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The ProSense cryoablation system is indicated for the local treatment of breast cancer in patients ≥70 years of age with biologically low-risk tumors ≤1.5 cm in size and treated with adjuvant endocrine therapy, including patients not suitable for surgery for breast cancer treatment.

Biologically low-risk breast cancer is defined as unifocal tumor, size ≤1.5 cm, ER-positive, PR-positive, HER2-negative, Ki-67<15% and/or genomic testing indicative of low-risk breast cancer, infiltrating ductal carcinoma (excluding lobular carcinoma, extensive intraductal component, or evidence of lymphovascular invasion), and clinically negative lymph node (N0).

The ProSense cryoablation system (Figure 1), previously cleared in K183213, is intended to destroy tissue by cooling the selected target to extremely low temperatures using pressurized liquid nitrogen and a single-use, disposable cryoprobe (Figure 2). Depending on the intended surgical use, the user can select from an array of cryoprobes with different gauges (10 G or 13 G), ice ball shapes (spherical or elliptical), and shaft lengths (ranging 124-185 mm). For the intended use in this De Novo submission, local treatment of breast cancer, a 10 G cryoprobe with elliptical ice ball shape and 140 mm shaft length (FAP7200000) is the only cryoprobe validated for use.

During a cryoablation procedure for the local treatment of breast cancer, the cryoprobe is inserted (with or without an introducer) through a small opening in the skin created by a surgical scalpel and advanced through underlying breast tissue, directly into the cancerous tumor. Under ultrasound visualization, the cryoprobe cooling zone is centered in all three planes of the lesion (sagittal, transverse, and anterior-posterior) based upon a calculation that relates the specifications of the selected cryoprobe with the tumor and anatomical site dimensions. The cancerous tissue is then frozen to sub-zero temperatures by the liquid nitrogen ice ball, which is formed on the cryoprobe around the cooling zone center. The cooling zone center of the cryoprobes reaches a minimum of -170°C.

The device has a manual mode and an automatic mode which determine the number and duration of freeze and thaw steps. The quick-freezing cycle causes ice crystal formation within the affected cells and consequent cell expansion, effectively destroying the tissue. Tumors are typically ablated in two freeze-thaw cycles, achieving a core temperature of -150°C or lower. Default treatment times are 9 minutes for each freeze cycle and 8 minutes for the thaw cycle. However, since the ice ball growth varies from patient to patient, treatment times can be adjusted at the operator's discretion. The system allows up to seven freeze-thaw steps. After completion of the procedure, the probe is extracted at a probe tip temperature no higher than 35°C. The procedure for local treatment of breast cancer typically takes 20 – 40 minutes.

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