(87 days)
Used for the delivery of aerosol medication for treatment of various respiratory conditions, such as asthma, on patients from adolescence through adults. Intended for indoor and outdoor use (50°F - 104°F, 15%-95% non condensing humidity)
The Invacare Ultrasonic Nebulizer is a portable, light weight device designed for use in the home . Its' intended function and use is to convert liquid medication to aerosol form, and deliver it to the patient through inhalation. The conversion from liquid to aerosol form is achieved using ultrasound technology. Ultrasonic energy is transmitted through the conducting chamber to the medication cup, which contains the medication. The high intensity sound waves break the medication into fine particles suitable for inhalation. Room air drawn in by a fan, propels the nebulized medication to the mouthpiece for the patient to inhale.
The provided text describes a 510(k) submission for the Invacare Model IRC 1199 Ultrasonic Nebulizer. However, it does not contain the specific details required to complete your request about acceptance criteria and a study proving device performance.
The document makes a general statement about performance: "The Model IRC 1199 Scout Ultrasonic Nebulizer 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 1992 document entitled 'Draft Reviewer Guidance for Home Use Respiratory Devices'. In all instances the Scout met the required performance criteria and functioned as intended."
This statement confirms that testing was done and the device met criteria, but it does not provide the acceptance criteria values themselves, nor does it detail the specifics of such a "study." This submission is focused on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical or performance study with the metrics you've requested.
Therefore, I cannot populate the table and answer the specific questions because the necessary information is not present in the provided 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).