(29 days)
Not Found
No
The 510(k) summary describes a physical medical device (laryngoscope handle) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No.
The device, a laryngoscope handle, is used to facilitate tracheal intubation, which is a diagnostic or procedural aid, not a therapeutic treatment itself.
No
The device is used to aid in tracheal intubation, which is a therapeutic or procedural action, not a diagnostic one.
No
The device description explicitly states it is a "Laryngoscope Handle," which is a physical hardware component used in conjunction with a blade for intubation. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a laryngoscope handle used to facilitate tracheal intubation. This is a medical procedure performed directly on a patient, not a test performed on a sample outside the body.
- Intended Use: The intended use is to aid in a medical procedure (intubation) within a specific environment (MRI/MR), not to diagnose or detect a condition from a biological sample.
Therefore, based on the provided information, this device falls under the category of a medical device used for a procedural purpose, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MR MR MR Fiber Optic Intubating Laryngoscope Handle, Short ("MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Short") 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 3.0 Tesla static magnetic field.
Product codes (comma separated list FDA assigned to the subject device)
CCW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI) or an interventional Magnetic Resonance (MR)
Anatomical Site
tracheal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K041852, Laryngoscope, Welch Allyn Laryngoscope, Sun Med
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
0
Image /page/0/Picture/0 description: The image shows a logo for MINRAD INC. The logo features the company name in bold, sans-serif font, with the "INC." abbreviation smaller and slightly offset. 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 circle, ending in a solid dot.
K06230
ATTACHMENT 6
510(k) SUMMARY
AUG 3 1 2006
11 - 1 - 1 - 1 - 1
MINRAD INC.'s MR Fiber Optic Intubating Laryngoscope Handle, Short
- 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
MR Fiber Optic Intubating Laryngoscope Handle, Short
- Name of Device
-
Common or Usual Name 3.
Laryngoscope, Rigid -
Classification Name 4.
Laryngoscope, Rigid (21 CFR 868.5540, Product Code CCW) -
- Predicate Devices
MINRAD INC. MR Tested Fiber Optic Short Laryngoscope Handle (K041852) Laryngoscope, Welch Allyn Laryngoscope, Sun Med
- Predicate Devices
-
- Intended Use
MR Fiber Optic Intubating Laryngoscope Handle, Short The ("MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Short") 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.
- Intended Use
1
Image /page/1/Picture/0 description: The image shows a logo for MINRAD INC. The logo features the word "MINRAD" in bold, sans-serif font, with "INC." in a smaller font size below it. 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 smaller, 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, Short.
The MR Fiber Optic Intubating Laryngoscope Handle, Short is substantially equivalent to the other currently marketed Laryngoscope Handles, which are referenced above. The MR Fiber Optic Intubating Laryngoscope Handle, Short and its predicate devices are all Laryngoscopes. Thus, the MR Fiber Optic Intubating Laryngoscope Handle, Short raises no new issues of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines forming the body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white.
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: K062230
Trade/Device Name: Minrad Inc. MR Fiber Optic Intubating Laryngoscope Handle, Short 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.
3
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,
Shi-Jinn PhD
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
4
ATTACHMENT 7
Indications for Use
510(k) Number (if known):
Device Name: MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Short
Indications for Use:
The MR MR MR Fiber Optic Intubating Laryngoscope Handle, Short ("MINRAD INC. MR Fiber Optic Intubating Laryngoscope Handle, Short") 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 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)
:
Cion Sign-Off)
sion of Anesthesiology, General Hospital,
cction Control, Dental Devices
) Number: K062230
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