(81 days)
Not Found
No
The summary describes a standard laryngoscope modified for use in an MR environment. There is no mention of AI, ML, image processing, or any data analysis beyond basic MR compatibility testing.
No
The device aids in tracheal intubation, which is a diagnostic or procedural step, but the device itself does not provide a therapeutic effect or treat a condition.
No
The device, a laryngoscope set, is used to facilitate tracheal intubation, which is a therapeutic or procedural aid, not a diagnostic process. Its purpose is to physically aid in a medical procedure within an MR environment.
No
The device description explicitly states it includes a laryngoscope handle, battery, and blades, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Tru-MR TM laryngoscope set is used to directly visualize the larynx and facilitate tracheal intubation within the body. It's a tool for a medical procedure, not for analyzing biological samples.
- Intended Use: The intended use clearly states it's for facilitating and aiding in tracheal intubation, a procedure performed on a patient.
- Device Description: The description focuses on its physical components (handle, battery, blades) and its suitability for an MR environment, not on any analytical or diagnostic capabilities.
The fact that it's used in an MR environment and has been tested for MR compatibility is relevant to its use case, but it doesn't make it an IVD.
N/A
Intended Use / Indications for Use
The Tru-MR ™ 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.
Product codes
CCW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Tracheal
Indicated Patient Age Range
No limitations
Intended User / Care Setting
Magnetic resonance (MR) environment up to 3.0 Tesla
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. In 3.0 Tesla
§ 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
0
Premarket Notification 510(k) Section 5 – 510(k) Summary
Truphatek Tru-MR™
5 510(k) Summary
| Non-Confidential Summary of Safety and Effectiveness |
|---|
| Page 1 of 2 |
| | Page 1 of 2
25-Aug-06 | NOV 17 2006 |
|----------------------------------------------------------------------------------------------|------------------------------------------------------|-------------|
| Truphatck International Ltd.
Park Poleg-C, Sapir Industrial zone
Netanya, 42504 ISRAEL | Tel - 011-972-9-885-1155
Fax - 011-972-9-885-1212 | |
| Official Contact: | David Grey, CEO | |
| Proprietary or Trade Name: | Tru-MR™ Laryngoscope set - MR Conditional | |
| Common/Usual Name: | Laryngoscope handle and blades - MR conditional | |
| Classification Name: | Rigid Laryngoscope | |
| Device: | Tru-MR™ | |
| Predicate Devices: | Minrad MR tested laryngoscope - K041852 | |
| 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.
| Indications for Use: | |
|---|---|
| Indicated Use -- | The Tru-MR ™ 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. | |
| Patient Population -- | No limitations |
| Environment of Use -- | Magnetic resonance (MR) environment up to 3.0 Tesla |
1
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 25-Aug-06
| Device Attributes: | |
|---|---|
| Design | |
| Configurations offered | Handles, many blades, i.e. Miller, Mac, etc. |
| Cleaning | Cold solution, autoclave |
| Testing |
| ASTM F2052-02
For Person Research Parcel of Children
A . A | In 3.0 Tesla