The VoqX Electronic Stethoscope 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 and with an integrated graphics display to show amplified heart sounds as phonocardiograms. It can be used on any person undergoing a physical assessment.

Device Description

The VoqX Electronic Stethoscope is intended for medical diagnostic purposes. 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 and with an integrated graphics display to show amplified heart sounds as phonocardiograms.

The VoqX Electronic Stethoscope is comprised of two parts: Back Unit (head piece) and Front Unit (chest piece).

The device has 3 modes of operation: General - emphasizes sounds from 20 to 2000Hz, Heart emphasizes sounds from 20 to 200Hz and Lungs - emphasizes sounds from 100 to 500Hz. In addition, the VoqX Electronic Stethoscope incorporates a software feature that displays sounds as a "Sound Signature". The "Sound Signature" algorithm generates intensity image based on the spectrogram of the output audio data. The device is supplied with an AC/DC power supply adapter and a charging cable.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VoqX Electronic Stethoscope, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document states that a "Performance Testing" study was conducted to compare the VoqX Electronic Stethoscope to its predicate device (3M Littmann Electronic Stethoscope, Model 3200). The main purpose was to verify that the VoqX's performance is similar to that of its predicate device in terms of frequency response.

Acceptance Criteria	Reported Device Performance
Frequency Response Similarity to Predicate Device	The test passed and met the predefined acceptance criteria. (Implies the frequency response of VoqX is similar to the 3M Littmann 3200).
Biocompatibility in compliance with ISO 10993-1	Performed and successfully completed.
Transportation validation	Performed and successfully completed.
Cleaning and disinfection validation	Performed and successfully completed.
Software verification and validation testing (Level of Concern: Moderate, per FDA Guidance)	Conducted, and documentation was provided. (Implies successful validation).
Electrical Safety per IEC 60601-1	Tests passed.
Electromagnetic compatibility (EMC) per IEC 60601-1-2	Tests passed.
Usability per IEC 60601-1-6	Tests passed.

Note: The document does not provide specific numerical values for the frequency response acceptance criteria or the actual measured performance of the VoqX. It only states that the tests "passed and met the predefined acceptance criteria" and that the performance is "similar to that of its predicate device."

2. Sample Size and Data Provenance

The document does not specify the sample size used for the performance testing related to "frequency response."

The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. Given that this is a premarket notification, the performance testing would typically be prospective, conducted by the manufacturer, Sanolla Ltd., which is based in Israel.

3. Number of Experts and Qualifications for Ground Truth

For the performance testing focused on frequency response, there's no mention of "experts" being used to establish a ground truth. This type of testing often relies on instrumental measurements and comparisons to a validated standard (the predicate device) rather than human expert interpretation of an outcome.

4. Adjudication Method

Not applicable for frequency response testing, as it's an objective measurement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or implied in the provided document. The performance testing described is focused on the inherent technical performance (frequency response) of the device itself compared to a predicate, not on how human readers' diagnostic accuracy is affected by using the device.

6. Standalone Performance Study

Yes, the "Performance Testing" described appears to be a standalone (algorithm only without human-in-the-loop performance) study in the sense that it evaluates the technical characteristics of the device (frequency response) objectively, rather than assessing a human user's performance with the device.

7. Type of Ground Truth Used

For the "Performance Testing" related to frequency response, the ground truth appears to be based on instrumental measurements and comparison to the technical specifications/performance of the legally marketed predicate device (3M Littmann Electronic Stethoscope, Model 3200).

8. Sample Size for the Training Set

The document does not mention a training set, as the device's main function is the detection and amplification of sounds, and the "Sound Signature" algorithm generates an intensity image based on the spectrogram of output audio data. This typically implies signal processing rather than a deep learning model that requires a large labeled training set for classification or detection.

