(164 days)
The Portable Nebulizer (MBPN002) is a 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 care use, schools, and long term care facilities.
The Portable Nebulizer (MBPN002) is a small, handheld general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.
The provided text describes a 510(k) submission for a modified Portable Nebulizer (MBPN002). This submission does not include a study involving AI, human readers, or a test set as would typically be described for an AI/ML device.
The "acceptance criteria" discussed are primarily related to performance specifications and compliance with standards for a medical device, rather than the performance of an AI algorithm based on a test set. The "study" mentioned is a set of non-clinical performance tests and verifications to demonstrate that the modified device is substantially equivalent to its predicate.
Here's an analysis based on the provided text, addressing the requested points where applicable, and noting when information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria here are drawn from the performance specifications and the "Comparison to Predicate" table, which highlight what the device should do, and the "reported device performance" is essentially the confirmation that it meets these as identical to the predicate or through specific tests.
| Acceptance Criteria (from Predicate/Modified Device Specifications) | Reported Device Performance (as demonstrated by testing/comparison) |
|---|---|
| Indications for use remain identical: Aerosolize liquid medications for inhalation by pediatric (5+ years) and adult patients in hospital/institutional, home care, school, and long-term care facilities. | Identical to predicate K170916. |
| Patient Population remains identical: Pediatric (5+ years) and adult patients. | Identical to predicate K170916. |
| Environment of Use remains identical: Hospital/institutional, home care, schools, and long-term care facilities. | Identical to predicate K170916. |
| Contraindications remain identical: None. | Identical to predicate K170916. |
| Principle of Operation remains identical: Vibrating mesh technology. | Identical to predicate K170916. |
| Aerosolization remains identical: Continuous during inhalation and exhalation. | Identical to predicate K170916. |
| Compressed gas source: None needed. | Identical to predicate K170916. |
| Reservoir volume: 6 ml. | Identical to predicate K170916. |
| Nebulization rate: > 0.25 ml/min. | Identical to predicate K170916. Particle characterization and nebulization rate are unchanged as the main unit operates at a consistent 15V. |
| Duration of Use: Single patient, multi-use. | Identical to predicate K170916. |
| Nebulizer components cleanable: Yes. | Identical to predicate K170916. Cleaning and disinfection validated. |
| Software driven: Yes (firmware). | Identical to predicate K170916. |
| Power source: 2 "AA" batteries OR external Class II IEC 60601-1 compliant supply. | The modified device adds external power, but "no change to device performance" is noted due to controlled 15V operation. Electrical safety and EMC testing confirmed compliance with relevant standards (ANSI/AAMI/ES 60601-1, IEC 60601-1-2, IEC 60601-1-11). |
| Power consumption: |
§ 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).