← Product Code [FAP](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FAP) · K962472 # RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER (K962472) _Rusch Intl. · FAP · Aug 27, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FAP/K962472 ## Device Facts - **Applicant:** Rusch Intl. - **Product Code:** [FAP](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FAP.md) - **Decision Date:** Aug 27, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1620 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## 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. ## Regulatory 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](/device/K952573.md)) - Porges Urodynamic Rectal Balloon Catheter (Preamendment) - Cook Urological Urodynamic Rectal Balloon Catheter ([K912451](/device/K912451.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K962472 AUG 27 1996 RÜSCH. INTERNATIONAL Group Regulatory Affairs A Subsidiary of Teleflex Incorporated (USA) Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108 # 510(k) SUMMARY [As required by 21 CFR 807.92] ## 1. Submitter and Contact Person Neil R. Armstrong Group Regulatory Affairs Manager Rüsch International Tall Pines Park Jaffrey NH 03452 Tel: (603) 532 7706 Fax: (603) 532 8211 ## 2. Device Name **Trade Name** Rüsch Urodynamic Rectal Balloon 2-way Catheter **Common Name** Urodynamic Rectal 2-way Catheter **Classification Name** Accessory to Urodynamics Measurement System 78 FAP; 21 CFR 876.1620; Class II medical device ## 3. Comparison Devices Rüsch Urodynamic Rectal Balloon Catheter - K952573 Porges Urodynamic Rectal Balloon Catheter - Preamendment Cook Urological Urodynamic Rectal Balloon Catheter - K912451 ## 4. Description of Device The Rüsch Urodynamic Rectal Balloon 2-way Catheter consists of a double lumen polyvinyl chloride tube upon which is affixed a latex balloon, with a radiopaque stripe. To use, the balloon is inflated with sterile water using a luer taper syringe. The catheter is then connected to a transducer, and can be used in conjunction with equipment for calculating the detrusor pressure (pressure necessary to open the urinary sphincter). {1} K962472 ## 5. Intended 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. ## 6. Summary of Technological Characteristics The Rüsch Urodynamic Rectal Balloon 2-way Catheter is manufactured of the same materials and by the same processes (including sterilization) as the Rüsch Urodynamic Rectal Balloon Catheter - K952573. The Rüsch Urodynamic Rectal Balloon 2-way Catheter has a double lumen shaft design similar to the Porges Urodynamic Rectal Balloon Catheter (Preamendment) and the Cook Urological Urodynamic Rectal Balloon Catheter (K912451). ## 7. Summary of Performance Data Biocompatibility testing has been completed based on the ISO 10993 matrix modified by FDA Blue Book Memo #G95/1. Laboratory bench testing has been completed to section #6 of the FDA "510(k) Checklist for Urodynamic Catheters": - Tensile Testing - Balloon Burst Testing The device's performance in these tests is comparable with that of the Rüsch Urodynamic Rectal Balloon Catheter (K952573). --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FAP/K962472](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FAP/K962472) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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