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The UC-CARE Positioning System is a mechanical positioning device, introduced into the urethra as a sterile urological catheter for visualizing the urethral course, aimed for assistance in diagnostic or therapeutic endorectal ultrasound-guided prostate procedures. The device is retained in place by inflating the balloon tip and by attaching it over an ultrasound-stepper and stabilizer with a Brachy-like template.

The UCP System is a positioning device used to outline the urethral course during diagnostic or therapeutic transperineal ultrasound-guided prostate procedures. The UCP System combines the function of a positioning and imaging-visibility enhancing device with the configuration of a urological Foley catheter. The configuration and material composition of the patient contact portion of the UCP System part are identical to a commercially available (FDA cleared) urological catheter including a balloon retention mechanism. The device is comprised of two main components: the Urethral Catheter and the Catheter Holder. The device is used together with any commercial endorectal ultrasound stepper and stabilizer as well as brachy-like template grid, available in the market for a transperineal prostate biopsy, brachytherapy, or cryotherapy. The use of the device facilitates simple and safe transperineal needle insertion for diagnostic and therapeutic prostate procedures. The UCP System's Catheter is introduced into the urethra as a sterile urological catheter and is retained in place by inflating the balloon tip and by the Catheter Holder, which is mounted over the ultrasound stepper and stabilizer.

The provided document is a 510(k) Summary for the UC-CARE Positioning System. It is a premarket notification for a medical device and therefore does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria.

The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than to prove its performance against specific acceptance criteria through a dedicated clinical study.

Therefore, the requested information regarding acceptance criteria, device performance, study details, and related elements cannot be extracted from this document, as it is not part of a 510(k) submission's scope.

Specifically, the document states:

• "UC-CARE Ltd. believes that, based on the information provided in this submission, the UCP System is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness concerns." (Page 1)
• The FDA letter confirms, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." (Page 2)

This indicates a regulatory clearance based on substantial equivalence, not a performance study against acceptance criteria.

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