(274 days)
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No
The device description and performance studies focus on the physical properties and MR compatibility of a laryngoscope handle, with no mention of AI or ML.
No
Explanation: This device is an intubation aid, not a device that treats a condition or disease. It facilitates a medical procedure rather than providing therapy.
No
The device is a laryngoscope handle, which facilitates tracheal intubation. Its function is to aid in a medical procedure, not to diagnose a condition or disease. The "Performance Studies" section focuses on safety in an MRI environment (artifact, heating, attraction), not on diagnostic accuracy.
No
The device description explicitly states it is a physical handle manufactured from brass and chrome plated, and uses a proprietary "c" size cell for the light source. This indicates it is a hardware device, not software only.
Based on the provided information, 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 Greatbatch Scientific MR Fiber Optic Laryngoscope Handle is a tool used to facilitate tracheal intubation. It is a physical instrument used directly on a patient, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for aiding in tracheal intubation in an MRI/MR environment. This is a procedural aid, not a diagnostic test.
The information provided describes a medical device used for a procedure, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
The MR Fiber Optic Intubating Laryngoscope Handle when used with the laryngoscope blades stated in the package insert will be used to facilitate and aid in tracheal intubation in a MRI or an interventional MR environment, not to exceed a 1.5 Tesla static magnet field.
The Greatbatch Scicntific MR Fiber Optic Laryngoscope Handle when used with a green color marking blade system, is intended 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 magnet field.
Product codes (comma separated list FDA assigned to the subject device)
73 CCW
Device Description
The MR Fiber Optic Intubating Laryngoscope consists of a handle which is manufactured from brass and is chrome plated. The cell used to provide the light source energy is a proprietary "c" size cell.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Greatbatch Scientific MR Fiber Optic Intubating Laryngoscope was tested in the center of a 1.5 Tesla static magnetic field, to assess artifact, RF Heating and the presence of attraction to the magnet. The device displayed an artifact level of twice the size of the device, less than 1° C of RF Heating, and a 4° angle of attraction. The device exhibited a 0° angle of attraction at the portal and at 15cm outside the magnet, which is the area of intended use. This device has been tested according to ASTM Standards F 965 and F 1185 and MR safety testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
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510(k) SUMMARY MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE
| Submitter Name: | Greatbatch Scientific
a division of Wilson Greatbatch Ltd. |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 4100 Barton Road
Clarence, New York 14031
NOV 19 1997 |
| Contact Person: | Gary J. Sfeir, RAC |
| Phone Number: | 716.759.5277 |
| Facsimile Number: | 716.759.5280 |
| Date Prepared: | 6 October, 1997 |
| Device Trade Name: | MR Fiber Optic Intubating Laryngoscope Handle |
| Device Common Name:
Classification Name: | Laryngoscope
Rigid Laryngoscope |
| Predicate Devices: | Fiber Optic Laryngoscope
Welch Allyn, Inc.
Sun Lite™ Laryngoscope
Sun Med, Inc.
Heine Fiber Optic Laryngoscope
Heine USA Ltd. |
| Device Description: | The MR Fiber Optic Intubating Laryngoscope consists of a handle
which is manufactured from brass and is chrome plated. The cell
used to provide the light source energy is a proprietary "c" size
cell. |
| Intended Use: | The MR Fiber Optic Intubating Laryngoscope Handle when used with
the laryngoscope blades stated in the package insert will be used to
facilitate and aid in tracheal intubation in a MRI or an
interventional MR environment, not to exceed a 1.5 Tesla static
magnet field. |
| Device Technological | The technological characteristics of all of the devices are similar in
design. The Greatbatch Scientific MR Fiber Optic Intubating
Laryngoscope was tested in the center of a 1.5 Tesla static magnetic
field, to assess artifact, RF Heating and the presence of attraction to
the magnet. The device displayed an artifact level of twice the size
of the device, less than 1° C of RF Heating, and a 4° angle of
attraction. The device exhibited a 0° angle of attraction at the
portal and at 15cm outside the magnet, which is the area of intended
use. |
| Predicate Devices(s):
Performance Data: | This device has been tested according to ASTM
Standards F 965 and F 1185 and MR safety testing |
1
The Greatbatch Scientific MR Fiber Optic Intubating Laryngoscope Conclusion: Handle is substantially equivalent in design and intended use to the predicate devices listed above. The only difference is that the Greatbatch Scientific MR Fiber Optic Laryngoscope can be safely used in a MRI or an interventional MR environment, not to exceed a 1.5 Tesla static magnetic field.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 19 1997
Mr. Gary J. Sfeir Greatbatch Scientific, Inc. 4100 Barton Road 14031 Clarence, New York
K970619 Re: MR Fiber Optic Laryngoscope Handle Regulatory Class: I (one) Product Code: 73 CCW October 6, 1997 Dated: October 8, 1997 Received:
Dear Mr. Sfeir:
.. .
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Gary J. Sfeir
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callhhan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Greatbacch Scientific Greatbatch Scientific MRI Compatible Fiber Optic Laryngoscope Handle 510(K) Premarket Notification
SECTION 4
INDICATIONS FOR USE
510 (k) Number (if known):
Device Name:
Greatbatch Scientific MR Fiber Optic Laryngoscope Handle
Indications For Use:
The Greatbatch Scicntific MR Fiber Optic Laryngoscope Handle when used with a green color marking blade system, is intended 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 magnet field.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH; OFFICE OF DEVICE EVALUATION (ODE)
| PRESCRIPTION USE | OR... | OVER-THE-COUNTER USE | |
|---|---|---|---|
| ------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------- | ---------------------- |
| Christy Forman (OPTIONAL FORMAT 1-2-96) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices |