(221 days)
GUS831 compressor nebulizer is designed for the production of compressed air to operate a nebulizer kit for the production of medical aerosol for respiratory disorders. The nebulizer kit is intended for multiple use by single patient for single medication. GUS831 compressor nebulizer is intended for domestic use with children from 5 years old, adolescent and adult patients and requires the order of a physician for medical use.
GUS831 Compressor Nebulizer is a portable aerosol nebulizer electronically powered by an external power adapter and by an internal rechargeable lithium polymer battery. The compressed air, created by the membrane pump of the device, flows into the nebulizer container kit. The air pressure forced the liquid through the nozzle where it is atomized against a plate within the container. The device is equipped with a mouthpiece to easily delivery the medical aerosol.
Here's a breakdown of the acceptance criteria and study information for the GUS831 Compressor Nebulizer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device (U-RIGHT Compressor Nebulizer, K121969) rather than explicitly stating pre-defined acceptance criteria with pass/fail thresholds against a specific standard for all performance parameters. However, the aerosol characterization section presents quantitative data for both the subject and predicate devices, implying those values serve as comparative criteria.
Note: The "acceptance criteria" here are implicitly defined by the predicate device's performance, with the goal being "statistically identical" or "substantially equivalent" performance.
| Performance Parameter | Test Condition | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (GUS831) | Conclusion on Meeting Acceptance Criteria |
|---|---|---|---|---|
| Aerosol Characterization (Adult Conditions @ 28 LPM) | ||||
| Particle Size (MMAD) Albuterol Sulfate (2.5 mg/3 ml) | Adult @ 28 LPM | 3.87±0.31 µm | 2.64±0.35 µm | Substantially Equivalent (implicitly) |
| Particle Size (MMAD) Ipratropium Bromide (0.5 mg/2.5 ml) | Adult @ 28 LPM | 3.37±0.46 µm | 2.51±0.36 µm | Substantially Equivalent (implicitly) |
| Particle Size (MMAD) Cromolyn Sodium (20 mg/2.0 ml) | Adult @ 28 LPM | 2.87±0.15 µm | 2.64±0.34 µm | Substantially Equivalent (implicitly) |
| Geometric Standard Deviation Albuterol Sulfate (2.5 mg/3 ml) | Adult @ 28 LPM | 3.77±0.48 | 3.32±0.57 | Substantially Equivalent (implicitly) |
| Geometric Standard Deviation Ipratropium Bromide (0.5 mg/2.5 ml) | Adult @ 28 LPM | 4.14±0.25 | 3.59±0.48 | Substantially Equivalent (implicitly) |
| Geometric Standard Deviation Cromolyn Sodium (20 mg/2.0 ml) | Adult @ 28 LPM | 3.70±0.55 | 3.37±0.70 | Substantially Equivalent (implicitly) |
| Total Dose Delivered Albuterol Sulfate (2.5 mg/3 ml) | Adult @ 28 LPM | 514±55 µg | 471±45 µg | Substantially Equivalent (implicitly) |
| Total Dose Delivered Ipratropium Bromide (0.5 mg/2.5 ml) | Adult @ 28 LPM | 89±12 µg | 91±9 µg | Substantially Equivalent (implicitly) |
| Total Dose Delivered Cromolyn Sodium (20 mg/2.0 ml) | Adult @ 28 LPM | 2772±441 µg | 3286±383 µg | Substantially Equivalent (implicitly) |
| Total Respirable Dose (0.5-5 um) Albuterol Sulfate | Adult @ 28 LPM | 259±37 µg | 263±38 µg | Substantially Equivalent (implicitly) |
| Total Respirable Dose (0.5-5 um) Ipratropium Bromide | Adult @ 28 LPM | 42±5 µg | 50±8 µg | Substantially Equivalent (implicitly) |
| Total Respirable Dose (0.5-5 um) Cromolyn Sodium | Adult @ 28 LPM | 1448±312 µg | 1913±328 µg | Substantially Equivalent (implicitly) |
| Coarse Particle Dose (>4.7 um) Albuterol Sulfate | Adult @ 28 LPM | 253±38 µg | 178±23 µg | Substantially Equivalent (implicitly) |
| Coarse Particle Dose (>4.7 um) Ipratropium Bromide | Adult @ 28 LPM | 41±8 µg | 35±6 µg | Substantially Equivalent (implicitly) |
| Coarse Particle Dose (>4.7 um) Cromolyn Sodium | Adult @ 28 LPM | 1143±106 µg | 1268±316 µg | Substantially Equivalent (implicitly) |
| Fine Particle Dose (4.7 um) Albuterol Sulfate | Pediatric @ 12 LPM | 701±107 µg | 576±36 µg | Substantially Equivalent (implicitly) |
| Coarse Particle Dose (>4.7 um) Ipratropium Bromide | Pediatric @ 12 LPM | 152±8 µg | 113±27 µg | Substantially Equivalent (implicitly) |
| Coarse Particle Dose (>4.7 um) Cromolyn Sodium | Pediatric @ 12 LPM | 4343±426 µg | 2920±113 µg | Substantially Equivalent (implicitly) |
| Fine Particle Dose ( |
§ 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).