Who is the manufacturer of VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM?

Vidamed, Inc. filed the 510(k) submission for VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM (K960918).

What is the FDA product code for VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM?

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 TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM?

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

What are the predicate devices for VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM?

VIDAMED TUNA System (K951245); VIDAMED TUNA System (K955035); Radionics (pre-amendments).

Who can help prepare an FDA 510(k) submission like VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM?

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 TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM

K960918 · Vidamed, Inc. · GEI · Oct 8, 1996 · General, Plastic Surgery

Device Facts

Record ID	K960918
Device Name	VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM
Applicant	Vidamed, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Oct 8, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The 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

TUNA System treats BPH via transurethral needle ablation; utilizes RF energy to ablate prostate tissue. Components: TUNA 3 Catheter, Model 7205 RF Generator, return electrode, rectal monitoring tape, optics. Generator delivers up to 30W (15W/channel); monitors tissue temperature via thermocouple sensors in electrodes; adjusts power output accordingly. Used in clinical setting by physicians. Provides controlled thermal ablation to reduce prostate volume; alleviates urinary obstruction symptoms.

Clinical Evidence

Confirmatory clinical data provided to support safety and effectiveness for BPH treatment.

Technological Characteristics

RF electrosurgical generator; 30W max power (15W/channel); thermocouple-based temperature sensing/feedback control. Compliance with ANSI, AAMI, and UL 544 standards. Class II device.

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 TUNA System (K951245)
VIDAMED TUNA System (K955035)
Radionics (pre-amendments)

Related Devices

K052413 — TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 · Medtronic Vascular · Nov 17, 2005
K014224 — PRECISION PLUS TUNA OFFICE SYSTEM · Vidamed, Inc. · Jan 23, 2002
K011787 — PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE · Vidamed, Inc. · Jul 6, 2001
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} OCT - 8 1996 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS $K960918$ # VIDAMED TUNA® (Trans Urethral Needle Ablation) System ## Indication The 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 TUNA® System consists of the TUNA® 3 Catheter, the VIDAMED Model 7205 RF Generator, the VIDAMED Return Electrode, the VIDAMED Rectal Monitoring Tape, and the TUNA® Optics. The electrosurgical generator is capable of delivering up to 30W (15W/channel) of power and is designed for use with VIDAMED accessory electrodes including the TUNA® 3 Catheter. When used with VIDAMED accessory electrodes, the electrosurgical generator is capable of reading temperature from thermocouple sensors within the electrode and controlling power output to the tissue. ## Substantial Equivalence The VIDAMED TUNA® 3 Catheter and VIDAMED Model 7205 RF Generator is substantially equivalent to devices provided by VIDAMED (K951245 and K955035), and Radionics (pre-amendments). Information is provided in the premarket notification to demonstrate that the properties of the TUNA® 3 Catheter and VIDAMED Model 7205 RF Generator are equivalent to equipment from the manufacturers listed above. Confirmatory clinical data is also provided to support the safety and effectiveness of the device for use in the treatment of symptoms due to urinary outflow obstruction secondary to BPH. ## Standards/Classifications The VIDAMED Model 7205 RF Generator and accessories are designed to be in compliance with ANSI, AAMI, and UL 544 standards. The VIDAMED Model 7205 RF Generator and accessories are Class II medical devices.