GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE

K971377 · Wilson Greatbatch Technologies, Inc. · CCW · Apr 30, 1998 · Anesthesiology

Device Facts

• Record ID: K971377
• Device Name: GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE
• Applicant: Wilson Greatbatch Technologies, Inc.
• Product Code: CCW · Anesthesiology
• Decision Date: Apr 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5540
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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 1.5 static magnetic field.

Device Story

The Greatbatch Scientific MR Compatible Laryngoscope is a rigid, autoclavable instrument (8.0mm, 70° angle) designed for endoscopic visualization and surgery of the trachea, pharynx, and larynx. It is specifically engineered for use within 1.5 Tesla magnetic resonance (MR) or interventional MR environments. The device functions as a manual surgical tool; it does not utilize electronic sensors or software. It is operated by clinicians in clinical or interventional MR settings to facilitate airway access and visualization during procedures. The device benefits patients by allowing surgical intervention or diagnostic visualization to occur safely within the MR environment without the risks associated with magnetic attraction, torque, or excessive RF heating.

Clinical Evidence

Bench testing only. Testing included magnetic attraction and torque (string deflection and 5-degree torque observed), MR artifact assessment (FSPGR sequence), and RF heating (1.1 W/kg SAR, 1.1°C maximum temperature rise over 26 minutes in a 45-liter phantom).

Technological Characteristics

Rigid laryngoscope, 8.0mm diameter, 70° angle. Autoclavable. Designed for MR compatibility in 1.5 Tesla static magnetic fields. Manual mechanical device; no energy source, connectivity, or software.

Indications for Use

Indicated for endoscopic visualization and surgery of the trachea, pharynx, and larynx in patients requiring procedures within a 1.5 Tesla MR or interventional MR environment.

Regulatory Classification

Identification

A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

Predicate Devices

• Optus Laryngoscope

Submission Summary (Full Text)

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APR 3 0 1998

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# 510(k) SUMMARY

# GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE

| Submitter Name: | Greatbatch Scientific<br>Division of Wilson Greatbatch Ltd. | |
|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter Address: | 9645 Wehrle Drive<br>Clarence, 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 Compatible<br>Laryngoscope | |
| Device Common Name: | Laryngoscope | |
| Classification Name: | Rigid Laryngoscope | |
| Predicate Devices: | Optus Laryngoscope | |
| Device Description: | The Greatbatch Scientific MR Compatible<br>Laryngoscope is available in standard and<br>autoclavable 8.0mm, 70° angle. | |
| Intended Use: | For use in endoscopic visualization and surgery on<br>the trachea, pharynx and larynx in a MR or an<br>interventional MR environment, not to exceed a 1.5<br>static magnetic field. | |
| Device Technological<br>Characteristics and<br>Comparison to<br>Predicate Devices(s): | The device technological characteristics<br>are similar in design to the predicate device | |
| Performance Data: | The device was tested for MR Compatibility and was<br>found to be acceptable for use in a 1.5 static magnetic<br>field. See attached MR Safety Testing Summary. | |
| Conclusion: | The Greatbatch Scientific MR Compatible<br>Laryngoscope as designed can be used in a MR or an<br>interventional MR environment not to exceed a 1.5<br>Tesla 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 -<br>Sequences -<br>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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

(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