(29 days)
The Model 90 Electrosurgical Probe is designed to supply energy (generated by the RITA Medical Systems' electrosurgical generator) for use in electrosurgery and is designed for the following:
Incorporation of multiple needles on each probe minimizing the number of invasive accesses necessary to achieve desired lesions.
Provide a minimally invasive laparoscopic, percutaneous, or intraoperative access to the targeted tissue.
Deliver radiofrequency energy in a controlled fashion to create coagulative necrotic lesions.
Incorporate thermocouples for temperature feedback.
Provide for local delivery of fluid.
This RITA® Model 90 device is available in 15 cm and 25 cm lengths for a variety of medical applications. The secondary electrodes deploy out from the trocar tip. The RITA Model 90 device consists of the following components: primary electrode: stainless-steel hypodermic tubing with a portion exposed as an electrode secondary electrodes: stainless-steel extendible flexible hypodermic tubing at the distal end of probe trocar insulation: fixed clear polymer shrink tubing handle: polymer materials with markings to indicate the amount of electrode array deployment from the trocar RF pathway: connection through a Lemo connector built into the handle fluid infusion: delivery through Luer port at side of the handle temperature sensors: Five temperature sensors at the periphery of the array depth indicators: Incremental 1-cm marks denote needle penetration depth.
The sponsor, RITA Medical Systems, Inc., conducted a study to verify that the Model 90 Electrosurgical Probe met its specifications.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Performance: (Specific criteria not detailed in the provided text, but implied by "battery of electrical... testing") | The devices met the specifications. |
| Mechanical Performance: (Specific criteria not detailed in the provided text, but implied by "battery of... mechanical testing") | The devices met the specifications. |
| Biocompatibility: (Specific criteria not detailed in the provided text, but implied by "battery of... biocompatibility testing") | The materials did not elicit toxicological responses. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the electrical, mechanical, and biocompatibility testing. It only mentions that the "Model 90 devices were subjected to a battery" of tests, implying multiple devices were tested. The data provenance is not specified, but it's likely to be internal testing conducted by the manufacturer, RITA Medical Systems, Inc., given the context of a 510(k) summary. It would be considered retrospective testing as it occurred prior to the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The testing appears to be objective performance testing against predefined engineering specifications rather than expert-derived ground truth.
4. Adjudication Method for the Test Set:
Not applicable. The testing described is performance-based against specifications, not a subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The study focuses on the device's technical specifications and safety (biocompatibility) rather than comparing its effectiveness in a clinical setting with or without human assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is an electrosurgical probe, which is a physical medical instrument, not an algorithm or an AI-powered system that would have standalone performance or human-in-the-loop evaluation.
7. The Type of Ground Truth Used:
The "ground truth" for the performance testing was derived from the engineering specifications for electrical and mechanical performance, and toxicological standards for biocompatibility. These are objective, pre-defined criteria that the device had to meet.
8. The Sample Size for the Training Set:
Not applicable. This document describes the testing of a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a physical electrosurgical probe.
§ 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.