(274 days)
The Greatbatch Scicntific MR Fiber Optic Laryngoscope Handle when used with a green color marking blade system, is intended to facilitate and aid in tracheal . - intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnet field.
The MR Fiber Optic Intubating Laryngoscope consists of a handle which is manufactured from brass and is chrome plated. The cell used to provide the light source energy is a proprietary "c" size cell.
The provided document describes the 510(k) premarket notification for the "MR Fiber Optic Intubating Laryngoscope Handle." This is a medical device submission, and the focus of the testing and acceptance criteria is on demonstrating the device's substantial equivalence to existing predicate devices, particularly its safety for use in an MRI environment.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria & Test | Specified Limit/Target | Reported Device Performance |
|---|---|---|
| Artifact Level in 1.5 Tesla Static Magnetic Field (tested in the center of the field) | Not explicitly stated as a numerical limit, but implied acceptable. | "The device displayed an artifact level of twice the size of the device." (This is presented as a characteristic, not a pass/fail against a specific numerical limit, but considered acceptable within the context of substantial equivalence.) |
| RF Heating in 1.5 Tesla Static Magnetic Field |
§ 868.5540 Rigid laryngoscope.
(a)
Identification. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9