(39 days)
This device is intended to accurately position the patient's body in a steady, precise position during X-Ray procedures (erect lateral thoracic, lateral lumbar, lateral chest and lateral abdomen plain film X-Rays).
Lower bar adjusts and locks to the horizontal position for the patient to hold onto and adjusts down to the vertical position so it can be moved close to the wall and out of the way when not in use.
Once the lower bar is in the horizontal position, the handle can be loosened and the height adjustment bar can be raised or lowered as well as be moved left or right along the tracks to adjust for differing patient heights and arm lengths.
The device can have two sets of tracks; one on either side of the X-Ray bucky. The height adjustment bar/lower bar/front block/rear block assembly can be removed by removing the set screw in the stop block between the end of the tracks, sliding the height adjustment bar/lower bar/front block/rear block assembly off the tracks and then sliding it onto the second set of tracks and putting the set screw in the stop block at the end of the second set of tracks.
The provided document is a 510(k) summary for the X-Ray Assist Bar, submitted in 1997. It describes a medical device intended to position patients for X-ray procedures. However, it does not contain any information about acceptance criteria or performance studies of the device itself.
Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices (Chest X-Support Steady Rest™ and Whitmore Ankle X-Ray Extension), which is the primary route for 510(k) clearance for low-to-moderate risk medical devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies for the X-Ray Assist Bar based on this document. The document explicitly states:
- "Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: Non-Applicable"
- "Discussion of Clinical Tests Performed: Non-Applicable"
This means no such tests were conducted or reported for the X-Ray Assist Bar in this 510(k) submission. The FDA cleared the device based on its substantial equivalence to predicate devices, assuming that if the predicate devices were safe and effective, and the new device was sufficiently similar in intended use, technology, and did not raise new questions of safety or effectiveness, it too would be safe and effective.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.