(158 days)
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.
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.
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 ( |
§ 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.