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The SELECTOR® Quantum Ultrasonic Aspirator System is indicated for use in surgical procedures where fragmentation emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.

The SELECTOR® Ouantum Ultrasonic Aspirator System dissects and fragments soft tissue and leaves essential elastic structures such as nerves and blood vessels relatively undamaged. It is particularly useful for the ablation of unwanted tissue adjacent or attached to vital structures. The system consists of a Console, which provides control and display of aspiration, irrigation and ultrasonic power, and one or more Handpieces for selective tissue removal at the surgical site. The handpieces have a titanium tip and silicone irrigation flue. The tips are interchangeable which allows the surgeon to use the same handpiece for different applications. The required settings on the Console are selected by operation of up-down controls on the front panel. The Console provides power to the footswitch, which has two controls. One pedal provides proportional control of ultrasonic power, and the other the flow of irrigation fluid. An accessory Service Module may be used to provide a convenient source of suction and waste collection. A range of handpieces are connected to the console, both electrically and by a disposable sterile tubing kit which delivers sterile saline for irrigation, and removes aspirated waste matter. A special version of the Selector system will be available for use within an MRI suite. All handpieces may be sterilized by steam autoclaving or by Ethylene Oxide.

This 510(k) summary for the SELECTOR® Quantum Ultrasonic Surgical Aspirator System does not provide the detailed acceptance criteria and study results in the format requested, as it is a premarket notification for a medical device seeking substantial equivalence to existing devices rather than a report on a clinical trial with specific performance metrics.

However, I can extract information related to performance and safety, and how the device's characteristics compare to predicate devices. It focuses on the device's technical specifications and adherence to relevant standards rather than a study with specific performance numbers against defined acceptance criteria.

Here's an attempt to structure the available information regarding "acceptance criteria" and "device performance" based on the provided text, recognizing that these terms are interpreted within the context of a 510(k) submission for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically inferred from the technical specifications of the predicate devices and relevant performance standards. The "reported device performance" is demonstrated by the new device meeting or being comparable to these specifications and standards.

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