(261 days)
The Non-Invasive Patient Tracker is indicated for use as a stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial and ENT software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Skull-Mount Patient Tracker is indicated for use as a stereotactic reference frame to track the position of patient anatomy during navigated cranial and ENT procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial and ENT software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Stylet is indicated for use in precisely locating anatomical structures during navigated cranial procedures. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Stylet is indicated for use in the following procedures:
- General ventricular catheter placement
- Pediatric ventricular catheter placement
- Tumor resections
- Skull base procedures
- Craniotomies/craniectomies
- Transsphenoidal procedures
The Tracer® Pointer is indicated for use in registering patient anatomy and in precisely locating anatomical structures during navigated cranial procedures in adult and pediatric patients. It is indicated for use with Medtronic computerassisted surgery systems using electromagnetic navigation and cranial software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Touch-n-Go Pointer is indicated for use in registent anatomy during navigated cranial procedures in adult and pediatric patients. It is indicated for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and cranial software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Navigation Pointer is indicated for use in precisely locating anatomical structures during navigated cranial procedures. It is indicated for use with Medironic computer-assisted surgery systems using electromagnetic navigation and cranial software.
The Medtronic computer assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT-based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Navigation Pointer is indicated for use in the following procedures:
- General tumor resections
- Pediatric tumor resections
- Skull base procedures
- Craniotomies/craniectomies
- Transsphenoidal procedures
The AxiEM™ Instruments (Stylet, 23cm, Tracer® Pointer, Touch-n-Go Pointer, Navigation Pointer) and Trackers (Skull-Mount Patient Tracker. Non-Invasive Patient Tracker) are singleuse, sterile devices compatible with AxiEM™-enabled Medtronic computer assisted surgery systems. The instruments and trackers are electromagnetically navigated devices used for the purpose of localizing patient anatomy, patient registration, and tracking patient location during stereotactic surgery procedures.
Each device incorporates a tracking system within the instrument or tracker. The mobile emitter of the navigation system generates a low-energy magnetic field that is detected by the tracking system within the device. The navigation system software displays the location of the instrument's tip within multiple patient image planes and other anatomical renderings.
The provided FDA 510(k) summary for the Medtronic Navigation, Inc. devices (Stylet, Tracer® Pointer, Touch-n-Go Pointer, Navigation Pointer, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker) details the acceptance criteria and the studies performed to demonstrate equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implicit from Predicate/Standard) | Reported Device Performance |
|---|---|---|
| System Accuracy | Mean positional 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).