(174 days)
The NEUWAVE™ Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors.
The NEUWAVE™ Microwave Ablation System is not indicated for use in cardiac procedures
The NEUWAVE™ Microwave Ablation System is a self-contained stand-alone system of hardware and software designed for the ablation of soft tissue which applies microwave energy to produce tissue heating effects generating tissue necrosis.
The system consists of three major components (1) a cart which contains the components necessary to deliver microwave power to the microwave ablation probes, monitor and control system functions, a graphical user interface for the user to interact with the system and a CO2 based cooling system, (2) a Power Distribution Module (PDM), and (3) a range of microwave ablation probe accessories for energy delivery.
The system has a single 2.45 GHz signal microwave source with three 140W microwave power amplifiers, a touch-screen graphical user interface, and a CO2 based cooling system for limiting the temperature of the ablation probe, handle, and cable.
The CO2 cooling system enables the Tissu-Loc function, which involves formation of an ice ball to adhere the probe in place prior to starting ablation therapy. This helps eliminate probe migration during imaging (CT scans, ultrasounds, etc.) and additional probe placement. The cooling system is responsible for controlling the pressure of the incoming CO2 gas from two E-sized CO2 cylinders located on the back of the system.
The graphical user interface allows the user to set, adjust and activate the power setting per probe, time setting for each probe, ability to synchronize ablation initiation on probes, ablation activation, cauterization activation, audible volume, probe temperature, and Tissu-Loc function.
Up to three (3) NEUWAVE Ablation Probes can connect to the PDM at once and the PDM allows power to be transferred from the system generator to the ablation probes.
The microwave ablation probes are accessories which transfer microwave energy from the system cart to the target tissue to create regions of thermal necrosis. Each probe contains thermocouples that monitor the temperature of the probes can be used for surgical mode or ablation mode with various limits of maximum selectable power and time based on the probe type.
The NeuWave Medical Inc. NEUWAVE™ Microwave Ablation System and Accessories (K220472) underwent non-clinical testing to demonstrate substantial equivalence to its predicate device (K200081). The study focused on assessing electrical safety, electromagnetic compatibility, and ex-vivo tissue ablation to ensure that updated hardware and software components did not compromise the device's design and performance specifications.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety Testing | Compliance with IEC 60601-1 3rd Edition (demonstrate electrical safety). | Pass |
| Electromagnetic Compatibility (EMC) Testing | Compliance with IEC 60601-1-2 4th Edition (requirements for immunity, radiated, and conducted emissions). | Pass |
| Ex-vivo tissue ablation testing | Ablation zone dimensions of the subject device are substantially equivalent to the predicate device for identical power settings. | Pass |
| Software Verification Testing | Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005." | Pass |
| Cybersecurity | Conformance to FDA's "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" guidance document, including strengthened cybersecurity posture. | Assessment performed and updates implemented. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a specific number of cases or samples. For electrical safety and EMC testing, "the NEUWAVE™ Microwave Ablation System with NEUWAVE™ Probes" was tested. For ex-vivo tissue ablation, the testing involved "ablation zone dimensions of the subject and predicate devices." This implies a sufficient number of tests were conducted to ensure comparability.
- Data Provenance: The studies were non-clinical design verification tests, performed by the manufacturer (NeuWave Medical Inc.) as part of their premarket notification. The data is prospective, generated specifically for this submission. The country of origin is implicitly the USA, where NeuWave Medical Inc. is based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided as the studies were non-clinical, hardware, and software verification tests. The "ground truth" was established by engineering specifications, relevant IEC standards, and direct comparison of a physical characteristic (ablation zone dimensions) rather than expert interpretation of medical images or outcomes.
4. Adjudication Method for the Test Set:
- This information is not applicable as the tests were non-clinical engineering and performance evaluations, not involving human interpretation or adjudication of medical data.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The submission explicitly states, "No clinical data was generated or is required to support of this Premarket 510(k) Notification." The focus was on demonstrating substantial equivalence through non-clinical performance data due to minor hardware and software updates to an already cleared predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- The device is a physical microwave ablation system with embedded software, not a standalone algorithm in the typical sense of AI image analysis. The "software verification testing" was done in a standalone manner (evaluating the software itself), but it's not an "algorithm only without human-in-the-loop performance" that would typically be described for diagnostic AI tools. The system requires human operation for its intended use.
7. The Type of Ground Truth Used:
- For Electrical Safety and EMC: Compliance with international safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2) served as the ground truth.
- For Ex-vivo tissue ablation: The "ground truth" was the physical measurement of ablation zone dimensions, compared directly between the subject and predicate devices for identical power settings. This is a direct physical measurement.
- For Software Verification: Compliance with FDA guidance for software in medical devices (functional correctness, robustness, etc.) served as the ground truth.
- For Cybersecurity: Conformance to FDA guidance on cybersecurity management.
8. The Sample Size for the Training Set:
- Not applicable. This submission focuses on a modified device and its non-clinical verification. It does not describe the development or training of a new AI algorithm that would typically involve a "training set" of data for machine learning. The software updates were primarily to support updated hardware due to component obsolescence, not to introduce new AI-driven functionalities requiring extensive data training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As no training set for an AI algorithm was described, the method for establishing its ground truth is not relevant to this submission.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.