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CRYO-HIT™ is intended for cryogenic destruction of tissue during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue, including liver metastases, skin lesions, warts, and prostate tissue.

CRYO-HIT™ is a cryosurgical system that consists of:

• 1, a structural enclosure (The CRYO-HIT™ system is housed in a rack assembly mounted on four cater wheels for ease of transport),
• 2. a power control panel,
• 3. a computer and control assembly,
• 4, a gas supply system: Argon (cooling) and Helium (thawing) gas reservoirs,
• 5. a gas distribution system (valve assembly ),
• 6. Accessories: cryoprobes (named galil-eo probes), temperature sensors and a remote control unit.
     The different CRYO-HIT™ models have the same performance, technology and intended use. The only difference between them are the number of probe ports available in each model (3-probe, 5-probe, 7-probes and 8-probe configurations) and the number of temperature sensor ports ( to meet the needs of different customers).
     The probes used for the 3-probe, 7-probes and 8-probe configurations are exactly the same.

This is a 510(k) premarket notification for a medical device (CRYO-HIT™ System) and as such does not contain a study section with acceptance criteria and a description of a study to prove the device meets those criteria. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than conducting new clinical performance studies with acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on establishing the substantial equivalence of the CRYO-HIT™ system to existing cryosurgical devices based on intended use, technology, and operating principles.

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