(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 ( |
§ 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).