(50 days)
Intended Use: The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196ºC, 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 Kits: Currently, there are 2 types of spray kits 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 CryoDecompression Tubes (CDTs) with associated tubing in individual pouches. Each carton within a spray kit contains Instructions for Use.
This 510(k) introduces a third Spray Kit to the truFreeze System, referred to as the Rapid AV Spray Kit. These catheters provided with the proposed truFreeze System are only to be used for active venting procedures and have been modified to shorten the time it takes to pre-cool the catheter so it can achieve frost quicker.
The proposed Rapid AV Spray Kit consists of a carton with five (5) sterile, single-use catheters with introducers in individual pouches. Additionally, the Rapid AV Spray Kit includes a carton of five (5) sterile, single-use, dual-lumen Cryo- Decompression Tubes (CDTs) with associated tubing in individual pouches. Each carton within a spray kit contains Instructions for Use.
This document describes the regulatory submission for the truFreeze® System with a new Rapid AV Spray Kit. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K162695). The changes primarily relate to the catheter design of the Rapid AV Spray Kit, which aims to shorten the pre-cooling time for faster frost formation.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative manner as typically seen for AI/ML performance metrics (e.g., target specificity, sensitivity, or AUC). Instead, the acceptance criteria are implicitly defined by a series of engineering and performance tests, all of which had a "Passed" result. The overall acceptance criterion for the submission is demonstrating substantial equivalence to the predicate device.
| Test Description | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Incoming Inspection | Conform to specifications | Passed |
| Measure Working Length | Conform to specifications | Passed |
| Measure Insulation Length | Conform to specifications | Passed |
| Distal Shaft Profile Dimensions | Conform to specifications | Passed |
| Visual Marker Band | Conform to specifications | Passed |
| Strain Relief | Conform to specifications | Passed |
| Handle Insertion and Removal | Conform to specifications | Passed |
| Catheter Insertion into Gastroscope | Conform to specifications | Passed |
| Marker Band Durability | Conform to specifications | Passed |
| Catheter Handle and Insulation Temperature Testing | Conform to specifications | Passed |
| Leak Testing | Conform to specifications | Passed |
| Static Burst Testing | Conform to specifications | Passed |
| Catheter Removal Force | Conform to specifications | Passed |
| Catheter Insertion Force | Conform to specifications | Passed |
| Bayonet Tensile Test | Conform to specifications | Passed |
| Time to Frost | Reduced pre-cooling time for faster frost | Passed |
| Temperature Exposure | Conform to specifications | Passed |
| Temperature Cycling | Conform to specifications | Passed |
| Bend Angle and Radius | Conform to specifications | Passed |
| Retroflex Power | Conform to specifications | Passed |
| Cooling Power | Conform to specifications | Passed |
| Biocompatibility | Meet biocompatibility standards | Passed |
| Sterilization Adoption | Accepted sterilization method | Accepted |
| Accelerated Aging | Support 6 months shelf life | Supports 6 months |
| Ship Test | Withstand shipping conditions | Passed |
2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: "Sample size required for each test was guided by the risk index as determined by the DFMEA. Sample size considered both attribute data and variable data." However, specific numerical sample sizes for each test are not provided in the document.
- Data Provenance: The tests are described as "bench data collected" for the truFreeze System. This indicates that the data was generated in a controlled laboratory or testing environment, likely in the US (where the company is based). It is prospective data derived from product testing, not retrospective patient data.
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):
This information is not applicable as the document describes a medical device (cryosurgical unit) performance validation, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth from images or clinical data. The "ground truth" for these engineering tests would be the established engineering specifications and performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the same reasons as point 3.
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 as the document is about a hardware medical device (cryosurgical unit), not an AI/ML algorithm or system that assists human readers/clinicians.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the document is about a hardware medical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the tests described is the engineering specifications, design requirements, and regulatory standards for a medical device. For example, for "Measure Working Length," the ground truth is the specified design length. For "Biocompatibility," the ground truth is meeting established biocompatibility standards.
8. The sample size for the training set:
This information is not applicable as the document is about a hardware medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as point 8.
In summary:
This document is a 510(k) summary for a hardware medical device (cryosurgical unit), not an AI/ML-driven device. Therefore, many of the requested categories pertaining to AI/MRMC studies, expert adjudication, or training/test sets for algorithms are not relevant to the information provided. The acceptance criteria are based on successful completion of a comprehensive set of engineering, mechanical, and safety tests, demonstrating that the modified device (Rapid AV Spray Kit) maintains the safety and effectiveness of its predicate, leading to a determination of substantial equivalence.
§ 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.