TRU-MR LARYNGOSCOPE SET

• K Number: K062523
• Device Name: TRU-MR LARYNGOSCOPE SET
• Manufacturer: TRUPHATEK INTERNATIONAL, LTD.
• Date Cleared: 2006-11-17 ( 81 days)
• Product Code: CCW
• Regulation Number: 868.5540
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: K041852

Intended Use

The Tru-MR TM laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Device Description

The Truphatek Tru-MRTM MR conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Truphatek Tru-MR™ Laryngoscope set, based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
ASTM F2052-02 (MR Safety Testing)	In 3.0 Tesla

Regulation Number and Section

§ 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