(130 days)
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.
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This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "MINRAD INC. MR Tested Fiber Optic Short Laryngoscope Handle."
Based on the provided text, there is no study described that proves the device meets specific acceptance criteria in the manner of a performance study for an AI/CADe device.
This document is a regulatory clearance for a traditional medical device (a laryngoscope handle) based on substantial equivalence to a predicate device, not on specific performance metrics from a clinical or technical study outlined in your request. The FDA's determination of substantial equivalence (510(k)) means they believe the new device is as safe and effective as a legally marketed predicate device.
Therefore, I cannot provide the requested information in the table or answer the subsequent questions. The document does not contain:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes for test sets, data provenance, or ground truth.
- Details about expert reviews, adjudication methods, or MRMC studies.
- Any mention of standalone algorithm performance.
- Information about training sets or their ground truth establishment.
The clearance is based on the device conforming to general controls and being equivalent to existing devices, specifically for use in an MRI environment up to 1.5 Tesla. The "indications for use" (Attachment 8, Page 2) simply state its purpose: "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." This is a statement of intended use, not a performance metric or acceptance criteria.
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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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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:_
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