9. How Ground Truth for Training Set Was Established

Not applicable, as a training set for a machine learning model is not explicitly mentioned for the described "Sound Signature" feature. The "Sound Signature" algorithm's output is described as an "intensity image based on the spectrogram of the output audio data," which suggests a deterministic signal processing method rather than a data-driven machine learning approach requiring a training set with established ground truth.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 15, 2022

Sanolla Ltd. Aharon Cohen QA&RA Director 25 Sirkin Street Kfar Saba, 4442156 Israel

Re: K212709

Trade/Device Name: VoqX Electronic Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DOD Dated: February 14, 2022 Received: February 18, 2022

Dear Aharon Cohen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

Enclosure

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Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use		Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2023See PRA Statement below.
510(k) Number (if known)K212709
Device NameVoqX Electronic Stethoscope
Indications for Use (Describe)
The VoqX Electronic Stethoscope is intended for medical diagnostic purposes only. It may be usedfor the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internalorgans with the use of a selective frequency and with an integrated graphics display to show amplifiedheart sounds as phonocardiograms. It can be used on any person undergoing a physical assessment.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.The burden time for this collection of information is estimated to average 79 hours per response, includingthe time to review instructions, search existing data sources, gather and maintain the data needed andcomplete and review the collection of information. Send comments regarding this burden estimate or anyother aspect of this information collection, including suggestions for reducing this burden, to:Department of Health and HumanServices Food and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA)Staff PRAStaff@fda.hhs.gov"An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)	Page 1 of 1 FDA	PSC Publishing Services (301) 443-6740 EF

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Traditional Premarket Notification Submission - 510(k) VoqX Electronic Stethoscope 510(k) Number K212709

Date Prepared: February 13, 2022

SUBMITTER I.

Sanolla Ltd. 19 Ha'mesila Street Nesher 3688519, Israel Tel: +972-4-8321663

Regulatory Correspondent:

Aharon Cohen QA RA Director 19 Ha'mesila Street, Nesher 3688519, Israel Phone: +972-52-3027547 aharon@Sanolla.com

Submitted by

Orly Maor 25 Sirkin Street Kfar Saba 4442156, Israel Tel: +972-9-7453607 oram.ma@gmail.com

II. DEVICE

Name of Device: VoqX Electronic Stethoscope Common or Usual Name: VoqX Electronic Stethoscope Classification Name: 21 CFR 870.1875; Stethoscope, Electronic Regulatory Class: II Product Code: DQD.

III. PREDICATE DEVICE

Sanolla Ltd. believes that the VoqX Electronic Stethoscope is substantially equivalent to the following predicate device:

3M Company 3M Littmann Electronic Stethoscope, Model 3200 cleared under K083903, ● product code DQD, regulation number 870.1875.
The following device is used as a reference device:

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StratoScientific. Inc. Steth IO® Stethoscope cleared under K160016, product code DQD, ● regulation number 870.1875 (Stethoscope and Phonocardiogram).

DEVICE DESCRIPTION IV.

The VoqX Electronic Stethoscope is comprised of two parts: Back Unit (head piece) and Front Unit (chest piece).

V. INDICATIONS FOR USE

OF TECHNOLOGICAL CHARACTERISTICS VI. COMPARISON WITH THE PREDICATE DEVICE

The VoqX Electronic Stethoscope has the same intended use as the predicate device. Its indications for use are identical to that of the predicate device.

The VoqX Electronic Stethoscope has similar technological characteristics as the predicate device as demonstrated in the table below:

