Who is the manufacturer of TUNA 5 CATHETER?

Vidamed, Inc. filed the 510(k) submission for TUNA 5 CATHETER (K965199).

What is the FDA product code for TUNA 5 CATHETER?

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 TUNA 5 CATHETER?

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

What are the predicate devices for TUNA 5 CATHETER?

TUNA 3 Catheter (K960918); VIDAMED AEC (K951245).

Who can help prepare an FDA 510(k) submission like TUNA 5 CATHETER?

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.

TUNA 5 CATHETER

K965199 · Vidamed, Inc. · GEI · Apr 30, 1997 · General, Plastic Surgery

Device Facts

Record ID	K965199
Device Name	TUNA 5 CATHETER
Applicant	Vidamed, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Apr 30, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The TUNA 5 Catheter is indicated for use as part of the VIDAMED TUNA System. 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

TUNA 5 Catheter functions as accessory to VIDAMED TUNA System RF generator; delivers RF energy to prostate tissue. Device features two deployable electrodes; deployed via cystoscopic sheath at angles 0°-90° and lengths 14-22 mm. Needles include base insulation to protect urethra during ablation. Used by physicians in clinical setting to treat BPH symptoms; reduces urinary outflow obstruction via targeted tissue ablation.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological similarity to predicate devices.

Technological Characteristics

RF energy delivery catheter; two deployable electrodes; adjustable deployment angles (0°-90°) and lengths (14-22 mm); insulated needle bases for urethral protection; 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

TUNA 3 Catheter (K960918)
VIDAMED AEC (K951245)

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
K973366 — COBRA HAND PIECE · Vidamed, Inc. · Nov 26, 1997
K014224 — PRECISION PLUS TUNA OFFICE SYSTEM · Vidamed, Inc. · Jan 23, 2002
K012587 — RF GENERATORS, DISPOSABLE CARTRIDGE KIT, DISPOSABLE CARTRIDGE, REUSABLE HANDLE, DISOISABLE HANDPIECE REUSABLE TELESCOPE · Vidamed, Inc. · Dec 11, 2001

Submission Summary (Full Text)

{0} APR 30 1997 K965199 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS TUNA® 5 Catheter ## Indication The TUNA 5 Catheter is indicated for use as part of the VIDAMED TUNA System. 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 TUNA System includes an RF generator and an accessory catheter for delivery of energy to the patient. The TUNA 5 Catheter contains two electrodes which can be deployed through a cystoscopic sheath at various angles between 0° and 90°, and various lengths between 14 and 22 mm. The needles are insulated at the base to protect the urethra during ablation of tissue. ## Substantial Equivalence The VIDAMED TUNA System is already cleared for the treatment of BPH. The TUNA 5 Catheter is substantially equivalent to two previously cleared VIDAMED accessory electrodes, the TUNA 3 Catheter which was cleared in 510(k) K960918, and the VIDAMED AEC which was cleared in 510(k) K951245. ## Standards/Classifications The VIDAMED TUNA System is a regulatory Class II medical device.