K965061 · Vidamed, Inc. · GEI · Jan 28, 1997 · General, Plastic Surgery
Device Facts
Record ID
K965061
Device Name
VIDAMED MODEDL 7600 RF GENERATOR
Applicant
Vidamed, Inc.
Product Code
GEI · General, Plastic Surgery
Decision Date
Jan 28, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4400
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The VIDAMED Model 7600 RF Generator is indicated for use as part of the VIDAMED TUNA System to deliver RF energy and record patient treatment data. The VIDAMED TUNA System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.
Device Story
RF generator delivers up to 30W (15W/channel) energy; used with VIDAMED TUNA catheter/electrodes. Inputs: thermocouple sensor data from electrodes. Operation: software controls RF energy delivery to prostate tissue; records/stores treatment data. Context: clinical use for BPH treatment. Output: RF energy to tissue; recorded treatment data for physician review. Benefit: symptom relief for BPH patients.
Clinical Evidence
No clinical data provided; substantial equivalence based on design and performance characteristics of predicate devices.
Technological Characteristics
RF energy delivery (up to 30W); thermocouple sensor input; electrical safety compliance with ANSI, AAMI, and UL standards. Regulatory Class II.
Indications for Use
Indicated for men >50 years old with urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) and prostate sizes 20-50 cc.
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.
VIDAMED Model 7312 RF Generator Data Recorder (K963180)
Submission Summary (Full Text)
{0}
JAN 28 1997
1965061
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
## VIDAMED Model 7600 RF Generator
### Indication
The VIDAMED Model 7600 RF Generator is indicated for use as part of the VIDAMED TUNA System to deliver RF energy and record patient treatment data. The VIDAMED TUNA System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.
### Device Description
The VIDAMED Model 7600 RF Generator is capable of delivering up to 30W (15W/channel) of RF energy and is designed for use with VIDAMED accessory electrodes including the TUNA Catheter. When used with VIDAMED accessory electrodes, the VIDAMED Model 7600 RF Generator is capable of reading, recording, and storing data obtained from thermocouple sensors within the electrode. Software within the RF generator and controls the RF energy output to the tissue.
### Substantial Equivalence
The VIDAMED TUNA System is already cleared for the treatment of BPH. The VIDAMED Model 7600 RF Generator is substantially equivalent to two previously cleared VIDAMED devices, the VIDAMED Model 7205 RF Generator, and the VIDAMED Model 7312 RF Generator Data Recorder. The VIDAMED Model 7600 RF Generator is substantially equivalent to the VIDAMED Model 7205 RF Generator which was cleared in 510(k) K960918. In addition, the features of the VIDAMED Model 7312 RF Generator Data Recorder previously cleared in 510(k) K963180 have been incorporated into the VIDAMED Model 7600 RF Generator.
### Standards/Classifications
The VIDAMED TUNA Model 7205 RF Generator is designed to be in compliance with ANSI, AAMI and UL electrical safety standards. The VIDAMED TUNA System is a regulatory Class II medical device.
