Who is the manufacturer of eKuore One Wireless Electronic Interface for stethoscope?

Chip Ideas Electronics S.L. filed the 510(k) submission for eKuore One Wireless Electronic Interface for stethoscope (K201742).

What is the FDA product code for eKuore One Wireless Electronic Interface for stethoscope?

DQD. It is classified under 21 CFR 870.1875 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for eKuore One Wireless Electronic Interface for stethoscope?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like eKuore One Wireless Electronic Interface for stethoscope?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

eKuore One Wireless Electronic Interface for stethoscope

Q: What are the predicate devices for eKuore One Wireless Electronic Interface for stethoscope?

Eko Electronic Stethoscope System (K151319).

K201742 · Chip Ideas Electronics S.L. · DQD · Nov 24, 2020 · Cardiovascular

Device Facts

Record ID	K201742
Device Name	eKuore One Wireless Electronic Interface for stethoscope
Applicant	Chip Ideas Electronics S.L.
Product Code	DQD · Cardiovascular
Decision Date	Nov 24, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1875
Device Class	Class 2
Attributes	Pediatric

Intended Use

The eKuore One Wireless 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 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.

Device Story

Stethoscope attachment device; collects acoustic body sounds via integrated MEMS microphone; digitizes and encodes audio signals; transmits data via Bluetooth to mobile application (Android/iOS). Used in clinical settings by healthcare professionals. Application allows real-time visualization, recording, and storage of auscultation data. Device powered by internal rechargeable battery. Provides diagnostic decision support by enabling remote or recorded review of physiological sounds; facilitates patient assessment for cardiac, vascular, pulmonary, or abdominal conditions.

Clinical Evidence

Bench testing only. No clinical data provided. Performance established through design verification, validation, and usability testing per ISO 62366 and IEC 60601-1-6. Safety and performance verified against standards for medical electrical equipment, software lifecycle, and cybersecurity.

Technological Characteristics

Materials: ABS, EPDM, PMMA. Sensing: MEMS microphone transducer. Frequency range: 20 Hz to 2 kHz. Connectivity: Bluetooth wireless transmission to mobile devices. Power: Internal rechargeable Lithium-Ion battery. Charging: Micro USB. Form factor: Stethoscope attachment. Software: Mobile application for visualization/recording. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971, ISO 62366.

Indications for Use

Indicated for pediatric and adult patients undergoing physical assessment by healthcare professionals to record and analyze 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

Eko Electronic Stethoscope System (K151319)

Reference Devices

eKuore One electronic interface for stethoscope (K181882)

