(287 days)
The portable (Ultrasonic) nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital/ institutional settings, home, schools, and long-term care facilities. It is not intended for use with Pentamidine.
The Portable (Ultrasonic) nebulizer NBM-1 is small, handheld, internally powered general purpose nebulizer which utilizes ultrasound vibrating mesh technology to generate aerosol. The Portable (Ultrasonic) nebulizer provides a vapor mist of medicine that has much smaller particles and can travel much deeper into the patient's lungs, resulting in much faster relief. The ultrasonic nebulizer is made up of main unit, medicine cup, adult mask, kid mask and mouth piece. The shell of nebulizer, battery cover and spray nozzle are made of ABS, the button decoration ring is silica gel, the medicine cup and button are made by PC, the mask is made of PVC, the mouth piece is made of PP and the nebulizer piece is stainless steel.
The provided FDA 510(k) summary for the "Portable (Ultrasonic) Nebulizer" (K230379) does not describe a study involving an AI/Machine Learning diagnostic device or human-in-the-loop performance. Instead, it describes a Class II medical device which is a nebulizer, and its substantial equivalence determination to a predicate device.
Therefore, the request for acceptance criteria and studies proving an AI device meets acceptance criteria (including details like expert ground truth, MRMC studies, standalone performance, training/test set sample sizes, etc.) cannot be fulfilled from the provided document. The document focuses on the physical and electrical safety, performance, and biocompatibility of a medical device, not on the performance metrics of an AI algorithm.
Here's a breakdown of what the document does provide, and why it doesn't fit the requested AI/ML framework:
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Device: Portable (Ultrasonic) Nebulizer (NBM-1) and its predicate device (Intelligent Mesh Nebulizer K171549). These are physical devices that aerosolize liquid medications.
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Acceptance Criteria/Performance (as reported for a physical device): The document reports various physical and performance characteristics, comparing them to the predicate device and relevant standards. This is done to demonstrate "substantial equivalence."
Acceptance Criteria (from predicate/standards) Reported Device Performance (NBM-1) General Product Code: CAF CAF (SE) Regulation #: 21CFR868.5630 21CFR868.5630 (SE) Intended Use Similar (Pediatric 5+ years, adult patients in hospital/institutional settings, home, schools, long-term care facilities; not for Pentamidine) (SE, Remark 1) Principle of operation: Vibrating mesh Vibrating mesh (SE) Aerosolization: Continuous during inhalation/exhalation Continuous during inhalation and exhalation (SE) Compressed gas source: None needed None needed (SE) Duration of Use: Single patient, multi-use Single patient, multi-use (SE) Waterproof: IP22 IP22 (SE) Protection against electric shock: Type BF applied part Type BF applied part (SE) Type of protection against electric shock: Internally power equipment Internally power equipment (SE) Model of operation: Continuous operation Continuous operation (SE) Power off: ON / OFF Button On/Off button (SE) Patient Connector: Mouthpiece/masks Mouthpiece or masks (SE) Biocompatibility: Compliance with ISO 10993 All patient contacting materials compliant with ISO 10993 (various parts, e.g., -3, -5, -6, -10, -11, -17, -18) and ISO 18562 (various parts, e.g., -1, -2, -3). Concluded biocompatible. (SE) Electrical Safety: Compliance with IEC 60601-1 and IEC 60601-1-11 Compliance with AAMI/ANSI ES60601-1:2005/(R)2012, C1:2009/(R)2012 and A IEC 60601-1-11:2015. (SE) EMC: Compliance with IEC 60601-1-2 Compliance with IEC 60601-1-2:2014. (SE) Software: Compliance with FDA Guidance & IEC 62304 Software verification and validation conducted per FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 1, 2005" and IEC 62304:2015. (SE) Clinical Performance Ultrasonic Oscillation Frequency: Approx. 110KHz 110 KHz ± 10KHz (SE) Nebulization rate: ≥ 0.2 ml/min >0.2mL/min. (SE) Medicine Capacity: 8ml max, 0.5ml min 6 ml (Similar, Remark 2: "within the predicate device"; tested for safety & performance) Aerosol Performance (Particle Size MMAD, GSD, Doses) Subject (NBM-1) vs. Predicate (NEB001) for Various Drugs (Albuterol Sulfate, Ipratropium Bromide, Cromolyn Sodium) - Adult & Pediatric: - Particle Size (MMAD):
NBM-1 Adult: 2.09-2.10; NEB001 Adult: 2.27-2.37
NBM-1 Pediatric: 3.66-3.64; NEB001 Pediatric: 3.73-3.73 - Geometric Standard Deviation:
NBM-1 Adult: 1.94-1.78; NEB001 Adult: 1.80-1.67
NBM-1 Pediatric: 2.01-1.97; NEB001 Pediatric: 2.10-1.90 - Total Dose Delivered by device:
NBM-1 Adult: 1,529-7,236; NEB001 Adult: 1,541-6,983
NBM-1 Pediatric: 1,593-7,394; NEB001 Pediatric: 1,624-7,279 - Total Respirable Dose (0.5-5um):
NBM-1 Adult: 1,048-5,341; NEB001 Adult: 1,133-5,157
NBM-1 Pediatric: 961-4,581; NEB001 Pediatric: 932-4,369 - Coarse Particle Dose (>4.7um):
NBM-1 Adult: 397-1,626; NEB001 Adult: 333-1,507
NBM-1 Pediatric: 618-2,715; NEB001 Pediatric: 665-2,790 - **Fine Particle Dose (
- Particle Size (MMAD):
§ 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).