(315 days)
The MedWaves Microwave Coagulation/Ablation System is intended for general surgery use in open procedures for the coagulation and ablation of soft tissues. The system is not intended for use in cardiac procedures.
The MedWaves Microwave Coagulation/Ablation System consists of a microwave generator and accessories used for the surgical ablation of soft tissue. The accessories include two types of sterile, handheld, single use surgical coagulation/ablation probes and required connector cables. The two versions of coagulation/ablation probes include short and longer length devices. The MedWaves microwave generator operates at a frequency of 902 to 928 MHz. For general surgery applications the generator is set by the manufacturer to deliver a maximum of 32 W and is user selectable up to 28 W. The system is capable of being run in two primary modes: power control mode and temperature control mode. A dynamic monitoring system within the generator maintains the set point selected by the user (either a power or temperature control point) in order to provide consistent and expected coaqulation/ablation performance. The system incorporates several monitored parameters that alert the user to potentially unsafe conditions during operation. These parameters and condition alerts include: high temperature, high-power, inefficient microwave delivery, catheter/probe disconnect and system errors. MedWaves microwave generator utilizes firmware to monitor these processes and post the ablation parameters and progress for the user on an LCD screen. MedWaves uses proprietary antenna technology coupled with a delivery system that efficiently transmits the microwave energy to the tip of the probe. The microwave antenna is 20 mm long mounted at the distal end. Efficiency of the system relieves the requirement of having high powered generator in order to create the desired coagulation/ablation results. The efficiency of the system allows the incorporation of monitoring and controls on the microwave energy delivery in order to deliver the most optimal performance available.
MedWaves Microwave Coagulation/Ablation System - Acceptance Criteria and Study Details
The provided documentation describes the MedWaves Microwave Coagulation/Ablation System, intended for surgical ablation of soft tissue. The "acceptance criteria" discussed are primarily related to general medical device standards and the device's functional performance in a lab setting, rather than clinical efficacy. The study focuses on demonstrating substantial equivalence to predicate devices through technical performance and compliance with relevant standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Test | Reported Device Performance |
|---|---|---|
| Electrical Safety/EMC | IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Safety: Electromagnetic Compatibility | Complies with standard |
| IEC 60601-2-2 2007 Standard Requirement Tests | Complies with standard | |
| Biocompatibility | ISO 10993, Biological Evaluation of Medical Devices | Complies with standard |
| Sterility | ANSI/AAMI/ISO 11135:1994 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization | Complies with standard |
| Packaging, Shelf Life | AAMI ANSI ISO 11607-1:2006 Packaging for Terminally Sterilized Medical Devices | Complies with standard |
| Mechanical Performance | MedWaves Catheter/Probes underwent mechanical and in vitro testing in accordance with the intended use. | Performed as expected and comparable to published performance of currently marketed products. |
| In Vitro Performance | MedWaves Catheter/Probes underwent mechanical and in vitro testing in accordance with the intended use. | Performed as expected and comparable to published performance of currently marketed products. |
| Firmware Testing | AAMI ANSI IEC 62304 Medical Device Software Software Lifecycle . Processes | Complies with standard |
| AAMI ANSI ISO 14971 & 14971 A1 Medical Devices Application of . Risk Management to Medical Devices | Complies with standard | |
| Substantial Equivalence | Comparison to predicate devices (Microsulis Tissue Ablation (MTA) System K052919, Tyco/Radionics Cool-Tip™ RF System K984552, VivaWave™ Microwave Ablation System K011676, VivaWave™ Microwave Ablation System K053535) | Device has the same intended use and general technological characteristics; performed comparably to a predicate device with respect to lesion size and tissue temperatures generated. No new questions of safety or efficacy raised. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of patients or cases. The "test set" primarily refers to physical units of the device (generator, probes, firmware) undergoing laboratory and in vitro testing.
- Data Provenance: The testing was conducted by MedWaves Incorporated. The context suggests these are internal company tests, typically performed in a controlled laboratory environment. No country of origin for a clinical data set is mentioned, as this is not a clinical study. The data is retrospective in the sense that it evaluates the manufactured device against pre-defined specifications and standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This document describes engineering and regulatory compliance testing, not a clinical study requiring expert consensus on clinical outcomes. Therefore, no "experts" in the sense of clinicians establishing ground truth for a test set of patient data are mentioned. The ground truth for functional performance and compliance is established by the specifications of the relevant international and national standards (e.g., IEC, ISO, AAMI, ANSI) and the device's design specifications. The "experts" would be the engineers and quality assurance personnel responsible for conducting and evaluating these technical tests. Their specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies to resolve discrepancies between readers in assessing ground truth. This document pertains to technical performance and regulatory compliance, where outcomes are typically objectively measured against defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. This 510(k) submission focuses on demonstrating substantial equivalence through technical performance and compliance with standards, not on clinical comparative effectiveness with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Yes, a standalone performance assessment was effectively done for the device's technical aspects. The testing described (electrical safety, biocompatibility, sterility, mechanical, in vitro, firmware) evaluates the device itself (generator, probes, software) without human-in-the-loop clinical interaction. The "device performed as expected and comparable to the published performance of currently marketed products" based on these tests.
7. The Type of Ground Truth Used
- The ground truth for this submission is based on:
- Engineering specifications and design requirements for the device's components and overall function.
- International and national medical device standards (e.g., IEC 60601, ISO 10993, ANSI/AAMI/ISO 11135, AAMI ANSI ISO 11607, AAMI ANSI IEC 62304, AAMI ANSI ISO 14971).
- Published performance data of predicate devices used for comparison of "lesion size and tissue temperatures generated" in in vitro or bench testing.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a "training set" of data. The device's "training" in this context would refer to its design and manufacturing process to meet specifications.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set mentioned for this type of medical device.
§ 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.