(200 days)
Not Found
Not Found
No
The summary describes a physical endoscopic device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is an endoscope used for visualization during sinus surgery and does not directly provide therapy.
No
The device is described as a sinuscope used for surgery, specifically sinus endoscopy surgery. Its purpose is interventional rather than diagnostic, despite being used in a medical environment.
No
The device description explicitly states it is available in physical sizes and angles, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "sinus endoscopy surgery in a MR or an interventional MR environment." This describes a surgical procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is a "Sinuscope," which is an instrument used to visualize the inside of the nasal cavity and nasal pharynx. This is a direct visualization tool, not a device used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
Therefore, the Greatbatch Scientific MR Compatible Sinuscope is a surgical instrument used for visualization during a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use by practitioners to examine and treat a patient's nasal cavity and nasal pharynx in a MR or an interventional MR environment, not to exceed a 1.5 Tesla static magnetic field.
The Greatbatch Scientific MR Compatible Sinuscope is intended for use in sinus endoscopy surgery in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.
Product codes
77 EOB
Device Description
The Greatbatch Scientific MR Compatible Sinuscope is available in standard and autoclavable 2.7mm and 4.0mm sizes, with 0°, 30° or 70° angles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal cavity, nasal pharynx, sinus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
practitioners, MR or an interventional MR environment
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)
The device was tested for MR Compatibility and was found to be acceptable for use in a 1.5 Tesla static magnetic field.
Magnetic Attraction and Torque:
Static field strength: 1.5 Tesla / GE Signa 64 MHz MR System
Type of test: String deflection
Observed deflection: None
Observed torque: None
Artifact:
Static field strength: 1.5 Tesla / GE Signa 64 MHz MR System
Sequences:
FSPGR: artifact same as the device in axial_plane and sagittal plane
T1 spin echo: artifact same as the device in axial_plane and sagittal plane
T1 fast spin echo: artifact slightly larger than size of the device in axial_plane and sagittal plane
RF Heating:
Phantom Test:
Type of phantom: A rectangular-shaped plastic Plexiglas phantom filled with 45 liters of physiologic saline
Type of RF Coil: Body coil
SAR applied: 1.1 W/kg
Length of time: 26 minutes
Maximum temperature rise observed:
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
510(k) SUMMARY GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
| Submitter Name: | Greatbatch Scientific
a division of Wilson Greatbatch Ltd. |
|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 4100 Barton Road
Clarence, New York 14031 |
| Contact Person: | Gary J. Sfeir, RAC |
| Phone Number: | 716.759.5277 |
| Facsimile Number: | 716.759.5280 |
| Date Prepared: | 17 October, 1997 |
| Device Trade Name: | Greatbatch Scientific MR Compatible Sinuscope |
| Device Common Name: | Sinuscope |
| Classification Name: | Nasopharyngoscope |
| Predicate Devices: | Optus Sinuscope and Accessories |
| Device Description: | The Greatbatch Scientific MR Compatible Sinuscope is
available in standard and autoclavable 2.7mm and 4.0mm sizes, with
0°, 30° or 70° angles. |
| Intended Use: | For use by practitioners to examine and treat a patient's nasal cavity and
nasal pharynx in a MR or an interventional MR environment, not to
exceed a 1.5 Tesla 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 Tesla static magnetic field. See attached MR
Safety Testing Summary. |
| Conclusion: | The Greatbatch Scientific MR Compatible Sinuscope and Accessories
as designed can be used in a MR or an interventional MR environment
not to exceed a 1.5 Tesla static magnetic field. |
1
MR COMPATIBLE SINUSCOPE 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 - | None |
| Observed torque - | None |
2. Artifact
Static field strength -1.5 Tesla / GE Signa 64 MHz MR System 3 Sequences -Amount of distortion:
| Sequence | axial_plane | sagittal plane |
|---|---|---|
| FSPGR | 444 | ++++ |
| T1 spin echo | 1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| T1 fast spin echo | ++ | ++ |
- artifact same as the device ++ artifact slightly larger than size of the device ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
Heating 3. RF
Phantom: A .
| Type of phantom - | A rectangular-shaped plastic Plexiglas
phantom filled with 45 liters of physiologic
saline |
|----------------------------------------|--------------------------------------------------------------------------------------------------|
| Type of RF Coil - | Body coil |
| SAR applied - | 1.1 W/kg |
| Length of time - | 26 minutes |
| Maximum temperature
rise observed - |