(57 days)
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.
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 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basket or forceps should be partially closed to keep the stone from dislodging while the device and endoscope are being withdrawn.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.
This K961248 document describes a medical device submission for the Bard® Platinum Class™ 3 French Flat Wire Stone Basket, High-Torque Helical Stone Basket, and Grasping Forceps, intended for the endoscopic removal of renal and ureteral stones and calculi.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on:
- Submitter's Information: Details of C. R. Bard, Inc.
- Device Names: Trade and common names, classification names.
- Predicate Device Names: Mentions the same devices as predicate.
- Device Description: Explains the construction and general use of the stone baskets and grasping forceps.
- Intended Use: Specifies the indications for each type of instrument.
- Technical Characteristics: Lists the biocompatible materials used in construction.
Therefore, I cannot provide the requested table or study details based on the information given. This document is a 510(k) Summary of Safety and Effectiveness Information, which typically summarizes the device and its intended use, rather than detailing the full extent of performance testing and acceptance criteria. Such detailed study information is usually found in the full 510(k) submission, which is not provided here.
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MAY 2 8 1996
0000062
Bard Urological Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30209-2695
Image /page/0/Picture/4 description: The image shows the word "BARD" in a stylized, bold, sans-serif font. The letters are interconnected, with the "A" and "R" sharing a common vertical stroke. The overall design has a modern and somewhat geometric appearance due to the font's blocky nature and the way the letters are joined together.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
- A. Submitter's Information:
| Submitter's Name: | C. R. Bard, Inc., Urological Division |
|---|---|
| Address: | 8195 Industrial BoulevardCovington, Georgia 30209 |
| Phone: | 770-784-6135 |
| Fax: | 770-784-6419 |
| Contact Person: | Donna J. Wilson |
| Date of Preparation: | March 29, 1996 |
| Device Names: | |
| Trade Names: | Bard® Platinum Class™ 3 French Flat Wire Stone BasketBard® Platinum Class™ 3 French High-Torque Helical Stone BasketBard® 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
B.
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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.
0000063
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.
§ 876.4680 Ureteral stone dislodger.
(a)
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.(b)
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.