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

{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: (770) 784-6946 Contact Person's Fax: (770) 784-6419 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 {1} 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