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K Number
K964078
Device Name
3050 SPORT-NEB
Manufacturer
MEDICAL INDUSTRIES AMERICA, INC.
Date Cleared
1997-01-10

(91 days)

Product Code
CAF
Regulation Number
868.5630
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The model 3050 "Sport-Neb" is a small air compressor designed to provide sufficient air pressure and flow to power a hand held nebulizer such as the Salter #8900.

Device Description

The Model 3050 "sport-Neb" is a small, lightweight, nebulizer compressor. It measures 7 1/2" X 7 1/2" X 4 1/2" The housing is groupe The housing is grey switch, filter housing, AC cord and the air outlet barb. An optional carry bag will be offered to store the patients hand held nebulizer. The handle is built into the housing The operating components are located internally. The compressor, some minor wiring and the exhaust/intake plumbing are located inside.

AI/ML Overview

This document describes a medical device, the Model 3050 "Sport-Neb" compressor, and references a predicate device, the Model 3002 "AEROMAX". However, it does not contain information about acceptance criteria, device performance metrics, or any studies proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information in the format of a table or answer the specific questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document primarily focuses on:

  • Device Description: Physical characteristics and internal components of the "Sport-Neb" and its predicate, the "AEROMAX".
  • Intended Use: Stating that the "Sport-Neb" has the same intended use as the "AEROMAX."
  • Comparison to Predicate: Highlighting that the "Sport-Neb" is "virtually the same as the 'AEROMAX' with the exception of the case which is smaller and more portable."

To answer your questions, additional documentation detailing performance specifications and testing would be required.

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).