(75 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical properties and performance of a balloon catheter, with no mention of AI or ML capabilities.
Yes
The device is designed for the dilation of the ureter or urethra, which is a therapeutic intervention aimed at treating medical conditions.
No
The device is intended for the dilation of the ureter or urethra, which is a therapeutic purpose, not for diagnosing a condition.
No
The device description clearly details a physical catheter with a balloon, lumens, radiopaque markers, and a stylette. It is a hardware device used for mechanical dilation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "dilation of the ureter or urethra through the working channel of an endoscope." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon designed for mechanical dilation. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) outside of the body, which is the core function of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for a therapeutic intervention.
N/A
Intended Use / Indications for Use
"Indicated for use in dilation of the ureter or urethra through the working channel of an endoscope."
Product codes
Not Found
Device Description
The Bard® A-Trac™ Urological Balloon Dilation Catheter is a multilumen catheter with a discrete balloon mounted on its distal tip. The clear lumen, labeled "balloon", is for balloon inflation. The lumen, labeled "distal", allows the catheter to track over a guidewire and can be used for monitoring of pressure or infusion of medication and/or contrast medium. The catheter shaft gradually tapers beneath the balloon, nominally one French size. The tip is further tapered to provide a smooth interface with a Bard 0.035" PTFE-coated guidewire. Two radiopaque markers are placed beneath the "working area" of the balloon. The balloon is wrapped clockwise (when viewed from the proximal shaft to the distal tip) around the shaft and is protected by a balloon folding tool prior to sterilization. A stylette is inserted in the distal (guidewire) lumen beneath the balloon folding tool. The Bard® A-Trac™ Urological Balloon Dilation Catheter is available in various models incorporating balloon diameters (inflated) of 4mm-10mm; balloon lengths of 2, 3, 4, 8 and 10 cm; shaft lengths ranging from 45 to 125cm (standard lengths of 45, 75, 85 and 125cm); and shaft diameter of 5 Fr. (for balloons with inflated diameters
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).
0
Bard Urological Division C. R. Bard. Inc. 8195 Industrial Blvd. Covington, GA 30209-2695
K962921 p 193
OCT - 9 1996
BARD
SECTION VI
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
A. Submitter Information:
Submitter's Name: C. R. Bard, Inc., Urological Division Submitter's Address: 8195 Industrial Blvd., Covington, GA 30209 Contact Person: Donna J. Wilson Contact Person's Address: 8195 Industrial Blvd., Covington, GA 30209 Contact Person's Telephone Number: 770-784-6135 Contact Person's FAX Number: 770-784-6419 Date of Preparation: July 23, 1996
- B. Device Name:
ﻤﻌﺘﻤ
Bard® A-Trac™ Urological Balloon Dilation Catheter
- C. Predicate Device Name:
Bard® Tru-Trac™ Peripheral Balloon Dilatation Catheters and Microvasive's (Boston Scientific Corporation) Uro Max™ II High Pressure Ureteral Balloon Dilatation Catheter and Phantom 5™ Plus ST (Short Tip) Ureteral Balloon Dilatation Catheter.
D. Device Description:
The Bard® A-Trac™ Urological Balloon Dilation Catheter is a multilumen catheter with a discrete balloon mounted on its distal tip. The clear lumen, labeled "balloon", is for balloon inflation. The lumen, labeled "distal", allows the catheter to track over a guidewire and can be used for monitoring of pressure or infusion of medication and/or contrast medium.
1
K962921 8203
The catheter shaft gradually tapers beneath the balloon, nominally one French size. The tip is further tapered to provide a smooth interface with a Bard 0.035" PTFE-coated guidewire. Two radiopaque markers are placed beneath the "working area" of the balloon.
The balloon is wrapped clockwise (when viewed from the proximal shaft to the distal tip) around the shaft and is protected by a balloon folding tool prior to sterilization. A stylette is inserted in the distal (guidewire) lumen beneath the balloon folding tool.
The Bard® A-Trac™ Urological Balloon Dilation Catheter is available in various models incorporating balloon diameters (inflated) of 4mm-10mm; balloon lengths of 2, 3, 4, 8 and 10 cm; shaft lengths ranging from 45 to 125cm (standard lengths of 45, 75, 85 and 125cm); and shaft diameter of 5 Fr. (for balloons with inflated diameters