NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET

K063477 · Novamed, LLC · CCW · Feb 9, 2007 · Anesthesiology

Device Facts

• Record ID: K063477
• Device Name: NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
• Applicant: Novamed, LLC
• Product Code: CCW · Anesthesiology
• Decision Date: Feb 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5540
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The NovaMed MRI Conditional laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

Device Story

NovaMed MRI Conditional laryngoscope set consists of handles, batteries, and blades (e.g., Miller, Mac configurations) modified for use in MR environments. Device facilitates tracheal intubation during MR imaging procedures. Operated by clinicians in MR suites. Safety verified for 3.0 Tesla static magnetic fields. Output is physical visualization and airway access provided by the laryngoscope blade and handle assembly. Benefits include enabling airway management during MR scanning without requiring patient removal from the MR environment.

Clinical Evidence

Bench testing only. Device tested for MR compatibility according to ASTM F2052-02 in a 3.0 Tesla environment, demonstrating < 45 degree string deflection.

Technological Characteristics

Rigid laryngoscope handle and blade set. Materials treated for MR compatibility. Tested per ASTM F2052-02. Compatible with 3.0 Tesla MR environments. Cleaning via cold solution or autoclave.

Indications for Use

Indicated for tracheal intubation in patients requiring airway management within a Magnetic Resonance (MR) environment up to 3.0 Tesla. No specific age or gender limitations.

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 MR tested laryngoscope (K041852)

Submission Summary (Full Text)

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

. . .

K063477

## Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 15-Nov-06

| NovaMed LLC | | | FEB 9 2007 |
|----------------------------|-------------------------------------------------|--|------------|
| 4 Nursery Lane | Tel - 914-967-3500 | | |
| Rye, NY 10580 | Fax - 914-967-3209 | | |
| Official Contact: | Peter Derrico - President | | |
| Proprietary or Trade Name: | NovaMed MRI Conditional Laryngoscope set | | |
| Common/Usual Name: | Laryngoscope handle and blades - MR conditional | | |
| Classification Name: | Rigid Laryngoscope | | |
| Device: | NovaMed MRI Conditional | | |
| Predicate Devices: | Minrad MR tested laryngoscope - K041852 | | |
| Device Description: | | | |

The NovaMed MRI Conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.

| Indications for Use: | |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indicated Use -- | The NovaMed MRI Conditional laryngoscope set is used to<br>facilitate and aid in tracheal intubation in a Magnetic<br>Resonance (MR) environment, not to exceed a 3.0 Tesla<br>static magnetic field. |
| Patient Population -- | No limitations |
| Environment of Use -- | Magnetic resonance (MR) environment up to 3.0 Tesla |

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ASTM F2052-02

1.1

# Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 15-Nov-06

| Device Attributes: | |
|------------------------|----------------------------------------------|
| Design | |
| Configurations offered | Handles, many blades, i.e. Miller, Mac, etc. |
| Cleaning | Cold solution, autoclave |
| Testing | |

In 3.0 Tesla < 45 degree string deflection

# Differences Between Other Legally Marketed Predicate Devices

The NovaMed MRI Conditional laryngoscope set viewed as substantially equivalent to the following predicate device – Minrad – K041852.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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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 consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circular seal. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NovaMed, LLC C/O Mr. Paul Dryden ProMedic, Incorporated 3460 Pointe Creek Court, #102 Bonita Springs, Florida 34134-2015

9 2007 FB

Re: K063477

Trade/Device Name: NovaMed MRI Conditional Laryngoscope Set Regulation Number: 21 CFR 868.5540 Regulation Name: Rigid Laryngoscope Regulatory Class: I Product Code: CCW Dated: November 15, 2006 Received: November 16, 2006

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.

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. Dryden

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 on wor of the Act or any Federal statutes and regulations administered by other Federal squarences. You must comply with all the Act's requirements, including, but not limited to: registeres: and listing (21 CFR Part 807); labeling (21 CFR Part 801); good monufacturing 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 regultion 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/cdrl/industry/support/index.html.

Sincerely yours,

Susan Rummer
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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Premarket Notification 510(k) Section 4 - Indications for Use Statement

## Indications for Use Statement

510(k) Number:

4

K 0634\$^{77}\$ (To be assigned)

NovaMed MRI Conditional

Device Name:

Indications for Use:

The NovaMed MRI Conditional laryngoscope set is used 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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Bump

Margaret Hodge

K063477

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