Search Results

The NEUWAVE™ Flex Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue.

The NEUWAVE™ Flex Microwave Ablation System is not indicated for use in cardiac procedures.

The system is designed for facility use and should only be used under the orders of a physician.

The design of the NEUWAVE Flex Microwave Ablation System (FLEX) is an evolution of the design of the legally marketed Certus 140 2.45GHz Ablation System (K160936). The FLEX is a fully featured soft tissue ablation system that uses small diameter flexible ablation probes, a single microwave source operating at 2.45 GHz, a CO2-based cooling system, a Power Distribution Module (PDM), and a support arm designed to hold the PDM in a user-selected position. Microwave energy is applied to the target tissue via a single flexible ablation probe, heating the tissue to the point of necrosis.

The FLEX is designed to be used in Target Ablation involves placing a probe into a substantial target and then ablating for up to several minutes until the target tissue is necrotic. The FLEX is designed for ablations in soft tissue in percutaneous (via an introducer) procedures, open surgical procedures, and procedures in which the target tissue is accessed via a lumen or scope such as an endoscope or laparoscopic port.

Two microwave ablation probes are available for use with the NEUWAVE Flex Microwave Ablation System: the FLEX4 and the FLEX6. They are comprised of a conical tip on the end of a flexible cable and a connector assembly. The probe with the sharper tip (FLEX6) is designed for easier tissue penetration while the probe with the less sharp (FLEX4) tip designed for improved navigation. Both FLEX probe models are French gauge 6 (outer diameter of less than 2 mm) and 150 cm long. Both probe models have the same antenna design and ablation performance characteristics.

Each probe contains three (3) temperature measurement sensors that help monitor performance and ensure patient and operator safety.

The FLEX probe antenna was designed to produce an ablation zone substantially equivalent to the predicate Certus® probe but within a flexible probe shaft. Like the predicate Certus® probe, the FLEX probes are designed to produce ablations that encompass the tip of the probe while limiting the overall length of the ablation. Testing in ex-vivo liver, lung and kidney tissue confirm that the FLEX probes produce ablations that are substantially equivalent to the predicate probes.

A PDM and Accessories Support Arm (The Arm) holds the PDM in a user-selected position. The Arm attaches to an imaging/procedure table via a rail mount. This allows the PDM and probe to move with the patient, greatly reducing the potential for patient injury due to accidental probe movement.

The Arm is comprised of three jointed lengths with two tension knobs that allow the user to maneuver and fix the Arm at the user-selected position. The PDM mount on the ARM has a dovetail design with magnetic retention for quick and easy mounting. Additionally, the Arm has a grasping mechanism that can be used to hold a scope such as an endoscope (if used) in a fixed position for an extended period of time.

A CO2 based cooling system ensures the non-active portion of the probe does not exceed temperature requirements.

The system uses two (2) customer supplied E-sized CO2 cylinders. The system monitors the pressure of the tanks and heats the tanks to maintain the desired tank pressure. The FLEX System will select which cylinder to initially use based upon tank pressures.

The provided document is a 510(k) summary for the NEUWAVE Flex Microwave Ablation System and Accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of an AI or algorithmic device. Therefore, many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set, ground truth for training set) are not applicable or cannot be extracted directly from this document.

However, the document does contain information about performance data and acceptance criteria related to its electrosurgical function.

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

The document mentions that "The system passed all pre-determined acceptance criteria identified in the test plan." and "Ex-vivo ablation sizes for the FLEX system were deemed to be substantially equivalent to the predicate devices."
While specific numerical acceptance criteria for ablation size are not explicitly stated in a table, the performance is reported in relation to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document mentions "Testing in ex-vivo liver, lung and kidney tissue" but does not specify the number of samples (e.g., how many livers, lungs, or kidneys were tested, or how many ablation procedures were performed on them).
• Data Provenance: The data is "ex-vivo" (meaning outside a living organism, likely in a lab setting) and was conducted for comparison to predicate devices and for data to be included in the Instructions for Use. The country of origin is not specified but the company is US-based (Madison, Wisconsin). The testing described is prospective in the sense that it was specifically conducted for this submission.

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. This is a medical device for tissue ablation, not an AI/algorithmic device for diagnosis or image interpretation. The "ground truth" here relates to physical parameters and performance (e.g., ablation size, temperature, power output) which are measured directly, not established by expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/algorithmic device involving subjective interpretation or expert consensus. Performance is measured against engineering specifications and comparison to a predicate device.

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. This is a medical device for tissue ablation, not an AI/algorithmic device requiring human reader studies.

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. Its "standalone" performance would be its ability to ablate tissue according to specifications, which was tested ex-vivo.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be:

• Direct physical measurements (e.g., ablation zone dimensions, temperature readings, power output).
• Compliance with pre-determined engineering and safety specifications.
• Substantial equivalence to the performance characteristics of the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device that requires a training set.

Ask a specific question about this device