FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Pregnant patients potential risks to patient and/or fetus have not been established .
Patients with implantable pacemakers or other electronic implanted electronic . devices may be adversely affected by microwave power

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

Device Description

The system has three (3) independent 2.45 GHz microwave generators, each capable of producing up to 140W each. One, easy to use, touch-screen user interface controls the system. Up to 3 microwave ablation probes can be connected to and powered by the system at one time. The maximum selectable power for the system is 140W when one probe is connected, 95Wper probe when 2 probes are connected and 65W per probe when 3 probes are connected. An intermediate junction box or Power Distribution Module (PDM) reduces system set up complexity.

Probes are provided sterile and are intended for single patient use only. Probes are available for both percutaeous and open surgical applications. Percutaneous probes are comprised of 17 gauge needles, a probe handle, a 1.4M cable and a connector assembly. Percutaneous probes are available in Certus M and Certus ". Certus " probes are designed to perform optimally, in terms of efficiently transferring energy into tissue, in liver and kidney tissue. Certus 1400 probes are designed to perform optimally, in terms of efficiently transferring energy into tissue. All percutaeous probes are available in 15cm and 20 cm lengths.

The open surgical probe, Certus 80, is 13 gauge and available in a 25cm length.

All probes have temperature sensing thermocouples at various places along the shaft to monitor the probe temperature.

A CO2 based cooling system ensures the non-active portion of the probe does not exceed temperature requirements. Additionally, the CO2 enables the Tissu-Loc function, which can be used to adhere or stick the probe in place prior to starting ablation therapy. This function is similar in use to the stick function available on cryogenic ablation systems.

The system uses two (2) E-sized CO2 cylinders. When a tank in use empties, the system will automatically switch to using the other tank and notify the user to replace the empty tank.

AI/ML Overview

This document is a 510(k) summary for the NeuWave Medical Certus 140 2.45 GHz Ablation System and Accessories, intended for soft tissue ablation. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria. Therefore, the provided text does not contain information on acceptance criteria or a study proving the device meets them.

The document discusses device description, intended use, and general compliance with International Standards, but it doesn't present a test plan with defined acceptance metrics or a study report detailing specific performance outcomes against those metrics.

Here is a breakdown of why the requested information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: This information is not present. The document mentions "rigorous testing" which "supports the compliance of Certus 140 2.45 GHz Ablation System and Accessories to the standards listed above" and that "Ex-vivo studies were conducted to compare the performance of the Certus 140 2.45 GHz Ablation System and Accessories to a predicate device." However, no specific performance metrics, acceptance thresholds, or reported device performance data are provided.
Sample size used for the test set and the data provenance: The document mentions "Ex-vivo studies" but does not specify any sample sizes for these studies, nor does it provide information on data provenance (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth determination by experts for a test set is described. The "ex-vivo studies" likely involved objective measurements rather than expert human interpretation.
Adjudication method for the test set: Not applicable, as no human-reviewed test set requiring adjudication is described.
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 device is a microwave ablation system, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to its regulatory submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for physical intervention, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. For "Ex-vivo studies," the ground truth would likely be objective measurements of ablation zone size or temperature distribution, rather than expert consensus, pathology, or outcomes data in the usual sense for diagnostic algorithms.
The sample size for the training set: Not applicable. This is a physical device, not a machine learning model, so there is no "training set."
How the ground truth for the training set was established: Not applicable, as there is no training set for a machine learning model.

Summary

Regulation Number and Section

§ 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.