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.

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.

AI/ML Overview

The provided text describes the eKuore Pro Series device, an electronic stethoscope, and its substantial equivalence to a predicate device (3M Littmann Electronic Stethoscope Model 3200, K083903) for FDA clearance. The document lists the general acceptance criteria of regulatory compliance and some performance characteristics but does not contain specific numerical acceptance criteria or detailed study results for the eKuore Pro Series device's performance.

Therefore, I cannot populate a table of acceptance criteria and reported device performance with specific numerical values for the eKuore Pro Series, nor can I provide details on sample size, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, or ground truth for the eKuore Pro Series itself, as this information is not present.

However, based on the information available, here's what can be inferred and stated:

1. A table of acceptance criteria and the reported device performance:

The document primarily focuses on demonstrating substantial equivalence to the predicate device. The acceptance criteria described are mainly regulatory and general performance comparisons rather than specific quantitative thresholds.

Acceptance Criteria Category	Specific Criteria (from predicate comparison)	eKuore Pro Series Performance (as stated in document)
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)
Indications for Use	Detection and amplification of sounds.Use on all persons for physical assessment.	Detection and amplification of sounds.Use on pediatric and adult patients for physical assessment/diagnostic decision support. (Similar to predicate device)
Principles of Operation	Device picks up, filters, amplifies, and sends sounds to user via earbuds/Bluetooth.	Device picks up, filters, amplifies, and sends sounds to user via earbuds/WiFi (Similar to predicate device)
Clinical Conditions	Human body sounds related	Human body sounds related (Identical to predicate device)
Use	Electronic stethoscope	Electronic stethoscope (Identical to predicate device)
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)
Cleaning & Maintenance	Cleaning between each patient use.	Cleaning between each patient use. (Identical to predicate device)
Sound Track Transfer Function	Yes	Yes (Identical to predicate device)
Wireless Data Transmission	Audio	Audio (Identical to predicate device)
Signal Input Method	Sound waves collected via Transducer.	Sound waves collected via Transducer. (Identical to predicate device)
Biological Equivalence (Body material)	ABS	ABS (Identical to predicate device)
Biological Equivalence (Contact with human tissues)	Chestpiece in contact with patients' skin.	Chestpiece in contact with patients' skin. (Identical to predicate device)
Sterility	Not intended to be sterilized	Not intended to be sterilized (Identical to predicate device)
Performance Requirements (Temperature Range)	-30°C to 40°C	0°C to +40°C (Similar to predicate device)
Performance Requirements (Humidity Range)	15% to 93%	15% to 93% (Similar to predicate device)
Acoustic Performance	Not explicitly stated numerical criteria for predicate.	"Device signal acquisition accuracy and acoustic transmission disturbance has been evaluated and successfully, presenting in all devices with similar acoustic characteristics."
Electrical Safety & EMC	Compliance with AAMI ANSI ES 60601-1:2005+A1:2012 and IEC 60601-1-2 Edition 4: 2014-02	Successfully completed.
Software Life Cycle	Compliance with IEC 62304:2015	Successfully completed.
Usability	Compliance with AAMI ANSI IEC 62366:2007	Successfully met.
Risk Management	Compliance with ISO 14971:2007	Identification, evaluation, and control of potential hazards performed.

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not specified in the provided text. The document mentions "An acoustic performance comparison between eKuore Pro Series and 3M Littmann electronic stethoscope model 3200 has been performed" but does not detail the sample size (e.g., number of recordings, number of patients).
Data provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The document does not describe the use of experts for establishing ground truth in the context of the acoustic performance comparison.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not specified.

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 MRMC study is described. The device is an electronic stethoscope that filters and transfers sounds, not an AI-assisted diagnostic tool in the sense of offering interpretations or classifications that would involve human reader improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device functions as an electronic stethoscope, amplifying and transferring sounds. Its primary performance claim is related to acoustic characteristics and signal acquisition, which would likely be evaluated in a "standalone" fashion (device output compared to a reference signal or predicate device output). The statement "Device signal acquisition accuracy and acoustic transmission disturbance has been evaluated and successfully, presenting in all devices with similar acoustic characteristics" suggests a standalone evaluation, but specific metrics and methodology are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the acoustic performance comparison, the "ground truth" would likely be a reference acoustic signal or the performance of the predicate device. However, the exact nature of this "ground truth" (e.g., gold standard recordings, simulated sounds with known characteristics) is not specified.

8. The sample size for the training set:

Not applicable/Not specified. The document does not describe machine learning or AI components that would require a "training set" in the conventional sense for image or signal classification. The device appears to be a signal processing and transmission tool.

9. How the ground truth for the training set was established:

Not applicable/Not specified as there is no apparent training set mentioned.

Summary

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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

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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,

LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K203007

Device Name

eKuore Pro Series

Indications for Use (Describe)

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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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)

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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 design of eKuore Pro Series lets the user change the chestpiece attached between different sizes depend on the patient to be auscultated.

Furthermore, eKuore Pro App has a tutorial to help the user and one "About App" screen where access to support is available.

