(27 days)
The Interstitial Needles are used with Varian High Dose Rate Afterloaders.
The device is a family of closed-ended, interstitial needles and associated obturators to be used in conjunction with a high dose rate (HDR) brachytherapy afterloading device. The needles are available in either 17 gauge O.D. or 18 gauge O.D. and in lengths of 113mm, 200 mm, 250mm and 320mm. The associated obturators are inserted into needles to stiffen the needles during implantation of the needles into the patient and to stiffen the needles between radiation therapy fractions. The obturators are available in lengths of 113mm, 200 mm, 250mm and 320mm. The needles are provided unsterile with instructions for steam sterilization. The obturators are provided unsterile with instructions for steam sterilization.
The provided document is a 510(k) Premarket Notification for "Varian Interstitial Needles." This type of document is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies with detailed acceptance criteria and performance evaluation against those criteria in the way a diagnostic AI device would.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or comparative effectiveness studies. The provided text is a regulatory submission for a physical medical device (needles) and not an AI or software-as-a-medical-device (SaMD) product that would typically involve such detailed performance studies.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.