BARD HIGH FLOW PAPILLOTOME

K963484 · Bard Interventional Products Div. · KNS · Nov 19, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K963484
• Device Name: BARD HIGH FLOW PAPILLOTOME
• Applicant: Bard Interventional Products Div.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Nov 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bard High Flow papillotome is indicated for use in transendoscopic papillotomy of the Papilla of Vater and/or the Sphincter of Oddi under endoscopic and/or fluoroscopic visualization.

Device Story

The Bard High Flow Papillotome is an endoscopic electrosurgical accessory used for performing papillotomies. The device is advanced through the biopsy channel of a side-viewing endoscope. It features a dual-lumen shaft allowing for guidewire placement and contrast medium injection. During operation, a diathermic current is applied to an integrated cutting wire to incise the Papilla of Vater or the Sphincter of Oddi. The device is operated by a physician in a clinical setting. The larger outer diameter of the shaft facilitates improved flow for contrast media and accessory device passage compared to previous models. The device is used to treat conditions requiring sphincterotomy, with clinical benefit derived from the ability to perform precise incisions under visualization.

Clinical Evidence

Bench testing only. Evidence includes comparative movement testing, in vitro flow testing, bow force, bow orientation, radiopacity, joint integrity, and electrical safety testing (ANSI/AMMI HF18-1993). Biocompatibility testing confirmed material safety.

Technological Characteristics

Dual-lumen shaft (nylon with MDX silicone coating); PVC luer fitting; ABS handle assembly; stainless steel set screw. 8 Fr O.D. tapering to 5.5 Fr tip. Electrosurgical device; energy source is external diathermic generator. Complies with ANSI/AMMI HF18-1993.

Indications for Use

Indicated for patients requiring transendoscopic papillotomy of the Papilla of Vater and/or the Sphincter of Oddi. Used under endoscopic and/or fluoroscopic visualization.

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

• Bard ProForma Papillotome (K894861)
• Microvasive Fluorotome/Ultratome/Ultratome XL Sphincterotomes (K930022)

Submission Summary (Full Text)

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BARD

Bard Interventional Products Division
C.R. Bard, Inc.
129 Concord Road
P.O. Box 7031
Billerica, MA 01821-7031
508-663-8989

NOV 19 1996

BARD

6.0 510(k) SUMMARY FOR THE BARD® HIGH FLOW PAPILLOTOME

As required under Section 12, part (a)(i)(3A) of the Safe Medical Device Act of 1990, an adequate summary of any information respecting safety and effectiveness follows.

6.1 General Information

- Name and address of submitter:

Bard Interventional Products Division, C.R. Bard, Inc.
129 Concord Road
Billerica, MA 01821-7031

- Contact:

Beth A. Rochette
Regulatory Affairs Manager
Phone: [phone]
Fax: [phone]

- Date of Summary:

August 12, 1996

- Name of Device:

Trade Name: Bard® High Flow Papillotome
Common/Usual Name: Papillotome
Classification Name: Endoscopic Electrosurgical
Accessory

- Predicate Device(s):

Bard ProForma Papillotome and the Microvasive® (Boston Scientific Corp.) Fluorotome™/Ultratome™/Ultratome XL Sphincterotomes

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- Description and Intended Use of Device:

The Bard High Flow papillotome is indicated for use in transendoscopic papillotomy of the Papilla of Vater and/or the Sphincter of Oddi under endoscopic and/or fluoroscopic visualization.

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## 6.2 Summary of Similarities and Differences

The High Flow papillotome is substantially equivalent to the currently marketed Bard® Proforma Papillotome (#K894861) manufactured by Wiltek Medical, Inc. and the Microvasive® (Boston Scientific Corporation) Sphincterotomes, which received concurrence through #K930022.

The indications for use of the High Flow papillotome are equivalent to both the Bard Proforma papillotome and the Microvasive sphincterotomes. The general design and functionality of the High Flow papillotome are similar to these currently marketed devices. All three of the papillotomes are advanced with or without a guidewire through the biopsy channel of a side viewing endoscope under endoscopic and/or fluoroscopic visualization and a diathermic current is applied to the cutting wire to incise the Papilla of Vater and/or the Sphincter of Oddi. The major differences between the papillotomes are:

1. The High Flow papillotome dual lumen shaft is constructed out of nylon with a MDX silicone coating, while both the Bard Proforma papillotome and the Microvasive sphincterotomes use PTFE. Comparative movement testing through a side viewing endoscope and guidewire movement testing has demonstrated substantial equivalence.

2. The High Flow papillotome uses a different plastic material for both the luer fitting and the handle assembly. The High Flow papillotome luer fitting is PVC and the handle assembly material is ABS; the Bard Proforma papillotome uses polycarbonate for both of these components.

3. The High Flow papillotome electrode assembly is similar in construction to the Bard Proforma except that the set screw is stainless steel versus nickel plated brass. Electrical testing has confirmed the High Flow papillotome meets the requirements of the ANSI/AMMI HF18-1993 standard.

4. The High Flow papillotome shaft is an 8 french O. D. that tapers to a 5.5 french tip O. D. The currently marketed papillotomes are labeled as either a 5 Fr., 7.5 Fr. or a 7 Fr. that tapers to a 5.5 Fr. O.D.

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Although some of the materials used for the High Flow papillotome are different from the Bard Proforma and Microvasive sphincterotomes they are commonly used materials in the medical device industry.

Biocompatibility testing has confirmed the materials used for the proposed High Flow papillotome are safe for contacting mucosa and tissue.

The larger O. D. of the High Flow papillotome shaft provides a slightly larger guide lumen for accessory devices and contrast medium injection. In Vitro flow testing has confirmed the device is substantially equivalent to the Microvasive® Ultratome XL sphincterotome.

In addition, bow force, bow orientation, radiopacity and joint integrity tests were completed to confirm device safety and effectiveness.

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