MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001

K062231 · Minrad, Inc. · CCW · Aug 31, 2006 · Anesthesiology

Device Facts

• Record ID: K062231
• Device Name: MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001
• Applicant: Minrad, Inc.
• Product Code: CCW · Anesthesiology
• Decision Date: Aug 31, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5540
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The MR Fiber Optic Intubating Laryngoscope Handle, Standard ("MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Standard") is used to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Device Story

Device is a fiber optic laryngoscope handle designed for use in MRI environments. It attaches to a laryngoscope blade to assist clinicians in performing tracheal intubation. The handle is constructed to be compatible with static magnetic fields up to 3.0 Tesla, allowing for safe operation during MRI or interventional MR procedures. It functions as a manual tool for airway visualization and access. The device is intended for use by healthcare professionals in clinical settings where MRI-compatible equipment is required to maintain patient safety during intubation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rigid laryngoscope handle; fiber optic illumination; MR-compatible construction for use in static magnetic fields up to 3.0 Tesla. No specific materials or software algorithms described.

Indications for Use

Indicated for use with a laryngoscope blade to facilitate tracheal intubation in patients requiring airway management within MRI or interventional MR environments (up to 3.0 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.

Predicate Devices

• MINRAD INC. MR Fiber Optic Laryngoscope Handle (K970619)

Reference Devices

• Welch Allyn Laryngoscope
• Sun Med Laryngoscope

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Minrad Inc. The logo features the company name in bold, sans-serif font, with the "MINRAD" portion larger than the "INC." part. To the right of the name is a circular shape with a smaller circle cut out of the center, resembling a ring. A line extends from the right side of the ring to a smaller, solid circle.

K062231

# ATTACHMENT 6

# 510(k) SUMMARY

AUG 3 1 2006

# MINRAD INC.'s MR Fiber Optic Intubating Laryngoscope Handle, Standard

- Submitter's Information 1.
MINRAD INC. 847 Main Street, Buffalo NY 14203

Phone: [phone] Facsimile: 716-855-1078

Contact Person: John McNeirney, VP and CTO

Date Prepared: 31 July 2006

- Name of Device য়ে
MR Fiber Optic Intubating Laryngoscope Handle, Standard

- 3. Common or Usual Name
Laryngoscope, Rigid

- Classification Name 4.
Laryngoscope, Rigid (21 CFR 868.5540, Product Code CCW)

- Predicate Devices 5.
MINRAD INC. MR Fiber Optic Laryngoscope Handle (K970619) Laryngoscope. Welch Allyn Laryngoscope, Sun Med

- Intended Use 6.
The MR Fiber Optic Intubating Laryngoscope Handle, Standard ("MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Standard") is used to facilitate and aid in tracheal intubation in a Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

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Image /page/1/Picture/0 description: The image shows a logo with the word "MINRAD" in bold, capital letters. Below "MINRAD" is the abbreviation "INC.". To the right of the text is a circular shape with a smaller circle inside, resembling a ring. A line extends from the right side of the ring to a solid circle.

#### Technological Characteristics and Substantial Equivalence 7.

The technological characteristics of all of the Laryngoscopes are similar to the MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Standard.

The MR Fiber Optic Intubating Laryngoscope Handle, Standard is substantially equivalent to the other currently marketed Laryngoscope Handles, which are referenced above. The MR Fiber Optic Intubating Laryngoscope Handle, Standard and its predicate devices are all Laryngoscopes. Thus, the MR Fiber Optic Intubating Laryngoscope Handle, Standard raises no new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three heads, symbolizing service to the nation. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2006

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

Re: K062231

Trade/Device Name: Minrad Inc. MR Fiber Optic Intubating Laryngoscope Handle, Standard Regulation Number: 21 CFR 868.5540 Regulation Name: Rigid Laryngoscope Regulatory Class: I Product Code: CCW Dated: August 1, 2006 Received: August 3, 2006

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, labeling, 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 (21CFR 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/industry/support/index.html.

Sincerely yours,

Chia-Lin, Ph.D.

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 7

#### Indications for Use

## 510(k) Number (if known):

# Device Name: MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Standard

# Indications for Use:

The MR MR Fiber Optic Intubating Laryngoscope Handle, Standard The MIN Fiber Option Optic Intubating Laryngoscope Handle, ("MITRE") is used, together with a Laryngoscope blade, to facilitate and aid in Standard ) is asou, vogetic Resonance Imaging (MRI) or an interventional tractical intubation in a magnosis not to exceed a 3.0 Tesla static magnetic field.

Prescription Use_ V (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)

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Number: K 062231

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