(81 days)
The DeVilbiss Model 3650 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease.
The DeVilbiss Model 3650 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease. In terms of function, safety and effectiveness this device is substantially equivalent to other legally marketed compressor / nebulizers commonly used for the treatment of respiratory diseases. The compressor is constructed of materials, both metal and plastic, that are similar or identical to legally marketed devices. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device (Underwriter's Laboratory Standard UL1431, Attachment D).
Used in conjunction with a jet (pneumatic) nebulizer, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The DeVilbiss Model 3650 compressor / nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter (per the requirements of the BSI standard, Attachment E). This aerosol particle size performance is comparable to other legally marketed devices as noted in the Table of Comparison and the Discussion of Similarities and Performance Data (Sections 6.0 & 7.0).
Given the provided text, it is not possible to provide a detailed response to the requested information regarding acceptance criteria and a study proving device conformance. The document is a 510(k) summary from 1997 for the DeVilbiss Model 3650 Compressor/Nebulizer, which pre-dates many of the modern requirements and practices for AI/ML device evaluations implicit in your questions.
Here's why and what can be extracted:
The document explicitly states: "The DeVilbiss Model 3650 Compressor / Nebulizer is substantially equivalent to other legally marketed compressor / nebulizers commonly used for the treatment of respiratory diseases." This indicates a predicate device comparison rather than a standalone clinical study with the kind of modern metrics you're requesting.
Here's what can be gathered, and what cannot:
-
A table of acceptance criteria and the reported device performance
- Acceptance Criteria Mentioned (Implicit/Explicit):
- "majority of the aerosol by mass contained in particles less than 5 microns in diameter (per the requirements of the BSI standard, Attachment E)."
- Compliance with electrical and mechanical safety standards (Underwriter's Laboratory Standard UL1431, Attachment D).
- Functional and safety equivalence to legally marketed predicate devices.
- Reported Device Performance:
- "This aerosol particle size performance is comparable to other legally marketed devices." No specific numerical value for "majority" is given within this summary, only that it meets the BSI standard requirement.
- Functionally, converts liquid medication into aerosol.
- Electrically and mechanically safe per UL1431.
Acceptance Criteria Reported Device Performance Majority of aerosol by mass - Acceptance Criteria Mentioned (Implicit/Explicit):
§ 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).