(57 days)
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No
The device description details a mechanical instrument for stone removal and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
Yes
The device is used for the endoscopic removal of renal and ureteral stones and calculi, which is a medical treatment.
No
This device is described as an instrument for removal of renal and ureteral stones and calculi (e.g., stone baskets or grasping forceps). It does not provide any diagnostic information about a disease or condition.
No
The device description clearly outlines physical components like a handle assembly, shaft assembly, and stone capture mechanism (basket or grasping forceps), indicating it is a hardware medical device.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that these instruments are used within the body (endoscopically) to remove stones. They are not used to analyze samples taken from the patient.
- The function is mechanical removal. The devices are designed to physically grasp and remove stones, not to perform diagnostic tests on biological samples.
These devices are surgical instruments used for a therapeutic procedure (stone removal), not diagnostic tests performed on in vitro samples.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
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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 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
renal and ureteral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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 Boulevard |
| Covington, 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 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
B.
1
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.