| Device |
ear, nose, and throat stereotaxic instrument |
| Regulation Description |
Stereotaxic instrument. |
| Definition |
Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy. |
| Physical State |
Navigation computing platform with navigation software, providing interfaces for screen and input devices including a navigation sensor, a navigation instrument and a patient reference localizer. |
| Technical Method |
The device measures the position of the surgical instrument and the position of the patient using a position measurement sensor. |
| Target Area |
Ear, nose and throat |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Ear Nose & Throat |
|---|
| Product Code | PGW |
|---|
| Premarket Review |
Division of Dental and ENT Devices
(DHT1B)
Division of Dental and ENT Devices
(DHT1B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.4560
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
