(24 days)
The truFreeze® System is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures.
The truFreeze® System is Indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.
The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the treatment area via a small, low pressure, open tipped catheter. The truFreeze System consists of (1) a console and (2) a disposable spray kit.
Console:
The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing. filling, pressure. cooling, defrost, suction, timing and data management functions. A wireless remote control provides alternative timer control from a distance in the treatment room. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction.
Disposable spray kit:
The truFreeze disposable spray kit consists of 5 individually packaged sterile single-use catheters (7 Fr Straight Tip Catheter and one Catheter Introducer.) and 5 individually packaged cryogen decompression tubes (CDTs) (each containing one Dual Lumen 20 Fr CryoDecompression Tube (CDT), Connector, and Suction Tubing.). The catheter is flexible and capable of retroflex in a scope. The CDT and accessory tubes are included for use with the on-board suction system.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically understood for AI/ML medical devices. The document is a 510(k) premarket notification for a cryosurgical unit, which is a hardware device, not an AI/ML diagnostic or prognostic tool.
The text does mention "Testing" but states: "The truFreeze System was previously subjected to a comprehensive test program that included electrical safety and electromagnetic compatibility testing, software testing, animal testing, biocompatibility and sterilization testing. Since the change does not involve any changes to the hardware or software of the truFreeze system, no additional testing was conducted to support demonstration of substantial equivalence in performance of the truFreeze system to its predicate device."
This indicates that the document is focused on demonstrating substantial equivalence to a predicate device based on minor labeling changes, not on establishing performance criteria for a new AI/ML algorithm or device.
Therefore, I cannot provide the requested information in the specified format from this text.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.