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 I
| Device Type ID | 1646 |
| Device Name | Ear, Nose, And Throat Stereotaxic Instrument |
| 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 Description | Stereotaxic Instrument. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.4560 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PGW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1646 |
| Device | Ear, Nose, And Throat Stereotaxic Instrument |
| Product Code | PGW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Stereotaxic Instrument. |
| CFR Regulation Number | 882.4560 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACCLARENT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIOSENSE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOSENSE WEBSTER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FIAGON GMBH | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
KARL STORZ GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER CORPORATE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Imprecision | 55 |
Communication Or Transmission Problem | 44 |
Device Operates Differently Than Expected | 39 |
Human-Device Interface Problem | 25 |
Device Stops Intermittently | 20 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 16 |
Mechanical Problem | 15 |
Computer Software Problem | 8 |
Device Displays Incorrect Message | 8 |
Output Problem | 7 |
Emitter | 6 |
CPU (Central Processing Unit Of Computer System) | 6 |
Electrical /Electronic Property Problem | 4 |
No Display / Image | 4 |
Display Or Visual Feedback Problem | 4 |
Material Deformation | 4 |
Application Program Problem | 3 |
Image Orientation Incorrect | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Device Inoperable | 3 |
Material Integrity Problem | 2 |
Cable | 2 |
Bent | 2 |
Application Program Freezes, Becomes Nonfunctional | 2 |
Intermittent Communication Failure | 2 |
Erratic Or Intermittent Display | 2 |
Image Display Error / Artifact | 2 |
Power Cord | 1 |
Monitor | 1 |
Environmental Compatibility Problem | 1 |
Installation-Related Problem | 1 |
Device Issue | 1 |
Computer Hardware | 1 |
Suction Problem | 1 |
Fracture | 1 |
Kit | 1 |
Data Problem | 1 |
| Total Device Problems | 301 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Navigation, Inc. | II | Aug-21-2017 |
| 2 | Stryker Instruments Div. Of Stryker Corporation | II | Apr-19-2017 |