STEALTHSTATION SYSTEM
Device Facts
| Record ID | K963173 |
|---|---|
| Device Name | STEALTHSTATION SYSTEM |
| Applicant | Surgical Navigation Technologies, Inc. |
| Product Code | HAW · Neurology |
| Decision Date | Oct 25, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
Device Story
StealthStation™ System; surgical navigation device. Submission adds STERRAD® Sterilization System as validated reprocessing option for specific system components. Validation performed by independent lab per AAMI TIR No. 12-1994 guidelines for reusable medical devices.
Clinical Evidence
Bench testing only; validation of sterilization process performed by independent laboratory in accordance with AAMI TIR No. 12-1994.
Technological Characteristics
Reusable medical device components; sterilization via STERRAD® Sterilization System; validation per AAMI TIR No. 12-1994.
Regulatory Classification
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.
Reference Devices
- StealthStation™ System (previous 510(k) submission)
Submission Summary (Full Text)
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K963173
OCT 25 1996
510(k)
Summary of Safety and Effectiveness
StealthStation™ System Sterilization
I. Company: Surgical Navigation Technologies
530 Compton St.
Broomfield, CO 80020
(303) 439-9709
II. Product Name: StealthStation™ System
III. This submission describes the addition of the STERRAD®* Sterilization System as a sterilization option for certain components of the StealthStation™ System which was cleared in a previous 510(k) submission. This sterilization option was validated by an independent laboratory in accordance with the AAMI TIR No. 12-1994, Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers.
*STERRAD is a registered trademark of Advanced Sterilization Products, a Division of Johnson and Johnson Medical, Inc.
