(29 days)
Not Found
No
The summary describes a digital stethoscope that records and displays audio data. There is no mention of any analytical or interpretive functions beyond basic filtering and display, nor any terms associated with AI/ML.
No
This device is for diagnostic purposes, specifically for physical assessment and recording sounds for diagnostic decision support, not for treating conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic decision support" and to assist with the "physical assessment of a patient... for diagnostic decision support in clinical settings." It also mentions its use in patients with "suspected diseases."
No
The device description clearly outlines both a hardware component ("eKuore Pro Series device") and a software component ("eKuore Pro App"). The hardware device is responsible for detecting and amplifying sounds, while the software app receives and processes this data. Therefore, it is not a software-only medical device.
Based on the provided information, the eKuore Pro Series is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- eKuore Pro Series Function: The eKuore Pro Series is a digital stethoscope. It works by detecting and amplifying sounds from within the patient's body (heart, lungs, etc.) through direct contact with the skin. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "part of a physical assessment of a patient" and to "record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination." This is a direct physical examination tool, not a laboratory-based diagnostic test.
Therefore, the eKuore Pro Series falls under the category of a medical device used for physical examination and diagnostic support, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DQD
Device Description
eKuore Pro Series is formed by eKuore Pro Series device and eKuore Pro App.
The eKuore Pro Series device introduce three different models:
- . eKuore Pro, the basic version of the stethoscope.
- eKuore Pro Amplified, that has a higher sound amplification designed for . people with hearing problems
The main purpose of eKuore Pro Series device is the detection and amplification of heart, lung, arteries, veins and internal sounds using selective frequency organ ranges. eKuore Pro and eKuore Pro Amplified creates a WLAN access point, to which the client is able to connect via Wi-Fi with smartphones and tablets, to send the data acquired during auscultation to the eKuore Pro App.
The design of eKuore Pro Series lets the user change the chestpiece attached between different sizes depend on the patient to be auscultated.
The main purpose of the eKuore Pro Series App is to get the acoustic signals from the eKuore Pro Series WLAN access point. Once the device is turn on, a new Wi-Fi signal could be detected by the smartphone/tablet, the signal name contains the last 6 digits of the serial number of the device for its identification.
After the connection, the eKuore Pro App displays the acoustic signal as a phonogram in real time, in the monitor screen there is a record button. When it is pressed the recording start, there is defined a record maximum duration of 30 seconds, it could be changed on the App configuration to 60. 90 or 120 seconds. 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 Pro 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 Pro App lets the user share the records.
Furthermore, eKuore Pro App has a tutorial to help the user and one "About App" screen where access to support is available.
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
An acoustic performance comparison between eKuore Pro Series and 3M Littmann electronic stethoscope model 3200 has been performed. Device signal acquisition accuracy and acoustic transmission disturbance has been evaluated and successfully, presenting in all devices with similar acoustic characteristics,
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 eKuore Pro Series and 3M Littmann electronic stethoscope model 3200 has been performed. Device signal acquisition accuracy and acoustic transmission disturbance has been evaluated and successfully, presenting in all devices with similar acoustic characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows 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.
October 30, 2020
Chip Ideas Electronics S.L. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K203007
Trade/Device Name: eKuore Pro Series Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DOD Dated: September 28, 2020 Received: October 1, 2020
Dear Dave Yungvirt:
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,
LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
eKuore Pro Series
Indications for Use (Describe)
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 cardias, vascular, pulmonary or abdominal organ systems.
| Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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3
Section 5 - 510(k) Summary
SUBMITTER
Submitter name: Submitter address:
Chip Ideas Electronics, S.L. 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:
2020-10-26
DEVICE
Device Trade Name: Common Name: Regulation Name: Regulatory Class: Product Code: Regulation Number:
eKuore Pro Series ELECTRONIC STETHOSCOPE ELECTRONIC STETHOSCOPE Class II DQD 870.1875
PREDICATE DEVICE
Predicate Device (S): 3M Littmann Electronic Stethoscope Model 3200 (K083903)
4
Section 5 - 510(k) Summary
5.1 DEVICE DESCRIPTION
eKuore Pro Series is formed by eKuore Pro Series device and eKuore Pro App.
