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510(k) Data Aggregation
(194 days)
The BESMED Jet Nebulizer Bottle Set is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.
The MAXHEALTH Air Nebulizer is intended to spray liquid medications in aerosol fonn into gases that re directly delivered to the patient.
The information provided describes the acceptance criteria and a study to demonstrate substantial equivalence for the BESMED Jet Nebulizer Bottle Set, Model PN-1128E, as part of a 510(k) submission.
This is a device for administering aerosol treatments. The studies conducted are primarily performance and biocompatibility tests, rather than studies involving human readers or AI algorithms for diagnostic purposes. Therefore, some of the requested information (like MRMC studies, effect size of AI, number of experts for ground truth, adjudication methods, and sample sizes for training/test sets in the context of AI) is not applicable to this type of device and submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list "acceptance criteria" in a quantitative table format for performance beyond what's compared with the predicate device. However, it indicates conformity to relevant standards and a comparative analysis.
| Aspect | Acceptance Criteria (Implied by equivalence to predicate & standards) | Reported Device Performance |
|---|---|---|
| Intended Use | Administer aerosol treatments to adult/pediatric patients; home/hospital. Used with FDA approved drugs as prescribed. | SAME as predicate device (HSINER Jet Nebulizer, K052811) |
| Principle | Aerosolizes liquid into aerosol form by compressing air. | SAME as predicate device |
| Capacity of Medication Cup | 6 ml | SAME as predicate device (6 ml) |
| Particle Size | < 5 micron (as per predicate device) | SAME as predicate device (< 5 micron) |
| Accessories | Mouthpiece, T-piece, Corrugate tube, Air tube | SAME as predicate device (1 piece of each) |
| Nebulizer Characterization | USFDA 21CFR part 58 | Study conducted. (Results not detailed beyond "Study conducted") |
| Biocompatibility | ISO 10993-5 (Cytotoxicity) & ISO 10993-10 (Skin irritation & sensitization) | Studies conducted. (Results not detailed beyond "Study conducted") |
| Dimensions | Not explicitly stated as acceptance criteria, but compared. | 7.8 x 4.5 (Tall x Diameter cm) |
| Features | Novel appearance, compact structure, cabinet bulk, simple operation, convenient carrying. | As above, plus non-oil lubrication single-cylinder piston pump for air pressure. |
Self-correction: The document explicitly states "Particle size < 5 micron" for both the predicate and new device under "Comparison Areas" as a "Similar" characteristic. This serves as an acceptance criterion implicitly met by the new device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of diagnostic AI algorithms. The studies mentioned (Nebulizer Characterization, Biocompatibility) would have their own sample sizes for parts or materials, but these are not specified in the summary.
- Data Provenance: Not applicable in the context of diagnostic AI algorithms as no "data" in that sense is being analyzed. The device is manufactured by Besmed Health Business Corp. in Taiwan. The testing would likely be performed in a controlled laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is a medical accessory, not a diagnostic AI intended to interpret medical images or data requiring expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for the performance and biocompatibility testing of a nebulizer.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the performance of diagnostic systems (often AI-assisted) and human readers. The BESMED Jet Nebulizer is a device for drug delivery, not diagnosis.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study (in the context of an AI algorithm) was not done. An AI algorithm is not part of this device. The studies mentioned are performance tests of the physical nebulizer.
7. Type of Ground Truth Used
The "ground truth" for this device's performance would be established through objective measurements against defined engineering specifications and regulatory standards. For example:
- Nebulizer Characterization: Measurements of aerosol particle size distribution, nebulization rate, and drug output, compared to the requirements of USFDA 21CFR part 58 and, implicitly, demonstrating equivalence to the predicate device.
- Biocompatibility: Laboratory testing (cytotoxicity, skin irritation, sensitization) following ISO 10993 standards, where the "ground truth" is the biological response observed in the test systems against acceptance limits defined by the standard.
There's no clinical "ground truth" in terms of disease presence/absence or medical condition for this type of device.
8. Sample Size for the Training Set
Not applicable. There is no AI algorithm involved, so no training set is used.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is involved.
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