(351 days)
The eKuore Stethoscope Touch 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.
The eKuore Stethoscope Touch is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to a compatible 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.
eKuore Stethoscope Touch is formed by eKuore Stethoscope Touch device, eKuore Medical Devices App and eKuore Touch Android Engine.
The eKuore Stethoscope Touch device introduces three different models:
- . ES001 is the basic version of the electronic stethoscope for general purposes.
- . ES002 is an electronic stethoscope designed for people with hearing problems and enable hearing aids connection.
- ES003 is an electronic stethoscope that can connect to third-party software ● using an Android Library.
The primary purpose of the eKuore Stethoscope Touch device is to detect and amplify heart, lung, arteries, veins, and internal sounds using selective frequency organ ranges.
The design of eKuore Stethoscope Touch lets the user change the chestpiece attached between different sizes depending on the patient to be auscultated.
The primary purpose of the eKuore Medical Devices App is to get the acoustic signals from the eKuore Stethoscope Touch device. Once the device is turned on, the smartphone/tablet could detect a Bluetooth device.
After the connection, the eKuore Medical Devices App displays the acoustic signal as a phonogram in real-time, on the monitor screen, there is a record button. When it is pressed, the recording start, a record maximum duration of 30 seconds is defined. To stop the record, the recording button must be pressed again. Recordings are stored in *.wav file format in the internal memory of the connected smartphone/tablet. Each recording is stored named with the date and time of the moment of the record.
eKuore Medical Devices App has a management screen where it is possible to play, remove and edit a recording. Only the length and the name of the record file could be edited. Also, the eKuore Medical Devices App lets the user share the records.
eKuore Touch Android Engine enable third party companies to connect eKuore Stethoscope Touch model ES003 to obtain the audio from the device and use it in their own software. Audio is transmitted without modifications or processing.
The provided text describes a 510(k) premarket notification for the eKuore Stethoscope Touch. This submission seeks to demonstrate the device's substantial equivalence to a legally marketed predicate device (eKuore Pro Series, K203007).
The document details the device's purpose, characteristics, indications for use, and a comparison to the predicate device. However, it does not contain specific acceptance criteria or the details of a study proving the device meets those criteria, as typically seen with performance metrics like sensitivity, specificity, or F1-score for AI-driven devices.
Instead, the submission focuses on demonstrating equivalence in terms of intended use, technological characteristics, and compliance with general medical device standards. The "study" mentioned is a "Summary discussion of non-clinical data," which outlines various tests and standards met, rather than a clinical performance study with predefined acceptance criteria for diagnostic accuracy.
Therefore, many of the requested items cannot be extracted directly from the provided text.
Here's a breakdown of what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the format of acceptance criteria and performance metrics for diagnostic accuracy. The document states "Device signal acquisition accuracy and acoustic transmission disturbance have been evaluated successfully, presenting in all devices with similar acoustic characteristics" as a general outcome of non-clinical testing. This indicates performance was compared to the predicate, implying similar performance is the "acceptance criterion" for these aspects, but no quantitative thresholds are given.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Acoustic Performance | Signal acquisition accuracy similar to predicate device (eKuore Pro Series) | "Device signal acquisition accuracy and acoustic transmission disturbance have been evaluated successfully, presenting in all devices with similar acoustic characteristics." |
| Acoustic Transmission Disturbance | Acoustic transmission disturbance similar to predicate device (eKuore Pro Series) | "Device signal acquisition accuracy and acoustic transmission disturbance have been evaluated successfully, presenting in all devices with similar acoustic characteristics." |
| Safety and Performance | Design, development, testing, verification, and validation according to documented procedures and specific protocols in line with FDA guidance and relevant standards (AAMI ANSI ES 60601-1:2005 and A1:2012, IEC 60601-1-2 Edition 4: 2014-02, IEC 62304:2015, AAMI ANSI IEC 62366:2007, ISO 14971:2019). | "Successfully complete following standard...", "successfully completed following standard...", "evaluated and successfully met as per standards...", "included identification, evaluation and control of potential hazards as per standard..." |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified (since it's a non-clinical "acoustic performance comparison" rather than a clinical study with patient data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study mentioned is an "acoustic performance comparison" and non-clinical testing, not a diagnostic accuracy study requiring expert-established ground truth.
4. Adjudication method for the test set
Not applicable. No expert-driven ground truth establishment or adjudication process is described for this non-clinical comparison.