The eKuore Pro Series device introduce three different models:
- . eKuore Pro, the basic version of the stethoscope.
- eKuore Pro Amplified, that has a higher sound amplification designed for . people with hearing problems
The main purpose of eKuore Pro Series device is the detection and amplification of heart, lung, arteries, veins and internal sounds using selective frequency organ ranges. eKuore Pro and eKuore Pro Amplified creates a WLAN access point, to which the client is able to connect via Wi-Fi with smartphones and tablets, to send the data acquired during auscultation to the eKuore Pro App.
The design of eKuore Pro Series lets the user change the chestpiece attached between different sizes depend on the patient to be auscultated.
The main purpose of the eKuore Pro Series App is to get the acoustic signals from the eKuore Pro Series WLAN access point. Once the device is turn on, a new Wi-Fi signal could be detected by the smartphone/tablet, the signal name contains the last 6 digits of the serial number of the device for its identification.
After the connection, the eKuore Pro App displays the acoustic signal as a phonogram in real time, in the monitor screen there is a record button. When it is pressed the recording start, there is defined a record maximum duration of 30 seconds, it could be changed on the App configuration to 60. 90 or 120 seconds. 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 Pro 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 Pro App lets the user share the records.
Furthermore, eKuore Pro App has a tutorial to help the user and one "About App" screen where access to support is available.
5
eKuore Pro Series 510(k) Premarket Notification
Section 5 – 510(k) Summary
| Equipment description | |
|---|---|
| Image: eKuore Pro Series main piece with the chestpiece attached | eKuore Pro Series main piece with the |
| chestpiece attached. | |
| Image: Hands using eKuore Pro Series | To use the eKure Pro Series devices the |
| chestpice must be attached and turn it on, | |
| as is shown in the pictogram. | |
| There are three models of chestpiece | |
| depend on the patient to be auscultated. | |
| S, M or L from neonatal to adults patients. | |
| Image: eKuore Pro Series device connected to a smartphone | eKuore Pro Series device is connected |
| via Wi-Fi with eKuore Pro App installed in | |
| the smartphone/tablet. | |
| Then the ekuore Pro App shows the | |
| phonogram in real time. | |
| Image: eKuore Pro Series product packaging | eKuore Pro Series product packaging. |
Table 5.1 Equipment Description
The following table shows the difference and similarities of each model:
6
eKuore Pro Series 510(k) Premarket Notification
| Characterictic | EP0002 | EP0099 |
|---|---|---|
| Form | Same for both models | Same for both models |
| Design | Same for both models | Same for both models |
| Material | Same for both models | Same for both models |
| Function | For healthcare professionals | For healthcare professionals that needs |
| increased volume | ||
| Connectivity | Create an WLAN access point | Create an WLAN access point |
| Volume control / gain | 5 steps, 2 dB of difference between | |
| levels | 5 steps, 2 dB of difference between | |
| levels with an offset of +6db | ||
| Energy Supply | Same for both models | Same for both models |
| Software | Compatible with eKuore Pro APP. | Compatible with eKuore Pro APP. |
| Firmware | eKuore Pro FW v1.10.07 | eKuore Pro FW v1.10.07 |
| DSP configuration | v00.00.08 | v00.00.58 |
| Hardware | Same for both models | Same for both models |
Section 5 - 510(k) Summary
Table 5.2 - eKuore Pro Series models comparison table
5.2 INDICATIONS FOR USE
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.
