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.

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 various body 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 volume controls on both modes enabling the user to adjust the sound to the level desired. The chestpiece of the device is sized for use with adult or pediatric patients and is a bell and diaphragm design incorporating a microphone. All of the 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.

AI/ML Overview

The provided document K082771 describes the ProTron Technologies, LLC Electronic Stethoscope, Model Stethotron, and its substantial equivalence to a predicate device. The information details the device's technical characteristics and the non-clinical testing performed.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ProTron Technologies, LLC Electronic Stethoscope, Model Stethotron are based on demonstrating substantial equivalence to the predicate device, the 3M Littman Electronic Stethoscope, Model 2000 (K961848). This means the ProTron device's performance characteristics needed to be equivalent or not raise new questions of safety or effectiveness compared to the predicate.

The primary performance aspect evaluated was the audio response and gain, ensuring it functioned similarly to an electronic stethoscope.

Acceptance Criteria	Reported Device Performance (ProTron Stethotron)
Predicate Equivalence in Audio Response and Gain (Non-filtered Mode)	Response and gain are equivalent to the predicate electronic stethoscope in the non-filtered (Mode 2: 20 Hz to 20,000 Hz) mode.
Predicate Equivalence in Audio Response and Gain (Filtered Mode)	Response and gain are equivalent to the predicate electronic stethoscope in the filtered (Mode 1: 350 Hz to 1,000 Hz) mode.
Biocompatibility for skin contact	All components with potential skin contact for limited (<24 hour) exposure have been reviewed (per ISO 10993-Part 1) and concluded to have no potential for adverse health concern.
Electrical Safety	Electrical testing demonstrated the device to be safe under label conditions.

2. Sample Size Used for the Test Set and Data Provenance

The documentation does not specify a "test set" in the traditional sense of a clinical trial with human subjects. Instead, the testing described is non-clinical electrical and acoustic testing.

Sample Size: Not applicable in the human subject sense. The testing involved the ProTron Technologies, LLC Electronic Stethoscope, Model Stethotron devices themselves. The specific number of devices tested is not mentioned, but it refers to the device's inherent characteristics.
Data Provenance: The testing was electrical and acoustic performance evaluation, not data collected from patients. The document does not specify the country of origin for the testing itself, but given the submission to the FDA, it is presumed to be conducted according to US regulatory standards. It is retrospective in the sense that the test results already existed at the time of the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. The "ground truth" for the non-clinical testing of audio response and gain was established by objective measurements using a computerized audio analysis system and a calibrated microphone.
Qualifications of Experts: Not applicable for establishing ground truth for this type of test.

4. Adjudication Method for the Test Set

Adjudication method: Not applicable. There was no human adjudication process described for the non-clinical performance tests. The system relied on direct measurement and comparison to the predicate's known performance characteristics.

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

MRMC study done? No. The document does not mention any MRMC comparative effectiveness study involving human readers. The device is a diagnostic tool (electronic stethoscope) that amplifies sounds, and the focus of the submission is on its technical performance characteristics rather than reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone study done? Yes, in a sense. The described "Test Data" refers to the standalone performance of the device's electrical and acoustic properties. The device's ability to amplify and filter sounds was evaluated purely based on its technical specifications, independent of human interaction or interpretation for the purpose of establishing substantial equivalence. The computerized audio analysis system measured the device's output compared to a known input, which is a standalone performance assessment of the device itself.

7. Type of Ground Truth Used

Type of Ground Truth: For the electrical and acoustic performance, the ground truth was based on objective physical measurements (frequency sweeps, gain measurements) against established engineering standards and comparison to the known performance of the legally marketed predicate device.
- For biocompatibility, the ground truth was established by adherence to ISO 10993-Part 1 standards and safety evaluations of material components.
- For electrical safety, the ground truth was based on electrical testing standards and safety compliance.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a hardware electronic stethoscope, not an AI or machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device.

Summary

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5. 510(k) Summary

[As required by 21 CFR 807.92]

FEB 2 7 2009

Submitted by	ProTron Technologies, LLC141 Oakdene AveLeonia, NJ 07605Phone 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 DQClass II

Intended Use

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 ElectronicStethoscope, ModelStethotron	3M Littman ElectronicStethoscope, Model 2000	Discussion
Two AAA alkaline batteries(maximum 1.5 volts)	One AAA alkaline battery(Maximum 3 volts)	A 1.5 volt increase in powerdoes not materially effectthe use or safety of thedevice
Two modes of operation,Mode 1 amplifies the rangefrom 350 Hz to 1,000 Hz;Mode 2 amplifies the fullrange, 20 Hz to 20,000 Hz	Three frequency responsemodes to choose from: Bell(20-200 Hz), Diaphragm(100-500 Hz) and ExtendedRange (20-1,000 Hz).	Sounds from 20-1,000 Hzcan be amplified with bothdevices. The collection ofsounds in Mode 2 from 1-50Hz does not significantlyalter the effectiveness ofthe device.
No automatic shutoff	Automatic shutoff	Automatic shutoff onlyserves to prolong batterylife and does notsignificantly alter theeffectiveness or safety ofthe 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 (<24 hour) skin contact for both patient and/or health care professional exposure. Each component with potential skin contact with either the user profononal oxpeed or for possible health concerns. ProTron Technologies Company concludes that all of the components of the Electronic Stethoscope, Model "Stethotron" that make skin contact would have no potential for adverse health concern, all materials that make only to has this specified role that is equivalent to this device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FFR 2 7 2009

ProTron Technologies, LLC c/o Mr. Leon M. Dondysh 141 Oakdene Avenue Leonia, NJ 07605

Re: K082771

Trade Name: Electronic Stethoscope Model Stethotron Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II (two) Product Code: DQD . Dated: January 9, 2009 Received: January 13, 2009

Dear Mr. Dondysh:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Leon M. Dondysh

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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark Teller for

D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

Indications for Use

510(k) Number (if known): K082771

Device Name: ProTron Technologies, LLC Electronic Stethoscope, Model Stethotron

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 adulf or paediatric patients undergoing physical examination.

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ANDIOR

Over-The-Counter Use (21 CFR 801 Subpert C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K082771

Page 1 ofPage 4-1 December 20, 2008 Pro Tron Technologies, LLC Electronic Stethoscope, Model Stethotron Submission to FDA

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.