(200 days)
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.
The Greatbatch Scientific MR Compatible Sinuscope is available in standard and autoclavable 2.7mm and 4.0mm sizes, with 0°, 30° or 70° angles.
Here's a breakdown of the acceptance criteria and study information for the Greatbatch Scientific MR Compatible Sinuscope, based on the provided documents:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| MR Compatibility | Acceptable for use in a 1.5 Tesla static magnetic field | Found to be acceptable for use in a 1.5 Tesla static magnetic field. The device can be used in an MR or interventional MR environment not to exceed a 1.5 Tesla static magnetic field. |
| Magnetic Attraction | No observed string deflection | None |
| Magnetic Torque | No observed torque | None |
| Artifact | Not explicitly specified, but implied to be minimal | For T1 spin echo, artifact was the same size as the device (1). For FSPGR and T1 fast spin echo, artifact was slightly larger than the device (444 for FSPGR, ++ for T1 fast spin echo). The specific numeric values (e.g., 444) for artifact size are not fully explained but indicate a relatively small field of distortion. No absolute maximum artifact size is given. |
| RF Heating | Maximum temperature rise |
§ 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.