Specification/Feature	VoqX ElectronicStethoscope(Proposed device)	3M LittmannElectronicStethoscope,Model 3200K083903	Steth IOStethoscope -Reference deviceK160016	SEJustification
Manufacturer	Sanolla Ltd.	3M Company	Stratoscientific,Inc.	-
Product Code	DQD	DQD	DQD	Same
Regulation no.	870.1875	870.1875	870.1875	Same
Intended Use	The VoqX ElectronicStethoscope is intendedfor medical diagnostic	The 3M™Littmann®Electronic	The Steth IOStethoscope andPhonocardiogram	Same
Specification /Feature	VoqX ElectronicStethoscope(Proposed device)	3M LittmannElectronicStethoscope,Model 3200K083903	Steth IOStethoscope -Reference deviceK160016	SEJustification
	purposes only. It may beused for the detectionand amplification ofsounds from the heart,lungs, arteries, veins,and other internalorgans with the use of aselective frequency andwith an integratedgraphics display to showamplified heart soundsas phonocardiograms. Itcan be used on anyperson undergoing aphysical assessment.	Stethoscope, Model3200 is intended formedical diagnosticpurposes only. Itmay be used for thedetection andamplification ofsounds from theheart, lungs, arteries,veins, and otherinternal organs withthe use of a selectivefrequency. It can beused on any personundergoing aphysical assessment	Model 1.0 isintended for medicaldiagnostic purposesonly. It may be usedfor the detection andamplificationof sounds from theheart, and lungs withthe use of selectivefrequency ranges. Ithas been tested foruse on adultsundergoing aphysical assessment.
Intendedpatientpopulation	Adults and pediatric	Adults and pediatric	Adults	Same as thepredicate
Chest-piece	Yes	Yes	Yes	Same
Principles ofoperation	VoqX electronicstethoscope picks upsounds, such as heartand lung sounds, from apatient's body. Afteramplification andfiltering, the sounds aresent to the user througha binaural headset. Also,the sounds can be sentvia Bluetooth tocompatible devicesusing a PC applicationavailable only tocompany personnel.	Model 3200electronicstethoscope picks upsounds, such asheart and lungsounds, from apatient's body. Afteramplification andfiltering, the soundsare sent to the userthrough a binauralheadset. Also, canbe sent viaBluetooth tocompatible devices	Steth IO picks upsounds, such asheart and lungsounds, from apatient's body. Thesounds are collectedusing via asmartphone to whichthe device connects,using a dedicatedapplication. Thecollected sounds canthen be sent tophysicians viamentionedapplication forremote patient care.	Same as thepredicate
Placement onthe subject	The VoqX is placed byclinician similar to atraditional stethoscope	The Littmann isplaced by cliniciansimilar to atraditionalstethoscope	The device is placedby the user similarto a traditionalstethoscope	Same
DiaphragmMaterial	Fiberglass / Epoxy sheet	Polyurethane coatedsilicone	Fiberglass / Epoxysheet	Same as StethIO
Specification/Feature	VoqX ElectronicStethoscope(Proposed device)	3M LittmannElectronicStethoscope,Model 3200	Steth IOStethoscope -Reference device	SEJustification
	K	K083903	K160016
Pickup sensor	Sound waves collectedvia Microphone	Sound wavescollected via amicrophone	Sound wavescollected via amicrophone	Same
SoundProcessing	Carried out with the aidof a digital signalprocessor	Carried out with theaid of a digitalsignal processor	Carried out with theaid of a digital signalprocessor out	Same
Audio OutputMethod	Earbuds	Earbuds	Audio port andheadphones	Same as thepredicate
Signal Storage	Onboard recordingprovides a means toacquire an auscultationsoundtrack for amaximum of 5 minutes.This track can betransmitted to anexternal device [PC]using the Bluetooth linkand dedicated softwareavailable only tocompany personnel.	Onboard recordingprovides a means toacquire and play anauscultationsoundtrack for amaximum of 29seconds.This track can beuploaded to anexternal deviceusing the Bluetoothlink and the softwareaccompanying theModel 3200.	No storage	Same as thepredicate.The timedifference doesnot raise newquestionsbecause it is atleast as much asthe predicateand thisdifference is notdetrimental toperformance
