(80 days)
The LeVeen™ Electrode is intended to be used in conjunction with a RadioTherapeutics Corporation radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions.
The device consists of a preshaped, multi-armed electrode array which is contained within a delivery cannula. The array is attached to a handle mechanism that deploys the array into the targeted tissue. In addition, each device is supplied with an insulated introducer sheath/stylet assembly to allow the physician to locate the target tissue prior to placing and deploying the electrode. The device is connected to a RadioTherapeutics RF generator so that RF energy passes from the array to a patient ground pad and heats the tissue surrounding the array.
This document does not contain the information requested in the prompt. The provided text is a 510(k) summary for a medical device (LeVeen™ Electrode), which primarily focuses on establishing substantial equivalence to a predicate device for marketing purposes.
Specifically, the document lacks details about:
- Acceptance criteria for device performance.
- A study proving the device meets acceptance criteria.
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets.
- Data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study or its effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for the training set was established.
The document states the device is "substantially equivalent" to a previously cleared device, implying that its safety and effectiveness are considered comparable based on existing data or device characteristics, rather than requiring a detailed new clinical or performance study with defined acceptance criteria to be presented in this summary.
§ 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.