(69 days)
The Varian Proton Therapy Multileaf Collimator is an accessory radiation collimator intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
The Varian Proton Therapy Multileaf Collimator is an accessory proton beam collimator designed to be mounted on a proton radiation therapy system and is designed to shape the treatment field perimeter. The Proton Therapy Multileaf Collimator is designed to shape a proton beam for cancer treatment. There are two operating modes: Pencil Beam Scanning (PBS) where proton therapy equipment nozzle scanning magnets direct a. the proton beam to the voxel of treatment while the Proton Therapy Multileaf Collimator is parked with the carriage fully retracted for largest possible exposure field. b. Beam Shaping where the Proton Therapy Multileaf Collimator collimates the beam for treatment, replacing the current patient-customized final collimator. This Proton Therapy Multileaf Collimator mode of operating is used for double and single scattering and uniform scanning proton treatment modes.
The provided text describes a 510(k) summary for the Varian Medical Systems Proton Therapy Multileaf Collimator (K093252). However, this document does not contain information regarding acceptance criteria, device performance metrics, or any study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) related to proving the device meets acceptance criteria.
The document focuses on:
- Identification of the device and submitter: Varian Medical Systems Proton Therapy Multileaf Collimator.
- Classification details: Class II device, product code LHN.
- Predicate device: Varian Medical Systems Millennium Multileaf Collimator (K050442).
- Description of the device: An accessory proton beam collimator used to shape the treatment field perimeter, with two operating modes (Pencil Beam Scanning and Beam Shaping).
- Intended Use Statement: To assist radiation oncologists in delivering proton radiation to target volumes while sparing normal tissue.
- Substantial Equivalence: Claimed equivalence to the predicate device.
- FDA Clearance Letter: Confirms substantial equivalence determination (K093250 - note: there's a discrepancy in the K number cited in the summary vs. the clearance letter, with the letter stating K093250).
Since the document is a 510(k) summary for a medical device accessory and not a diagnostic or AI-driven tool, the type of performance studies and acceptance criteria typically associated with such technologies (e.g., sensitivity, specificity, AUC, human reader improvement with AI) are not applicable or, at least, not detailed in this specific submission. The "substantial equivalence" claim is typically based on performance data (e.g., mechanical, electrical, software validation as appropriate for a mechatronic device) demonstrating that the new device is as safe and effective as the predicate, but these specific criteria and the studies proving them are not elaborated upon in this summary.
Therefore, I cannot provide the requested information based on the given text.
§ 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.