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510(k) Data Aggregation
K Number
K162246Device Name
ProNova SC360 Proton Therapy System
Manufacturer
Date Cleared
2016-12-08
(120 days)
Product Code
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
ProNova Solutions, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SC360 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Device Description
Using a beam of protons, the SC360 is designed to accurately and safely deliver a prescribed dose to a Treatment Volume in a patient with a solid tumor or other disease susceptible to radiation. The SC360 includes a method to; 1) accelerate protons to a fixed energy; 2) vary the proton beam energy to adjust its range in the patient; 3) transport the protons; 4) deliver the dose; 5) image the patient using Cone Beam CT (CBCT) or planar images; 6) position the patient relative to the proton beam delivery; and 7) record the details of the dose delivery.
The functions of each treatment room of the SC360 are performed by six independent systems that may be described as the Beam Production System (BPS), the Beam Modification System (BMS), the Dose Delivery System (DDS), the Positioning System (POS), the Independent Safety System (ISS), and the Treatment Room Control System (TRCS). The primary user interface is presented by the TRCS where treatment workflow and clinical Quality Assurance activities may be controlled. Servicing is accomplished through Service Interfaces for each independent system. Access to the service interfaces may be through the TRCS or the individual system control computer, all accessible only by qualified service engineers.
In the SC360, the cyclotron and fixed energy portion of the beamline make up the BPS and are independent of the BMS, which degrades the beam energy and finally transports the protons to the DDS through either a fixed beamline or 360-degree rotating gantry beamline. The ISS monitors all safety related signals and uses a high confidence method to control beam admission into a Treatment Room.
In each Treatment Room, prior to patient setup and treatment, information from a treatment plan is downloaded to the SC360. Next, the patient is immobilized on a robotic couch and moved to a treatment position as specified in the treatment plan. Volumetric (or orthogonal planar) x-ray images are acquired using a couch-mounted CBCT imaging ring. These images are used to determine the current location/orientation of the Treatment Volume by comparing and aligning with reference images and regions of interest provided in the treatment plan. The couch position/orientation is adjusted to bring the treatment isocenter to beam isocenter (in the prescribed orientation). The proton beam is delivered to the Treatment Volume in accordance with the treatment plan. During irradiation, the DDS controls and monitors the dose delivered to each spot, the spot location, and the total dose delivered. Results are recorded and stored in a format compatible with an Oncology Information System (OIS).
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