OncoPatch

OncoPatch is a surface brachytherapy device that delivers low-energy beta radiation from yttrium-90 (Y-90) to treat localized skin tumors such as basal cell carcinoma, squamous cell carcinoma, and keloids. The device uses radioactive foils adhered to a shielded applicator with collimators to concentrate radiation to the epidermis and upper dermis while sparing deeper tissues, and is applied temporarily to the skin for single or multiple treatment fractions typically lasting less than 60 minutes.

OncoPatch uses yttrium-90 (Y-90) as the radionuclide source in a foil-array configuration, whereas the predicate uses phosphorus-32 (P-32) in a planar array. Both deliver 200 mCi of beta radiation and share identical classification, intended use, and mode of use (Rx only). OncoPatch has a higher endpoint energy (2.28 MeV vs. 1.71 MeV) and uses composite tungsten collimators, photopolymer shielding, and neodymium magnets rather than polymeric film and silicone.

Testing was conducted per ISO 14971:2019 risk management, ASTM D7386-16 for simulated distribution and package integrity, and ISO 10993-18 for material characterization and biocompatibility. Testing included bench studies on shielding and bremsstrahlung attenuation, dose distribution accuracy, simulated-use testing on anatomically relevant phantoms, and package integrity assessment.

OncoPatch is substantially equivalent to the RIC Conformal Source Model 100 (K090321) because both are surface brachytherapy systems using beta-emitting radionuclides for temporary, non-invasive treatment of superficial tumors with identical intended use and therapeutic mechanism. Differences in radionuclide type, source configuration, and shielding materials do not raise new safety or effectiveness questions, as demonstrated by comprehensive non-clinical testing showing comparable dose delivery, shielding, mechanical stability, and biocompatible materials.