(201 days)
No
The description focuses on sound amplification, frequency filtering, and basic signal processing (spectrogram generation for "Sound Signature"). There is no mention of AI/ML terms, training data, or complex pattern recognition beyond simple visualization.
No
The device is solely intended for diagnostic purposes (detection and amplification of sounds) and does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for medical diagnostic purposes only."
No
The device description explicitly states it is comprised of two physical parts: a Back Unit (head piece) and a Front Unit (chest piece), and is supplied with an AC/DC power supply adapter and charging cable, indicating it includes hardware components beyond just software.
Based on the provided information, the VoqX Electronic Stethoscope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done in vitro (outside the body).
- VoqX Function: The VoqX Electronic Stethoscope is used to detect and amplify sounds from within the human body (heart, lungs, etc.). This is an in vivo (within the body) diagnostic method.
- No Specimen Analysis: The description does not mention the analysis of any biological specimens.
Therefore, the VoqX Electronic Stethoscope falls under the category of a medical device used for physical examination and auscultation, not an IVD.
N/A
Intended Use / 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.
Product codes
DOD
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.
Mentions image processing
The "Sound Signature" algorithm generates intensity image based on the spectrogram of the output audio data.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, lungs, arteries, veins, and other internal organs
Indicated Patient Age Range
Adults and pediatric
Intended User / Care Setting
Medical Facilities Hospitals Outpatient Clinics Physician Offices
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image contains 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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
| Indications for Use Statement | ||
|---|---|---|
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | ||
| Food and Drug Administration | ||
| Indications for Use | Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2023 | ||
| See PRA Statement below. | ||
| 510(k) Number (if known) | ||
| K212709 | ||
| Device Name | ||
| VoqX Electronic Stethoscope | ||
| Indications for Use (Describe) | ||
| 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. | ||
| 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, including | ||
| the time to review instructions, search existing data sources, gather and maintain the data needed and | ||
| complete and review the collection of information. Send comments regarding this burden estimate or any | ||
| other aspect of this information collection, including suggestions for reducing this burden, to: | ||
| Department of Health and Human | ||
| Services Food and Drug Administration | ||
| Office of Chief Information Officer | ||
| Paperwork 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 of | ||
| information 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 |
3
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:
4
- 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
/
Feature | VoqX Electronic
Stethoscope
(Proposed device) | 3M Littmann
Electronic
Stethoscope,
Model 3200
K083903 | Steth IO
Stethoscope -
Reference device
K160016 | SE
Justification |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Electronic
Stethoscope is intended
for medical diagnostic | The 3M™
Littmann®
Electronic | The Steth IO
Stethoscope and
Phonocardiogram | Same |
| Specification /
Feature | VoqX Electronic
Stethoscope
(Proposed device) | 3M Littmann
Electronic
Stethoscope,
Model 3200
K083903 | Steth IO
Stethoscope -
Reference device
K160016 | SE
Justification |
| | 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. | 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 | Model 1.0 is
intended for medical
diagnostic purposes
only. It may be used
for the detection and
amplification
of sounds from the
heart, and lungs with
the use of selective
frequency ranges. It
has been tested for
use on adults
undergoing a
physical assessment. | |
| Intended
patient
population | Adults and pediatric | Adults and pediatric | Adults | Same as the
predicate |
| Chest-piece | Yes | Yes | Yes | Same |
| Principles of
operation | VoqX 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 through
a binaural headset. Also,
the sounds can be sent
via Bluetooth to
compatible devices
using a PC application
available only to
company personnel. | 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
through a binaural
headset. Also, can
be sent via
Bluetooth to
compatible devices | Steth IO picks up
sounds, such as
heart and lung
sounds, from a
patient's body. The
sounds are collected
using via a
smartphone to which
the device connects,
using a dedicated
application. The
collected sounds can
then be sent to
physicians via
mentioned
application for
remote patient care. | Same as the
predicate |
| Placement on
the subject | The VoqX is placed by
clinician similar to a
traditional stethoscope | The Littmann is
placed by clinician
similar to a
traditional
stethoscope | The device is placed
by the user similar
to a traditional
stethoscope | Same |
| Diaphragm
Material | Fiberglass / Epoxy sheet | Polyurethane coated
silicone | Fiberglass / Epoxy
sheet | Same as Steth
IO |
| Specification
/
Feature | VoqX Electronic
Stethoscope
(Proposed device) | 3M Littmann
Electronic
Stethoscope,
Model 3200 | Steth IO
Stethoscope -
Reference device | SE
Justification |
| | K | K083903 | K160016 | |
| Pickup sensor | Sound waves collected
via Microphone | Sound waves
collected via a
microphone | Sound waves
collected via a
microphone | Same |
| Sound
Processing | Carried out with the aid
of a digital signal
processor | Carried out with the
aid of a digital
signal processor | Carried out with the
aid of a digital signal
processor out | Same |
| Audio Output
Method | Earbuds | Earbuds | Audio port and
headphones | Same as the
predicate |
| Signal Storage | Onboard recording
provides a means to
acquire an auscultation
soundtrack for a
maximum of 5 minutes.
