(20 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 provided text is a 510(k) Summary for the truFreeze System, which is a cryosurgical tool. This document primarily focuses on demonstrating substantial equivalence to a predicate device and addresses labeling changes, rather than presenting a performance study with acceptance criteria for a new or modified device.
Therefore, most of the requested information regarding acceptance criteria and performance study details is not available in this document. The document explicitly states:
- "No performance testing was conducted as the subject of this submission is changes to the labeling only."
This means there is no study described that "proves the device meets the acceptance criteria" in the traditional sense of a clinical or performance study for a new device. The submission is for administrative and labeling changes.
However, I can extract information related to the device's characteristics and the basis for its substantial equivalence, which implicitly indicates its expected performance based on the predicate device.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as "acceptance criteria" for a new performance study. However, the "Technological Characteristics Comparison Table" (Table 1 on page 5) lists performance specifications that the device is expected to meet because it's identical to the predicate device. These characteristics essentially serve as the "performance" assumed to be met.
- Reported Device Performance: The document states the device's characteristics are "Identical" to the predicate, K171626. Therefore, the performance values are the same as those established for the predicate device.
| Characteristic | Acceptance Criteria (from predicate) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate | Identical |
| Construction | Same as predicate | Identical |
| Sterile/Non-sterile | Non-sterile (console), Sterile (catheters & CDTs) | Identical |
| Sterilization Method | Ethylene Oxide | Identical |
| Sterilization Assurance Level | 10-6 | Identical |
| Usage | Single Use (catheters & CDTs), Reusable (console) | Identical |
| Principle of Operation to Achieve Cooling | Via pressurized liquid nitrogen (LN2) | Identical |
| Method to Destroy Tissue | Uses freeze/thaw/freeze cycle | Identical |
| Ability to Reach Equivalent Dose | Achieve a 4 cm ice ball within 12 min (total elapsed time) | Identical |
| Point Source for Destruction of Tissue | Catheter head | Identical |
| Liquid Nitrogen Capability to Freeze Tissue | -196°C | Identical |
| Output Temperature at Catheter Tip | -196°C | Identical |
| Equivalent Ice Formation | Able to produce an average 23.4 mm (radius) ice ball within 5 minutes | Identical |
| Equivalent Temperature Distribution | @ freeze depth of 21.87mm at 0°C; -20°C isotherm at 15.5mm depth; -40°C isotherm at 11.8mm depth | Identical |
| Delivery of Cryogen | A spray through a 2.2mm (7 F) sterile conduit; straight catheter, Controlled by user | Identical |
| Consistent delivery of cryogen controlled for target site | Computer driven | Identical |
| Guidance required for procedure | Direct visualization via an endoscope or bronchoscope | Identical |
| Safety Features/Mitigations | Stop dose via foot pedal/emergency button; compatible catheter check (RFID); audible beeper/visual timer; computerized system test/monitoring/abort | Identical |
| Ensure patient is not exposed to high pressure gases | Uses active suction pump and CDT, or natural orifice, as per IFU; venting guidance | Identical |
| Protect healthy tissue from excessive temperatures | Uses endoscope/bronchoscope for insulation; insulation outside of scope | Identical |
| Pressure Controls | Valves and pressure transducer for LN2 pressure control; redundant pressure switch; mechanical relief | Identical |
| Thermal/Defrost | Active defrost using warm Nitrogen gas | Identical |
| Safe storage of cryogenic agent | Single Dewar tank | Identical |
| Biocompatibility | Patient contact materials comply with ISO -10993 | Identical |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document states "No performance testing was conducted." Therefore, there is no test set, sample size, or data provenance from a new study to report.
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 applicable / Not provided. No new performance study was conducted that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No new performance study was conducted.
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 / Not provided. This device is a cryosurgical tool, not an AI/imaging diagnostic device. No MRMC study was mentioned or performed for this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This is a hardware device, not an algorithm. No standalone algorithm performance was assessed for this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No new performance study requiring ground truth establishment was conducted for this submission. The basis for safety and effectiveness is substantial equivalence to the predicate device, which would have had its performance and safety established through prior testing and clinical use.
8. The sample size for the training set
- Not applicable / Not provided. No machine learning or AI model development is described, so there is no training set mentioned.
9. How the ground truth for the training set was established
- Not applicable / Not provided. No machine learning or AI model development is described, so there is no training set or ground truth establishment for it.
In summary, this 510(k) submission is for administrative and labeling changes for a cryosurgical system and explicitly states that no new performance testing was conducted. Therefore, the detailed information about acceptance criteria, study design, and ground truth establishment requested for a performance study is not available within the provided document. The device's performance is assumed to be identical to its predicate, K171626, based on the lack of changes affecting performance.
§ 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.