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510(k) Data Aggregation
(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 | Adult @ 28 LPM | 261±17 µg | 293±45 µg | Substantially Equivalent (implicitly) |
| Fine Particle Dose (<4.7 um) Ipratropium Bromide | Adult @ 28 LPM | 48±4 µg | 56±7 µg | Substantially Equivalent (implicitly) |
| Fine Particle Dose (<4.7 um) Cromolyn Sodium | Adult @ 28 LPM | 1628±338 µg | 2018±430 µg | Substantially Equivalent (implicitly) |
| Ultra-Fine Particle Dose (<1.0 um) Albuterol Sulfate | Adult @ 28 LPM | 56±33 µg | 87±23 µg | Substantially Equivalent (implicitly) |
| Ultra-Fine Particle Dose (<1.0 um) Ipratropium Bromide | Adult @ 28 LPM | 17±3 µg | 20±3 µg | Substantially Equivalent (implicitly) |
| Ultra-Fine Particle Dose (<1.0 um) Cromolyn Sodium | Adult @ 28 LPM | 540±80 µg | 687±133 µg | Substantially Equivalent (implicitly) |
| Aerosol Characterization (Pediatric Conditions @ 12 LPM) | ||||
| Particle Size (MMAD) Albuterol Sulfate (2.5 mg/3 ml) | Pediatric @ 12 LPM | 5.57±0.45 µm | 5.00±0.95 µm | Substantially Equivalent (implicitly) |
| Particle Size (MMAD) Ipratropium Bromide (0.5 mg/2.5 ml) | Pediatric @ 12 LPM | 6.80±0.61 µm | 4.57±1.12 µm | Substantially Equivalent (implicitly) |
| Particle Size (MMAD) Cromolyn Sodium (20 mg/2.0 ml) | Pediatric @ 12 LPM | 7.23±0.49 µm | 4.93±0.47 µm | Substantially Equivalent (implicitly) |
| Geometric Standard Deviation Albuterol Sulfate (2.5 mg/3 ml) | Pediatric @ 12 LPM | 3.90±0.29 | 3.00±0.07 | Substantially Equivalent (implicitly) |
| Geometric Standard Deviation Ipratropium Bromide (0.5 mg/2.5 ml) | Pediatric @ 12 LPM | 3.74±0.24 | 3.42±0.09 | Substantially Equivalent (implicitly) |
| Geometric Standard Deviation Cromolyn Sodium (20 mg/2.0 ml) | Pediatric @ 12 LPM | 3.63±0.79 | 4.35±0.62 | Substantially Equivalent (implicitly) |
| Total Dose Delivered Albuterol Sulfate (2.5 mg/3 ml) | Pediatric @ 12 LPM | 1148±69 µg | 1106±53 µg | Substantially Equivalent (implicitly) |
| Total Dose Delivered Ipratropium Bromide (0.5 mg/2.5 ml) | Pediatric @ 12 LPM | 232±11 µg | 221±26 µg | Substantially Equivalent (implicitly) |
| Total Dose Delivered Cromolyn Sodium (20 mg/2.0 ml) | Pediatric @ 12 LPM | 6633±595 µg | 5523±154 µg | Substantially Equivalent (implicitly) |
| Total Respirable Dose (0.5-5 um) Albuterol Sulfate | Pediatric @ 12 LPM | 423±15 µg | 541±93 µg | Substantially Equivalent (implicitly) |
| Total Respirable Dose (0.5-5 um) Ipratropium Bromide | Pediatric @ 12 LPM | 79±5 µg | 103±19 µg | Substantially Equivalent (implicitly) |
| Total Respirable Dose (0.5-5 um) Cromolyn Sodium | Pediatric @ 12 LPM | 2263±207 µg | 2370±132 µg | Substantially Equivalent (implicitly) |
| Coarse 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 (<4.7 um) Albuterol Sulfate | Pediatric @ 12 LPM | 447±39 µg | 531±88 µg | Substantially Equivalent (implicitly) |
| Fine Particle Dose (<4.7 um) Ipratropium Bromide | Pediatric @ 12 LPM | 80±2 µg | 108±32 µg | Substantially Equivalent (implicitly) |
| Fine Particle Dose (<4.7 um) Cromolyn Sodium | Pediatric @ 12 LPM | 2290±478 µg | 2603±111 µg | Substantially Equivalent (implicitly) |
| Ultra-Fine Particle Dose (<1.0 um) Albuterol Sulfate | Pediatric @ 12 LPM | 51±4 µg | 80±26 µg | Substantially Equivalent (implicitly) |
| Ultra-Fine Particle Dose (<1.0 um) Ipratropium Bromide | Pediatric @ 12 LPM | 17±3 µg | 17±5 µg | Substantially Equivalent (implicitly) |
| Ultra-Fine Particle Dose (<1.0 um) Cromolyn Sodium | Pediatric @ 12 LPM | 571±161 µg | 737±51 µg | Substantially Equivalent (implicitly) |
Overall Conclusion: The document states that "almost all the performance parameters of the two different nebulizers were statistically identical for adult conditions and substantially equivalent in the therapeutic amount of medication delivered for pediatric conditions. The measured differences raise no new safety and efficacy issues; therefore, device equivalence is proved."
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify the exact numerical sample size for the aerosol characterization testing (e.g., number of nebulizers tested, number of runs per condition). It reports mean and standard deviation, implying replicate measurements were performed.
- Data Provenance: The testing was conducted by an "independent source" according to the relevant CDRH Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH – 1993). The country of origin of the data is not explicitly stated. The study appears to be prospective for the device testing itself, as it was performed to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device and study. The testing for a compressor nebulizer involves objective physical and chemical measurements (e.g., particle size, dose delivery) rather than expert interpretation of images or patient data. The ground truth is established by the standardized measurement methods themselves.
4. Adjudication Method for the Test Set
This information is not applicable for this type of device and study, as it did not involve expert review or consensus for establishing ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical cases, sometimes with and without AI assistance. The GUS831 Compressor Nebulizer is a therapeutic device (drug delivery), not a diagnostic one.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance evaluation was done. The aerosol characterization and biocompatibility testing were conducted directly on the device (GUS831 Compressor Nebulizer) and compared to the predicate device, without involving human users in a clinical setting for performance assessment.
7. The Type of Ground Truth Used
The ground truth for the aerosol characterization was established through objective physical and chemical measurements obtained using a cascade impactor, following the methodology outlined in the CDRH Guidance Document "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH – 1993). This is a form of objective measurement data, not expert consensus, pathology, or outcomes data typically associated with diagnostic AI.
The ground truth for biocompatibility was established by testing against recognized international standards (ISO 10993-1, ISO 18562 family).
8. The Sample Size for the Training Set
This information is not applicable. The GUS831 Compressor Nebulizer is a physical medical device; it is not an AI/ML algorithm that requires a training set. The "testing" referred to in the document is for the physical performance and biocompatibility of the device compared to a predicate, not for training a model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as the device is not an AI/ML algorithm requiring a training set.
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