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The RespiChamber Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

The RespiChamber* Valved Holding Chamber (VHC) is a device used for the administration of metered dose inhaler medication to a spontaneously breathing patient. By means of a one-way valve, medication particles are held in the chamber for several seconds after actuation has occurred enabling inhalation by the patient. The device is designed to minimize delivery of the larger particles of aerosolized medication, which may otherwise lodge in the mouth, throat and upper airway, while allowing the smaller therapeutic particles to be inspired.

This document describes a 510(k) premarket notification for the RespiChamber* Valved Holding Chamber (VHC). The submission aims to demonstrate substantial equivalence to a predicate device, the OptiChamber Advantage Valved Holding Chamber (K962822).

Here's an analysis of the acceptance criteria and study information provided:

1. A table of acceptance criteria and the reported device performance

The provided document doesn't explicitly state acceptance criteria in a quantitative format with corresponding reported performance values. Instead, it refers to a qualitative assessment of "no new issues of safety or effectiveness."

The core performance evaluation is based on "Particle size distribution testing" with the metric "Fine Particle Mass (μg

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