(43 days)
The HP PRO Positioning Device is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery and treatment with protons.
The HP PRO Positioning Device is used by first attaching the base plate to the couch top utilizing the appropriate indexing. Then the health care provider positions the immobilization devices on to the HP PRO Positioning Device. Next the patient is helped onto the couch and positioned onto HP PRO Positioning Device in the appropriate immobilization device. An example of an immobilization device is the overlay base plate of the Proton Immobilization Solution.
The HP PRO Positioning Device is a device that assists in the proper positioning and repositioning of patients for radiation therapy and radiosurgery with protons. It is an accessory to the Proton Immobilization Solution. The HP PRO Positioning Device is typically attached to the treatment table and supports the patient during treatment. The proposed HP PRO Positioning Device is essentially an extension of the treatment table.
The HP PRO Positioning Device is made up of 4 components: Base Plate (PMMA and Carbon Fiber), Interface (Aluminum), Indexing Pins (POM (Polyoxymethylene)), and Sheet Screws (Stainless Steel).
The provided document describes the HP PRO Positioning Device and its substantial equivalence to a predicate device, K151207 Proton Immobilization Solution. The study focuses on demonstrating that the new device performs comparably to the predicate device across various physical and dosimetric properties.
Here's an analysis of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria/Requirement | Reported Device Performance (HP PRO Positioning Device) |
|---|---|---|
| Physical Properties | ||
| Length | Range 45-52" | 50.17 inches (within range) |
| Width | 21" | 21.61 inches (comparable, deemed SE) |
| Height | 1.9" | 1.62 inches (comparable, deemed SE) |
| Sag at cranial end (135kg distributed load) | 2.51 mm (from predicate) | 9.21 mm (Predicate: 2.51mm; Device: 9.21mm; Deemed SE, with a note that a 6DOF Robotic patient couch top can compensate for bending effect. **Implicit acceptance: Sag + Creep |
§ 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.