510(k) DEN220077

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

October 3, 2025

Date Received

October 19, 2022

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer

Device Class

Class II

Regulation Number

878.4355

Review Panel

SU

Submission Type

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.