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510(k) Data Aggregation
(25 days)
TOTIM Patient Cushion Immobilization System
The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the body, head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon treatments. The device is also used during image acquisition, including Computed Tomography (CT), Magnetic Resonance (MR) Imaging, to support treatment planning.
TOTIM is a fully sealed, polyurethane foam cushion covered with microfiber polyester tissue for patient positioning and immobilization during simulation, planning and radiation treatment. The cushion shapes and molds around the patient after activation of the internal components. It maintains its formed shape during all sessions of radiotherapy treatment, enabling reproducibility of patient position. The device is molded at the back of the patient's body, parts of the body or the head in order to hinder the usual range of movement occurring with non-customizable supports.
The provided text is a 510(k) summary for the TOTIM Patient Cushion Immobilization System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study data for new acceptance criteria. Therefore, a comprehensive description of acceptance criteria and a detailed study proving the device meets those criteria, as typically found in clinical trial reports or performance studies for novel devices, is not present in this document.
However, based on the information provided, we can infer some aspects related to performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) summary, specific numerical acceptance criteria for performance metrics (like accuracy of immobilization) are not explicitly stated as they would be for a novel device. Instead, the performance is primarily demonstrated through the equivalence to the predicate device and the results of non-clinical testing.
| Feature | Implicit Acceptance Criteria (Inferred) | Reported Device Performance (from text) |
|---|---|---|
| Material Safety | Biocompatibility comparable to predicate and relevant standards. | Biocompatibility testing completed for patient-contacting materials in accordance with ISO 10993-5:2009, 10993-12:2012, and ISO 10993-10:2010. Device intended for limited contact duration ( |
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