(158 days)
Not Found
No
The device description explicitly states it is a "battery powered analog device" with user-selectable modes for amplification and filtering based on fixed frequency ranges. There is no mention of AI, ML, or any learning or adaptive capabilities. The testing described is electrical and audio analysis, not related to AI/ML performance.
No
The device is described for "medical diagnostic purpose only" and is used to listen to body sounds for examination, not to treat or cure any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for medical diagnostic purpose only."
No
The device description explicitly states it is a battery-powered analog device with physical components like a chestpiece, microphone, electronic casing, ON/OFF switch, volume control, and mode selection control. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The ProTron Technologies, Electronic Stethoscope, Model Stethotron is used to listen to body sounds directly from the patient's body (heart, lungs, arteries, etc.). It does not analyze samples taken from the body.
Therefore, based on the provided information, the Stethotron is a medical device used for physical examination and diagnosis, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ProTron Technologies, Electronic Stethoscope, Model Stethotron is intended for medical diagnostic purpose only. Stethotron has two modes of operation, amplification with filtering (Mode 1) and amplification only (Mode 2). Mode 1 filters out sounds below 350 Hz and above 1,000 Hz and used to listen specifically for vascular pathology. Mode 2 is used to listen for heart, lung, arteries, and other body sounds from 20 Hz to 20,000 Hz during routine physical examinations. Stethotron can be used on adult or paediatric patients undergoing physical examination.
Product codes (comma separated list FDA assigned to the subject device)
DQD
Device Description
The ProTron Technologies, LLC Electronic Stethoscope, Model Stethotron is a battery powered analog device with two user selectable modes of operation for detecting, amplifying and filtering sounds of the heart, lungs, arteries, and internal organs: Mode 1 filters out sounds below 350 Hz and above 1,000 Hz. Mode 2 provides amplification only, 20 Hz to 20,000 Hz. Stethotron has controls that enable the user to adjust the volume and non-filtrated sounds to the level desired. The chestpiece of the device is sized for use with adult or pediatic patients and has a bell and diaphragm design incorporating a microphone. All electronics are contained in a plastic casing positioned below the bifurcation of the stethoscope yoke that connects to the headset that terminates at the eartips. The electronic casing includes the ON/OFF switch, volume control, and mode of operation selection control on the face. It is powered by two AAA alkaline batteries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, lungs, arteries, and other body
Indicated Patient Age Range
adult or paediatric patients
Intended User / Care Setting
Not Found
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
Testing to determine response and gain are equivalent to the predicate electronic stethoscope was preformed with a computerized audio analysis system sweeps a frequency oscillator from 20 to 10,000 Hz. This frequency sweep is presented to a transdicer on which the stethoscope is placed. The computer measures the response from the stethoscope with a small calibrated microphone placed in the eartip. The signal from the microphone is fed back to the computer where it is recorded, stored, and can be printed. The test was done in each of the two amplification modes, filtered and nonfiltered.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test data includes electrical testing demonstrating the The ProTron Technologies, LLC Electronic Stethoscope, Model Stethotron to be safe and effective under label conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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Page | 13
5. 510(k) Summary
[As required by 21 CFR 807.92]
FEB 2 7 2009
| Submitted by | ProTron Technologies, LLC
141 Oakdene Ave
Leonia, NJ 07605
Phone 201.297.7377 |
|---------------------|---------------------------------------------------------------------------------------------|
| Contact person | Leon M. Dondysh |
| Date Prepared | December 20, 2008 |
| Device trade name | ProTron Technologies, LLC, Electronic Stethoscope Model:
Stethotron |
| Common name | Electronic Stethoscope |
| Classification name | Stethoscope;
21 CFR Sec. 870.1875(b) Electronic stethoscope, Product code DQ
Class II |
Intended Use
The ProTron Technologies, Electronic Stethoscope, Model Stethotron is intended for medical diagnostic purpose only. Stethotron has two modes of operation, amplification with filtering (Mode 1) and amplification only (Mode 2). Mode 1 filters out sounds below 350 Hz and above 1,000 Hz and used to listen specifically for vascular pathology. Mode 2 is used to listen for heart, lung, arteries, and other body sounds from 20 Hz to 20,000 Hz during routine physical examinations. Stethotron can be used on adult or paediatric patients undergoing physical examination.
Predicate Device to which Substantial Equivalence is Claimed
The ProTron Technologies, LLC Electronic Stethoscope, Model Stethotron is substantial equivalent to the 3M Littman Electronic Stethoscope, Model 2000 cleared for market under Premarket Notification K961848.
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Summary of how the differences in technological characteristic compare to the predicate device [807.92(a){6)]:
| ProTron Technologies,
LLC Electronic
Stethoscope, Model
Stethotron | 3M Littman Electronic
Stethoscope, Model 2000 | Discussion |
|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Two AAA alkaline batteries
(maximum 1.5 volts) | One AAA alkaline battery
(Maximum 3 volts) | A 1.5 volt increase in power
does not materially effect
the use or safety of the
device |
| Two modes of operation,
Mode 1 amplifies the range
from 350 Hz to 1,000 Hz;
Mode 2 amplifies the full
range, 20 Hz to 20,000 Hz | Three frequency response
modes to choose from: Bell
(20-200 Hz), Diaphragm
(100-500 Hz) and Extended
Range (20-1,000 Hz). | Sounds from 20-1,000 Hz
can be amplified with both
devices. The collection of
sounds in Mode 2 from 1-50
Hz does not significantly
alter the effectiveness of
the device. |
| No automatic shutoff | Automatic shutoff | Automatic shutoff only
serves to prolong battery
life and does not
significantly alter the
effectiveness or safety of
the device. |
Description of Device
The ProTron Technologies, LLC Electronic Stethoscope, Model Stethotron is a battery The From To Fron Tronstic device with two user selectable modes of operation for powerod analog alagrious aring sounds of the heart, lungs, arteries, and internal detecting, antiplitying and filters out sounds below 350 Hz and above organs: Mode 2 provides amplification only, 20 Hz to 20,000 Hz. Stethotron has 1,000 Hz. Mode 2 provided amplitudes and non-filtrated sounds enabling the user adjust the volume controls on both mirated anastpiece of the device is sized for use with adult or sound to the level desired. The endeaphragm design incorporating a microphone. All pediatic patients and to a bell and trend of electronics casing positioned below the bifurcation election are contained in a plactic sto the headset that terminates at the eartips. The of the stethoscope yoke that oblinests to witch, volume control, and mode of operation electionic casing includes the ON/Offication and filtering electronics, a selection control on the lace. It somethis and is powered by two AAA alkaline batteries.
December 20, 2008 ProTron Technologies, LLC Electronic Stethoscope, Model Stethotron Submission to FDA
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Test Data
Test data includes electrical testing demonstrating the The ProTron Technologies, LLC Electronic Stethoscope, Model Stethotron to be safe and effective under label conditions.
Non-clinical Testing Brief Description:
Testing to determine response and gain are equivalent to the predicate electronic stethoscope was preformed with a computerized audio analysis system sweeps a frequency oscillator from 20 to 10,000 Hz. This frequency sweep is presented to a transdicer on which the stethoscope is placed. The computer measures the response from the stethoscope with a small calibrated microphone placed in the eartip. The signal from the microphone is fed back to the computer where it is recorded, stored, and can be printed. The test was done in each of the two amplification modes, filtered and nonfiltered.
Biocompatability
All components of the Electronic Stethoscope, Model "Stethotron" have been reviewed for biocompatibility. With respect to ISO 10993-Part 1 Biological Evaluation of Medical Devices for limited (