(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:
-
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.
-
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.
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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). 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 (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
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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)
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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
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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.
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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 ofcomparison | eKuore One Wirelesselectronic interface forstethoscope (CandidateDevice) | Eko electronic stethoscopesystem.(Reference device) | Comparison |
|---|---|---|---|
| Regulatory data | |||
| Regulatory Class | Class II | Class II | Identical to predicatedevice |
| DeviceClassificationname | Electronic Stethoscope | Electronic Stethoscope | Identical to predicatedevice |
| RegulationNumber | 21 CFR 870.1875 | 21 CFR 870.1875 | Identical to predicatedevice |
| ClassificationProduct code | DQD | DQD | Identical to predicatedevice |
| Manufacturer | Chip Ideas Electronics,S.L. | Eko Devices, Inc. | - |
| FDA Clearance | Pending | K151319 | - |
| USE | |||
| Intended use | The eKuore One Wirelesselectronic interface forstethoscope is intended tobe used as a part of aphysical assessment of apatient by healthcareprofessionals fordiagnostic decisionsupport in clinical settings.eKuore One Wireless isindicated for use onpediatric and adultpatients. It canelectronically filter andtransfer sounds to theaccompanying mobile | The Eko ElectronicStethoscope System isintended to be used as a partof a physical assessment of apatient by healthcareprofessionals for diagnosticdecision support in clinicalsettings. Eko is intended foruse on pediatric and adultpatients. It can electronicallyamplify, filter and transfersounds to the accompanyingmobile application for storageand sharing. | Similar to predicatedevice.Predicate device alsoamplify sound. |
| Elements ofcomparison | eKuore One Wirelesselectronic interface forstethoscope (CandidateDevice) | Eko electronic stethoscopesystem.(Reference device) | Comparison |
| software application.It can be used to recordheart sounds and cardiacmurmurs, bruits,respiratory sounds andabdominal sounds duringphysical examination innormal patients or thosewith suspected diseasesof the cardiac, vascular,pulmonary or abdominalorgan systems. | It can used to record heartsounds and cardiac murmurs,bruits, respiratory sounds andabdominal sounds duringphysical examination innormal patients or those withsuspected diseases of thecardiac, vascular, pulmonaryor abdominal organ systems. | ||
| Characteristics | |||
| Principles ofoperation | The device consists in amicrophone and someelectronics for theirdigitalization andcodification to a standardformat, and sending viawireless (Bluetooth) tosmartphones and tablets. | Dispositive introduced in anacoustic stethoscope andgives sound amplification andaudio transmission to asmartphone via Bluetooth thatallows the user to open andplayback sounds in a mobileapplication on compatible iOSsmartphones and tablets. | Similar to predicatedevice. Both acquireand transmit sound to amobile app. |
| Clinical conditions | Human body soundsrelated | Human body sounds related | Identical to predicatedevice |
| Use | Electronic stethoscope | Electronic stethoscope | Identical to predicatedevice |
| Compatibility | -Littmann 3M CardiologyIII/IV-Littmann 3M classic II/III | -Littmann 3M Cardiology II/III-Welch Allyn Harvey Elite-ADC601 lines of analogstethoscopes | Similar to predicatedevice.Both devices arecompatible withstethoscopes Littmann3M Cardiology III |
| Prescription/OTC | Prescription use | Prescription use | Identical to predicatedevice |
| Intended for DirectConnection toPatient | No | No | Identical to predicatedevice |
| Use environment | Clinical | Clinical | Identical to predicatedevice |
| Type of users | Health-care personnel | Health-care personnel | Identical to predicatedevice |
| Target population | All types of patients | All types of patients | Identical to predicatedevice |
| Cleaning &Maintenance | Before clean eKuore OneWireless, please detach it | The stethoscope and COREshould be cleaned between | Identical to predicatedevice |
| Elements ofcomparison | eKuore One Wirelesselectronic interface forstethoscope (CandidateDevice) | Eko electronic stethoscopesystem.(Reference device) | Comparison |
| of the stethoscope. It canbe easily cleaned bysuing an alcohol wipe.Cleaning of stethoscopeshould be done betweeneach patient use. Is notnecessary to cleaneKuore One Wireless foreach use with the samepatient. | eachpatient use. All cleaninginstructions pertaining to theoriginalstethoscope apply.Under normal conditions it isunnecessary to removeCORE fromthe stethoscopetubing for cleaning. Allexternal parts of thehardwarecan be cleaned with 70%isopropyl alcohol wipes. | ||
| Technical equivalence | |||
| Sound tracktransfer function | Yes | Yes | Identical to predicatedevice |
| Signaltransmission forvisualization | Bluetooth transmission tocompatiblesmartphones/tablets | Bluetooth transmission tocompatiblesmartphones/tablets | Identical to predicatedevice |
| Energy Source | Rechargeable Lithium IonBattery | Rechargeable Lithium IonBattery | Identical to predicatedevice |
| System required | Android and iOS | Android and iOS | Identical to predicatedevice |
| Hardware andsoftware platforms | Mobile devices or tablets | Mobile devices or tablets | Identical to predicatedevice |
| Connections | Micro USB connector onlyto charge internal batteryof the device | Micro USB connector only tocharge internal battery of thedevice | Identical to predicatedevice |
| Frequency range | 20 Hz to 2 KHz | 20 Hz to 2 kHz | Identical to predicatedevice |
| Signal InputMethod | Sound was collected via aTransducer. MEMS | Sound waves collected via aTransducer. Electro micro-phone | Identical to predicatedevice |
| Audio OutputMethod | Earbuds and 3.5mm Jackwhen connected withsmartphone/tablets | Earbuds and 3.5mm Jackwhen connected withsmartphone/tablets | Identical to predicatedevice |
| Signal Storage | Allows signal storagedepending on technicalfeatures (capacity,...) ofconnected device(smartphone or tablet). | Allows signal storagedepending on technicalfeatures (capacity,...) ofconnected device(smartphone or tablet). | Identical to predicatedevice |
| Performancerequirements | Temp range: -20℃ to+45℃Humidity range: 0% to90% | The operating range is 10℃to 40℃, and 0% to 90%relative humidity | Similar to predicatedevice. |
| Biological Equivalence | |||
| Materials | •Cover: ABS and EPDM | Body: ABS (Acrylonitrile | Similar to predicate |
| Elements ofcomparison | eKuore One Wirelesselectronic interface forstethoscope (CandidateDevice) | Eko electronic stethoscopesystem.(Reference device) | Comparison |
| (ethylene propylene dienemonomer)•Pushbutton: PMMA(para-Methoxy-N-methylamphetamine)•Gasket: EPDM | Butadiene Styrene). | device | |
| Contact withhuman tissues orbody fluids | Does not contact patient'sbody. Attachedstethoscope does. | Does not contact patient'sbody. Attached stethoscopedoes. | Identical to predicatedevice |
| Sterility | Sterility considerationsare not applicable | Sterility considerations arenot applicable | Identical to predicatedevice |
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e a
eKuore One Wireless
Electronic Interface for Stethoscope 510(k) Premarket Notification
Section 5 – 510(k) Summary
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Electronic Interface for Stethoscope 510(k) Premarket Notification
Section 5 – 510(k) Summary
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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
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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.
§ 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.