# Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer
> **Product code: QXW** · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4355
## Classification
- **FDA Product Code:** QXW
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 878.4355
- **Review panel:** SU
- **Medical specialty:** General, Plastic Surgery
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QXW)
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