VoqX Electronic Stethoscope

K212709 · Sanolla , Ltd. · DQD · Mar 15, 2022 · Cardiovascular

Device Facts

• Record ID: K212709
• Device Name: VoqX Electronic Stethoscope
• Applicant: Sanolla , Ltd.
• Product Code: DQD · Cardiovascular
• Decision Date: Mar 15, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Electronic stethoscope; captures body sounds (heart, lung, vascular) via microphone; amplifies and filters signals using digital signal processor; provides three modes (General 20-2000Hz, Heart 20-200Hz, Lungs 100-500Hz). Features integrated 1.54" color TFT LCD display showing phonocardiograms and "Sound Signature" (intensity image based on spectrogram). Used in hospitals, clinics, and physician offices by clinicians. Audio output via earbuds; onboard storage for up to 5 minutes of audio. Bluetooth Low Energy (BLE) link allows data transfer to PC for software updates and data management by company personnel. Enhances auscultation by providing visual feedback alongside traditional audio, aiding diagnostic assessment.

Clinical Evidence

Bench testing only. Performance testing compared frequency response against the 3M Littmann 3200 predicate; results met predefined acceptance criteria. Biocompatibility testing per ISO 10993-1, electrical safety per IEC 60601-1, EMC per IEC 60601-1-2, and usability per IEC 60601-1-6 were successfully completed.

Technological Characteristics

Fiberglass/epoxy diaphragm; microphone sensor; digital signal processor; 1.54" 240x240 color TFT LCD; rechargeable Li-ion battery (micro-USB charging); Bluetooth Low Energy (BLE) for PC connectivity. Modes: General (20-2000Hz), Heart (20-200Hz), Lungs (100-500Hz). Standards: IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (Usability), ISO 10993-1 (Biocompatibility).

Indications for Use

Indicated for medical diagnostic purposes, including detection and amplification of heart, lung, arterial, venous, and other internal organ sounds. Intended for use on any person (adults and pediatric) undergoing a physical assessment.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*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.

Predicate Devices

• 3M Littmann Electronic Stethoscope, Model 3200 (K083903)

Reference Devices

• Steth IO Stethoscope (K160016)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 SERVICES<br>Food and Drug Administration<br>Indications for Use | | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2023<br>See PRA Statement below. |
| 510(k) Number (if known)<br>K212709 | | |
| Device Name<br>VoqX Electronic Stethoscope | | |
| Indications for Use (Describe) | | |
| The VoqX Electronic Stethoscope is intended for medical diagnostic purposes only. It may be used<br>for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal<br>organs with the use of a selective frequency and with an integrated graphics display to show amplified<br>heart 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.<br>*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*<br>The burden time for this collection of information is estimated to average 79 hours per response, including<br>the time to review instructions, search existing data sources, gather and maintain the data needed and<br>complete and review the collection of information. Send comments regarding this burden estimate or any<br>other aspect of this information collection, including suggestions for reducing this burden, to:<br>Department of Health and Human<br>Services Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA)<br>Staff [e-mail]<br>"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of<br>information unless it displays a currently valid OMB number." | | |
| FORM FDA 3881 (6/20) | Page 1 of 1 FDA | PSC Publishing Services [phone] 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: [phone]

## Regulatory Correspondent:

Aharon Cohen QA RA Director 19 Ha'mesila Street, Nesher 3688519, Israel Phone: [phone] [e-mail]

## Submitted by

Orly Maor 25 Sirkin Street Kfar Saba 4442156, Israel Tel: [phone] [e-mail]

### 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 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.

## V. INDICATIONS FOR USE

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.

