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510(k) Data Aggregation
(267 days)
The Quality Life Technologies Compressor Nebulizer is an AC powered air compressor that provides a source of compressed air for home health care use. The product is used in conjunction with a jet (pneumatic) nebulizer to convert liquid medication into an aerosol form with particles smaller than 5 microns diameter for inhalation into the patient's respiratory tract for the treatment of respiratory disorders.
The target population for this device consists of adult patients suffering from, but not limited to asthma, cystic fibrosis, and chronic obstructive pulmonary disease. Further, additional applications for aerosolized medication are constantly under investigation and this device may be deemed suitable for such applications as prescribed.
The intended environment for use of the product is in the patient's home on the order of a physician.
Our Quality Life Technologies Compressor Nebulizer works to convert the medication to a high-quality mist of fine particles and spray liquid medications in aerosol form into gases that are directly delivered to the patient.
The provided text describes a 510(k) summary for the Quality Life Technologies Compressor Nebulizer, comparing it to predicate devices. The submission focuses on demonstrating substantial equivalence rather than presenting an exhaustive study of acceptance criteria and performance against those criteria as would be done for a novel device.
However, based on the non-clinical tests mentioned, we can infer some "acceptance criteria" and the reported performance.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission, the "acceptance criteria" are implied by the performance of the predicate devices and general medical device safety and efficacy standards. The "reported device performance" is largely presented as meeting these standards or being substantially equivalent to the predicates.
| Acceptance Criterion (Implied) | Reported Device Performance (Quality Life Technologies Compressor Nebulizer) |
|---|---|
| Biocompatibility: Meet requirements of ISO 10993 Part-1. | Biocompatible: "The patient contact components of the Quality Life Technologies Compressor Nebulizer met the requirements of ISO 10993 Part-1, Biological Evaluation of Medical Devices." |
| Electrical Safety: Meet requirements of IEC 60601-1. | Met Electrical Safety Standards: "Quality Life Technologies Compressor Nebulizer met the requirements of IEC 60601-1." |
| Electromagnetic Compatibility (EMC): Meet requirements of IEC 60601-1-2. | Met EMC Standards: "Quality Life Technologies Compressor Nebulizer met the requirements of IEC 60601-1-2." |
| Functional Performance (Substantial Equivalence to Predicate K870027 - SALTER LABS): | |
| - MMAD (Mean Mass Aerodynamic Diameter) for Albuterol Sulfate (<5 micron, Predicate: 3.13) | - MMAD for Albuterol Sulfate: 2.21 (within <5 micron, better than predicate) |
| - MMAD (Mean Mass Aerodynamic Diameter) for Ipratropium Bromide (<5 micron, Predicate: 3.10) | - MMAD for Ipratropium Bromide: 3.04 (within <5 micron, better than predicate) |
| - MMAD (Mean Mass Aerodynamic Diameter) for Cromolyn Sodium (<5 micron, Predicate: 2.40) | - MMAD for Cromolyn Sodium: 2.87 (within <5 micron) |
| - Percent of drug delivered in respirable fraction for Albuterol Sulfate (Predicate: 53.5%) | - Percent of drug delivered in respirable fraction for Albuterol Sulfate: 24.5% (Lower than predicate in this specific comparison, but the overall conclusion is still substantial equivalence to predicates, which might have other varying performance metrics or the difference is deemed acceptable for the intended use.) |
| - Percent of drug delivered in respirable fraction for Ipratropium Bromide (Predicate: 48.0%) | - Percent of drug delivered in respirable fraction for Ipratropium Bromide: 47.7% (Similar to predicate) |
| - Percent of drug delivered in respirable fraction for Cromolyn Sodium (Predicate: 29.5%) | - Percent of drug delivered in respirable fraction for Cromolyn Sodium: 18.1% (Lower than predicate, similar rationale as Albuterol Sulfate) |
| - Max. flow rate of compressor (Predicate: 10.0 l/min) | - Max. flow rate of compressor: 9.9 l/min (Similar to predicate) |
| - Max. pressure (Predicate: 40.0 psig) | - Max. pressure: 40.0 psig (Identical to predicate) |
| Overall Performance: Substantial equivalence to predicate device. | "The performance of the Quality Life Technologies Compressor Nebulizer was tested by third party lab and demonstrated substantially equivalent to that of the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in terms of patient data or a specific number of units tested for performance. The non-clinical tests mentioned are likely standard engineering and laboratory tests performed on a representative sample of the manufactured device. The data provenance is not explicitly stated beyond "third party lab," which suggests an external accredited testing facility. It's not retrospective or prospective study data in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device is a compressor nebulizer, and the testing described is primarily engineering performance testing, not clinical studies requiring expert interpretation of ground truth in areas like medical imaging or pathology.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study that would involve expert adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a compressor nebulizer, not an AI-powered diagnostic tool, and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a hardware compressor nebulizer, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the performance metrics (MMAD, respirable fraction, flow rate, pressure), the "ground truth" would be established by validated measurement techniques and equipment within the testing laboratory, adhering to relevant standards (e.g., pharmacopeial methods for aerosol characterization). For biocompatibility, the ground truth is defined by the adherence to ISO 10993 standards, demonstrated through specific tests (e.g., cytotoxicity, sensitization). For electrical safety and EMC, the ground truth is adherence to IEC 60601 series standards, demonstrated through specific electrical and electromagnetic compatibility tests.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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