This track can be
transmitted to an
external device [PC]
using the Bluetooth link
and dedicated software
available only to
company personnel. | Onboard recording
provides a means to
acquire and play an
auscultation
soundtrack for a
maximum of 29
seconds.
This track can be
uploaded to an
external device
using the Bluetooth
link and the software
accompanying the
Model 3200. | No storage | Same as the
predicate.
The time
difference does
not raise new
questions
because it is at
least as much as
the predicate
and this
difference is not
detrimental to
performance |
| Frequency
Response | The 'Heart' mode
emphasizes sounds
between 20 - 200Hz.
The 'Lungs' mode
emphasizes the sounds
between 100 - 500Hz.
The 'General' mode
amplifies sounds from
20 - 2000Hz | Bell mode but
emphasizes lower
frequency sounds
between 20 - 200Hz.
Diaphragm mode,
but emphasizes the
sounds between 100
- 500Hz.
Extended Range
mode amplifies
sounds from 20 -
2000Hz | No available
information | Similar to the
predicate |
| Power Source | Rechargeable Lithium-Ion battery, charged via
micro USB Connector | Alkaline battery,
Lithium-Ion battery,
or NIMH battery. | Lithium-Ion Battery
provided by
smartphone | Different.
Specific energy
power source in
this case
does not have a
significant
impact on |
| Specification
Feature | VoqX Electronic
Stethoscope
(Proposed device) | 3M Littmann
Electronic
Stethoscope,
Model 3200 | Steth IO
Stethoscope -
Reference device
K160016 | SE
Justification |
| | K | K083903 | | |
| | | | | performance of
the stethoscope
device. |
| Signal
Transmission
for
Visualization | No transmission
necessary for analysis
and review, processed
and displayed on device | Bluetooth
transmission to
compatible PC | No transmission
necessary for
analysis and review,
processed and
displayed on
smartphone | Same as the
reference
device.
Improved
efficacy as there
is no need for
data
transmission for
processing, so
decreased
opportunity for
error. No safety
or efficacy
concerns. |
| Signal
Transmission | VoqX provides a mean
to connect the device to
a PC for data transfer
and software updates by
technicians through a
data transfer BLE
(Bluetooth Low Energy)
link. | The Model 3200
sound track record
can be uploaded to
an external device
using the Bluetooth
link and the software
accompanying the
Model 3200. | No transmission
necessary
for analysis and
review,
processed and
displayed on
smartphone | Same as 3M |
| Display | 1.54" 240x240 Wide
Angle Color TFT LCD
Display on the device | LCD Display | Smartphone display | Similar to the
predicate.
Different screen
size, Color
display (VoqX)
vs. monochrome
(3M).
Differences do
not affect safety
and performance |
| Form Factor | Similar to traditional
stethoscope | Similar to traditional
stethoscope | Device that is held
in the doctor's hand
is the form of
the smartphone | Same as the
predicate and
traditional
stethoscope |
| Environment
of use | Medical Facilities
Hospitals
Outpatient Clinics
Physician Offices | Medical Facilities
Hospitals
Outpatient Clinics
Physician Offices | Medical Facilities
Hospitals
Outpatient Clinics
Physician Offices | Same |
| Application | Real time | Real time | Real time | Same |
| Specification/
Feature | VoqX Electronic
Stethoscope
(Proposed device) | 3M Littmann
Electronic
Stethoscope,
Model 3200
K083903 | Steth IO
Stethoscope -
Reference device
K160016 | SE
Justification |
| Sound
signature | On-screen
phonocardiogram and
spectral representation
of picked-up sounds | NA | On-screen
phonocardiogram
and spectral
representation of
picked-up sounds | Same as Steth
IO |
| Dimensions | Weight:200 g
Length: 82 cm | Weight: 185 g
Length: 69 cm | No information
available | Similar to the
predicate. Slight
difference in
length and
weight does not
alter the device
performance. |
| Condition of
Use | Reusable | Reusable | Reusable | Same |
| Prescription
vs. O.T.C. | Prescription use | Prescription use | Prescription use | Same |
5
6
7
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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
9
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.