(56 days)
Operio is a portable device for use in a surgical operating environment that produces a directed, non-turbulent flow of air to the surgical site during ophthalmic, orthopedic and neuro surgery and to the sterile instruments used during surgery. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter to reduce the microorganisms to a level of
The air zone unit Operio is used in a surgical operating room for cleaning the air in a given area by re-circulating the ambient air and cleaning it from airborne particles. The air is filtered through a HEPA filter and the air is generated over the areas where the demands of clean air are especially high. The air zone unit Operio is equipped with a control panel for adjustments and for positioning of the unit.
The air zone unit Operio is a mobile unit that with the help of castors easily can be moved around the patient to an optimal position or, when needed, transported inside the hospital between wards. It is also equipped with an optional instrument tray.
By using a unique sterile shield as a protective barrier the air zone unit can be placed close to the OR table and deliver HEPA filtered air to the surgical site and instruments to reduce the presence of airborne particulate and microorganisms.
Here's a summary of the acceptance criteria and study information for the Operio device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (from Indications for Use) | Reported Device Performance (Operational, from Summary of Testing) |
|---|---|---|
| Microorganism Reduction | Reduce microorganisms to a level of 99.995% against 0.3 µm particles. | |
| Particulate Density at Surgical Incision | Not explicitly stated as a numerical acceptance criterion, but the predicate device has a measured average particulate density of 1.1 particulate of 0.5 µm/f³. The subject device has the same reported value. | 1.1 particulate of 0.5 µm/f³ (This matches the predicate device and implies equivalence). |
| Directed Airflow Coverage | Air flow intended to be directed parallel to the surgical site and/or instruments within: 20" (50 cm) in width, 47" (120 cm) in length and 15" (40 cm) in height. Device effectiveness may not be reliably detectable at a distance of 47 inches (120 cm) from the air flow outlet, and effectiveness depreciates beyond this specified area. | Smoke test and turbulence tests were conducted to demonstrate airflow patterns, but specific numerical data on coverage within the specified dimensions is not explicitly detailed in the provided text. However, the CFU reduction results within the clinical tests imply effective coverage. |
Note: The primary acceptance criterion highlighted in the document for the expanded indications (Orthopedic and Neurosurgery) is the microorganism reduction to
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.