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.

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.

AI/ML Overview

Acceptance Criteria and Study for Airtraq® MR and Airtraq® Avant

This summary details the acceptance criteria a medical device needs to meet and the study conducted to prove it, based on the provided 510(k) Premarket Notification.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Airtraq® MR and Airtraq® Avant devices, as described in the provided document, primarily relate to their magnetic resonance (MR) compatibility.

Acceptance Criteria (Performance Testing)	Reported Device Performance
Deflection of < 45 degrees in a 3.0 Tesla MR environment, according to ASTM F2052-02 (Standard Test Method of Magnetically Induced Displacement Force of Medical Devices in the Magnetic Resonance Environment)	Device performance meets the criteria (implicitly, as it is deemed substantially equivalent and the testing method and pass criteria are identical to the predicate device).

Note: The document explicitly states that the "Pass criteria is deflection of < 45 degrees" for the ASTM F2052-02 test. For the proposed device, it states "Testing has been performed according to ASTM F2052-02 for deflection in a 3.0 Tesla environment," and the device is deemed substantially equivalent, which implies successful adherence to this pass criterion.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a distinct "test set" sample size in terms of a patient cohort or a number of device units tested. The performance testing refers to the ASTM F2052-02 standard, which is a laboratory-based physical test on the device itself.
Data Provenance: The testing is laboratory-based performance testing of the device's physical properties in a simulated MR environment. It is not patient data from a specific country or collected retrospectively/prospectively.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable to the provided information. The ground truth for this device's acceptance criteria is based on a standardized physical test (ASTM F2052-02) for magnetic compatibility, not on expert consensus from clinical evaluation or image interpretation.

4. Adjudication Method for the Test Set

This section is not applicable to the provided information. The performance testing is a standardized physical measurement, not a clinical study requiring expert adjudication of results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

A MRMC comparative effectiveness study was not conducted or described. The document focuses on demonstrating the device's physical compatibility with an MR environment, not its clinical effectiveness compared to unassisted human readers or other devices in a reader-based study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device is an optical laryngoscope, a physical medical instrument, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth used for the acceptance criterion is defined by the standardized measurement of physical deflection of the device when exposed to a 3.0 Tesla static magnetic field, as stipulated by the ASTM F2052-02 standard. It is a direct physical measurement against a quantitatively defined threshold.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical instrument, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the reasons stated in section 8.

Summary

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Premarket Notification 510(k) Section 5 - 510(k) Summary

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 ManagerTel (86) 756 382 6999Fax (86) 756 382 6979
Proprietary or Trade Name:	Airtraq® SP – MRAirtraq® Avant
Common/Usual Name:	Rigid Laryngoscope
Classification Name:	Rigid LaryngoscopeProduct code – CCW21 CFR 868.5540Class 1
Predicate Devices:	Truphatek Tru-MR™ – K062523

Device Description:

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.

1. 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.
1. 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.

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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	TruphatekTru-MRTM K062523	Proposed DeviceAirtraq® SP –MRAirtraq® Avant
Indications for use	The Tru-MR TM laryngoscope set isused to facilitate and aid in trachealintubation in a Magnetic Resonance(MR) environment, not to exceed a3.0 Tesla static magnetic field.	The Airtraq® SP – MR and Avantare intended to facilitate and aid intracheal intubation in a MagneticResonance (MR) environment, notto exceed a 3.0 Tesla staticmagnetic field.
Environment of Use	MR environmentsNot to exceed 3.0 Tesla	SameNot to exceed 3.0 Tesla
Patient Population	Patients to be intubated	Patients to be intubated
Configurations	HandlesBatteryBlades	Airtraq® SP MRBladeAAA BatteryInternal OpticsAirtraq® AvantBladeReusable OpticsRechargeable battery
PerformanceTesting	ASTM F2052-02Standard Test Method ofMagnetically InducedDisplacement Force of Medicaldevices in the Magnetic ResonanceEnvironmentPass criteria is deflection of < 45degrees	ASTM F2052-02Standard Test Method ofMagnetically InducedDisplacement Force of Medicaldevices in the Magnetic ResonanceEnvironmentPass criteria is deflection of < 45degrees

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510(k) Summary Page 3 of 3 06-May-2012

Substantial Equivalence Discussion

The Airtrag® SP - MR and Airtraq® Avant optical laryngoscopes are viewed as substantially equivalent to the predicate device because:

Indications -

. Identical to predicate - K062523
Intended to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) . environment, not to exceed a 3.0 Tesla static magnetic field.

Technology -

. Similar - handle, battery, blade design to predicate - K062523
Both devices are Class 1 exempt from PMN .

Materials -

. The materials are part of a Class I exempt device.

Environment of Use -

Identical to predicate K062523 .
Adding Magnetic Resonance (MR) environments up to 3.0 Tesla strength. .

Patient Population -

Identical to predicates K062523 .
. Patients who are to be intubated

Performance Testing

· Identical to predicate K062523
Testing has been performed according to ASTM F2052-02 for deflection in a 3.0 Tesla . environment

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of a stylized eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 2 1 2012

Prodol Meditec Limited C/O Mr. Paul E. Dryden Authorized Representative Airtraq LLC 24301 Woodsage Drive Bonita Springs, Florida 34134

Re: K121378

Trade/Device Name: Airtraq® SP MR, Airtraq® Avant Regulation Number: 21 CFR 868.5540 Regulation Name: Rigid Laryngoscope Regulatory Class: I Product Code: CCW Dated: May 6, 2012 Received: May 21, 2012

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. Dryden

Enclosure

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm1 for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Th for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

510(k) Number:

K121378 (To be assigned)

Device Name:

Airtraq® SP MR Airtraq® Avant

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.

Prescription Use XX (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

Page 1 of 1

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schult

(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices

510(k) Number: K121378

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