(351 days)
No
The summary describes a digital stethoscope that records and displays audio signals. There is no mention of AI/ML for analysis, interpretation, or diagnostic support beyond basic signal processing and recording. The "diagnostic decision support" mentioned in the intended use appears to refer to the healthcare professional using the device as part of their assessment, not the device itself providing AI-driven insights.
No
The device is intended for diagnostic decision support by filtering and transferring sounds for physical assessments, not for treating any condition or disease.
Yes
The intended use states that the device is for "diagnostic decision support," indicating its role in the diagnostic process.
No
The device description explicitly includes hardware components (eKuore Stethoscope Touch device models ES001, ES002, and ES003) which are integral to the device's function of detecting and amplifying sounds. While it includes software components (eKuore Medical Devices App and eKuore Touch Android Engine), it is not solely software.
Based on the provided information, the eKuore Stethoscope Touch is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- eKuore Stethoscope Touch Function: The eKuore Stethoscope Touch is used for in vivo (within the body) physical assessment. It detects and amplifies sounds directly from the patient's body (heart, lungs, etc.) through a chestpiece placed on the skin. It does not analyze any biological specimens.
Therefore, the eKuore Stethoscope Touch falls under the category of a medical device used for physical examination and diagnostic support, but not as an In Vitro Diagnostic device.
N/A
Intended Use / 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, and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
Product codes
DOD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac, vascular, pulmonary or abdominal organ systems.
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
healthcare professionals for diagnostic decision support in clinical settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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.
Key Metrics
Not Found
Predicate Device(s)
eKuore Pro Series (K203007)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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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3
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):
4
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.
5
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 from | ||||
| the date of | ||||
| manufacture | 10 years | Manufacturing date included in labeling | ||
| Frequency | ||||
| response | 20Hz to 8KHz | |||
| Signal to Noise | ||||
| Ratio | 62.5dB | |||
| Data representation | 16-24 bits | |||
| Environmental | ||||
| range | Temperature: 10°C to +40°C | |||
| Humidity: 0-90% | ||||
| Maximum audio | ||||
| delay | 50ms | |||
| Internal memory | Up to 10 recordings | |||
| Battery | 1400mAH rechargeable LiPo Battery | 1400mAH rechargeable LiPo Battery | 1400mAH rechargeable LiPo Battery | |
| Functionalities: | USB-C audio output | |||
| 3 selective filters | ||||
| Android and iOS | ||||
| compatible | USB-C audio output | |||
| 3 selective filters | ||||
| Bluetooth audio | ||||
| devices compatible | USB-C audio output | |||
| 3 selective filters | ||||
| Compatible with | ||||
| eKuore ES Android | ||||
| Engine 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 | |
| Wireless | ||||
| communication | Bluetooth | Bluetooth | Bluetooth/WiFi | ES001 Bluetooth for app communication. |
| ES002 Bluetooth for |
Rev 02
6
eKuore Stethoscope Touch
510(k) Premarket Notification
| Section 5 - 510(k) Summary | |||
|---|---|---|---|
| -- | -- | -- | ---------------------------- |
| Specification | ES001 | ES002 | ES003 | Note: |
|---|---|---|---|---|
| Use combined with | iOS / Android App | |||
| Interchangeable | ||||
| chestpieces | A2DP Bluetooth | |||
| receivers | ||||
| Interchangeable | ||||
| chestpieces | Android Engine library | |||
| Interchangeable | ||||
| chestpieces | the audio stream. | |||
| ES0003 Bluetooth and | ||||
| WiFi for the audio | ||||
| stream | ||||
| 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
7
Section 5 - 510(k) Summary
| Elements of
| comparison | eKuore Stethoscope Touch (Candidate Device) | eKuore Pro Series (Predicate Device) | Comparison | ||
|---|---|---|---|---|---|
| comparison | ES001 | ES002 | ES003 | ||
| Regulatory data | |||||
| Regulatory | |||||
| Class | Class II | Class II | Identical to predicate 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 | ||
| 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 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. | | | The eKuore Pro Series 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 Pro Series 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. | Similar to predicate device with the following
gap:
Predicate Device: connects only to mobile
apps.
