(99 days)
The Qfix® Symphony Patient Transport System is indicated to aid in the support, positioning, and transfer of a patient for procedures involving imaging, including MRI; and external beam radiation therapy treatment with electrons, photons or protons; and other procedures requiring transfer of a patient. The Symphony is designed to interface with other positioning devices, such as couchtops, inserts, thermoplastic masks, and positioning pads.
Qfix, has developed the Symphony™ Patient Transport System to seamlessly move patients among multiple imaging modalities such as MR and CT to treatment modalities, such as those utilizing photon or proton and other procedures requiring the transfer of a patient. The Symphony™ Patient Transport System is designed to utilize a low-friction air bearing to transfer patients from one surface to another, eliminating the need to manually lift the patient. Additionally, the design enables clinicians to set up a patient on the Symphony™ for subsequent transfer and immobilization throughput in cancer treatments and other procedures. Qfix intends to market the Symphony™ Patient Transport System which consists of the Symphony™ trolley and several transfer surfaces including; a standard transfer surface, a head/neck transfer surface, and a brachytherapy solution which are compatible with existing patient positioning devices. The Symphony™ Patient Transport System is designed to optimize workflow efficiencies and improve patient outcomes.
The provided document describes the Qfix® Symphony™ Patient Transport System and its safety and effectiveness information. However, it does not contain the detailed information required for a comprehensive answer regarding acceptance criteria and a specific study proving the device meets those criteria.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical & Electrical Safety | Compliance with IEC 60601-1 Ed. 3 (hardware specs, power, control, load rating, deflection, electrical/mechanical hazards, durability, EMC) |
| Transfer Method Verification | Verification of transfer method |
| Usability of Components | Verification of usability (side rails, emergency stop, memory sets) |
| Component Life Cycle | Life cycle testing and analysis (side rails, pillars, batteries, blower, power, emergency stop) |
| Radiographic Properties | Radiographic measurements indicated transfer surfaces were radiolucent and low attenuating (Aluminum Equivalence |
§ 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.