STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE

• K Number: K022414
• Device Name: STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE
• Manufacturer: MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
• Date Cleared: 2002-08-14 ( 21 days)
• Product Code: HAW
• Regulation Number: 882.4560
• Type: Special
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

The StealthStation® System is intended as an aid for precisely locating anatomical structures 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 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 or fluoroscopy images of the anatomy.

Example procedures include, but are not limited to:

Cranial Procedures: Cranial Biopsies, Tumor Resections, Craniotomies/ Craniectomies, Skull Base procedures, Thalamotomies/Pallidotomies, Pituitary Tumor Removal, CSF Leak Repair

Spinal Procedures: Spinal Implant Procedures, such as Pedicle Screw Placement

ENT Procedures: Transphenoidal Procedures, Intranasal Procedures, Orbital Decompression Procedures, Optic Nerve Decompression Procedures, Polyposis Procedures, Endoscopic Dacryocystorhinostomy, Encephalocele Procedures, Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies

Orthopedic Procedures: Total Knee Arthroplasty (Primary and Revision), Unicompartmental Knee Arthroplasty

Device Description

This submission describes updates made to the StealthStation® System to include an interface that enables the StealthStation® System to cohesively communicate with a Three Dimensional C-Arm.

AI/ML Overview

The provided text is a 510(k) summary for the StealthStation® System Three Dimensional C-Arm Interface. It describes a device modification and claims substantial equivalence to previously cleared devices. However, it does not contain any information regarding acceptance criteria, device performance metrics, or any specific study results demonstrating that the device meets defined acceptance criteria.

The document primarily focuses on:

• Identification of the device and manufacturer.
• Contact information.
• Product name and classification.
• Description of the device modification: an interface enabling communication between the StealthStation® System and a Three Dimensional C-Arm.
• Claim of substantial equivalence to previous StealthStation® System devices, stating that "all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence."
• Indications for Use, which are identical to the predicate device.
• FDA's clearance letter, confirming substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I populate the table. The provided text lacks the necessary information for these points.

Regulation Number and Section

§ 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).