RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
Device Facts
| Record ID | K962472 |
|---|---|
| Device Name | RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER |
| Applicant | Rusch Intl. |
| Product Code | FAP · Gastroenterology, Urology |
| Decision Date | Aug 27, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1620 |
| Device Class | Class 2 |
Indications for Use
The Rüsch Urodynamic Rectal Balloon 2-way Catheter is intended to provide a fluid conduit for urodynamic studies, where the detrusor pressure is to be calculated from rectal pressure.
Device Story
Double lumen polyvinyl chloride tube with affixed latex balloon and radiopaque stripe; used as fluid conduit in urodynamic studies. Balloon inflated with sterile water via luer taper syringe; catheter connected to pressure transducer. Used in clinical settings by healthcare professionals to measure rectal pressure for detrusor pressure calculation. Facilitates diagnostic assessment of urinary sphincter function.
Clinical Evidence
Bench testing only. Biocompatibility testing per ISO 10993/FDA G95/1. Laboratory bench testing included tensile testing and balloon burst testing per FDA 510(k) Checklist for Urodynamic Catheters. Results demonstrate performance comparable to predicate K952573.
Technological Characteristics
Materials: Polyvinyl chloride (PVC) tube, latex balloon. Features: Double lumen shaft, radiopaque stripe. Sterilization: Same process as K952573. Connectivity: Luer taper syringe interface for inflation; transducer interface for pressure measurement.
Indications for Use
Indicated for patients undergoing urodynamic studies requiring rectal pressure measurement for detrusor pressure calculation.
Regulatory Classification
Identification
A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.
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
- Rüsch Urodynamic Rectal Balloon Catheter (K952573)
- Porges Urodynamic Rectal Balloon Catheter (Preamendment)
- Cook Urological Urodynamic Rectal Balloon Catheter (K912451)
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- K032138 — MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER · Medtronic Vascular · Oct 9, 2003
- K030813 — PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND · Primary Care Solutions, Inc. · May 30, 2003
- K971643 — RUSCH BRILLANT BALLOON CATHETER · Rusch Intl. · Oct 7, 1997
