(44 days)
Not Found
No
The description focuses on the optical and mechanical design of a laryngoscope and does not mention any computational or algorithmic components indicative of AI/ML.
No.
The device is intended to facilitate and aid in tracheal intubation, which is a procedure, not a therapeutic intervention aimed at treating a disease or condition. It's a tool for a medical procedure, not a treatment itself.
No
The device is an optical laryngoscope intended to facilitate and aid in tracheal intubation by allowing the user to visualize the airway anatomy. It does not diagnose any medical condition.
No
The device description clearly details physical components like lenses, mirrors, batteries, PCBs, and blades, indicating it is a hardware device with optical and electrical components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Airtraq® SP - MR and Airtraq® Avant are described as optical laryngoscopes intended to facilitate and aid in tracheal intubation. They are used to visualize the airway anatomy and guide the insertion of an endotracheal tube.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is purely mechanical and optical, providing visualization and guidance during a medical procedure.
Therefore, the device falls under the category of a medical device used for a procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Airtraq® SP - MR and Airtraq® Avant are intended 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 (comma separated list FDA assigned to the subject device)
CCW
Device Description
Airtraq® Optical laryngoscope is an anatomical shaped rigid laryngoscope which allows the user to see the airway anatomy during insertion and intubation. It is designed with a guide channel in which one loads the endotracheal tube ("ET tube") that is then advanced once the glottis opening has been identified and centered in the view field of the Airtraq® optics. Prodol Meditec offers two (2) models.
Airtraq® SP - single patient
This model is a completely self-contained unit that operates on standard non-magnetic AAA batteries. It is a single patient use, disposable.
Airtraq® Avant
Avant once assembled is identical in its design and function as the Airtraq@ SP model.
Avant is designed as 2 components unlike the Airtraq® SP model.
-
- Optics This is a limited life reusable components which contains the lenses and mirrors of the optical system plus the rechargeable, non-magnetic battery, and PCB which controls the LED light, heater and diagnostics for the battery.
-
- Blade There are 2 blade sizes, Regular (ET tube size 7.0 mm to 8.5 mm) and Small (ET tube 6.0 mm to 7.5 mm). These are single use disposables in which the Optics are inserted and then the assembled device used. There is an eye cap that incorporates a protective lens that fits over the Optics once it has been inserted into the Blade.
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
Patients who are to be intubated as determined by the clinician.
Intended User / Care Setting
Not Found
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)
Performance Testing:
ASTM F2052-02 Standard Test Method of Magnetically Induced Displacement Force of Medical devices in the Magnetic Resonance Environment. Pass criteria is deflection of
§ 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
r
Airtraq® MR
510(k) Summarv K 12137 Page 1 of 3 06-May-2012
JUN 2 1 2012
Prodol Meditec Ltd. 1/F Block C, No.18 7th Science Ave. Hi-Tech Innovation Coast Tangjia Bay Zhuhai, 519085 China PR
| Official Contact: | Tanya Tan – General Manager
Tel (86) 756 382 6999
Fax (86) 756 382 6979 |
|----------------------------|-------------------------------------------------------------------------------|
| Proprietary or Trade Name: | Airtraq® SP – MR
Airtraq® Avant |
| Common/Usual Name: | Rigid Laryngoscope |
| Classification Name: | Rigid Laryngoscope
Product code – CCW
21 CFR 868.5540
Class 1 |
| Predicate Devices: | Truphatek Tru-MR™ – K062523 |
Device Description:
Airtraq® Optical laryngoscope is an anatomical shaped rigid laryngoscope which allows the user to see the airway anatomy during insertion and intubation. It is designed with a guide channel in which one loads the endotracheal tube ("ET tube") that is then advanced once the glottis opening has been identified and centered in the view field of the Airtraq® optics. Prodol Meditec offers two (2) models.
Airtraq® SP - single patient
This model is a completely self-contained unit that operates on standard non-magnetic AAA batteries. It is a single patient use, disposable.
Airtraq® Avant
A vant once assembled is identical in its design and function as the Airtraq@ SP model.
Avant is designed as 2 components unlike the Airtraq® SP model.
-
- Optics This is a limited life reusable components which contains the lenses and mirrors of the optical system plus the rechargeable, non-magnetic battery, and PCB which controls the LED light, heater and diagnostics for the battery.
-
- Blade There are 2 blade sizes, Regular (ET tube size 7.0 mm to 8.5 mm) and Small (ET tube 6.0 mm to 7.5 mm). These are single use disposables in which the Optics are inserted and then the assembled device used. There is an eye cap that incorporates a protective lens that fits over the Optics once it has been inserted into the Blade.
1
510(k) Summary Page 2 of 3 06-May-2012
Indications for Use:
(
Airtraq® SP – MR and Airtraq® Avant are intended 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:
Patients who are to be intubated as determined by the clinician.
Environment of Use:
Adding Magnetic Resonance (MR) environments up to 3.0 Tesla strength.
Comparison to Predicates
| Features | Truphatek
Tru-MRTM K062523 | Proposed Device
Airtraq® SP –MR
Airtraq® Avant |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for 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. | The Airtraq® SP – MR and Avant
are intended to facilitate and aid in
tracheal intubation in a Magnetic
Resonance (MR) environment, not
to exceed a 3.0 Tesla static
magnetic field. |
| Environment of Use | MR environments
Not to exceed 3.0 Tesla | Same
Not to exceed 3.0 Tesla |
| Patient Population | Patients to be intubated | Patients to be intubated |
| Configurations | Handles
Battery
Blades | Airtraq® SP MR
Blade
AAA Battery
Internal Optics
Airtraq® Avant
Blade
Reusable Optics
Rechargeable battery |
| Performance
Testing | ASTM F2052-02
Standard Test Method of
Magnetically Induced
Displacement Force of Medical
devices in the Magnetic Resonance
Environment
Pass criteria is deflection of