(220 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. VortexTM Radial Spray catheter: The Vortex™ Radial Spray catheter is indicated for use as a cryosurgical tool to ablate benign (e.g., Barrett's Esophagus with high grade and/or low grade dysplasia) in the upper gastrointestinal tract using active venting.
The CSA Medical (CSA) truFreeze® System consists of a truFreeze Console and a truFreeze Spray Catheter Kit. The truFreeze Console is to be used only with a truFreeze Spray Kit. This document specifically applies to the Vortex Radial Spray Kit (20-00360) for use with the truFreeze® System. Vortex Radial delivers liquid nitrogen in a 3-cm long, 360° spray pattern to ablate circumferential, epithelium such as Barrett's Esophagus.
The Vortex Radial Spray Kit (20-00360) consists of one (1) truFreeze Vortex Radial Spray Catheter (20-00187), one (1) 4-inch Suction Canister Connector, and one (1) Patient Tube.
The catheter is connected to the console and transports cryogen from the console to the targeted ablation area. The Suction Cannector and Patient Tube provide the connection from the suction source in the console to the Cryo-Decompression Tube (CDT) at the end of the catheter, to provide active evacuation (suction) of nitrogen gas at the ablation site. The spray head is surrounded by the Mesh that expands to dilate the lumen to a diameter of 20 mm and center the device during the delivery of cryogen spray.
The provided text is a 510(k) Premarket Notification for the CSA Medical, Inc. truFreeze® System, specifically the Vortex™ Radial Spray Catheter. This document primarily focuses on establishing substantial equivalence to a predicate device (K171626) by comparing technological characteristics and presenting performance testing results.
Crucially, this document does not contain a typical "acceptance criteria and study that proves the device meets the acceptance criteria" in the format of a clinical trial designed with defined endpoints (like sensitivity, specificity, accuracy) for a diagnostic AI device.
Instead, this submission is for a cryosurgical treatment device, not an AI/ML diagnostic tool. Therefore, the "acceptance criteria" and "study" are geared towards demonstrating the device's safety and effectiveness compared to a predicate device that performs a similar function.
Based on the provided text, here's an attempt to extract relevant information, adapting to the nature of the device:
1. Table of "Acceptance Criteria" (interpreted as performance specifications/comparisons to predicate) and Reported Device Performance:
| Characteristic / Acceptance Metric | Predicate Device (K171626) Performance | Proposed Device (Vortex™ Radial) Performance / Comparison |
|---|---|---|
| Intended Use | Cryogenic destruction of tissue using Liquid Nitrogen spray (-196°C), active/passive venting. | Same. |
| Indication for Use | Cryosurgical tool in dermatology, gynecology, general surgery to ablate benign (e.g., Barrett's Esophagus with HGD/LGD) and malignant lesions. | Cryosurgical tool to ablate benign lesions (e.g., Barrett's Esophagus with HGD/LGD) in the upper gastrointestinal tract using active venting. |
| Cryogen | Liquid nitrogen | Liquid nitrogen (Same) |
| Principle of Operation | Pressure Propelled Cryogen | Pressure Propelled Cryogen (Same) |
| Mode of Ablation | ≥1 freeze-thaw cycles, quantity determined by physician | ≥1 freeze-thaw cycles, quantity determined by physician (Same) |
| Delivery/Cryoprobe | Spray Tip (Linear) | Spray Tip (Circumferential) - This is a key differentiator and the focus of the submission's evidence. |
| Output Temperature | -196°C | -196°C (Same) |
| Cooling Power Density (Normal Flow) | 5.3 to 8.0 W/cm² | 5.3 W/cm² (Comparable) |
| Depth of Freeze in Hydrogel (mean ± SD) | 1.0 mm ± 0.4 mm | 1.0 mm ± 0.2 mm (Comparable) |
| Delivery of Cryogen (spray dosimetry) - Duration | 0s to 60s, 5s increment | 10s to 20s, 1s increment (Different, specific to radial spray) |
| Procedure Visualization | Direct visualization via endoscope | Direct visualization via endoscope (Same) |
| Early spray termination | User control via foot pedal release or emergency stop button | User control via foot pedal release or emergency stop button (Same) |
| Prevent use/reuse of expired/invalid catheter | Confirms use of valid catheter using RFID | Confirms use of valid catheter using RFID (Same) |
| Notifies physician to stop spraying | Audible beeper/visual display of timer | Audible beeper/visual display of timer. Console terminates spray (Same/Enhanced) |
| Computerized test of system prior to use | Software test confirms system is properly operating | Software test confirms system is properly operating (Same) |
| Computerized continuous monitoring of system during procedures | Uses computer program to abort freezing if system failure detected | Uses computer program to abort freezing if system failure detected (Same) |
| Ensure patient not exposed to high pressure gases | Active suction pump and CDT (active) or natural orifice (passive) per IFU. | Active suction pump and integral CDT (active) and passive egress channels per IFU. Console pump activation during spray delivery. (Same/Enhanced) |
