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K Number
K091972
Device Name
MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01
Manufacturer
STETHOSCOPE TECHNOLOGIES, INC
Date Cleared
2009-09-23

(84 days)

Product Code
DQD
Regulation Number
870.1875
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Milscope Floating Mass Electronic Stethoscope, Model 300-01 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of 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.

Device Description

Milscope Floating Mass Stethoscope

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Stethoscope Technologies, Inc. for their Milscope Floating Mass Electronic Stethoscope, Model 300-01.

This document does not contain information regarding:

  • Acceptance criteria or reported device performance for a study.
  • Details about a study (sample size, data provenance, number/qualifications of experts, adjudication method).
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size.
  • Whether a standalone (algorithm only) performance study was done.
  • The type of ground truth used.
  • Sample size for a training set or how its ground truth was established.

The document primarily states that the FDA found the device substantially equivalent to legally marketed predicate devices and that it can be marketed. It also includes the Indications for Use statement for the device.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and study design based on the provided input.

§ 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.