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The StealthStation™ System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation™ System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy. The StealthStation™ System with the ENT option is also indicated for intranasal or sinus use.

This submission describes updates made to the StealthStation™ System to provide the option for sterilizing instruments using an additional steam autoclave cycle.

This submission is a 510(k) Pre-Market Notification for a sterilization change to the StealthStation™ System. The provided text is a summary of the 510(k) and the FDA's response. It does not contain a study demonstrating device performance against specific acceptance criteria.

The 510(k) states that "Validation information was provided to support the change" regarding the additional steam autoclave cycle. However, the details of that validation information, including acceptance criteria, study design, sample sizes, ground truth, or expert qualifications, are not included in the provided document.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on the regulatory approval for a sterilization change, asserting substantial equivalence to a previously cleared device.

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