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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 thechestpiece attached.
Image: Hands using eKuore Pro Series	To use the eKure Pro Series devices thechestpice must be attached and turn it on,as is shown in the pictogram.There are three models of chestpiecedepend 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 connectedvia Wi-Fi with eKuore Pro App installed inthe smartphone/tablet.Then the ekuore Pro App shows thephonogram 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:

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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 needsincreased volume
Connectivity	Create an WLAN access point	Create an WLAN access point
Volume control / gain	5 steps, 2 dB of difference betweenlevels	5 steps, 2 dB of difference betweenlevels 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

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

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eKuore Pro Series 510(k) Premarket Notification

Section 5 - 510(k) Summary

Elements ofcomparison	eKuore Pro Series (New Device)		3M Littmann ElectronicStethoscope 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 tobe used as a part of a physicalassessment of a patient by healthcareprofessionals for diagnostic decisionsupport in clinical settings. eKuorePro Series is intended for use onpediatric and adult patients. It canelectronically filter and transfersounds to the accompanying mobilesoftware application.It can be used to record heart soundsand cardiac murmurs, bruits,respiratory sounds and abdominalsounds during physical examinationin normal patients or those withsuspected diseases of the cardiac,vascular, pulmonary or abdominalorgan systems.	The eKuore Pro Series is intended tobe used as a part of a physicalassessment of a patient by healthcareprofessionals for diagnostic decisionsupport in clinical settings. eKuorePro Series is intended for use onpediatric and adult patients. It canelectronically filter and transfersounds to the accompanying mobilesoftware application.It can be used to record heart soundsand cardiac murmurs, bruits,respiratory sounds and abdominalsounds during physical examinationin normal patients or those withsuspected diseases of the cardiac,vascular, pulmonary or abdominalorgan systems.	The 3MTM Littmann® Electronicstethoscope, Model 3200 is intended formedical diagnostic purposes only. It may beused for the detection and amplification ofsounds from the heart, lungs, arteries, veins,and other internal organs with the use of aselective frequency. It can be used on anyperson undergoing a physical assessment	Similar to predicate device
Principles of operation	The device picks up sounds from apatient's body. This sound is filtered,amplified and sent it to the userthrough earbuds, also it can be sent	The device picks up sounds from apatient's body. This sound is filtered,amplified + 6dB offset and sent it tothe user through earbuds, also it can	Model 3200 electronic stethoscope picks upsounds, such as heart and lung sounds, froma patient's body. After amplification andfiltering, the sounds are sent to the user	Similar to predicate device
Elements ofcomparison	eKuore Pro Series (New Device)		3M Littmann Electronic	Comparison
	eKuore Pro	eKuore Pro Amplified	Stethoscope Model 3200(Predicate device)
	via WiFi to compatible smartphonesand tablets.	be sent via WiFi to compatiblesmartphones and tablets.	through a binaural headset. Also, can besent 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 DirectConnection 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 hearingdifficulties	Health-care personnel	Similar to predicate device.eKuore Pro Amplified isdesigned for Health-carepersonnel with hearingdifficulties due to increasedamplification
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, theentire plastic surface can be cleanedsliding an alcohol pad. Excess fluidduring cleaning can cause leakage ofmoisture on internal components.Clean the stethoscope from patient topatient.	When the power supply is off, theentire plastic surface can be cleanedsliding an alcohol pad. Excess fluidduring cleaning can cause leakage ofmoisture on internal components.Clean the stethoscope from patient topatient	Cleaning of stethoscope should be donebetween each patient use.Cleaning the ChestpieceUnder normal conditions, it is unnecessaryto remove the diaphragm for cleaning. Thediaphragm can easily be cleaned by usingan alcohol wipe.	Identical to predicate device
Technical equivalence
Sound track transferfunction	Yes	Yes	Yes	Identical to predicate device
Signal transmissionfor visualization	Wireless transmission to compatiblesmartphones/ tablet via WiFi	Wireless transmission to compatiblesmartphones/ tablet via WiFi	Wireless transmission to compatiblesmartphones/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 chargethe internal battery of the device	Micro USB connector only to chargethe 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 datatransmission	Audio	Audio	Audio	Identical to predicate device
Signal Input Method	Sound waves collected via aTransducer. Microelectro-mechanicalmicrophone	Sound waves collected via aTransducer. Microelectro-mechanicalmicrophone	Sound waves collected via aTransducer. Electret microphone	Identical to predicate device
Audio Output Method	Earbuds connected with the devicethrough the 3.5mm Jack directly tothe eKuore device or from thesmartphone/tablet audio outputs	Earbuds connected with the devicethrough the 3.5mm Jack directly tothe eKuore device or from thesmartphone/tablet audio outputs	Binaural headset	Different to predicate device
Signal Storage	Depend on Smartphone/tablet internalmemory, eKuore Pro App lets theuser record 30, 60, 90 or 120 seconds.eKuore Pro Series devices does notstored data.	Depend on Smartphone/tablet internalmemory, eKuore Pro App lets theuser record 30, 60, 90 or 120 seconds.eKuore Pro Series devices does notstored data.	Up to 12 separate 30-second sound tracksfor later playback in internal storage.	Different to predicate device
Performancerequirements	Temp range: 0°C to +40°CHumidity range: 15% to 93%	Temp range: 0°C to +40°C	Temp range: -30°C to 40°CHumidity range: 15% to 93%	Similar to predicate device
Biological Equivalence
Body material	ABS (Acrylonitrile ButadieneStyrene)	ABS (Acrylonitrile ButadieneStyrene)	ABS	Identical to predicate device
Diaphragm material	Membrane: Epoxy and FiberglassMembrane's ring: PVC	Membrane: Epoxy and FiberglassMembrane's ring: PVC	Polyurethane coated silicone	Different to predicate device
Contact with humantissues or body fluids	The chestpiece is in contact withpatients' skin.	The chestpiece is in contact withpatients' 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

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eKuore Pro Series 510(k) Premarket Notification

Section 5 - 510(k) Summary

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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

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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.

Regulation Number and Section

§ 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.