(76 days)
This device is indicated for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan Ultrasound/ system. This device is indicated for performing planned and targeted ultrasound guided transrectal biopsies of the prostate when used with the Envisioneering TargetScan model TS-360-P probe.
The sterile TargetScan™ Biopsy needle Guide is designed to be used with the Targetscan™ Transrectal Ultrasound system. This needle guide contains a curved needle path which is positioned along the shaft of the probe and is held in place by a biopsy attachment. It allows a flexible biopsy needle to be directed into the tissue at an angle to the probe shaft.
This needle quide is intended for use with the TargetScan™ transrectal probe Model #TS-360-P which is the subject of a separate submission.
The provided text describes a 510(k) summary for the TargetScan™ Biopsy Needle Guide. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.
The document states that the TargetScan™ Biopsy Needle Guide is intended for use with the Envisioneering TargetScan Ultrasound system (specifically the TS-360-P probe) for performing planned and targeted ultrasound-guided transrectal biopsies of the prostate. It also identifies the Civco Transrectal Needle Guide (K970514) as the predicate device.
The FDA's letter (K041637) confirms that the device has been found substantially equivalent to legally marketed predicate devices based on the indications for use. This means the FDA determined that the new device is as safe and effective as a legally marketed device and does not require premarket approval (PMA).
Because the provided text is a 510(k) summary and FDA clearance letter, it primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.
Therefore, I cannot provide the requested information in a table or structured response as it is not present in the input. If this information were available, it would typically be found in sections describing performance data, clinical studies, or non-clinical tests.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.