Co-Ablation System with Sterile Co-Ablation Probe

The Co-Ablation System is a Class II cryosurgical device designed for the destruction of solid tumors in diverse surgical settings, including open, minimally invasive, and endoscopic procedures. Its substantial equivalence to legally marketed devices was affirmed through non-clinical data, demonstrating that its co-ablation technology and operating principles are comparable to existing solutions without introducing new safety or effectiveness concerns.

The Co-Ablation System with Sterile Co-Ablation Probe, developed by Hygea Medical Technology Co., Ltd., is a Class II medical device categorized as a Cryosurgical Unit and Accessories. Following a regulatory review on January 29, 2025, it was determined to be substantially equivalent to legally marketed devices, thereby permitting its marketing for specified indications for use. This conclusion was supported by non-clinical performance data which indicated that the device's technological characteristics and operating principles are similar to existing devices and do not raise new safety or effectiveness concerns. Its intended use is the destruction of solid tumors across a wide range of surgical procedures, including open, minimally invasive, and endoscopic approaches, spanning general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary, and thoracic surgery. The device is also subject to comprehensive general controls and regulations, such as annual registration, device listing, good manufacturing practices, specific labeling guidelines, the Quality System (QS) regulation, and the Unique Device Identification (UDI) System rule, ensuring its ongoing compliance and safety.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific types of solid tumors has the Co-Ablation System demonstrated efficacy in destroying across the various surgical specialties mentioned?; What are the precise technological characteristics and operating principles of the Co-Ablation System that were deemed similar to predicate devices, and how do they achieve tumor destruction?; What specific non-clinical performance data were submitted to support the determination of substantial equivalence, particularly regarding safety profiles and effectiveness metrics?; Are there any contraindications or specific patient populations for which the Co-Ablation System is not recommended, despite its broad indications for use?; How does the Co-Ablation System's ablation method compare in terms of precision, recovery time, and long-term recurrence rates to other established cryosurgical or ablation techniques?