(104 days)
TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Their use is indicated for any medical condition in which the use of navigated surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.
TruDi® Shaver Blades may be used in, but is not limited to, the following procedures:
- · Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty)
- · Drainage of mucoceles or abscesses that have extended from the paranasal sinuses and up to the dura mater
- · Orbital decompression
- · Any other of a number of tumors involving the lateral nasal wall, paranasal sinuses and orbit
- · Access to the sphenoid sinus
The subject device, TruDi® Shaver Blade, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended to be used with the Bien-Air S120 Shaver Handpiece (reference device, K083720) and the TruDi® Navigation System (K192397) to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. The device is tracked by the navigation system within the low energy magnetic field volume generated by the TruDi® Navigation System. The TruDi® Navigation System software displays the position of the shaver blade distal tip on preoperative scans (e.g. CT, MRI). The TruDi® Shaver Blade consists of several configurations ranging from straight to curved blades of different diameters.
The TruDi® Shaver Blade underwent various performance tests to demonstrate its substantial equivalence to its predicate device. This device is an electromagnetically (EM) navigated instrument intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in incision and removal of soft and hard tissue or bone in various ENT and maxillofacial surgeries.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional Specifications | All specified dimensions are within established tolerances. | Met all acceptance criteria for attributes such as dimensional specifications. |
| Electrical Tests | Compliance with relevant electrical safety and performance standards. | Met all acceptance criteria for attributes such as electrical tests. Electrical safety and EMC tests were performed to verify compliance with IEC 60601-1 (3rd Edition) and IEC60601-1-2 (4th Edition). |
| Connector Joint Separation Force | Connector joint separation force meets established minimum requirements to ensure secure connection during use. | Met all acceptance criteria for attributes such as connector joint separation force. |
| Heat Shrink Slip | Heat shrink components remain securely in place, without slipping, under specified conditions. | Met all acceptance criteria for attributes such as heat shrink slip. |
| Strain Relief Axial Force | Strain relief mechanisms exhibit sufficient axial force to prevent damage or unintended disconnections. | Met all acceptance criteria for attributes such as strain relief axial force. |
| Navigational Location Accuracy | Accuracy of the TruDi® Shaver Blade when used with the TruDi® Navigation System is $\le$ 2mm RMS over the entire navigation volume. (Predicate device requirement: 95% confidence / 99.5% reliability, of $\le$ 3.00 mm). | The accuracy of TruDi® Shaver Blade used in conjunction with the navigation views of the TruDi® Navigation System is $ |
§ 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).