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K Number
K983002
Device Name
MYSTIQUE ULTRASONIC NEBULIZER
Manufacturer
AIRSEP CORP.
Date Cleared
1998-10-16

(49 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 Airsep Mystique ultrasonic nebulizer is intended for use in the treatment of asthma, COPD and other respiratory ailments in which an aerosolized medication is required during therapy. It may be necessary to perform respiratory therapy at anytime and anywhere the patient needs it. The Mystique nebulizer is not intended for use with Pentamidine. It is intended for single patient use.

Device Description

Mystique ultrasonic nebulizer

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for the Mystique Ultrasonic Nebulizer, confirming its substantial equivalence to a legally marketed predicate device.

It primarily discusses:

  • The FDA's decision to clear the device for market.
  • Regulatory classifications and requirements.
  • Instructions for the manufacturer regarding marketing and compliance.
  • Indications for Use for the Mystique ultrasonic nebulizer.

There is no mention of specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

§ 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).