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
No, an MRMC comparative effectiveness study was not done. The eKuore Stethoscope Touch is an electronic stethoscope that facilitates sound recording and transfer, but it is not explicitly stated to be an AI-assisted diagnostic device that would involve "human readers improve with AI vs without AI assistance." Its indication is for "diagnostic decision support," but this appears to be through improved sound quality and digital record-keeping rather than an AI interpretation. The document explicitly focuses on demonstrating substantial equivalence to a predicate electronic stethoscope through non-clinical performance and safety data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. As noted above, the device is an electronic stethoscope producing amplified and filtered sounds, and it's not described as having a standalone diagnostic algorithm for interpretation without human intervention. The "eKuore Medical Devices App" displays the acoustic signal (phonogram), allows recording, and basic editing/sharing, but not AI-driven interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "acoustic performance comparison" for the non-clinical data would likely compare the device's output to a known, calibrated acoustic standard or the output of the predicate device, not a diagnostic ground truth like pathology for AI performance evaluation.
8. The sample size for the training set
Not applicable. The document does not describe the development of an AI algorithm or a training set for machine learning.
9. How the ground truth for the training set was established
Not applicable. No AI algorithm or training set is described.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 26, 2022
Chip Ideas Electronics S.L. Bernardo Trillo Regulatory Affairs Manager Calle Alfareria 3 B Burjasot, Valencia 46100 Spain
Re: K211779
Trade/Device Name: eKuore Stethoscope Touch Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DOD Dated: May 25, 2021 Received: December 13, 2022
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
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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 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 (QS) 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 medical devices and radiation-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,
LCDR 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) K211779
Device Name eKuore Stethoscope Touch
Indications for Use (Describe)
The eKuore Stethoscope Touch is intended to be used as a part of a physical assessment of a patient by healtheare professionals for diagnostic decision support in clinical settings.
The eKuore Stethoscope Touch is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to a compatible software application.
It can be used to record heart sounds and cardiac murmurs, bruits, 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
eKuore Stethoscope Touch
510(k) Premarket Notification
Section 5 - 510(k) Summary
SUBMITTER
Chip Ideas Electronics, S.L. Submitter name: Submitter address: C/ Alfarería 3 B. 46100 Burjasot, Valencia SPAIN
Registration Number: Owner Operator Number:
3017140534 10075275
Contact person: Phone: e-mail:
Bernardo Plaza Trillo +34 640742454 bernardo.plaza@ekuore.com
Date Prepared:
2022-01-11
DEVICE
Device Trade Name: Common Name: Regulation Name: Regulatory Class: Product Code: Regulation Number: eKuore Stethoscope Touch ELECTRONIC STETHOSCOPE ELECTRONIC STETHOSCOPE Class II DQD 870.1875
PREDICATE DEVICE
eKuore Pro Series (K203007) Predicate Device (S):
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ekuore
eKuore Stethoscope Touch
510(k) Premarket Notification
Section 5 - 510(k) Summary
5.1 DEVICE DESCRIPTION
eKuore Stethoscope Touch is formed by eKuore Stethoscope Touch device, eKuore Medical Devices App and eKuore Touch Android Engine.
The eKuore Stethoscope Touch device introduces three different models:
- . ES001 is the basic version of the electronic stethoscope for general purposes.
- . ES002 is an electronic stethoscope designed for people with hearing problems and enable hearing aids connection.
- ES003 is an electronic stethoscope that can connect to third-party software ● using an Android Library.
The primary purpose of the eKuore Stethoscope Touch device is to detect and amplify heart, lung, arteries, veins, and internal sounds using selective frequency organ ranges.
The design of eKuore Stethoscope Touch lets the user change the chestpiece attached between different sizes depending on the patient to be auscultated.
The primary purpose of the eKuore Medical Devices App is to get the acoustic signals from the eKuore Stethoscope Touch device. Once the device is turned on, the smartphone/tablet could detect a Bluetooth device.
After the connection, the eKuore Medical Devices App displays the acoustic signal as a phonogram in real-time, on the monitor screen, there is a record button. When it is pressed, the recording start, a record maximum duration of 30 seconds is defined. To stop the record, the recording button must be pressed again. Recordings are stored in *.wav file format in the internal memory of the connected smartphone/tablet. Each recording is stored named with the date and time of the moment of the record.
eKuore Medical Devices App has a management screen where it is possible to play, remove and edit a recording. Only the length and the name of the record file could be edited. Also, the eKuore Medical Devices App lets the user share the records.
eKuore Touch Android Engine enable third party companies to connect eKuore Stethoscope Touch model ES003 to obtain the audio from the device and use it in their own software. Audio is transmitted without modifications or processing.
