(85 days)
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.
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.
The NovaMed MRI Conditional Laryngoscope set was evaluated for safety in a Magnetic Resonance (MR) environment up to 3.0 Tesla. The primary study was to determine the device's magnetic attraction in this environment.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| < 45 degree string deflection | In 3.0 Tesla < 45 degree string deflection (Implied: Passed) |
2. Sample Size and Data Provenance
The document does not specify the exact sample size used for the test set of laryngoscope components. It states "many handle and blade configurations offered" were tested.
The data provenance is not explicitly stated as retrospective or prospective, nor the country of origin. However, the study involves testing the physical device in a lab setting rather than clinical patient data. The standard used, ASTM F2052-02, is an American Society for Testing and Materials standard.
3. Number and Qualifications of Experts for Ground Truth
This information is not provided. The ground truth for this type of test (magnetic attraction) is objectively measured based on physical properties and adherence to the ASTM standard, rather than expert consensus on medical image interpretation.
4. Adjudication Method
This information is not applicable for this type of physical device testing. The results of the magnetic attraction test against the ASTM standard are objective measurements, not subject to adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not conducted. This device is a physical instrument, and its performance regarding magnetic safety is determined by objective physical testing, not by human reader interpretation of images. The device facilitates a medical procedure; it is not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical medical instrument, not an algorithm or software. Its performance is inherent to its material properties and design.
7. Type of Ground Truth Used
The ground truth used is based on objective physical measurements related to magnetic attraction as defined by the ASTM F2052-02 standard. This standard specifies a method for measuring the magnetic attraction of medical devices in an MR environment.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI model requiring a training set.
9. How Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a physical medical instrument.
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Premarket Notification 510(k) Section 5 -- 510(k) Summary
. . .
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 tofacilitate and aid in tracheal intubation in a MagneticResonance (MR) environment, not to exceed a 3.0 Teslastatic 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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
Page 1 of 1
§ 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