5.3 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 Pro Series compared to the predicate device K083903, 3M Littmann Electronic Stethoscope Model 320
7
eKuore Pro Series 510(k) Premarket Notification
Section 5 - 510(k) Summary
| Elements of
comparison | eKuore Pro Series (New Device) | | 3M Littmann Electronic
Stethoscope Model 3200
(Predicate device) | Comparison |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | eKuore Pro | eKuore Pro Amplified | | |
| Regulatory Class | Class II | Class II | Class II | Identical to predicate device |
| Classification name | Electronic Stethoscope | Electronic Stethoscope | Electronic Stethoscope | Identical to predicate device |
| Regulation Number | 21 CFR 870.1875 | 21 CFR 870.1875 | 21 CFR 870.1875 | Identical to predicate device |
| Product code | DQD | DQD | DQD | Identical to predicate device |
| Manufacturer | Chip Ideas Electronics, SL. | Chip Ideas Electronics, SL. | 3M Company | - |
| FDA Clearance | Pending | Pending | 510(k) cleared: K083903 | - |
| Indications for use | 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. | 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. | The 3MTM Littmann® Electronic
stethoscope, Model 3200 is intended for
medical diagnostic purposes only. It may be
used for the detection and amplification of
sounds from the heart, lungs, arteries, veins,
and other internal organs with the use of a
selective frequency. It can be used on any
person undergoing a physical assessment | Similar to predicate device |
| Principles of operation | The device picks up sounds from a
patient's body. This sound is filtered,
amplified and sent it to the user
through earbuds, also it can be sent | The device picks up sounds from a
patient's body. This sound is filtered,
amplified + 6dB offset and sent it to
the user through earbuds, also it can | Model 3200 electronic stethoscope picks up
sounds, such as heart and lung sounds, from
a patient's body. After amplification and
filtering, the sounds are sent to the user | Similar to predicate device |
| Elements of
comparison | eKuore Pro Series (New Device) | | 3M Littmann Electronic | Comparison |
| | eKuore Pro | eKuore Pro Amplified | Stethoscope Model 3200
(Predicate device) | |
| | via WiFi to compatible smartphones
and tablets. | be sent via WiFi to compatible
smartphones and tablets. | through a binaural headset. Also, can be
sent via Bluetooth to compatible devices. | |
| Clinical conditions | Human body sounds related | Human body sounds related | Human body sounds related | Identical to predicate device |
| Use | Electronic stethoscope | Electronic stethoscope | Electronic stethoscope | Identical to predicate device |
| Prescription/O.T.C. | Prescription use | Prescription use | Prescription use | Identical to predicate device |
| Intended for Direct
Connection to Patient | YES | YES | YES | Identical to predicate device |
| Use environment | Clinical settings | Clinical settings | Clinical settings | Identical to predicate device |
| Type of users | Health-care personnel | Health-care personnel with hearing
difficulties | Health-care personnel | Similar to predicate device.
eKuore Pro Amplified is
designed for Health-care
personnel with hearing
difficulties due to increased
amplification |
| Target population | Pediatric and adult patients | Pediatric and adult patients | Adult, pediatric and infants | Similar to predicate device |
| Cleaning &
Maintenance | When the power supply is off, the
entire plastic surface can be cleaned
sliding an alcohol pad. Excess fluid
during cleaning can cause leakage of
moisture on internal components.
Clean the stethoscope from patient to
patient. | When the power supply is off, the
entire plastic surface can be cleaned
sliding an alcohol pad. Excess fluid
during cleaning can cause leakage of
moisture on internal components.
Clean the stethoscope from patient to
patient | Cleaning of stethoscope should be done
between each patient use.
