DEN220077 is an FDA 510(k) submission for the ProSense™ System. This device is classified as a Cryoablation Device For Local Treatment Of Low-risk Breast Cancer (Class II - Special Controls, product code QXW).
Submitted by Icecure Medical (Caesarea, IL). The FDA issued a Not Cleared (DENG) decision on October 3, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4355. A Cryoablation Device For Local Treatment Of Low-risk Breast Cancer Is A Prescription Device That Uses Cold Temperatures To Destroy A Breast Tumor And Its Surrounding Tissue. The Device Is Intended As A Local Treatment And May Be Used With Adjuvant Therapies (e.g., Endocrine Therapy, Radiation Therapy) To Reduce The Risk Of Local Disease Progression. The Device Is Intended For Use In Patients With A Well-defined Solid Tumor (e.g., Invasive Ductal Carcinoma) And With Low Risk Of Recurrence And Metastasis, As Determined By Clinical Risk Factors Consistent With The Indications For Use. The Device Is Not Intended To Treat Breast Cancers With High Risk Of Local Recurrence (e.g., Lobular Carcinoma), Patients With Aggressive Forms Of Breast Cancer (e.g., Breast Cancers With Inflammatory Features), Or Patients In Whom Targeted Systemic Therapy Is Indicated..
| 510(k) Number | DEN220077 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | October 19, 2022 |
| Decision Date | October 03, 2025 |
| Days to Decision | 1080 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | QXW - Cryoablation Device For Local Treatment Of Low-risk Breast Cancer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4355 |
| Definition | A Cryoablation Device For Local Treatment Of Low-risk Breast Cancer Is A Prescription Device That Uses Cold Temperatures To Destroy A Breast Tumor And Its Surrounding Tissue. The Device Is Intended As A Local Treatment And May Be Used With Adjuvant Therapies (e.g., Endocrine Therapy, Radiation Therapy) To Reduce The Risk Of Local Disease Progression. The Device Is Intended For Use In Patients With A Well-defined Solid Tumor (e.g., Invasive Ductal Carcinoma) And With Low Risk Of Recurrence And Metastasis, As Determined By Clinical Risk Factors Consistent With The Indications For Use. The Device Is Not Intended To Treat Breast Cancers With High Risk Of Local Recurrence (e.g., Lobular Carcinoma), Patients With Aggressive Forms Of Breast Cancer (e.g., Breast Cancers With Inflammatory Features), Or Patients In Whom Targeted Systemic Therapy Is Indicated. |