MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002

K041852 · Minrad, Inc. · CCW · Nov 15, 2004 · Anesthesiology

Device Facts

• Record ID: K041852
• Device Name: MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002
• Applicant: Minrad, Inc.
• Product Code: CCW · Anesthesiology
• Decision Date: Nov 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5540
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The MR Tested Fiber Optic Short Laryngoscope Handle ("MINRAD INC. MR Tested Fiber Optic Laryngoscope Handle") is used, together with a Laryngoscope blade, to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnetic field.

Device Story

Device is a fiber optic laryngoscope handle designed for use in MRI environments. Operates by attaching to a laryngoscope blade to facilitate tracheal intubation. Used by clinicians in MRI suites; specifically engineered for compatibility with static magnetic fields up to 1.5 Tesla. Benefits patient by allowing airway management during procedures requiring MRI imaging.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Fiber optic laryngoscope handle; MR-compatible materials; designed for use in static magnetic fields up to 1.5 Tesla; manual operation.

Indications for Use

Indicated for patients requiring tracheal intubation within an MRI or interventional MR environment (up to 1.5 Tesla).

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 5 2004

Mr. John McNeirney Vice President and Chief Technical Officer Minrad, Incorporated 847 Main Street Buffalo, New York 14203

Re: K041852

Trade/Device Name: MINRAD INC. MR Tested Fiber Optic Short Laryngoscope Handle Regulation Number: 868.5540 Regulation Name: Rigid Laryngoscope Regulatory Class: I Product Code: CCW Dated: October 1, 2004 Received: October 18, 2004

Dear Mr. Mcneirney:

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, labcling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Mcneirney

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincercly yours,

Curls

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ATTACHMENT 8

## Indications for Use

510(k) Number (if known): K.041852

Device Name: MINRAD INC. MR Tested Fiber Optic Short Laryngoscope Handle

Indications For Use:

The MR Tested Fiber Optic Short Laryngoscope Handle ("MINRAD INC. MR Tested Fiber Optic Laryngoscope Handle") is used, together with a Laryngoscope blade, to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 1.5 Tesla static magnetic field.

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K041852 Quy Sulom

(Division Sign-Off) Division of Anesthesiology, General Hosp Infection Control, Dental Devic

510(k) Number:_

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