(88 days)
This product is intended for use by radiologists and surgeons for:
- Patient positioning and immobilization
- Stereotactic diagnostic localization
- Stereotactic radiotherapy of extracranial targets
The BodyFIX system is a patient positioning and immobilization device for use with radiotherapy, radiosurgery, sonography, surgery/CAS, imaging neurosurgery and brachytherapy treatments of extracranial targets. The five principal parts of the system include the vacuum cushion, fixation sheet, vacuum supply, target positioner and localizer, and carbon fiber baseplate.
This 510(k) submission for the BodyFIX system states that no performance data was required or submitted. Therefore, it's not possible to extract the requested information about acceptance criteria and a study proving the device meets those criteria.
The relevant section explicitly states:
"No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."
And further:
"No data submitted for section 807.92 6[(b)(1)(2)(3c)]."
This indicates that the device's substantial equivalence was determined based on its similarity to legally marketed predicate devices, rather than through a performance study against specific acceptance criteria.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.