(30 days)
The PC Version of the IVD Model 1133 has the same Indications for Use as the rf IVD submitted under K011332 which is quoted here: Sun Nuclear's Model 1133 rf-IVD is a battery operated dosimetry system designed to measure the patient's dose during radiation therapy treatment.
The Sun Nuclear Model 1133 rf-IVD (In-Vivo Dosimetry) is a system that measures the radiation output of a linear accelerator or a radioactive substance such as a Co-60 source, during the treatment of a patient. It has 3 detector inputs per detector pod, with only one detector pod usable at a time. The radiation therapist connects the radiation detectors (diodes) to the Detector Module and then positions them on the patient in order to measure the radiation from the accelerator. The Detector Module communicates with the Base Station by radio frequency communication. The measurement data is then sent through a line to an optically isolated interface, then to the PC. The Detector Module and Base Station are battery powered. The therapist leaves the treatment room. Dose measurement is then remotely started on the rf-IVD from the control room using the PC Software and then the radiation beam is turned on. When the beam turns off, the rf-IVD is stopped and the dose value is displayed. The rf-IVD display value is recorded or printed on an accessory printer. The therapist then enters the room and removes the detector from the patient.
I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text does not contain this information.
The document discusses the "Sun Nuclear Model 1133 IVD PC Version" which is a patient radiation dose monitor. It describes its function, intended use, and technological characteristics, and notes its substantial equivalence to a previously marketed device (Model 1133 IVD, K011332). It also lists various safety and operational features and mentions the effectiveness of the tool in radiation oncology departments.
However, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details of any specific study (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Information about MRMC comparative effectiveness studies or standalone algorithm performance.
- Training set details.
The text is a 510(k) Premarket Notification Summary, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed efficacy or performance studies with specific acceptance criteria that would typically be found in a clinical trial report or a more comprehensive validation study.
§ 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.