VIDAMED RF GENERATOR DATA RECORDER

K963180 · Vidamed, Inc. · GEI · Oct 10, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K963180
• Device Name: VIDAMED RF GENERATOR DATA RECORDER
• Applicant: Vidamed, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

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.

Device Story

Accessory to VIDAMED RF Generators (e.g., Model 7205); records procedural parameters including lesion temperature, proximal shield (urethral) temperature, needle impedance, power delivered, and total energy delivered. Software does not control RF power output; not intended for diagnosis or treatment. Used in clinical settings by medical personnel to log treatment data for review.

Clinical Evidence

No clinical data; device is a data recording accessory.

Technological Characteristics

Software-based data recorder; interfaces with VIDAMED RF Generators to log temperature, impedance, and energy parameters. No specific materials or hardware standards cited.

Indications for Use

Indicated for recording patient treatment data during procedures using VIDAMED RF Generators. No specific patient population, age, or disease state specified as the device is for data recording only.

Regulatory Classification

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.

Predicate Devices

• VIDAMED Model 7205 RF Generator (K955035)

Submission Summary (Full Text)

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OCT 10 1996
K963180

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## VIDAMED RF Generator Data Recorder

### Indication

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.

### Device Description

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.

### Substantial Equivalence

The VIDAMED RF Generator Data Recorder Software is considered an accessory to a previously cleared device. The VIDAMED RF Generator Data Recorder is designed solely for use with VIDAMED RF Generators such as the VIDAMED Model 7205 RF Generator which was previously cleared in 510(k) K955035.

### Standards/Classifications

No performance standard(s) or special controls applicable to this device have been promulgated under Section 514 of the Act.