AerFrame Patient Immobilization System (AFPIS)

The AerFrame Patient Immobilization System (AFPIS) is a reusable, non-powered mechanical device designed to position and immobilize patients during diagnostic imaging (CT, MRI) and photon-based radiotherapy. It consists of a rigid base frame with integrated side rails, a coordinate arch for coarse alignment, a foam headrest, and an optional abdominal compression assembly. When used for radiotherapy, it must be used with image-guided radiotherapy (IGRT) for final patient alignment and is limited to patients weighing up to 300 lb (136 kg).

The AerFrame is a passive, non-invasive, reusable mechanical immobilization system with radiolucent composite materials designed to minimize imaging artifacts and beam attenuation. It features integrated fiducial markers for visual reference on CT/MRI imaging and includes removable accessories (coordinate arch, abdominal compression assembly). Like the predicate Stereotactic Body Frame, it is not powered, contains no software, is not fixed to the treatment couch, and relies on patient weight for stabilization with final alignment verification performed via IGRT or clinical workflow.

The document references FDA human factors guidance (2016) and IEC 62366-1 usability engineering principles. Radiation attenuation acceptance criteria are based on AAPM TG-215 negligible attenuation threshold of <3% attenuation (Transmission Factor ≥0.97). No other specific consensus standards (ISO, ASTM, etc.) are explicitly cited in the summary.

Substantial equivalence is demonstrated because the AerFrame and the predicate Stereotactic Body Frame (K960338) are both passive mechanical patient immobilization systems with similar intended purposes, primary functions, and principles of operation. Although the AerFrame specifies photon-based radiotherapy and requires IGRT for final alignment, these differences do not constitute new intended use as they do not change the fundamental purpose of immobilization or introduce new therapeutic modalities. Nonclinical testing confirmed structural integrity under maximum loading, negligible dosimetric impact (<3% attenuation), and usability by trained clinical staff.