The Greatbatch Scientific MR Compatible Laryngoscope is intended for use in endoscopic visualization and surgery on the trachea, pharynx and larynx in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.

Device Description

The Greatbatch Scientific MR Compatible Laryngoscope is available in standard and autoclavable 8.0mm, 70° angle.

AI/ML Overview

The provided text describes the Greatbatch Scientific MR Compatible Laryngoscope and its MR safety testing.

Here's an analysis of the acceptance criteria and study as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test / Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
MR Compatibility	Static Field Strength	Applicable for 1.5 Tesla MR Systems	1.5 Tesla / GE Signa 64 MHz MR System
	Magnetic Attraction	Minimal deflection/attraction	"Very slight" deflection
	Magnetic Torque	Minimal torque	5 degrees
	Artifact	Acceptable level of distortion	"artifact same as the device ++" (indicating comparable to predicate)
	RF Heating	Temperature rise within safe limits	1.1°C temperature rise
	Gradient Induced Voltage	Not explicitly stated/tested (See "Gradient Induced Voltage 4.")	No phantom tests conducted

Note on Implied Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for magnetic attraction, torque, or artifact. However, the FDA's clearance implies that the reported performance was deemed "acceptable" for MR compatibility. For RF heating, a 1.1°C rise is reported, which is generally considered a safe and acceptable level for medical devices in an MR environment. The "artifact same as the device ++" implies that the new device's artifact profile is comparable to, and thus acceptable relative to, the predicate device.

2. Sample Size and Data Provenance

Sample Size for Test Set:
- The document describes a single device being tested for MR compatibility. It's not a study with a "test set" in the typical sense of evaluating diagnostic performance with multiple patient cases. Instead, it's a physical device testing to ensure safety and compatibility in an MR environment. Therefore, the "sample size" is 1 device.
Data Provenance:
- The testing was performed directly on the Greatbatch Scientific MR Compatible Laryngoscope.
- The location of the testing is implied by the "GE Signa 64 MHz MR System," suggesting a controlled laboratory or clinical setting where such equipment is available. No specific country of origin for the data is mentioned, but the submitter is based in New York, USA.
- The study is prospective in the sense that the new device was subjected to specific MR compatibility tests.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This submission is for device safety and compatibility testing, not for diagnostic performance evaluation or establishing a "ground truth" for clinical outcomes or interpretations. The "truth" in this context is the physical behavior of the device in an MR environment. The experts involved would be engineers and physicists conducting and interpreting the MR safety tests according to established standards.

4. Adjudication Method

Not applicable. This study is not a clinical performance study requiring adjudication of expert interpretations. The results are objective measurements of physical properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the diagnostic performance of AI or imaging interpretation by human readers, which is not the purpose of this submission.

6. Standalone Performance (Algorithm Only without Human-in-the-loop)

Yes, in spirit. The MR compatibility tests performed are akin to a "standalone" evaluation of the device's physical properties without human interaction influencing the measurements. The device itself (the laryngoscope) is the subject of the performance evaluation in the MR environment. There is no algorithm involved.

7. Type of Ground Truth Used

The "ground truth" for this study is based on objective physical measurements and established MR safety standards/guidelines. For example, magnetic attraction is measured by string deflection and torque, artifact by visual inspection of images, and RF heating by temperature sensors. There isn't a "pathology" or "outcomes data" ground truth in this context.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set." The device is a physical instrument.

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

Not applicable. As there is no training set involved, this question is not relevant.

Summary

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APR 3 0 1998

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510(k) SUMMARY

GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE

Submitter Name:	Greatbatch ScientificDivision of Wilson Greatbatch Ltd.
Submitter Address:	9645 Wehrle DriveClarence, New York 14031
Contact Person:	Gary J. Sfeir, RAC
Phone Number:	716.759.5655
Facsimile Number:	716.759.5654
Date Prepared:	13 April, 1998
Device Trade Name:	Greatbatch Scientific MR CompatibleLaryngoscope
Device Common Name:	Laryngoscope
Classification Name:	Rigid Laryngoscope
Predicate Devices:	Optus Laryngoscope
Device Description:	The Greatbatch Scientific MR CompatibleLaryngoscope is available in standard andautoclavable 8.0mm, 70° angle.
Intended Use:	For use in endoscopic visualization and surgery onthe trachea, pharynx and larynx in a MR or aninterventional MR environment, not to exceed a 1.5static magnetic field.
Device TechnologicalCharacteristics andComparison toPredicate Devices(s):	The device technological characteristicsare similar in design to the predicate device
Performance Data:	The device was tested for MR Compatibility and wasfound to be acceptable for use in a 1.5 static magneticfield. See attached MR Safety Testing Summary.
Conclusion:	The Greatbatch Scientific MR CompatibleLaryngoscope as designed can be used in a MR or aninterventional MR environment not to exceed a 1.5Tesla static magnetic field.

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GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE MR SAFETY TESTING SUMMARY

Magnetic Attraction and Torque 1 .

Static field strength-	1.5 Tesla / GE Signa 64 MHz MR System
Type of test-	String deflection
Observed deflection -	Very slight
Observed torque -	5 degrees

2. Artifact

Static field strength -Sequences -Amount of distortion:	1.5 Tesla / GE Signa 64 MHz MR System
Sequence	axial plane	sagittal plane
FSPGR	++	++

artifact same as the device ++

3. RF Heating

Phantom: A .

Type of phantom -Type of RF Coil -SAR applied -Length of time -Maximum temperature rise observed -

A 45 liter fluid filled rectangular shaped plastic Plexiglas phantom Body coil 1.1 W/kg 26 minutes 1.1℃C

Gradient Induced Voltage 4 .

No phantom tests were conducted.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 30 1998

Mr. Gary J. Sfeir Greatbatch Scientific, Ltd. 4100 Barton Road Clarence, NY 14031

Re: K971377 Magnetic Resonance (MR) Compatible Laryngoscope Requlatory Class: I (one) Product Code: 73 CCW Dated: February 3, 1998 February 4, 1998 Received:

Dear Mr. Sfeir:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Gary J. Sfeir

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4 INDICATIONS FOR USE

510 (k) Number (if known):

K971377

Device Name:

Greatbatch Scientific MR Compatible Laryngoscope

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED CONCURRENCE OF CDRH; OFFICE OF DEVICE EVALUATION (ODE) PRESCRIPTION USE NAL FORMAT 1-2-96) (Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

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