(232 days)
The eRapid NCP Nebulizer System is to be used with patients for whom doctors have prescribed medicine for nebulization. It is intended for adult and pediatric patients age 4 and older who can coordinate breathing through a mouthpiece, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.
Both the eRapid NCP and the predicate eRapid device are identical in purpose, function, core technology and method of operation. They are single-patient use, reusable electronic nebulizers, using micro-perforated vibrating membrane technology to aerosolize liquid medications. They are for adult and pediatric inhalation therapy in a home care, nursing home, sub-acute institution, or hospital environment. The devices are hand-held and portable, consisting of a controller and a nebulizer handset, connected with a connection cord. Power input for both devices is provided by either AA batteries, or a DC or AC adapter. Alternate power cords, plugs and adapters allow their use in any country.
The provided text is a 510(k) Premarket Notification from the FDA, specifically concerning the eRapid NCP Nebulizer System. It outlines the device's technical specifications, intended use, and comparison to a predicate device. However, it does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML powered medical device.
The document primarily focuses on demonstrating substantial equivalence to a previously cleared nebulizer, relying on the fact that the core aerosol generation technology (the handset) remains identical, and the changes are limited to the controller, connection cord, and power supply. The performance data provided are related to:
- Biocompatibility and Airpath Testing: Ensures materials are safe.
- Electromagnetic Compatibility (EMC) and Electrical Safety: Confirms the device meets relevant safety standards.
- Software Verification and Validation Testing: Addresses the moderate level of concern for the software, confirming it meets IEC 62304 standards.
- Aerosol Performance: Demonstrates that the new controller does not negatively impact the aerosol generation, which is solely determined by the unchanged nebulizer handset.
- Simulated Use Testing: Shows the device performs within specifications throughout its useful life.
- Validation of Cleaning and Disinfection Methods: Confirms the effectiveness of cleaning procedures.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and study details because the provided document does not describe an AI/ML powered medical device or studies related to its performance in classification/prediction tasks.
The document states: "There is no other mechanism in place that changes the aerosol particle size, whether through software and/or user interface. This micro-perforated membrane vibrates at a high frequency against a body of fluid. The vibration source is the piezoelectric actuator that is activated by an electronic drive circuit of the Controller. The actuator and the perforated membrane are the main components of the aerosol head that is in contact with the liquid medication to be aerosolized. Liquid jets are created as an inertial response to the vibration of the membrane. Surface tension and hydrodynamic effects then cause these jets to disperse to produce a stream of precisely controlled droplets." This description clearly indicates a mechanical process for aerosol generation, not one driven or significantly influenced by AI/ML.
To answer your request, I would need a document detailing the validation of an AI/ML powered medical device.
§ 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).