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To be used as a general purpose suction and/or irrigation device during open or laparoscopic surgical procedures; including general, gynecologic, thoracic, otolaryngologic, plastic and urologic.

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This FDA document is a 510(k) clearance letter for the VTI Suction Irrigation System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document provided does not contain any information regarding specific acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications. The letter is an administrative notification of clearance and refers to a premarket notification, but the content of that notification (which would contain the study details) is not included here.

Therefore, I cannot fulfill your request for the tables and study descriptions based solely on the provided text.

To answer your request, I would need access to the actual 510(k) premarket notification (K141323) submitted by Vascular Technology, Inc. to the FDA. This notification would typically include:

• A summary of the non-clinical and/or clinical performance data.
• A comparison to a predicate device, including performance data.
• The deemed acceptance criteria for performance.
• The details of any validation studies performed.

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