Who is the manufacturer of BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)?

C.R. Bard, Inc. filed the 510(k) submission for BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06) (K961841).

What is the FDA product code for BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)?

FAS. It is classified under 21 CFR 876.4300 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

K961841 · C.R. Bard, Inc. · FAS · Oct 9, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K961841
Device Name	BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)
Applicant	C.R. Bard, Inc.
Product Code	FAS · Gastroenterology, Urology
Decision Date	Oct 9, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4300
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Monopolar electrosurgical electrode; delivers radio frequency (RF) energy from external generator to soft tissue. Used for ablation and coagulation. Operated by physicians in clinical settings (e.g., OR) via compatible resectoscopes (Circon ACMI, Wolf, Storz, Olympus). Device consists of conductive wire, polymer insulator, and stainless steel outer shaft with metal roller tip. Output is RF energy for tissue effect; enables precise tissue vaporization/coagulation during urological or similar endoscopic procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Monopolar electrosurgical electrode. Materials: conductive wire, polymer insulator tubing, stainless steel outer shaft, metal roller tip. Energy source: external electrosurgical generator. Form factor: endoscopic electrode compatible with Circon ACMI, Wolf, Storz, and Olympus resectoscopes. No software or electronic processing components.

Indications for Use

Indicated for ablation 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

Circon ACMI VaporTrode™

Related Devices

K962538 — BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06) · C.R. Bard, Inc. · Dec 17, 1996
K974515 — ENDOLAP RESECTOSCOPE ROLLER ELECTRODE · Endolap, Inc. · Dec 22, 1997
K974516 — ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE · Endolap, Inc. · Dec 22, 1997
K954710 — VAPOR-TECH ROLLER BALL ELECTRODE 24 FR. · Northgate Technologies, Inc. · Apr 24, 1996
K970717 — VAPOR-TECH SLED ELECTRODE · Northgate Technologies, Inc. · May 8, 1997

Submission Summary (Full Text)

{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. |