| Protect healthy tissue from excessive temperatures | Sufficient insulation on patient/user exposure surfaces | Sufficient insulation on patient/user exposure surfaces (Same) |
| Pressure Controls | Valves, pressure transducer, redundant pressure switch, mechanical relief valve, redundant burst disc. | Valves, pressure transducer, redundant pressure switch, mechanical relief valve, redundant burst disc. (Same) |
| Thermal/Defrost | Active defrost capability to thaw catheter using warm nitrogen gas | Active defrost capability to thaw catheter using warm nitrogen gas (Same) |
| Safe Storage of Cryogen | Internal Pressure-rated vacuum insulated Dewar | Internal Pressure-rated vacuum insulated Dewar (Same) |
| Product Label | Uniquely identifies catheter as linear spray for active or passive venting. | Uniquely identifies catheter as radial spray for active venting. (Specific to device) |
| Sterility | Sterile catheter using Ethylene Oxide with SAL 10-6 | Sterile catheter using Ethylene Oxide with SAL 10-6 (Same) |
| Biocompatibility | Patient contacting materials comply with ISO 10993 | Patient contacting materials comply with ISO 10993 (Same) |
| Safety and Effectiveness (Clinical Equivalence to Predicate) | Established via prior clearance (K171626) with literature/RWD on linear spray | Bench, pre-clinical (swine), and clinical (literature/RWD for linear spray) to support safety and similar effect for radial spray |
| Procedural Safety (via pre-clinical swine studies) | N/A (implied by previous clearance) | All animals survived, no serious adverse events. Controlled depth of injury without reaching serosa. |
| Treatment Zone (via pre-clinical swine studies) | N/A (different spray pattern) | 3-cm-long circumferential treatment zone confirmed. |
2. Sample Size Used for the Test Set and Data Provenance:
- Bench Tests: "A number of bench tests were conducted to verify the product design met the predetermined product performance specifications." No specific sample sizes for these tests are mentioned.
- Pre-clinical (GLP Studies): "Three preclinical GLP studies were completed utilizing the Vortex™ Radial Spray catheter in swine." The exact number of swine used is not specified, only the number of studies.
- Clinical Data (Literature/RWD for Predicate Device):
- Literature: "Three scientific, peer-reviewed literature articles have been published demonstrating the ability of the predicate device (i.e. linear spray) to achieve circumferential freezing of diseased tissue in the esophagus."
- Patient Count from Literature: "73 patients have been treated with spray LN2 circumferentially since 2012 to ablate BE lesions."
- Real-World Data (RWD) from Registry: "Real-World Data (RWD) has been extracted from an ongoing prospective, multi-center patient registry."
- Patient Count from RWD: "Of the 112 patients identified in the registry as having Barrett's Esophagus, 49 of those patients received circumferential ablation."
- Provenance: No specific country of origin is mentioned for the literature or RWD, but it can be inferred to be from regions where such studies are conducted (likely US/Europe). The RWD is "prospective, multi-center."
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable in the context of this submission. This is not an AI diagnostic device requiring expert reading for ground truth establishment. The "ground truth" for this device's performance would be direct measurements (e.g., cooling power, depth of freeze in hydrogel) and histological assessment in animal models. Clinical outcomes cited from literature/RWD would be physician-documented.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study requiring adjudication of expert readings from a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This type of study (MRMC) is typically performed for diagnostic imaging devices to assess human reader performance with and without AI assistance. This submission is for a medical device that performs a physical ablation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm. Bench and preclinical data are provided for the device's standalone physical performance.
7. The Type of Ground Truth Used:
- Bench Testing: Engineering specifications and direct physical measurements (e.g., temperature, power density, dimensional measurements).
- Pre-clinical (Swine Studies): Histopathology data (e.g., assessment of lesion size, depth of injury) and survival/adverse event data.
- Clinical Data (from Literature/RWD for predicate): Clinical outcomes (ablation endpoint, adverse events like stricture), and physician observations.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device with a distinct training set. The "training" in this context refers to the development and iterative testing of the device throughout its design process.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the reasons stated above.
§ 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.