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ekuore
eKuore Stethoscope Touch
510(k) Premarket Notification
Image /page/5/Figure/4 description: The image shows an eKuore Stethoscope Touch device with the chestpiece attached. According to the text, there are three models of chestpieces that depend on the patient to be auscultated. The models are S, M, or L from neonatal to adults patients. The image is labeled with the title "Equipment description".
Section 5 – 510(k) Summary
Table 5.1 Equipment Description
The following table shows the difference and similarities of each model:
| Specification | ES001 | ES002 | ES003 | Note: |
|---|---|---|---|---|
| Model | ES001 | ES002 | ES003 | |
| Basic UDI-DI | 8437021515ES001T9 | 8437021515ES002TB | 8437021515ES003TD | |
| Dimensions | 1325535mm | |||
| Screen | 1,54 OLED with resistive touchscreen | |||
| Device lifetime fromthe date ofmanufacture | 10 years | Manufacturing date included in labeling | ||
| Frequencyresponse | 20Hz to 8KHz | |||
| Signal to NoiseRatio | 62.5dB | |||
| Data representation | 16-24 bits | |||
| Environmentalrange | Temperature: 10°C to +40°CHumidity: 0-90% | |||
| Maximum audiodelay | 50ms | |||
| Internal memory | Up to 10 recordings | |||
| Battery | 1400mAH rechargeable LiPo Battery | 1400mAH rechargeable LiPo Battery | 1400mAH rechargeable LiPo Battery | |
| Functionalities: | USB-C audio output3 selective filtersAndroid and iOScompatible | USB-C audio output3 selective filtersBluetooth audiodevices compatible | USB-C audio output3 selective filtersCompatible witheKuore ES AndroidEngine library | |
| GMDN | 13754 | |||
| Weight | 75g | |||
| Power supply | EN 60601-1 compliant | |||
| Battery charger | Not included. Use USB-C cable provided with a 5V DC charger | |||
| Data interface | USB-C Audio | USB-C Audio | USB-C Audio | |
| Wirelesscommunication | Bluetooth | Bluetooth | Bluetooth/WiFi | ES001 Bluetooth for app communication.ES002 Bluetooth for |
Rev 02
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eKuore Stethoscope Touch
510(k) Premarket Notification
| Section 5 - 510(k) Summary | |||
|---|---|---|---|
| -- | -- | -- | ---------------------------- |
| Specification | ES001 | ES002 | ES003 | Note: |
|---|---|---|---|---|
| Use combined with | iOS / Android AppInterchangeablechestpieces | A2DP BluetoothreceiversInterchangeablechestpieces | Android Engine libraryInterchangeablechestpieces | the audio stream.ES0003 Bluetooth andWiFi for the audiostream |
| Manufacturer | CHIP IDEAS ELECTRONICS SL |
Table 5.2 - Comparison table of eKuore Stethoscope Touch models
5.2 INDICATIONS FOR USE
The eKuore Stethoscope Touch 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.
The eKuore Stethoscope Touch is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to a compatible 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.
5.3 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The electronic stethoscopes are mainly used on auscultation to detect 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 or computers.
In the establishment of substantial equivalence, eKuore Stethoscope Touch compared to the predicate device (K203007) eKuore Pro Series.
eKuore Stethoscope Touch is the evolution of CHIP IDEAS ELECTRONICS SL, electronic stethoscopes.
