(52 days)
Intended Use: The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196 C requiring either active or passive venting during surgical procedures.
Indications for Use: 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 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 kit: 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 include are provided in a carton of five (5) individually packaged sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit is provided with includes a carton of five (5) individually packaged sterile, single-use CDTs with associated tubing in individual pouches. Each carton within a spray kit contains the instructions for use.
The provided text is a 510(k) summary for the truFreeze System, a cryosurgical tool. It describes the device, its intended use and indications for use, and a comparison to a predicate device (K152668).
However, the document explicitly states: "Since the change in the truFreeze System is limited to the Indications for Use and adds to it information currently present in truFreeze System labeling, no additional testing was performed."
This indicates that no new study was conducted specifically for this 510(k) submission (K160273) to establish new acceptance criteria or prove device performance for new claims. The submission relies on the substantial equivalence to a previously cleared device (K152668) and its existing testing.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from this document, because this document states no new studies were performed.
If information from the previous 510(k) submission (K152668) were available, it might contain the details of studies that established performance for the original truFreeze System. Without that context, I can only report what is stated in this document.
Based on the provided text, the following points can be made:
- 1. A table of acceptance criteria and the reported device performance: Not available in this document as no new testing was performed. The device is deemed substantially equivalent based on label and technology comparison to a predicate device.
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available as no new testing was performed.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not available as no new testing was performed.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available as no new testing was performed.
- 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: Not applicable. The truFreeze System is a cryosurgical tool, not an AI-assisted diagnostic or imaging device used by human readers. No MRMC study was mentioned.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The truFreeze System is a physical surgical device, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available as no new testing was performed.
- 8. The sample size for the training set: Not applicable as a training set for an algorithm is not relevant to this type of device and no new testing was performed.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.