← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K965199

# TUNA 5 CATHETER (K965199)

_Vidamed, Inc. · GEI · Apr 30, 1997 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K965199

## Device Facts

- **Applicant:** Vidamed, Inc.
- **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md)
- **Decision Date:** Apr 30, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4400
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Indications for 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.

## Regulatory 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](/device/K960918.md))
- VIDAMED AEC ([K951245](/device/K951245.md))

## Submission Summary (Full Text)

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>
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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.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K965199](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K965199)

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