(21 days)
The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (eg. Barrett's Esophagus with high grade dysplasia) and malignant lesions.
The truFreeze System is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and 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 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 Kits:
Currently, there are 2 types of spray kits available. One kit is available for active venting procedures and one kit is available for passive venting procedures. Both active and passive venting kits are provided in a carton of five (5) sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit includes a carton of five (5) sterile, single-use, dual-lumen Active Venting Cryo Decompression Tubes (CDTs) with associated tubing in individual pouches. Each carton within a spray kit contains Instructions for Use.
CryoDecrompression Tube (CDT):
Proposed changes involve the CryoDecrompression Tube (CDT) only. The CDT is a necessary part of the truFreeze Active Venting Kit to suction gas out of the patient when liquid nitrogen is sprayed.
The document provided describes modifications to the truFreeze System, specifically to the CryoDecompression Tube (CDT). The purpose of these modifications is to address user annoyance related to tube kinking and an orange indicator display during use, without changing the intended use or indications for use of the device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Specification Test associated with proposed modifications | Acceptance Criteria (Implicit) | Reported Device Performance (Result) |
|---|---|---|
| Measure the maximum OD of the CDT | OD |
§ 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.