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K Number
K051260
Device Name
SCHUCO MIST AND SCHUCO DELUXE MIST
Manufacturer
ALLIED HEALTHCARE PRODUCTS, INC.
Date Cleared
2005-09-15

(123 days)

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

The air compressor for use with a nebulizer is a device intended to provide a source of compressed air to nebulizer medication cups and delivery systems. These air compressors have a flowrate of 11 +/- 2 LPM, minimum pressure of 35 psi, a storage temperature of 5 C to 50 C (41F to 122F) and a operating temperature 10 C to 40 C ( 50 F to 104 F).

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for a medical device (air compressor for use with a nebulizer). It does not contain information about acceptance criteria for a study, reported device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, or any comparative effectiveness studies.

The document primarily focuses on:

  • Device Name: Schuco Mist and Schuco Deluxe Mist (Trade/Device Name), and AIR COMPRESSOR FOR USE WITH A NEBULIZER (Indicated Device Name).
  • Regulation Number: 21 CFR 868.5630 (Nebulizer).
  • Regulatory Class: II.
  • FDA's finding: Substantial equivalence to legally marketed predicate devices.
  • Indications for Use: "The air compressor for use with a nebulizer is a device intended to provide a source of compressed air to nebulizer medication cups and delivery systems. These air compressors have a flowrate of 11 +/- 2 LPM, minimum pressure of 35 psi, a storage temperature of 5 C to 50 C (41F to 122F) and an operating temperature 10 C to 40 C ( 50 F to 104 F)."
  • Prescription Use: Yes.

To answer your specific questions, information about acceptance criteria, study details, and data specifics would need to be found in a separate performance study report or clinical trial documentation, which is not part of this 510(k) approval letter. The document only lists the technical specifications the device has (flowrate, pressure, temperatures) as part of its Indications for Use, but these are not presented as "acceptance criteria" against which a study's results are compared in this text.

§ 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).