FrequencyResponse	The 'Heart' modeemphasizes soundsbetween 20 - 200Hz.The 'Lungs' modeemphasizes the soundsbetween 100 - 500Hz.The 'General' modeamplifies sounds from20 - 2000Hz	Bell mode butemphasizes lowerfrequency soundsbetween 20 - 200Hz.Diaphragm mode,but emphasizes thesounds between 100- 500Hz.Extended Rangemode amplifiessounds from 20 -2000Hz	No availableinformation	Similar to thepredicate
Power Source	Rechargeable Lithium-Ion battery, charged viamicro USB Connector	Alkaline battery,Lithium-Ion battery,or NIMH battery.	Lithium-Ion Batteryprovided bysmartphone	Different.Specific energypower source inthis casedoes not have asignificantimpact on
SpecificationFeature	VoqX ElectronicStethoscope(Proposed device)	3M LittmannElectronicStethoscope,Model 3200	Steth IOStethoscope -Reference deviceK160016	SEJustification
	K	K083903
				performance ofthe stethoscopedevice.
SignalTransmissionforVisualization	No transmissionnecessary for analysisand review, processedand displayed on device	Bluetoothtransmission tocompatible PC	No transmissionnecessary foranalysis and review,processed anddisplayed onsmartphone	Same as thereferencedevice.Improvedefficacy as thereis no need fordatatransmission forprocessing, sodecreasedopportunity forerror. No safetyor efficacyconcerns.
SignalTransmission	VoqX provides a meanto connect the device toa PC for data transferand software updates bytechnicians through adata transfer BLE(Bluetooth Low Energy)link.	The Model 3200sound track recordcan be uploaded toan external deviceusing the Bluetoothlink and the softwareaccompanying theModel 3200.	No transmissionnecessaryfor analysis andreview,processed anddisplayed onsmartphone	Same as 3M
Display	1.54" 240x240 WideAngle Color TFT LCDDisplay on the device	LCD Display	Smartphone display	Similar to thepredicate.Different screensize, Colordisplay (VoqX)vs. monochrome(3M).Differences donot affect safetyand performance
Form Factor	Similar to traditionalstethoscope	Similar to traditionalstethoscope	Device that is heldin the doctor's handis the form ofthe smartphone	Same as thepredicate andtraditionalstethoscope
Environmentof use	Medical FacilitiesHospitalsOutpatient ClinicsPhysician Offices	Medical FacilitiesHospitalsOutpatient ClinicsPhysician Offices	Medical FacilitiesHospitalsOutpatient ClinicsPhysician Offices	Same
Application	Real time	Real time	Real time	Same
Specification/Feature	VoqX ElectronicStethoscope(Proposed device)	3M LittmannElectronicStethoscope,Model 3200K083903	Steth IOStethoscope -Reference deviceK160016	SEJustification
Soundsignature	On-screenphonocardiogram andspectral representationof picked-up sounds	NA	On-screenphonocardiogramand spectralrepresentation ofpicked-up sounds	Same as StethIO
Dimensions	Weight:200 gLength: 82 cm	Weight: 185 gLength: 69 cm	No informationavailable	Similar to thepredicate. Slightdifference inlength andweight does notalter the deviceperformance.
Condition ofUse	Reusable	Reusable	Reusable	Same
Prescriptionvs. O.T.C.	Prescription use	Prescription use	Prescription use	Same

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility -

Biocompatibility evaluation in compliance with ISO 10993-1 was performed.

-Packaging and Cleaning and Disinfection Testing

Transportation validation and cleaning and disinfection validation were performed. All tests were successfully completed.

-Performance Testing

Performance testing included comparison testing of the VoqX Electronic Stethoscope to its predicate device. The main purpose of this test was to verify the VoqX's performance is similar to that of its predicate device, the 3M Littmann 3200 electronic stethoscope, in terms of frequency response.

The test passed and met the predefined acceptance criteria.

Software Validation -

The VoqX Electronic Stethoscope level of concern is moderate. Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket

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Submissions for Software Contained in Medical Devices".

Electrical Safely and EMC -

Electrical Safety per IEC 60601-1, Electromagnetic compatibility (EMC) per IEC 60601-1-2 and usability per IEC 60601-1-6 were conducted on the VoqX Electronic Stethoscope. The tests passed.

VIII. CONCLUSION

The VoqX Electronic Stethoscope was determined to be substantially equivalent to the predicate and reference 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.