(82 days)
The Invacare Model IRC 1001 Aerosol Compressor is a prescription device for use in the treatment of respiratory disorders, such as asthma, in a household environment. Its intended use is to provide compressed air to a nebulizer for the generation of aerosolized medications, based on a physician's prescription. Nebulizers are used to convert liquid medication to aerosol form for delivery to a patient through inhalation.
This product is an electrically powered device designed for use in the treatment of respiratory disorders, such as asthma, in a household environment. Its' intended use is to provide compressed air to a nebulizer for the generation of aerosolized medications, based on a physicians' prescription. Nebulizers are used to convert liquid medication to aerosol form for delivery to a patient through inhalation. The device is comprised of three major components: (1) an enclosure; (2) a compressor; and (3) wiring components. The enclosure is made of a flame retardant material which provides mechanical protection from the environmental effects and impact loads to the device Air is drawn through the polypropylene filter to remove dust particles. The power switch is located on the rear of the unit between the two shrouds. The oil-free, small piston diaphragm compressor is the primary performance component of the Model IRC 1001 Aerosol Compressor, and provides the compressed air to the nebulizer. The compressor is kept cool during operation by an integral thermoplastic fan. The main wiring components are the power cord, and the power switch. Power to the compressor is controlled by actuation of the power switch when the unit is connected to line voltage. The IRC 1001 Aerosol Compressor is portable, weighing 3.5 pounds. It has a nominal nebulizer operating pressure of 10 psig and nebulization rate of 5.5 -6.0 lpm. It includes one of two different disposable nebulizer packages. These are the Medic-Aid Ltd. "Side Stream" Nebulizer (Invacare Model MS 2100) and the Allegiance "Misty-Ncb" Nobulizer (Invacare Model Number MS 2200). Each nebulizer package includes a mouthpiece, a nebulizer, a connector tube and flexible air tubing. The nebulization particle size varies slightly depending on which of the above nebulizers is used. When used with the Sidestream nebulizer, mass median diameter is 3.0 um. When used with the Misty-Neb nebulizer, mass median diameter is 2.01 um (Average ± 0.12 std. dev.). To operate the Model IRC 1001 Aerosol Compressor, one end of the air tubing is secured to the compressor air outlet while the nebulizer is fitted to the other end of the tubing. The patient then adds the liquid medication according to the physician's prescription and plugs the power cord into the wall outlet. The clean nebulizer mouthpiece is inserted into the nebulizer and the unit is turned on to start the compressor. After passing through the compressor, the air expands and the resulting high pressure causes liquid in its path to break into droplets of microscopic size. These droplets are projected on an air current for disposition into the respiratory tract.
I am sorry, but based on the provided text, I cannot extract the detailed information requested regarding the acceptance criteria, specific device performance, sample sizes, expert qualifications, or ground truth establishment for a study about the Invacare Model IRC 1001 Aerosol Compressor.
The document states that:
- "The Model IRC 1001 Aerosol Compressor was tested in accordance with the electrical, mechanical and environmental performance requirements for home use respiratory devices set forth in the Anesthesiology and Respiratory Devices Branch's March 1993 document entitled 'Reviewer Guidance for Premarket Notification Submissions'."
- "In all instances the device met the required performance criteria and functioned as intended."
- "Additionally, this device meets the requirements specified in Underwriters Laboratory (UL) UL 544 Standard for Medical and Dental Equipment and UL 1431 Standard for Personal Hygiene and Healthcare Appliances."
However, it does not provide:
- A specific table of acceptance criteria and reported device performance values.
- Details on the sample sizes used for testing.
- Information on data provenance (country of origin, retrospective/prospective).
- The number or qualifications of experts (as this is a mechanical device, not typically requiring expert review in the clinical sense for performance testing).
- Adjudication methods.
- A multi-reader multi-case (MRMC) comparative effectiveness study, as this type of study is not relevant for this device.
- A standalone (algorithm-only) performance study, as this is a mechanical device, not an AI algorithm.
- The type of ground truth used (again, this is typically for diagnostic/AI devices, not mechanical performance).
- Sample size for the training set (not applicable for this device).
- How ground truth for the training set was established (not applicable).
The document is a 510(k) summary for a medical device and primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to general safety and performance standards for mechanical devices, rather than clinical performance metrics that would involve patient data, expert review, or algorithms.
§ 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).