(30 days)
The PointerShell Universal and PointerShell LS are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation.
Both the instruments 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 - PointerShell Universal and PointerShell LS are reusable instruments intended to be used with the Fiagon Navigation system. The instruments are electromagnetically navigated devices that are
- Instrument adapters (designed for mechanical connection to shavers or surgical instruments a. with different diameters without motor).
Each device incorporates a sensor device, which is tracked by the navigation system with in the lowenergy 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)
This document describes Fiagon GmbH's K160479 510(k) submission for the PointerShell Universal and PointerShell LS, which are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures using electromagnetic navigation.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a dedicated table format. However, it indicates a comparison against the predicate devices. The implicit acceptance criterion for precision/accuracy is that the new devices perform comparably to or better than the predicate devices, which had a mean target registration error of less than 1.5 mm.
| Performance Metric | Acceptance Criteria (Implied from Predicate) | Reported Device Performance (PointerShell Universal) | Reported Device Performance (PointerShell LS) |
|---|---|---|---|
| Bench Accuracy (Mean Target Registration Error) |
§ 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).