(57 days)
The VIDAMED RF Generator Data Recorder is indicated for use in recording patient treatment data when used in conjunction with VIDAMED RF Generators such as the VIDAMED Model 7205 RF Generator. The data recorder software does not control or effect the output of power from the RF Generator, nor is it intended to be used in the treatment or diagnosis of any disease.
The VIDAMED RF Generator Data Recorder is designed for use with VIDAMED RF Generators such as the VIDAMED Model 7205 RF Generator. When used with VIDAMED RF Generators, the VIDAMED RF Generator Data Recorder Software is capable of recording the lesion temperature, proximal shield (urethral) temperature, needle impedance, power delivered, and total energy delivered.
The provided text describes a medical device, the "VIDAMED RF Generator Data Recorder," and its intended use. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth, or expert involvement for the purpose of validating performance.
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study report. The key points from the provided text are:
- Indication: Records patient treatment data when used with VIDAMED RF Generators.
- Function: Records lesion temperature, proximal shield (urethral) temperature, needle impedance, power delivered, and total energy delivered.
- Limitation: The software does not control or affect the output of power from the RF Generator and is not intended for treatment or diagnosis.
- Substantial Equivalence: It is an accessory to the VIDAMED Model 7205 RF Generator (K955035).
Therefore, I cannot provide the requested information based on the input text. The text explicitly states: "No performance standard(s) or special controls applicable to this device have been promulgated under Section 514 of the Act," which further implies that a specific performance study with acceptance criteria, as one might find for a diagnostic or therapeutic device, is not detailed here.
To answer your questions, I would need a different type of document, such as a clinical study report, a validation study report, or a detailed performance specification document for the 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.