(152 days)
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.
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.
The provided text is a 510(k) Premarket Notification for the "eKuore One Wireless Electronic Interface for Stethoscope" and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to diagnostic accuracy, sensitivity, specificity, or other clinical efficacy metrics. Instead, the document discusses technical characteristics and regulatory compliance to demonstrate equivalence to a previously cleared device.
Therefore, most of the requested information regarding acceptance criteria and clinical study details cannot be extracted from this document.
Here's what can be gathered, along with what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
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Acceptance Criteria: Not explicitly stated as pass/fail metrics for clinical performance. The document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and regulatory compliance.
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Reported Device Performance: The document lists technical characteristics of the eKuore One Wireless electronic interface for stethoscope and compares them to a predicate device. This is not "performance" in the sense of diagnostic accuracy or clinical outcomes.
Elements of Comparison (as per provided text) 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 Device Classification name Electronic Stethoscope Electronic Stethoscope Identical Regulation Number 21 CFR 870.1875 21 CFR 870.1875 Identical Classification Product code DQD DQD Identical FDA Clearance Pending K151319 - USE Intended use Diagnostic decision support... record heart sounds, cardiac murmurs, bruits, respiratory, and abdominal sounds. Diagnostic decision support... record heart sounds, cardiac murmurs, bruits, respiratory, and abdominal sounds. Similar (Predicate also amplifies sound) Characteristics Principles of operation Microphone & electronics for digitalization/codification, wireless (Bluetooth) to mobile. Dispositive introduced in acoustic stethoscope, sound amplification, audio transmission to smartphone via Bluetooth. Similar (Both acquire and transmit sound to a mobile app) Clinical conditions Human body sounds related Human body sounds related Identical Use Electronic stethoscope Electronic stethoscope Identical 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 (Both compatible with Littmann 3M Cardiology III) Prescription/OTC Prescription use Prescription use Identical Intended for Direct Connection to Patient No No Identical Use environment Clinical Clinical Identical Type of users Health-care personnel Health-care personnel Identical Target population All types of patients All types of patients Identical Cleaning & Maintenance Detach, alcohol wipe cleaning of eKuore One. Stethoscope cleaned between each patient. Stethoscope and CORE cleaned between each patient. External parts with 70% isopropyl alcohol wipes. Identical Technical equivalence Sound track transfer function Yes Yes Identical Signal transmission for visualization Bluetooth transmission to compatible smartphones/tablets Bluetooth transmission to compatible smartphones/tablets Identical Energy Source Rechargeable Lithium Ion Battery Rechargeable Lithium Ion Battery Identical System required Android and iOS Android and iOS Identical Hardware and software platforms Mobile devices or tablets Mobile devices or tablets Identical Connections Micro USB connector only to charge internal battery Micro USB connector only to charge internal battery Identical Frequency range 20 Hz to 2 KHz 20 Hz to 2 kHz Identical Signal Input Method Sound collected via a Transducer. MEMS Sound waves collected via a Transducer. Electro microphone Identical Audio Output Method Earbuds and 3.5mm Jack when connected with smartphone/tablets Earbuds and 3.5mm Jack when connected with smartphone/tablets Identical Signal Storage Allows signal storage depending on technical features of connected device. Allows signal storage depending on technical features of connected device. Identical 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 Biological Equivalence Materials Cover: ABS and EPDM; Pushbutton: PMMA; Gasket: EPDM Body: ABS (Acrylonitrile Butadiene Styrene). Similar 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 Sterility Sterility considerations are not applicable Sterility considerations are not applicable Identical
2. Sample size used for the test set and the data provenance: Not provided. The submission relies on non-clinical test data and comparison to a predicate device, not a clinical test set for diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such clinical test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document does not describe an AI device or a comparative effectiveness study. The device is a "Wireless Electronic Interface for stethoscope" which electronically filters and transfers sounds.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is an electronic interface for a stethoscope, meant to be used by healthcare professionals. It's not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical performance study requiring ground truth is described.
8. The sample size for the training set: Not applicable, as no machine learning algorithm requiring a training set is described.
9. How the ground truth for the training set was established: Not applicable.
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
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.