Cleaning the Chestpiece
Under normal conditions, it is unnecessary
to remove the diaphragm for cleaning. The
diaphragm can easily be cleaned by using
an alcohol wipe. | Identical to predicate device |
| Technical equivalence | | | | |
| Sound track transfer
function | Yes | Yes | Yes | Identical to predicate device |
| Signal transmission
for visualization | Wireless transmission to compatible
smartphones/ tablet via WiFi | Wireless transmission to compatible
smartphones/ tablet via WiFi | Wireless transmission to compatible
smartphones/tablets via Bluetooth | Similar to predicate device. |
| Energy Source | Lithium-Ion Battery | Lithium-Ion Battery | AA Alkaline, Lithium or NiMH battery | Similar to predicate device. |
| System required | Android device and Apple, Inc | Android device and Apple, Inc | PC/Mac | Different to predicate device |
| Hardware and | Mobile devices or tables | Mobile devices or tables | PC/Mac | Different to predicate device |
| Elements of | eKuore Pro Series (New Device) | | 3M Littmann Electronic | Comparison |
| comparison | eKuore Pro | eKuore Pro Amplified | Stethoscope Model 3200
(Predicate device) | |
| software platforms | | | | |
| Connections | Micro USB connector only to charge
the internal battery of the device | Micro USB connector only to charge
the internal battery of the device | None | Different to predicate device |
| Filter frequency range | • Heart (50-150 Hz)
• Lung (50-500 Hz)
• Extended (40-600 Hz) | • Heart (50-150 Hz)
• Lung (50-500 Hz)
• Extended (40-600 Hz) | • Bell (20-200 Hz)
• Diaphragm (100-500 Hz)
• Extended Range (50-500 Hz) | Similar to predicate device |
| Wireless data
transmission | Audio | Audio | Audio | Identical to predicate device |
| Signal Input Method | Sound waves collected via a
Transducer. Microelectro-mechanical
microphone | Sound waves collected via a
Transducer. Microelectro-mechanical
microphone | Sound waves collected via a
Transducer. Electret microphone | Identical to predicate device |
| Audio Output Method | Earbuds connected with the device
through the 3.5mm Jack directly to
the eKuore device or from the
smartphone/tablet audio outputs | Earbuds connected with the device
through the 3.5mm Jack directly to
the eKuore device or from the
smartphone/tablet audio outputs | Binaural headset | Different to predicate device |
| Signal Storage | Depend on Smartphone/tablet internal
memory, eKuore Pro App lets the
user record 30, 60, 90 or 120 seconds.
eKuore Pro Series devices does not
stored data. | Depend on Smartphone/tablet internal
memory, eKuore Pro App lets the
user record 30, 60, 90 or 120 seconds.
eKuore Pro Series devices does not
stored data. | Up to 12 separate 30-second sound tracks
for later playback in internal storage. | Different to predicate device |
| Performance
requirements | Temp range: 0°C to +40°C
Humidity range: 15% to 93% | Temp range: 0°C to +40°C | Temp range: -30°C to 40°C
Humidity range: 15% to 93% | Similar to predicate device |
| Biological Equivalence | | | | |
| Body material | ABS (Acrylonitrile Butadiene
Styrene) | ABS (Acrylonitrile Butadiene
Styrene) | ABS | Identical to predicate device |
| Diaphragm material | Membrane: Epoxy and Fiberglass
Membrane's ring: PVC | Membrane: Epoxy and Fiberglass
Membrane's ring: PVC | Polyurethane coated silicone | Different to predicate device |
| 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. | Identical to predicate device |
| Sterility | Not intended to be sterilized | Not intended to be sterilized | Not intended to be sterilized | Identical to predicate device |
8
eKuore Pro Series 510(k) Premarket Notification
Section 5 - 510(k) Summary
9
eKuore Pro Series 510(k) Premarket Notification
Section 5 - 510(k) Summary
Table 5.3. Substantial Equivalence Comparison – eKuore Pro Series and Predicate Device K083903
10
eKuore Pro Series 510(k) Premarket Notification
Section 5 - 510(k) Summary
Information provided in these 510(k) submissions shows that eKuore Pro Series is substantially equivalent to the predicate device 3M Littmann Electronic Stethoscope Model 3200 cleared under K083903 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 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 complete 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 14971:2007.
An acoustic performance comparison between eKuore Pro Series and 3M Littmann electronic stethoscope model 3200 has been performed. Device signal acquisition accuracy and acoustic transmission disturbance has been evaluated and 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 Pro Series is substantially equivalent to the listed legally marketed predicate device.