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1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4355

Medical specialty

General, Plastic Surgery

FDA 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.

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