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U.S. Department of Health and Human Services

Product Classification
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Device cryoablation device for local treatment of low-risk breast cancer
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.
Physical State Cryoablation System
Technical Method Cryoablation
Target Area Breast
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeQXW
Premarket Review General Surgery Devices (DHT4A)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 878.4355
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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