#### 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<br>/<br>Feature | VoqX Electronic<br>Stethoscope<br>(Proposed device) | 3M Littmann<br>Electronic<br>Stethoscope,<br>Model 3200<br>K083903 | Steth IO<br>Stethoscope -<br>Reference device<br>K160016 | SE<br>Justification |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Sanolla Ltd. | 3M Company | Stratoscientific,<br>Inc. | - |
| Product Code | DQD | DQD | DQD | Same |
| Regulation no. | 870.1875 | 870.1875 | 870.1875 | Same |
| Intended Use | The VoqX Electronic<br>Stethoscope is intended<br>for medical diagnostic | The 3M™<br>Littmann®<br>Electronic | The Steth IO<br>Stethoscope and<br>Phonocardiogram | Same |
| Specification /<br>Feature | VoqX Electronic<br>Stethoscope<br>(Proposed device) | 3M Littmann<br>Electronic<br>Stethoscope,<br>Model 3200<br>K083903 | Steth IO<br>Stethoscope -<br>Reference device<br>K160016 | SE<br>Justification |
| | purposes only. It may be<br>used for the detection<br>and amplification of<br>sounds from the heart,<br>lungs, arteries, veins,<br>and other internal<br>organs with the use of a<br>selective frequency and<br>with an integrated<br>graphics display to show<br>amplified heart sounds<br>as phonocardiograms. It<br>can be used on any<br>person undergoing a<br>physical assessment. | Stethoscope, Model<br>3200 is intended for<br>medical diagnostic<br>purposes only. It<br>may be used for the<br>detection and<br>amplification of<br>sounds from the<br>heart, lungs, arteries,<br>veins, and other<br>internal organs with<br>the use of a selective<br>frequency. It can be<br>used on any person<br>undergoing a<br>physical assessment | Model 1.0 is<br>intended for medical<br>diagnostic purposes<br>only. It may be used<br>for the detection and<br>amplification<br>of sounds from the<br>heart, and lungs with<br>the use of selective<br>frequency ranges. It<br>has been tested for<br>use on adults<br>undergoing a<br>physical assessment. | |
| Intended<br>patient<br>population | Adults and pediatric | Adults and pediatric | Adults | Same as the<br>predicate |
| Chest-piece | Yes | Yes | Yes | Same |
| Principles of<br>operation | VoqX electronic<br>stethoscope picks up<br>sounds, such as heart<br>and lung sounds, from a<br>patient's body. After<br>amplification and<br>filtering, the sounds are<br>sent to the user through<br>a binaural headset. Also,<br>the sounds can be sent<br>via Bluetooth to<br>compatible devices<br>using a PC application<br>available only to<br>company personnel. | Model 3200<br>electronic<br>stethoscope picks up<br>sounds, such as<br>heart and lung<br>sounds, from a<br>patient's body. After<br>amplification and<br>filtering, the sounds<br>are sent to the user<br>through a binaural<br>headset. Also, can<br>be sent via<br>Bluetooth to<br>compatible devices | Steth IO picks up<br>sounds, such as<br>heart and lung<br>sounds, from a<br>patient's body. The<br>sounds are collected<br>using via a<br>smartphone to which<br>the device connects,<br>using a dedicated<br>application. The<br>collected sounds can<br>then be sent to<br>physicians via<br>mentioned<br>application for<br>remote patient care. | Same as the<br>predicate |
| Placement on<br>the subject | The VoqX is placed by<br>clinician similar to a<br>traditional stethoscope | The Littmann is<br>placed by clinician<br>similar to a<br>traditional<br>stethoscope | The device is placed<br>by the user similar<br>to a traditional<br>stethoscope | Same |
| Diaphragm<br>Material | Fiberglass / Epoxy sheet | Polyurethane coated<br>silicone | Fiberglass / Epoxy<br>sheet | Same as Steth<br>IO |
| Specification<br>/<br>Feature | VoqX Electronic<br>Stethoscope<br>(Proposed device) | 3M Littmann<br>Electronic<br>Stethoscope,<br>Model 3200 | Steth IO<br>Stethoscope -<br>Reference device | SE<br>Justification |
| | K | K083903 | K160016 | |
| Pickup sensor | Sound waves collected<br>via Microphone | Sound waves<br>collected via a<br>microphone | Sound waves<br>collected via a<br>microphone | Same |
| Sound<br>Processing | Carried out with the aid<br>of a digital signal<br>processor | Carried out with the<br>aid of a digital<br>signal processor | Carried out with the<br>aid of a digital signal<br>processor out | Same |
| Audio Output<br>Method | Earbuds | Earbuds | Audio port and<br>headphones | Same as the<br>predicate |
