(90 days)
The Model 8660 Series Nebulizers have the same intended use as their predicate device, The Salter Model 8900 Nebulizer, which was cleared for marketing by 510(k) No. K870027. The nebulizer is a reusable single patient use device (whereas the 8900 is a disposable single patient use device) which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted . It does not use software, nor is it sterile, although it must be cleaned or disinfected per the label instructions before reuse. The device is for single patient use. It is intended to be used with accessories, such tubing which is an industry standard device used with nebulizers.
Each of the Salter Labs 8660 Series Nebulizers consists of a Nebulizer Top which is screwed onto a Nebulizer Cup. The bottom of the cup has a fitting to accept a source of nebulizing gas. Liquids to be nebulized are placed in the nebulizer cup. The nebulizer housing is then applied, and the supply line for the nebulizing gas source is then connected to the bottom of the nebulizer cup. After the pressurized nebulizing gas is applied to the nebulizer, the solution in the cup is nebulized and pushed from the unit in aerosol form that can be inhaled by the patient.
This 510(k) summary does not contain information regarding acceptance criteria or a study proving the device meets said criteria. It outlines the device's purpose, identification, predicate device comparison, and intended use, but lacks details on performance metrics or validation studies typically found in such reports.
§ 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).