BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS

K961248 · C.R. Bard, Inc. · FFL · May 28, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961248
• Device Name: BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS
• Applicant: C.R. Bard, Inc.
• Product Code: FFL · Gastroenterology, Urology
• Decision Date: May 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bard® Platinum Class™ Ureteroscopic 3 French Flat Wire Stone Basket is indicated for use in the endoscopic removal of renal and ureteral stones and calculi. Bard® Platinum Class™ Ureteroscopic 3 French High-Torque Helical Stone Basket is indicated for use in the endoscopic removal of renal and ureteral stones and calculi. Bard® Platinum Class™ Ureteroscopic 3 French Grasping Forceps is indicated for use in the endoscopic removal of renal and ureteral stones and calculi.

Device Story

Ureteroscopic instruments (3 Fr. diameter) designed for stone retrieval; includes flat wire basket, helical stone basket, and grasping forceps. Operation: device inserted through endoscope working channel to ureter/renal pelvis; tip advanced past stone; basket/forceps opened, manipulated, and closed around stone; device and endoscope withdrawn with captured stone. Used by urologists in clinical settings. Benefits: minimally invasive stone removal.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

3 Fr. outer diameter; lengths 70cm, 90cm, 115cm. Materials: 300/400 series stainless steel, nickel titanium, thermoplastics, fluoropolymers, polyimide, solder, cyanoacrylate, epoxy. Mechanical actuation via handle assembly.

Indications for Use

Indicated for endoscopic removal of renal and ureteral stones and calculi in patients requiring ureteroscopic intervention.

Regulatory Classification

Identification

A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.

Predicate Devices

• Bard® Platinum Class™ 3 French Flat Wire Stone Basket (K961248)
• Bard® Platinum Class™ 3 French High-Torque Helical Stone Basket (K961248)
• Bard® Platinum Class™ 3 French Grasping Forceps (K961248)

Submission Summary (Full Text)

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K961248
MAY 28 1996
0000062

Bard Urological Division
C. R. Bard, Inc.
8195 Industrial Blvd.
Covington, GA 30209-2695

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

## A. Submitter's Information:

Submitter's Name: C. R. Bard, Inc., Urological Division
Address: 8195 Industrial Boulevard
Covington, Georgia 30209
Phone: [phone]
Fax: [phone]
Contact Person: Donna J. Wilson
Date of Preparation: March 29, 1996

## B. Device Names:

Trade Names:
Bard® Platinum Class™ 3 French Flat Wire Stone Basket
Bard® Platinum Class™ 3 French High-Torque Helical Stone Basket
Bard® Platinum Class™ 3 French Grasping Forceps

Common Name: Ureteral Stone Dislodger

Classification Names: Dislodger, stone, basket, ureteral, metal
[Flat Wire Stone Basket, Helical Stone Basket, Grasping Forceps]

## C. Predicate Device Names:

Trade Names:
Bard® Platinum Class™ 3 French Flat Wire Stone Basket
Bard® Platinum Class™ 3 French High-Torque Helical Stone Basket
Bard® Platinum Class™ 3 French Grasping Forceps

## D. Device Description:

The Bard® Platinum Class™ 3 French Ureteroscopic Instrument product line consists of three separate instruments or stone dislodgers: the Flat Wire Stone Basket, the High-Torque Helical Stone Basket, and the Grasping Forceps. These instruments are each constructed of three main assemblies: a handle assembly, shaft assembly, and stone capture mechanism consisting of an expandable basket or grasping forceps assembly. Stone dislodgers (baskets or grasping forceps) may be used in the removal of renal and ureteral stones and calculi by inserting the stone basket or grasping forceps (while in a closed position) through the working channel of an endoscope and into the ureter or renal pelvis. The tip of the basket or forceps is advanced past the stone

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K961248 0000063

and the expandable basket or forceps is opened, manipulated and closed around the stone, thereby capturing it for removal. Once the stone has been captured, the basket or forceps should be partially closed to keep the stone from dislodging while the device and endoscope are being withdrawn.

The devices have a 3 Fr. outer diameter shaft size and each is available in three different lengths, 70cm, 90cm and 115cm.

## E. Intended Use:

Bard® Platinum Class™ Ureteroscopic 3 French Flat Wire Stone Basket is indicated for use in the endoscopic removal of renal and ureteral stones and calculi.

Bard® Platinum Class™ Ureteroscopic 3 French High-Torque Helical Stone Basket is indicated for use in the endoscopic removal of renal and ureteral stones and calculi.

Bard® Platinum Class™ Ureteroscopic 3 French Grasping Forceps is indicated for use in the endoscopic removal of renal and ureteral stones and calculi.

## F. Technical Characteristics:

The Bard® Platinum Class™ 3 French Ureteroscopic Instruments are constructed of biocompatible materials. Most of the materials used in the construction are typical for similar accessories. These include thermoplastics, 300 or 400 series stainless steel, solder, nickel titanium, fluoropolymers, polyimide, cyanoacrylate and epoxy.