| Signal Storage | Onboard recording<br>provides a means to<br>acquire an auscultation<br>soundtrack for a<br>maximum of 5 minutes.<br>This track can be<br>transmitted to an<br>external device [PC]<br>using the Bluetooth link<br>and dedicated software<br>available only to<br>company personnel. | Onboard recording<br>provides a means to<br>acquire and play an<br>auscultation<br>soundtrack for a<br>maximum of 29<br>seconds.<br>This track can be<br>uploaded to an<br>external device<br>using the Bluetooth<br>link and the software<br>accompanying the<br>Model 3200. | No storage | Same as the<br>predicate.<br>The time<br>difference does<br>not raise new<br>questions<br>because it is at<br>least as much as<br>the predicate<br>and this<br>difference is not<br>detrimental to<br>performance |
| Frequency<br>Response | The 'Heart' mode<br>emphasizes sounds<br>between 20 - 200Hz.<br><br>The 'Lungs' mode<br>emphasizes the sounds<br>between 100 - 500Hz.<br><br>The 'General' mode<br>amplifies sounds from<br>20 - 2000Hz | Bell mode but<br>emphasizes lower<br>frequency sounds<br>between 20 - 200Hz.<br><br>Diaphragm mode,<br>but emphasizes the<br>sounds between 100<br>- 500Hz.<br><br>Extended Range<br>mode amplifies<br>sounds from 20 -<br>2000Hz | No available<br>information | Similar to the<br>predicate |
| Power Source | Rechargeable Lithium-Ion battery, charged via<br>micro USB Connector | Alkaline battery,<br>Lithium-Ion battery,<br>or NIMH battery. | Lithium-Ion Battery<br>provided by<br>smartphone | Different.<br>Specific energy<br>power source in<br>this case<br>does not have a<br>significant<br>impact on |
| Specification<br>Feature | VoqX Electronic<br>Stethoscope<br>(Proposed device) | 3M Littmann<br>Electronic<br>Stethoscope,<br>Model 3200 | Steth IO<br>Stethoscope -<br>Reference device<br>K160016 | SE<br>Justification |
| | K | K083903 | | |
| | | | | performance of<br>the stethoscope<br>device. |
| Signal<br>Transmission<br>for<br>Visualization | No transmission<br>necessary for analysis<br>and review, processed<br>and displayed on device | Bluetooth<br>transmission to<br>compatible PC | No transmission<br>necessary for<br>analysis and review,<br>processed and<br>displayed on<br>smartphone | Same as the<br>reference<br>device.<br>Improved<br>efficacy as there<br>is no need for<br>data<br>transmission for<br>processing, so<br>decreased<br>opportunity for<br>error. No safety<br>or efficacy<br>concerns. |
| Signal<br>Transmission | VoqX provides a mean<br>to connect the device to<br>a PC for data transfer<br>and software updates by<br>technicians through a<br>data transfer BLE<br>(Bluetooth Low Energy)<br>link. | The Model 3200<br>sound track record<br>can be uploaded to<br>an external device<br>using the Bluetooth<br>link and the software<br>accompanying the<br>Model 3200. | No transmission<br>necessary<br>for analysis and<br>review,<br>processed and<br>displayed on<br>smartphone | Same as 3M |
| Display | 1.54" 240x240 Wide<br>Angle Color TFT LCD<br>Display on the device | LCD Display | Smartphone display | Similar to the<br>predicate.<br>Different screen<br>size, Color<br>display (VoqX)<br>vs. monochrome<br>(3M).<br>Differences do<br>not affect safety<br>and performance |
| Form Factor | Similar to traditional<br>stethoscope | Similar to traditional<br>stethoscope | Device that is held<br>in the doctor's hand<br>is the form of<br>the smartphone | Same as the<br>predicate and<br>traditional<br>stethoscope |
| Environment<br>of use | Medical Facilities<br>Hospitals<br>Outpatient Clinics<br>Physician Offices | Medical Facilities<br>Hospitals<br>Outpatient Clinics<br>Physician Offices | Medical Facilities<br>Hospitals<br>Outpatient Clinics<br>Physician Offices | Same |
| Application | Real time | Real time | Real time | Same |
| Specification/<br>Feature | VoqX Electronic<br>Stethoscope<br>(Proposed device) | 3M Littmann<br>Electronic<br>Stethoscope,<br>Model 3200<br>K083903 | Steth IO<br>Stethoscope -<br>Reference device<br>K160016 | SE<br>Justification |
| Sound<br>signature | On-screen<br>phonocardiogram and<br>spectral representation<br>of picked-up sounds | NA | On-screen<br>phonocardiogram<br>and spectral<br>representation of<br>picked-up sounds | Same as Steth<br>IO |
| Dimensions | Weight:200 g<br>Length: 82 cm | Weight: 185 g<br>Length: 69 cm | No information<br>available | Similar to the<br>predicate. Slight<br>difference in<br>length and<br>weight does not<br>alter the device<br>performance. |
| Condition of<br>Use | Reusable | Reusable | Reusable | Same |
| Prescription<br>vs. 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.