Mould Probe MR Safe

The Mould Probe MR Safe is a brachytherapy applicator that guides radioactive sources to treatment locations during cancer therapy. It is intended for intraoperative radiation therapy (IORT), interstitial and intraluminal treatments, and superficial disease treatments using high-dose-rate (HDR) or pulsed-dose-rate (PDR) brachytherapy. The device is made from non-metallic elastomer material with stabilizing stainless steel mandrins and is sterilizable, biocompatible for up to 24 hours patient contact, and now MR Safe without the mandrins.

The primary change is the probe connector material, switched from titanium to PEEK (polyetheretherketone), which eliminates magnetic properties and renders the device MR Safe rather than MR Conditional. The 2.8 mm diameter size was discontinued. The single-use limitation for the 1.8 mm probe was removed because cleaning validation demonstrates it can be reused for 25 cycles. The mandrin is now included as a principal component rather than a separately cleared device. The biocompatibility contact duration was reduced from 7 days to 24 hours for the 1.8 mm probe.

Biocompatibility testing per ISO 10993-1:2020 including cytotoxicity, irritation, delayed hypersensitivity, material-mediated pyrogens, and acute systemic toxicity. Sterilization and reprocessing per ANSI/AAMI and ASTM standards. Electrical safety and electromagnetic compatibility per IEC 60601-1 and IEC 60601-2-17. Quality management per ISO 13485 and risk management per ISO 14971. Additional standards include ISO 17664 and 17665 for reprocessing and ISO 11737 for sterilization validation.

The intended use and indications for use remain identical to the predicate device (Mould Applicator Set K162615). The device principle of operation is unchanged—it functions to guide radioactive sources to treatment locations. Although the connector material changed from titanium to PEEK, this modification improves the device's MR safety profile without compromising its core function or safety. The removal of the single-use restriction is supported by validated cleaning procedures demonstrating 25 reuse cycles. All performance testing, biocompatibility studies, and conformance to relevant safety standards demonstrate the device meets established safety criteria and performs equivalently to or better than the predicate.