(85 days)
Not Found
No
The summary describes a standard laryngoscope modified for use in an MRI environment, with no mention of AI or ML capabilities.
No.
The device facilitates tracheal intubation, which is a diagnostic or procedural aid, not a treatment itself.
No
Explanation: The device is described as a laryngoscope set used to facilitate and aid in tracheal intubation, which is a therapeutic or procedural action, not a diagnostic one. Its functionality is to allow intubation in an MR environment, not to diagnose a condition.
No
The device description explicitly states it includes a handle, battery, and blades, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate and aid in tracheal intubation." This is a procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is a laryngoscope set, which is a tool used for direct visualization of the larynx during intubation. It's a physical instrument used in a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This laryngoscope set does not fit that description.
N/A
Intended Use / Indications for Use
The NovaMed MRI Conditional 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 NovaMed MRI 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
Not Found
Anatomical Site
Not Found
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
. . .
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 15-Nov-06
| NovaMed LLC | FEB 9 2007 | ||
|---|---|---|---|
| 4 Nursery Lane | Tel - 914-967-3500 | ||
| Rye, NY 10580 | Fax - 914-967-3209 | ||
| Official Contact: | Peter Derrico - President | ||
| Proprietary or Trade Name: | NovaMed MRI Conditional Laryngoscope set | ||
| Common/Usual Name: | Laryngoscope handle and blades - MR conditional | ||
| Classification Name: | Rigid Laryngoscope | ||
| Device: | NovaMed MRI Conditional | ||
| Predicate Devices: | Minrad MR tested laryngoscope - K041852 | ||
| Device Description: |
The NovaMed MRI 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 NovaMed MRI Conditional 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
ASTM F2052-02
1.1
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 15-Nov-06
| Device Attributes: | |
|---|---|
| Design | |
| Configurations offered | Handles, many blades, i.e. Miller, Mac, etc. |
| Cleaning | Cold solution, autoclave |
| Testing |
In 3.0 Tesla