(381 days)
Not Found
Not Found
No
The summary describes a physical laryngoscope and its MR compatibility, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is used for visualization during surgery in an MR environment, not therapy.
No
The device is described as an MR Compatible Laryngoscope intended for "endoscopic visualization and surgery." Its purpose is to allow a user to see and operate, not to diagnose a condition based on derived data or imagery.
No
The device description clearly states it is a physical laryngoscope, which is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic visualization and surgery on the trachea, pharynx and larynx in a MR or an interventional MR environment." This describes a device used directly on or within the patient for visualization and surgical procedures.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro).
- Device Description: The description of a "Laryngoscope" aligns with a medical instrument used for direct visualization of the airway, not for testing biological samples.
- Lack of IVD-related information: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the Greatbatch Scientific MR Compatible Laryngoscope is a medical device used for visualization and surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use in endoscopic visualization and surgery on the trachea, pharynx and larynx in a MR or an interventional MR environment, not to exceed a 1.5 static magnetic field., The Greatbatch Scientific MR Compatible Laryngoscope is intended for use in endoscopic visualization and surgery on the trachea, pharynx and larynx in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.
Product codes
73 CCW
Device Description
The Greatbatch Scientific MR Compatible Laryngoscope is available in standard and autoclavable 8.0mm, 70° angle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea, pharynx and larynx
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
The device was tested for MR Compatibility and was found to be acceptable for use in a 1.5 static magnetic field. MR Safety Testing Summary: Magnetic Attraction and Torque - Static field strength: 1.5 Tesla / GE Signa 64 MHz MR System; Type of test: String deflection; Observed deflection: Very slight; Observed torque: 5 degrees. Artifact - Static field strength: 1.5 Tesla / GE Signa 64 MHz MR System; Sequences: FSPGR; Amount of distortion: ++ in axial plane and ++ in sagittal plane; artifact same as the device ++. RF Heating - Phantom: A 45 liter fluid filled rectangular shaped plastic Plexiglas phantom; Type of RF Coil: Body coil; SAR applied: 1.1 W/kg; Length of time: 26 minutes; Maximum temperature rise observed: 1.1℃C. Gradient Induced Voltage - No phantom tests were conducted.
Key Metrics
Static field strength- 1.5 Tesla / GE Signa 64 MHz MR System. Type of test- String deflection. Observed deflection - Very slight. Observed torque - 5 degrees. Static field strength - 1.5 Tesla / GE Signa 64 MHz MR System. Maximum temperature rise observed - 1.1℃C.
Predicate Device(s)
Optus Laryngoscope
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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APR 3 0 1998
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רר1377
510(k) SUMMARY
GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE
| Submitter Name: | Greatbatch Scientific
Division of Wilson Greatbatch Ltd. | |
|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter Address: | 9645 Wehrle Drive
Clarence, New York 14031 | |
| Contact Person: | Gary J. Sfeir, RAC | |
| Phone Number: | 716.759.5655 | |
| Facsimile Number: | 716.759.5654 | |
| Date Prepared: | 13 April, 1998 | |
| Device Trade Name: | Greatbatch Scientific MR Compatible
Laryngoscope | |
| Device Common Name: | Laryngoscope | |
| Classification Name: | Rigid Laryngoscope | |
| Predicate Devices: | Optus Laryngoscope | |
| Device Description: | The Greatbatch Scientific MR Compatible
Laryngoscope is available in standard and
autoclavable 8.0mm, 70° angle. | |
| Intended Use: | For use in endoscopic visualization and surgery on
the trachea, pharynx and larynx in a MR or an
interventional MR environment, not to exceed a 1.5
static magnetic field. | |
| Device Technological
Characteristics and
Comparison to
Predicate Devices(s): | The device technological characteristics
are similar in design to the predicate device | |
| Performance Data: | The device was tested for MR Compatibility and was
found to be acceptable for use in a 1.5 static magnetic
field. See attached MR Safety Testing Summary. | |
| Conclusion: | The Greatbatch Scientific MR Compatible
Laryngoscope as designed can be used in a MR or an
interventional MR environment not to exceed a 1.5
Tesla static magnetic field. | |
1
GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE MR SAFETY TESTING SUMMARY
Magnetic Attraction and Torque 1 .
| Static field strength- | 1.5 Tesla / GE Signa 64 MHz MR System |
|---|---|
| Type of test- | String deflection |
| Observed deflection - | Very slight |
| Observed torque - | 5 degrees |
2. Artifact
| Static field strength -
Sequences -
| Amount of distortion: | 1.5 Tesla / GE Signa 64 MHz MR System | |
|---|---|---|
| Sequence | axial plane | sagittal plane |
| FSPGR | ++ | ++ |
artifact same as the device ++
3. RF Heating
Phantom: A .
Type of phantom -Type of RF Coil -SAR applied -Length of time -Maximum temperature rise observed -
A 45 liter fluid filled rectangular shaped plastic Plexiglas phantom Body coil 1.1 W/kg 26 minutes 1.1℃C
Gradient Induced Voltage 4 .
No phantom tests were conducted.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, ribbon-like appearance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 30 1998
Mr. Gary J. Sfeir Greatbatch Scientific, Ltd. 4100 Barton Road Clarence, NY 14031
Re: K971377 Magnetic Resonance (MR) Compatible Laryngoscope Requlatory Class: I (one) Product Code: 73 CCW Dated: February 3, 1998 February 4, 1998 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, Druq, 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 aqainst 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 Requlations, 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 requlation 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. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4
INDICATIONS FOR USE
510 (k) Number (if known):
Device Name:
Greatbatch Scientific MR Compatible Laryngoscope
Indications For Use:
The Greatbatch Scientific MR Compatible Laryngoscope is intended for use in endoscopic visualization and surgery on the trachea, pharynx and larynx in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED CONCURRENCE OF CDRH; OFFICE OF DEVICE EVALUATION (ODE) PRESCRIPTION USE NAL FORMAT 1-2-96) (Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number