(62 days)
The devices FlexPointer 1.5 Single Use and FlexTube 3 Single Use are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The devices are indicated for use with the Fiagon Navigation system using electromagnetic navigation.
The devices are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to:
ENT Procedures;
Transphenoidal access procedures.
Intranasal procedures.
Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies.
ENT related anterior skull base procedures.
The Fiagon Navigation - FlexPointer 1.5 Single Use and FlexTube 3 Single Use are disposable instruments intended to be used with the Fiagon Navigation system. The FlexPointer 1.5 Single Use is an electromagnetically navigated pointing device (malleable, sensor within the tip). The FlexTube 3 Single Use is an electromagnetically navigated suction device (malleable, sensor within the tip).
Each device incorporates a sensor device, which is tracked by the navigation system within the low-energy magnetic field of a field generator (part of the navigation system). The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy).
The provided text describes a 510(k) submission for the Fiagon Navigation - FlexPointer 1.5 Single Use and FlexTube 3 Single Use devices. The primary purpose of the submission is to gain clearance for modified versions of previously cleared instruments, specifically a change in material and a change from reprocessed to sterile, single-use, disposable devices. The FDA's review determines substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study proving compliance, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria. However, it states the performance benchmark for accuracy.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Mean accuracy of the device on an anatomical phantom (mean target registration error on fiducial markers) |
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).