(a) Identification. A whole room microbial reduction device is a medical device to be used to reduce microbial load on medical device surfaces following cleaning and disinfection.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Performance testing must demonstrate microbial log reduction of the demonstrated most resistant microorganism on medical device surfaces commensurate with the intended level of microbial reduction;

(ii) Simulated use testing must evaluate device performance under simulated worst-case use conditions (e.g., soiling, room objects and surfaces, distances);

(iii) In-use testing must evaluate device performance under real-world use conditions;

(iv) Performance testing must demonstrate the photobiological safety of any lamps or lamp systems;

(v) Performance testing must evaluate safety features intended to prevent exposure and ensure that device operation can only occur in an unoccupied environment; and

(vi) Performance testing must characterize the long-term material compatibility of the microbiocidal agent on clinically relevant surfaces and/or devices.

(2) Biocompatibility testing must demonstrate safe residual levels of chemicals on medical devices surfaces and/or gaseous byproducts in air.

(3) Software verification, validation, and hazard analysis must be performed for any software components.

(4) Performance data must demonstrate the electromagnetic compatibility and electrical safety of the device.

(5) Labeling must include:

(i) Warnings and instructions to ensure the device is operated in an unoccupied environment;

(ii) Setup and positioning instructions; and

(iii) Information regarding material compatibility.