VAPOR-TECH ROLLER BALL ELECTRODE 24 FR.

K954710 · Northgate Technologies, Inc. · FAS · Apr 24, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K954710
• Device Name: VAPOR-TECH ROLLER BALL ELECTRODE 24 FR.
• Applicant: Northgate Technologies, Inc.
• Product Code: FAS · Gastroenterology, Urology
• Decision Date: Apr 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Northgate Technologies Inc. Resectoscope Electrodes are intended to be used in urological procedures.

Device Story

Electrosurgical resectoscope electrodes; tip configurations include roller, grooved roller, ball, and scoop. Used with major brands of resectoscopes for cutting and coagulating soft tissue during urological procedures. Operated by physicians in clinical settings. Device facilitates tissue resection and hemostasis.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Electrosurgical electrodes with roller, grooved roller, ball, and scoop tip configurations. Materials are non-toxic and biocompatible, consistent with predicate devices. Compatible with major resectoscope brands.

Indications for Use

Indicated for use in urological electrosurgical procedures for cutting and coagulating soft tissue.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Predicate Devices

• Circon/ACMI resectoscope electrodes
• Olympus resectoscope electrodes
• Storz Products, Inc. resectoscope electrodes
• Richard Wolf resectoscope electrodes

Submission Summary (Full Text)

{0}

K954710
CONFIDENTIAL

# EXHIBIT #9a

## SUMMARY OF SAFETY AND EFFECTIVENESS

**Common/Usual Name:** Resectoscope Electrodes
**Proprietary Name:** Vapor-Tech Roller, Vapor-Tech Grooved Roller, Vapor-Tech Ball, Vapor-Tech Scoop
**Classification:** CLASS II

**Materials:**
All materials used to manufacture the Northgate Technologies Inc. Electrodes are non-toxic and have been previously used to manufacture other medical devices.

**Description:**
Northgate’s Cutting Loops and Knife Resectoscope Electrodes are designed to be used with most major brands of Resectoscopes. The electrodes are used to cut and coagulate soft tissue during electrosurgical procedures.

The Vapor-Tech Series Electrodes are designed with several tip configurations: roller, grooved roller, ball, and scoop.

**Substantial Equivalence:**
Northgate’s Resectoscope Electrodes are substantially equivalent in design, materials, and intended use to numerous currently marketed devices. Other manufacturers of similar devices are Circon/ACMI, Olympus, Storz Products, Inc., and Richard Wolf.

**Intended Use:**
Northgate Technologies Inc. Resectoscope Electrodes are intended to be used in urological procedures.

41