(326 days)
The intended purpose of the I-neb AAD System is that is it is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.
The I-neb AAD system is a portable, single patient use, reusable, ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.
The I-neb AAD system consists of a hand-piece containing:-
- an ultrasonic horn (to vibrate the mesh) .
- a pressure transducer, (to monitor patient breathing) .
- a microprocessor (to calculate aerosol pulse time based on breathing pattern) ●
- a medication chamber (to hold the medication) .
- a porous mesh (to create aerosol and determine particle size). .
- a mouthpiece, which includes a bi-directional flap valve (to guide aerosol to the patient) .
- a disc, which has a bi-directional, inductively coupled, Rf transponder (to enable fine . tuning operational parameters to be sent to the device).
The I-neb AAD system incorporates the vibrating mesh technology developed and utilized in Omron's ultrasonic nebulizers, and the Adaptive Aerosol Delivery (AAD) technology developed and utilized by Profile's AAD system jet nebulizers.
The vibrating mesh technology creates a low velocity aerosol by squeezing the liquid medication through 5-6,000 separate 3 micron holes during each vibration, creating thousands of droplets. the AAD technology is based on sensitive pressure transducers, microprocessors and firmware which together analyses a patient's breathing pattern and determines the appropriate aerosol wilse time to ensure that medication is only delivered during patient inspiration. The length of each pulse of aerosol is calculated based on the measured inspiration time of the r ne single or breaths and the I-neb continues to monitor the breathing pattern throughout provious into creatis any changes in the breathing pattern. When the appropriate dose of medication has been delivered, the system indicates that the treatment is complete.
The provided document does not contain information about specific acceptance criteria, a study proving the device meets these criteria, or any of the detailed aspects like sample sizes, expert qualifications, or MRMC studies that would be expected for such a description.
The document is a 510(k) Premarket Notification for the I-neb AAD System, primarily focusing on establishing substantial equivalence to predicate devices. It describes the device, its intended use, and compares its attributes and differences with existing legally marketed nebulizers (Prodose AAD System, Halolite AAD System, and NeU04).
Therefore, I cannot provide the requested table and study details as they are not present in the provided text.
The document confirms that:
- Device Name: I-neb AAD System
- Intended Use: An ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.
- Regulatory Status: The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. This allows the device to be marketed.
However, specific performance acceptance criteria (e.g., aerosol particle size distribution, drug delivery efficiency, dosage accuracy) and details of a study demonstrating compliance with such criteria are not included in this summary of safety and effectiveness or the accompanying FDA approval letter. These details would typically be found in test reports, which are not part of this submission summary.
§ 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).