# DEN220077: ProSense™ System

- Pathway: De Novo (Direct)
- Applicant: Icecure Medical
- Decided: Oct 3, 2025 after 1,080 days
- Product code: QXW (Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer)
- Device class: 2
- Regulation: 21 CFR 878.4355
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
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).

Source page: https://510kreport.com/device/DEN220077
Methodology: https://510kreport.com/methodology