Co-Ablation System with Sterile Co-Ablation Probe
Hygea Medical Technology Co., Ltd.The Co-Ablation System with Sterile Co-Ablation Probe is a medical device that freezes and destroys solid tumors and abnormal tissue in various surgical fields using extreme cold temperatures. It is used in open, minimally invasive, or endoscopic procedures to treat cancers, benign tumors, skin lesions, and for pain management by freezing nerve tissue. The system works by delivering liquid nitrogen through a probe to freeze the target tissue under imaging guidance, allowing doctors to visualize the ice ball formation and control the treatment precisely for safer and more effective ablation.
Intended Use
The Co-Ablation System with Sterile Co-Ablation Probe is designed to destroy solid tumors in open, minimally invasive or endoscopic surgical procedures across multiple surgical areas including general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary and thoracic surgery.
Technology
The system uses liquid nitrogen as a cryogen delivered through a sterile, single-use probe to the target tissue. It utilizes phase change effect to generate extremely low temperatures (-186°C) to freeze and ablate tissue, with a warming mode using high temperature steam to thaw tissue allowing probe removal. The system includes a cryotank, warmtank, valves, insulated pipes, a control/display system, and sterile temperature probes for monitoring.
Performance
The device underwent extensive non-clinical testing including electrical safety, electromagnetic compatibility, usability, software verification, sterilization validation, biocompatibility, shelf life, ex-vivo and animal testing. The tests confirmed the system's safety, effectiveness, and ability to produce predictable ablation volumes with stable operation and no observed device abnormalities in animal models. Clinical data was not required for substantial equivalence determination.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/27/2024
4 months - 2
FDA Approval
1/29/2025
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