Related Devices

K200776 — Eko CORE · Eko Devices, Inc. · Apr 6, 2020
K211779 — ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. · Chip Ideas Electronics S.L. · May 26, 2022
K172296 — Stethee Pro · M3Dicine Pty , Ltd. · Oct 30, 2017
K220099 — eClinic Stethopod · Homediagnostic, LLC · Oct 20, 2022
K173663 — Electronic Stethoscope DS3011A · Imediplus, Inc. · Aug 17, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION". 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). 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 {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {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 comparison | eKuore One Wireless electronic interface for stethoscope (Candidate Device) | Eko electronic stethoscope system. (Reference device) | Comparison | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | Regulatory data | | | | | Regulatory Class | Class II | Class II | Identical to predicate device | | Device Classification name | Electronic Stethoscope | Electronic Stethoscope | Identical to predicate device | | Regulation Number | 21 CFR 870.1875 | 21 CFR 870.1875 | Identical to predicate device | | Classification Product code | DQD | DQD | Identical to predicate device | | Manufacturer | Chip Ideas Electronics, S.L. | Eko Devices, Inc. | - | | FDA Clearance | Pending | K151319 | - | | USE | | | | | Intended use | The eKuore One Wireless 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 Wireless is indicated for use on pediatric and adult patients. It can electronically filter and transfer sounds to the accompanying mobile | The Eko Electronic Stethoscope System 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. Eko is intended for use on pediatric and adult patients. It can electronically amplify, filter and transfer sounds to the accompanying mobile application for storage and sharing. | Similar to predicate device. Predicate device also amplify sound. | | Elements of comparison | eKuore One Wireless electronic interface for stethoscope (Candidate Device) | Eko electronic stethoscope system. (Reference device) | Comparison | | | 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. | It can 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. | | | | Characteristics | | | | Principles of operation | The device consists in a microphone and some electronics for their digitalization and codification to a standard format, and sending via wireless (Bluetooth) to smartphones and tablets. | Dispositive introduced in an acoustic stethoscope and gives sound amplification and audio transmission to a smartphone via Bluetooth that allows the user to open and playback sounds in a mobile application on compatible iOS smartphones and tablets. | Similar to predicate device. Both acquire and transmit sound to a mobile app. | | Clinical conditions | Human body sounds related | Human body sounds related | Identical to predicate device | | Use | Electronic stethoscope | Electronic stethoscope | Identical to predicate device | | Compatibility | -Littmann 3M Cardiology III/IV -Littmann 3M classic II/III | -Littmann 3M Cardiology II/III -Welch Allyn Harvey Elite -ADC601 lines of analog stethoscopes | Similar to predicate device. Both devices are compatible with stethoscopes Littmann 3M Cardiology III | | Prescription/OTC | Prescription use | Prescription use | Identical to predicate device | | Intended for Direct Connection to Patient | No | No | Identical to predicate device | | Use environment | Clinical | Clinical | Identical to predicate device | | Type of users | Health-care personnel | Health-care personnel | Identical to predicate device | | Target population | All types of patients | All types of patients | Identical to predicate device | | Cleaning & Maintenance | Before clean eKuore One Wireless, please detach it | The stethoscope and CORE should be cleaned between | Identical to predicate device | | Elements of comparison | eKuore One Wireless electronic interface for stethoscope (Candidate Device) | Eko electronic stethoscope system. (Reference device) | Comparison | | | of the stethoscope. It can be easily cleaned by suing an alcohol wipe. Cleaning of stethoscope should be done between each patient use. Is not necessary to clean eKuore One Wireless for each use with the same patient. | eachpatient use. All cleaning instructions pertaining to the originalstethoscope apply. Under normal conditions it is unnecessary to remove CORE fromthe stethoscope tubing for cleaning. All external parts of thehardware can be cleaned with 70% isopropyl alcohol wipes. | | | Technical equivalence | | | | | Sound track transfer function | Yes | Yes | Identical to predicate device | | Signal transmission for visualization | Bluetooth transmission to compatible smartphones/tablets | Bluetooth transmission to compatible smartphones/tablets | Identical to predicate device | | Energy Source | Rechargeable Lithium Ion Battery | Rechargeable Lithium Ion Battery | Identical to predicate device | | System required | Android and iOS | Android and iOS | Identical to predicate device | | Hardware and software platforms | Mobile devices or tablets | Mobile devices or tablets | Identical to predicate device | | Connections | Micro USB connector only to charge internal battery of the device | Micro USB connector only to charge internal battery of the device | Identical to predicate device | | Frequency range | 20 Hz to 2 KHz | 20 Hz to 2 kHz | Identical to predicate device | | Signal Input Method | Sound was collected via a Transducer. MEMS | Sound waves collected via a Transducer. Electro micro- phone | Identical to predicate device | | Audio Output Method | Earbuds and 3.5mm Jack when connected with smartphone/tablets | Earbuds and 3.5mm Jack when connected with smartphone/tablets | Identical to predicate device | | Signal Storage | Allows signal storage depending on technical features (capacity,...) of connected device (smartphone or tablet). | Allows signal storage depending on technical features (capacity,...) of connected device (smartphone or tablet). | Identical to predicate device | | Performance requirements | Temp range: -20℃ to +45℃ Humidity range: 0% to 90% | The operating range is 10℃ to 40℃, and 0% to 90% relative humidity | Similar to predicate device. | | Biological Equivalence | | | | | Materials | •Cover: ABS and EPDM | Body: ABS (Acrylonitrile | Similar to predicate | | Elements of comparison | eKuore One Wireless electronic interface for stethoscope (Candidate Device) | Eko electronic stethoscope system. (Reference device) | Comparison | | | (ethylene propylene diene monomer) •Pushbutton: PMMA (para-Methoxy-N- methylamphetamine) •Gasket: EPDM | Butadiene Styrene). | device | | Contact with human tissues or body fluids | Does not contact patient's body. Attached stethoscope does. | Does not contact patient's body. Attached stethoscope does. | Identical to predicate device | | Sterility | Sterility considerations are not applicable | Sterility considerations are not applicable | Identical to predicate 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.