Rev 02
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Section 5 - 510(k) Summary
| Elements ofcomparison | eKuore Stethoscope Touch (Candidate Device) | eKuore Pro Series (Predicate Device) | Comparison | ||
|---|---|---|---|---|---|
| comparison | ES001 | ES002 | ES003 | ||
| Regulatory data | |||||
| RegulatoryClass | Class II | Class II | Identical to predicate device | ||
| Classificationname | Electronic Stethoscope | Electronic Stethoscope | Identical to predicate device | ||
| RegulationNumber | 21 CFR 870.1875 | 21 CFR 870.1875 | Identical to predicate device | ||
| Product code | DQD | DQD | Identical to predicate device | ||
| Manufacturer | Chip Ideas Electronics, SL. | Chip Ideas Electronics, SL. | Identical to predicate device | ||
| FDA Clearance | K211779 Pending | K203007 | - | ||
| USE | |||||
| Indications foruse | The eKuore Stethoscope Touch is intended to be used as apart of a physical assessment of a patient by healthcareprofessionals for diagnostic decision support in clinicalsettings.The eKuore Stethoscope Touch is intended for use onpediatric and adult patients. It can electronically filter andtransfer sounds to a compatible software application.It can be used to record heart sounds and cardiac murmurs,bruits, respiratory sounds, and abdominal sounds duringphysical examination in normal patients or those withsuspected diseases of the cardiac, vascular, pulmonary orabdominal organ systems. | The eKuore Pro Series is intended to beused as a part of a physical assessment ofa patient by healthcare professionals fordiagnostic decision support in clinicalsettings. eKuore Pro Series is intended foruse on pediatric and adult patients. It canelectronically filter and transfer sounds tothe accompanying mobile softwareapplication.It can be used to record heart sounds andcardiac murmurs, bruits, respiratory soundsand abdominal sounds during physicalexamination in normal patients or thosewith suspected diseases of the cardiac,vascular, pulmonary or abdominal organsystems. | Similar to predicate device with the followinggap:Predicate Device: connects only to mobileapps.Canidate device can connects to mobile appsbut also other devices. | ||
| CHARACTERISTICS | |||||
| Principles ofoperation | The device consists in a microphone and some electronics fortheir digitalization, amplification, and codification to a standardformat, and sending using wireless technology to compatibledevices and software. | The device consists in a microphone andsome electronics for their digitalization,amplification, and codification to a standardformat, and sending via WiFi to | Similar to predicate devicewith the following gaps:WiFi transmission vs WiFi and Bluetoothtransmission | ||
| Elements ofcomparison | eKuore Stethoscope Touch (Candidate Device) | eKuore Pro Series (Predicate Device) | Comparison | ||
| ES001 | ES002 | ES003 | |||
| Clinicalconditions | Human body sounds related | Human body sounds related | Identical to predicate device | ||
| Use | Electronic stethoscope | Electronic stethoscope | Identical to predicate device | ||
| Compatibility | Android and iOSdevices | Bluetoothreceivers | Third partyAndroid projects | Android and iOS devices | Predicate device is an electronic stethoscopethat can send audio to iOS and Androiddevices, candidate device can also transfersound to other compatible systems. |
| Prescription/O.T.C. | Prescription use | Prescription use | Identical to predicate device | ||
| Intended forDirectConnection toPatient | YES | YES | Identical to predicate device | ||
| Useenvironment | Clinical settings | Clinical settings | Identical to predicate device | ||
| Type of users | Healthcarepersonnel | Healthcarepersonnel withhearing aids | Healthcarepersonnel | Healthcare personnel | Similar to predicate device. ES002 is designedto transfer sound to Bluetooth hearing aids |
| Targetpopulation | All types of patients | All types of patients | Identical to predicate device | ||
| TECHNICAL EQUIVALENCE | |||||
| Sound tracktransferfunction | Yes | Yes | Identical to predicate device | ||
| Signaltransmission forvisualization | Wireless transmission to compatible systems via WiFi andBluetooth | Wireless transmission to compatiblesmartphones/tablet via WiFi | Different from predicate device, candidatedevice can also transfer sound using Bluetoothconnectivity | ||
| Device control | 1.4' touch screen | Touching buttons | Different to predicate device. | ||
| Energy Source | Lithium-Ion Battery | Lithium-Ion Battery | Identical to predicate device | ||
| System required | Android and iOS | Bluetooth | Third party | Android and iOS devices | Predicate device can send audio to iOS and |
| Elements ofcomparison | eKuore Stethoscope Touch (Candidate Device) | eKuore Pro Series (Predicate Device) | Comparison | ||
| ES001 | ES002 | ES003 | |||
| devices | receivers | Android projects | Android devices, candidate device can alsotransfer sound to other compatible systems. | ||
