(90 days)
The HL100 Ultrasonic Nebulizer System utillizes the state-of-the-art elecctrospray technology that sprays liquid medication in aerosol form and deliveries it directly to the adult and pediatric patients who suffer from asthma, Chronic Obstructive Pulmonary Disease (COPD) such as emphysema and chronic bronchitis, or other respiratory diseases that are characterized by obstruction to air flow for breathing.
The Health and Life Model HL100 is a mesh screen ultrasonic nebulizer that operates in an identical fashion as other mesh screen ultrasonic nebulizers, including the referenced predicate device. The device creates aerosols of liquid medication of droplets from a mesh (aperture plate) vibrated at ultrasonic frequencies. As with other mesh screen ultrasonic nebulizers, the mesh is caused to vibrate by fluidic contact with a ultrasonic piezoelectric member that is energized by application of a high frequency alternating voltage. The HL100 Ultrasonic Nebulizer System consists primarily of a Main Unit and a Medication Chamber. The Main Unit and the Medication Chamber are single patient re-usable. The Main Unit contains all control circuitry and is powered by a cable connecting to a 115 VAC power source with the AC adapter or two AA alkaline batteries. No medication comes into contact with the Main Unit, only the Medication Chamber. The patient interface consists of a mouthpiece or an optional mask. When the device is turned on, the ultrasonic piezoelectric member vibrates, causing the mesh to vibrate. Liquid medication in the reservoir is caused to be aerosolized by the vibrating mesh into the patient interface where the aerosol particles can be inhaled by the patient.
The provided text describes a 510(k) summary for the Health and Life Model HL100 Ultrasonic Nebulizer System. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is not an AI/ML device.
The document primarily focuses on establishing substantial equivalence to a predicate device (Omron Model NE-U22V MicroAir Nebulizer K062263) through non-clinical tests.
Here's a breakdown of why an AI/ML framework cannot be applied:
- Device Type: The HL100 is a physical medical device (ultrasonic nebulizer) that mechanically aerosolizes medication. It does not use algorithms, AI, or machine learning for any part of its function or diagnosis.
- Study Type: The submission explicitly states: "Nonclinical tests have been performed comparing the HL100 Ultrasonic Nebulizer System to the predicate device and have shown that the performance of the HL100 Ultrasonic Nebulizer System is substantially equivalent to the performance of the predicate device. No clinical tests were conducted." This means no human subject data was collected or analyzed in the manner required for an AI/ML device study.
- Lack of AI/ML Specific Information: The document contains no mention of:
- Algorithms, models, or software
- Performance metrics like sensitivity, specificity, AUC, or accuracy typically used for AI/ML.
- Training data, test sets, ground truth establishment by experts, or adjudication methods.
- Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML device studies because the provided document describes a conventional medical device demonstrated to be substantially equivalent via non-clinical performance comparisons, not an AI/ML product.
§ 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).