PROTRON TECHNOLOGIES, LLC STETHOTRON

K082771 · Protron Technologies, LLC · DQD · Feb 27, 2009 · Cardiovascular

Device Facts

• Record ID: K082771
• Device Name: PROTRON TECHNOLOGIES, LLC STETHOTRON
• Applicant: Protron Technologies, LLC
• Product Code: DQD · Cardiovascular
• Decision Date: Feb 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Battery-powered electronic stethoscope; captures body sounds (heart, lung, arteries) via chestpiece-integrated microphone. Two user-selectable modes: Mode 1 (350-1,000 Hz) for vascular pathology; Mode 2 (20-20,000 Hz) for general auscultation. Device includes volume control, mode selection, and ON/OFF switch. Operated by clinicians during routine physical exams. Output delivered via eartips to clinician; aids in diagnostic decision-making by amplifying and filtering acoustic signals. Benefits include enhanced sound detection for diagnostic assessment.

Clinical Evidence

Bench testing only. Performance verified using a computerized audio analysis system with a frequency oscillator (20-10,000 Hz) and calibrated microphone to measure response and gain in both filtered and non-filtered modes. Biocompatibility evaluated per ISO 10993-Part 1 for limited skin contact.

Technological Characteristics

Battery-powered (2x AAA alkaline) electronic stethoscope. Plastic casing with integrated microphone, volume control, and mode selection switch. Frequency response: Mode 1 (350-1,000 Hz), Mode 2 (20-20,000 Hz). Biocompatible materials per ISO 10993-Part 1. Analog signal processing.

Indications for Use

Indicated for adult and pediatric patients undergoing physical examination for the auscultation of heart, lung, arterial, and other body sounds, including vascular pathology 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 Littman Electronic Stethoscope, Model 2000 (K961848)

Submission Summary (Full Text)

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# 5. 510(k) Summary

[As required by 21 CFR 807.92]

FEB 2 7 2009

| Submitted by | ProTron Technologies, LLC<br>141 Oakdene Ave<br>Leonia, NJ 07605<br>Phone [phone] |
|---------------------|---------------------------------------------------------------------------------------------|
| Contact person | Leon M. Dondysh |
| Date Prepared | December 20, 2008 |
| Device trade name | ProTron Technologies, LLC, Electronic Stethoscope Model:<br>Stethotron |
| Common name | Electronic Stethoscope |
| Classification name | Stethoscope;<br>21 CFR Sec. 870.1875(b) Electronic stethoscope, Product code DQ<br>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,<br>LLC Electronic<br>Stethoscope, Model<br>Stethotron | 3M Littman Electronic<br>Stethoscope, Model 2000 | Discussion |
|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Two AAA alkaline batteries<br>(maximum 1.5 volts) | One AAA alkaline battery<br>(Maximum 3 volts) | A 1.5 volt increase in power<br>does not materially effect<br>the use or safety of the<br>device |
| Two modes of operation,<br>Mode 1 amplifies the range<br>from 350 Hz to 1,000 Hz;<br>Mode 2 amplifies the full<br>range, 20 Hz to 20,000 Hz | Three frequency response<br>modes to choose from: Bell<br>(20-200 Hz), Diaphragm<br>(100-500 Hz) and Extended<br>Range (20-1,000 Hz). | Sounds from 20-1,000 Hz<br>can be amplified with both<br>devices. The collection of<br>sounds in Mode 2 from 1-50<br>Hz does not significantly<br>alter the effectiveness of<br>the device. |
| No automatic shutoff | Automatic shutoff | Automatic shutoff only<br>serves to prolong battery<br>life and does not<br>significantly alter the<br>effectiveness or safety of<br>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 (<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 [phone]. 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 [phone] or [phone] 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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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