(29 days)
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.
The MR Fiber Optic Intubating Laryngoscope Handle, Standard
This document is a 510(k) summary for a medical device called the "MINRAD INC.'s MR Fiber Optic Intubating Laryngoscope Handle, Standard." It outlines the device's information, intended use, and substantial equivalence to predicate devices, leading to its clearance by the FDA in 2006.
1. Table of acceptance criteria and the reported device performance
This document does not list specific acceptance criteria related to quantifiable performance metrics (e.g., accuracy, precision, sensitivity, specificity) or any reported device performance data in that context. The clearance is based on substantial equivalence, implying the device performs similarly to predicate devices without needing a new clinical performance study for this specific 510(k). The primary "acceptance criteria" for this submission are related to its similarity in technological characteristics and intended use to existing, legally marketed devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) summary does not describe a clinical study with a test set in the traditional sense of evaluating performance metrics like sensitivity or specificity. The submission is based on demonstrating substantial equivalence to predicate devices, not on original clinical performance data for the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As noted above, there is no mention of a test set with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical medical instrument (a laryngoscope handle), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is described as having been established for this submission.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would require a training set.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth for it is relevant to this device submission.
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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.
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: 716-855-1068 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 -
- Common or Usual Name
Laryngoscope, Rigid
- Common or Usual Name
-
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 (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 (240) 276-3150 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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ction of Anesthesiology, General Hospital, cotion Control, Dental Devices
Number: K 062231
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