Who is the manufacturer of VIDAMED MODEDL 7600 RF GENERATOR?

Vidamed, Inc. filed the 510(k) submission for VIDAMED MODEDL 7600 RF GENERATOR (K965061).

What is the FDA product code for VIDAMED MODEDL 7600 RF GENERATOR?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for VIDAMED MODEDL 7600 RF GENERATOR?

510(k) clearance (submission type: Traditional).

What are the predicate devices for VIDAMED MODEDL 7600 RF GENERATOR?

VIDAMED Model 7205 RF Generator (K960918); VIDAMED Model 7312 RF Generator Data Recorder (K963180).

Who can help prepare an FDA 510(k) submission like VIDAMED MODEDL 7600 RF GENERATOR?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VIDAMED MODEDL 7600 RF GENERATOR

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

Intended 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.

Predicate Devices

VIDAMED Model 7205 RF Generator (K960918)
VIDAMED Model 7312 RF Generator Data Recorder (K963180)

Related Devices

K960918 — VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM · Vidamed, Inc. · Oct 8, 1996
K052413 — TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 · Medtronic Vascular · Nov 17, 2005
K014224 — PRECISION PLUS TUNA OFFICE SYSTEM · Vidamed, Inc. · Jan 23, 2002
K965199 — TUNA 5 CATHETER · Vidamed, Inc. · Apr 30, 1997
K021804 — PRECISION PLUS TUNA OFFICE SYSTEM; PRESISION TUNA OFFICE SYSTEM; PROVU TUNA SYSTEM · Medtronic Vascular · Aug 28, 2002

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.