology in this system, so those differences between our system and its predicate do not affect the safety and performance. - General information of the propose and predicate device are the same. - - -Intended use and indication/principle of operations of the propose device and predicate device are the same. - There are minimum differences in the technological characteristics of the propose device and the predicate device. Based on the information provided in this premarket notification, Chip Ideas Electronics S.L., concludes that eKuore One Wireless electronic interface for stethoscope does not suppose any new or increased risk compared with the predicate device, we conclude that eKuore One Wireless is substantially equivalent to the listed legally marketed predicate device.