Canidate device can connects to mobile apps
but also other devices. |
| CHARACTERISTICS | | | | | |
| Principles of
operation | The device consists in a microphone and some electronics for
their digitalization, amplification, and codification to a standard
format, and sending using wireless technology to compatible
devices and software. | | | The device consists in a microphone and
some electronics for their digitalization,
amplification, and codification to a standard
format, and sending via WiFi to | Similar to predicate device
with the following gaps:
WiFi transmission vs WiFi and Bluetooth
transmission |
| Elements of
comparison | eKuore Stethoscope Touch (Candidate Device) | | | eKuore Pro Series (Predicate Device) | Comparison |
| | ES001 | ES002 | ES003 | | |
| Clinical
conditions | Human body sounds related | | | Human body sounds related | Identical to predicate device |
| Use | Electronic stethoscope | | | Electronic stethoscope | Identical to predicate device |
| Compatibility | Android and iOS
devices | Bluetooth
receivers | Third party
Android projects | Android and iOS devices | Predicate device is an electronic stethoscope
that can send audio to iOS and Android
devices, candidate device can also transfer
sound to other compatible systems. |
| Prescription/O.T
.C. | Prescription use | | | Prescription use | Identical to predicate device |
| Intended for
Direct
Connection to
Patient | YES | | | YES | Identical to predicate device |
| Use
environment | Clinical settings | | | Clinical settings | Identical to predicate device |
| Type of users | Healthcare
personnel | Healthcare
personnel with
hearing aids | Healthcare
personnel | Healthcare personnel | Similar to predicate device. ES002 is designed
to transfer sound to Bluetooth hearing aids |
| Target
population | All types of patients | | | All types of patients | Identical to predicate device |
| TECHNICAL EQUIVALENCE | | | | | |
| Sound track
transfer
function | Yes | | | Yes | Identical to predicate device |
| Signal
transmission for
visualization | Wireless transmission to compatible systems via WiFi and
Bluetooth | | | Wireless transmission to compatible
smartphones/tablet via WiFi | Different from predicate device, candidate
device can also transfer sound using Bluetooth
connectivity |
| 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 of
comparison | eKuore Stethoscope Touch (Candidate Device) | | | eKuore Pro Series (Predicate Device) | Comparison |
| | ES001 | ES002 | ES003 | | |
| | devices | receivers | Android projects | | Android devices, candidate device can also
transfer sound to other compatible systems. |
| Connections | Micro USB connector to charge the internal battery of the
device and audio output | Micro USB connector to charge the internal battery of the
device and audio output | Micro USB connector to charge the internal battery of the
device and audio output | Micro USB connector only to charge the
internal battery of the device
3.5mm Jack audio output | Different to predicate device. Candidate
outputs the audio using USB-C connector. |
| Frequency
range | 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 Input
Method | 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 Output
Method | USB-C | USB-C | USB-C | 3.5mm Jack | Different to predicate device. Candidate
outputs 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 on
technical features (capacity, OS) of
connected device (smartphone or tablet). | Different to predicate device. Candidate has
internal memory for up to 10 auscultations |
| Performance
requirements | Temp range: 10°C to +40°C
Humidity range: 15% to 93% | Temp range: 10°C to +40°C
Humidity range: 15% to 93% | Temp range: 10°C to +40°C
Humidity range: 15% to 93% | Temp range: -20°C to +45°C
Humidity 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 Butadiene
Styrene)
Chestpiece base: AISI 303 (stainless steel).
Chestpiece ring and membrane: PVC. | Body material similar to predicate device.
Identical materials for chestpiece and parts |
| Contact with
human tissues
or 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 |
8
eKuore Stethoscope Touch 510(k) Premarket Notification
Section 5 - 510(k) Summary
Rev 02
9
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.