BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06)

K962538 · C.R. Bard, Inc. · FAS · Dec 17, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962538
• Device Name: BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06)
• Applicant: C.R. Bard, Inc.
• Product Code: FAS · Gastroenterology, Urology
• Decision Date: Dec 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bard Coagulating Resector is indicated for resection and coagulation of soft tissue and is intended for use with compatible resectoscopes.

Device Story

Monopolar electrosurgical electrode; delivers radio frequency energy from cleared electrosurgical generator to soft tissue. Used for resection and coagulation. Operated by surgeons in clinical settings (e.g., OR) via compatible resectoscopes (CIRCON ACMI, Wolf, Storz, Olympus). Device consists of metal loop tip, conductive wire, polymer insulator tubing, and stainless steel outer shaft. Facilitates tissue removal and hemostasis during urological or similar endoscopic procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Monopolar electrosurgical electrode; metal loop tip; conductive wire with polymer insulator tubing; distal stainless steel outer shaft; compatible with standard electrosurgical generators; manual operation via resectoscope.

Indications for Use

Indicated for resection and coagulation of soft tissue in patients requiring electrosurgical procedures using compatible resectoscopes.

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

• Microvasive (Boston Scientific Corporation) Wedge Electrosurgical Resection Device
• CIRCON ACMI Right Angle Cutting Loop Electrode

Submission Summary (Full Text)

{0}

Bard Urological Division
C. R. Bard, Inc.
8195 Industrial Blvd.
Covington, GA 30209-2695
K962538
p172
DEC 17 1996
BARD

# SECTION VI

## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

A. Submitter's Information:

Submitter's Name: C. R. Bard, Inc.
Address: 8195 Industrial Boulevard
Covington, Georgia 30209
Contact Person: Evans Yi-Wen Wuu
Contact Person's Phone: [phone]
Contact Person's Fax: [phone]
Date of Preparation: June 25, 1996

B. Device Name:

Trade Name: Bard Coagulating Resector
Common / Usual Name: Electrode, Electrosurgical
Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories

C. Predicate Device Name:

Trade Name: Microvasive® (Boston Scientific Corporation)
Wedge™ Electrosurgical Resection Device
Trade Name: CIRCON ACMI Right Angle Cutting Loop Electrode

D. Device Description:

The Bard Coagulating Resector is a monopolar electrode designed to deliver radio frequency energy that is supplied by an electrosurgical generator cleared for medical use.

E. Intended Use:

The Bard Coagulating Resector is indicated for resection and coagulation of soft tissue and is intended for use with compatible resectoscopes.

F. Technological Characteristics Summary:

Table VI.1 provides a tabulated comparison of the technological characteristics of the Bard Coagulating Resector versus the two predicate devices.

VI.1

480-06

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K962538
p272

# Table VI.1
## Comparison Summary of Technological Characteristics

| Comparison Topic | Bard Coagulating Resector | Microvasive Wedge™ Electrosurgical Resection Device (Predicate Device) | CIRCON ACMI Right Angle Cutting Loop Electrode (Predicate Device) |
| --- | --- | --- | --- |
| **Indications or Intended Use** | (Indications) The Bard Coagulating Resector is indicated for resection and coagulation of soft tissue and is intended for use with compatible resectoscopes. | (Intended Use) Intended for cutting and coagulation during resection. To be used with compatible resectoscopes. | (Intended Use) Intended for cutting (resection). To be used with compatible resectoscopes. |
| **Resectoscope Compatibility** | Examples of resectoscope compatibility include CIRCON ACMI (both USA and Classic series), Wolf, Storz (both Single and Double stem), and Olympus resectoscope. | Models available for CIRCON ACMI USA series and Storz (Single stem) resectoscopes. | Fits compatible CIRCON ACMI resectoscopes. |
| **Electrode Tip** | Metal loop. | Metal loop. | Wire loop. |
| **Body Construction** | Conductive wire jacketed with black (polymer) insulator tubing and further jacketed with distal stainless steel outer shaft. | Conductive wire jacketed with polymer insulator tubing. | Conductive wire jacketed with polymer insulator tubing. |
| **Proximal Construction** | Conductive contact compatible with specific resectoscopes. | Conductive contact compatible with specific resectoscopes. | Conductive contact compatible with specific resectoscopes. |
| **Stabilizer** | On applicable models. | On all models. | On all models. |

VI.2