(24 days)
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
The Paragon 2 is a mobile x-ray unit that covers all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These battery or line operated units combine stand-alone feature for exposures with battery assisted motor drive. Any of the following digital x-ray acquisition panels are available: Toshiba's FDX4343RPW, FDX 3543RPW, or FDX2520RPW. Integration of the panels and the software with the mobile system was straightforward since the panels and software have already been cleared. (K130883) The device complies with the US Federal Safety Performance Standard and is UL listed. The Paragon 2 has a telescoping tubestand which enhances visibility while transporting the unit. The Paragon 2 employs the digital x-ray panels and software employed in our premarket notification K143232.
This document describes a 510(k) premarket notification for the Paragon 2, a mobile x-ray system, and states that no clinical study was required for its clearance. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully addressed in the typical manner of a clinical trial.
Instead, the submission relies on bench and laboratory testing to demonstrate substantial equivalence to previously cleared predicate devices. The key aspects of the device's performance are evaluated against established safety and performance standards for x-ray equipment.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since no specific numerical clinical acceptance criteria are defined in this document (due to the nature of the 510(k) submission for substantial equivalence based on bench testing), the "acceptance criteria" are implied by compliance with safety and performance standards, and the "reported device performance" is its demonstrated adherence to these standards and equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with US Federal Safety Performance Standard (21 CFR 1020.30) | Complies with 21 CFR 1020.30 |
| Electrical Safety (IEC 60601) | Meets Electrical Safety per IEC-60601 |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2) | Meets EMC per IEC 60601-1-2 |
| Radiation Protection (IEC 60601-1-3) | Meets IEC 60601-1-3 Radiation protection |
| Basic Safety and Essential Performance of |
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.