(28 days)
The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (e.g. Barrett's Esophagus with high grade dysplasia and/or low 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. 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. There are 2 types of spray kits available. One kit is available for active venting procedures and one is available for passive venting procedures. Both active and passive venting kits are provided in a carton of five (5) individually packaged sterile, single-use catheters with introducers (an introducer is a spring that is introduced into the accessory channel port of the endoscope to provide additional strain relief to the catheter during insertion and retraction from the endoscope) in individual pouches. These catheters are used to introduce the liquid nitrogen to the desired site. Additionally, the active venting kit is provided with a carton of five (5) individually packaged sterile, single-use cryo decompression tubes (CDTs) with associated tubing in individual pouches. The CDTs are used for the removal of the gaseous nitrogen from the patient. Each carton within a spray kit contains the instructions for use.
The truFreeze System is a cryosurgical tool validated through a series of non-clinical performance tests. The acceptance criteria and the study results are as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implicit from "Pass") | Reported Device Performance |
|---|---|---|
| Suction flow rate | Meets specified flow rate requirements | Pass |
| Kink Resistance | Maintains patency under specified kinking conditions | Pass |
| Dimensional measurements | Adheres to design specifications | Pass |
| Tensile strength of bonded joints | Meets specified tensile strength requirements | Pass |
| Biocompatibility testing | Complies with ISO-10993 requirements | Pass |
| Product sterility adoption | Achieves a Sterility Assurance Level (SAL) of 10^-6 | Pass |
| Simulated use testing | Performs as intended during simulated use scenarios | Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for each specific test in the "Summary of Non-Clinical Performance Testing." The tests are labeled as "verification testing," which typically involves conducting tests on a representative number of units to ensure consistency and compliance.
The data provenance is from non-clinical testing conducted by STERIS Corporation for a modification to their existing truFreeze System (K222272). This is presumably prospective testing, as it was specifically done to validate the redesigned 16 French (Fr) cryo-decompression tube. The country of origin of the data is not explicitly stated, but given STERIS Corporation's address in Mentor, Ohio, USA, it can be inferred that the testing was conducted in the USA or by labs commissioned by them.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the described study is a series of non-clinical performance tests, not a clinical study involving human or image-based ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the same reason as point 3. The testing involves objective physical and functional measurements against predefined specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The truFreeze System is a cryosurgical tool, not an AI-assisted diagnostic or imaging device used with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The truFreeze System is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical performance testing, the "ground truth" is defined by engineering specifications, established standards (e.g., ISO-10993 for biocompatibility), and functional requirements derived from the intended use of the device. For example, for "Suction flow rate," the ground truth would be a predetermined flow rate range that the device must achieve.
8. The sample size for the training set:
This information is not applicable. The device is a hardware system, and the reported testing is traditional engineering verification, not machine learning model training.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
§ 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.