BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)

{0} OCT - 9 1996 p 1072 K961841 BARD Bard Urological Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30209-2695 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: May 7, 1996 B. Device Name: Trade Name: Bard V-Max²⁴ Roller Bar Common / Usual Name: Electrode, Electrosurgical Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories C. Predicate Device Name: Trade Name: Circon ACMI VaporTrode™ D. Device Description: The Bard V-Max²⁴ Roller Bar 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 V-Max²⁴ Roller Bar is indicated for ablation and coagulation of soft tissue and is intended for use with compatible resectoscopes. 489-06 {1} 1 # F. Technological Characteristics Summary: Table VI.1 provides a tabulated comparison of the technological characteristics of the Bard V-Max²⁴ Roller Bar versus the predicate device. Table VI.1: Comparison Summary of Technological Characteristics | Comparison Topic | Bard V-Max²⁴ Roller Bar | Circon ACMI VaporTrode (Predicate Device) | | --- | --- | --- | | Indications or Intended Use | (Indications) The Bard V-Max²⁴ Roller Bar is indicated for ablation and coagulation of soft tissue and is intended for use with compatible resectoscopes. | (Intended Use) Used with compatible resectoscopes for vaporization and coagulation of tissue. | | Resectoscope Compatibility | Examples of resectoscope compatibility include Circon ACMI (both USA and Classic series), Wolf, Storz and Olympus resectoscope. | Models available for Circon ACMI (both USA and Classic series) resectoscope. | | Electrode Tip | Surface finished (smooth, grooved, etc.) metal roller. | Grooved metal roller. | | Body Construction | Conductive wire jacketed with polymer insulator tubing and further jacketed with distal stainless steel outer shaft. | Conductive wire jacketed with polymer insulator tubing and further jacketed with distal stainless steel outer shaft. | | Proximal Construction | Conductive contact compatible with specific resectoscopes. | Conductive contact compatible with specific resectoscopes. | | Stabilizer | On applicable models. | On both models. |