Device Information

Indications

The Microwave Ablation Device Exceed S10U is indicated for soft tissue coagulation (ablation) during procedures by healthcare professionals in healthcare facilities. It is not intended for cardiac use. Sterile Microwave Ablation Probe is used with Microwave Ablation Device.

• MedDRA Code: 10054002 – Soft tissue coagulation

Intended Use of Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)

The device is used for coagulation and ablation of soft tissue in medical procedures, typically performed in a healthcare facility.

Availability

Prescription use only

Contraindications

The device is contraindicated for cardiac use. It should not be used in cardiac procedures or on patients with known sensitivities to the materials used in the device.

Limitations

The device is designed for single use and should only be used by trained healthcare professionals within a clinical setting. It is not suitable for home use or by untrained individuals.

Study Results

Non-clinical testing confirmed that the device meets performance and safety standards and demonstrates substantial equivalence to the predicate devices. Key tests included electrical safety, electromagnetic compatibility, performance, software validation, and biocompatibility.

Regulatory Information

The device complies with the Quality System (QS) regulation (21 CFR Part 820), including design control requirements, nonconforming products, and corrective and preventive actions.

Manufacturer Information

• Name: Hygea Medical Technology Co., Ltd.
• Address: Floor 6&7, West Area of Building No. 8, No. 30 YuHua Road, Shunyi, Beijing, 101318, China
• Contact: Jinping Duan, RA Manager

Predicate Device Information

The predicate devices include the Nanjing ECO Microwave System Co., Ltd’s microwave therapeutic system (K201262) and disposable microwave therapeutic antennas (K201265).

Implications

The Microwave Ablation Device with Sterile Microwave Ablation Probe offers a safe and effective solution for soft tissue ablation in medical settings. Its substantial equivalence to existing devices ensures confidence in its performance.

References

• Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact). K233140. FDA summary link https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K233140
• Manufacturer website: https://www.hygeamed.com/