| Connections | Micro USB connector to charge the internal battery of thedevice and audio output | Micro USB connector to charge the internal battery of thedevice and audio output | Micro USB connector to charge the internal battery of thedevice and audio output | Micro USB connector only to charge theinternal battery of the device3.5mm Jack audio output | Different to predicate device. Candidateoutputs the audio using USB-C connector. |
| Frequencyrange | 40 Hz to 600 Hz | 40 Hz to 600 Hz | 40 Hz to 600 Hz | 40 Hz to 600 Hz | Identical to predicate device |
| Signal InputMethod | Sound waves collected via a Transducer. Electro micro-phone | Sound waves collected via a Transducer. Electro micro-phone | Sound waves collected via a Transducer. Electro micro-phone | Sound waves collected via a Transducer.Electro micro-phone | Identical to predicate device |
| Audio OutputMethod | USB-C | USB-C | USB-C | 3.5mm Jack | Different to predicate device. Candidateoutputs the audio using USB-C connector. |
| Signal Storage | Allows signal storage depending on technical features(capacity, OS) of connected device (smartphone or tablet).Internal memory with 10 recording slots | Allows signal storage depending on technical features(capacity, OS) of connected device (smartphone or tablet).Internal memory with 10 recording slots | Allows signal storage depending on technical features(capacity, OS) of connected device (smartphone or tablet).Internal memory with 10 recording slots | Allows signal storage depending ontechnical features (capacity, OS) ofconnected device (smartphone or tablet). | Different to predicate device. Candidate hasinternal memory for up to 10 auscultations |
| Performancerequirements | Temp range: 10°C to +40°CHumidity range: 15% to 93% | Temp range: 10°C to +40°CHumidity range: 15% to 93% | Temp range: 10°C to +40°CHumidity range: 15% to 93% | Temp range: -20°C to +45°CHumidity range: 15% to 93% | Different to predicate device |
| BIOLOGICAL EQUIVALENCE | |||||
| Materials | Body: ABS (Acrylonitrile Butadiene Styrene) and PMMA(Polymethyl methacrylate)Chestpiece base: AISI 303 (stainless steel).Chestpiece ring and membrane: PVC. | Body: ABS (Acrylonitrile Butadiene Styrene) and PMMA(Polymethyl methacrylate)Chestpiece base: AISI 303 (stainless steel).Chestpiece ring and membrane: PVC. | Body: ABS (Acrylonitrile Butadiene Styrene) and PMMA(Polymethyl methacrylate)Chestpiece base: AISI 303 (stainless steel).Chestpiece ring and membrane: PVC. | Body: ABS (Acrylonitrile ButadieneStyrene)Chestpiece base: AISI 303 (stainless steel).Chestpiece ring and membrane: PVC. | Body material similar to predicate device.Identical materials for chestpiece and parts |
| Contact withhuman tissuesor body fluids | The chestpiece is in contact with patients' skin. | The chestpiece is in contact with patients' skin. | The chestpiece is in contact with patients' skin. | The chestpiece is in contact with patients'skin. | Identical to predicate device |
| Sterility | Not intended to be sterilized | Not intended to be sterilized | Not intended to be sterilized | Not intended to be sterilized | Identical to predicate device |
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eKuore Stethoscope Touch 510(k) Premarket Notification
Section 5 - 510(k) Summary
Rev 02
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eKuore Stethoscope Touch 510(k) Premarket Notification
Section 5 - 510(k) Summary
Table 5.3. Substantial Equivalence Comparison – eKuore Stethoscope Touch and Predicate Device K203007
{10}------------------------------------------------
eKuore Stethoscope Touch
510(k) Premarket Notification
Section 5 - 510(k) Summary
Information provided in these 510(k) submissions shows that eKuore Stethoscope Touch is substantially equivalent to the predicate device eKuore Pro Series under K203007 in terms of indications for use, compatibility and technological characteristics. There are no new questions of the safety or effectiveness of the device when used as labeled.
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 requirements for basic safety standard requirements for medical electrical equipment test have been successfully complete following standard of AAMI ANSI ES 60601-1:2005 and A1:2012 and IEC 60601-1-2 Edition 4: 2014-02
Integration verification and validation testing have been successfully completed following standard IEC 62304:2015.
Usability testing requirements have been evaluated and successfully met as per standards AAMI ANSI IEC 62366:2007.
Design and development included identification, evaluation and control of potential hazards as per standard ISO 14971:2019.
An acoustic performance comparison between the eKuore Stethoscope Touch and the eKuore Pro Series has been performed. Device signal acquisition accuracy and acoustic transmission disturbance have been evaluated successfully, presenting in all devices with similar acoustic characteristics.
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 predicate device.
5.4 CONCLUSIONS
Based on the information provided in this premarket notification, Chip Ideas Electronics S.L., concludes that eKuore Stethoscope Touch 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.