← Product Code [FHA](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA) · K970308 # MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE (K970308) _Mentor Urology, Inc. · FHA · Apr 2, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K970308 ## Device Facts - **Applicant:** Mentor Urology, Inc. - **Product Code:** [FHA](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA.md) - **Decision Date:** Apr 2, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5160 - **Device Class:** Class 1 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence is indicated for any male, who has urinary incontinence, either on a temporary or long term basis. It is also indicated for those patients who have an adverse reaction to natural latex rubber. ## Device Story Two-piece compression device for male urinary incontinence; consists of silicone gel-filled penile compression wrap and silicone ring. Provides temporary urinary continence via urethral occlusion. Designed as reusable, soft-sided alternative to rigid clamps. Used by patients with moderate to heavy incontinence. Patient applies device to penis; requires clean, dry skin. Benefits include non-rigid comfort and latex-free material for sensitive users. ## Clinical Evidence Bench testing only. Biological safety testing performed on all components per Tripartite and ISO 10993 standards; all results satisfactory. Physical testing and design verification performed to confirm device adequacy for intended use. ## Technological Characteristics Materials: Silicone gel and silicone. Form factor: Two-piece compression wrap with triple rib design. Energy source: None (mechanical compression). Sterilization: Not specified. ## Regulatory Identification A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp. ## Predicate Devices - Bard Cunningham Incontinence Clamp ([K884426](/device/K884426.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} APR 01 '97 01:40PM MENTOR UROLOGY P.2 APR - 2 1997 K970308 p1072 # SUMMARY OF SAFETY AND EFFECTIVENESS ## MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR ## MALE INCONTINENCE ## (510K SUMMARY) ### 1. Submitter's Data Mentor Urology, Inc. 1615 West River Road North Minneapolis, MN 55411 Date Prepared: 23 January 1997 ### 2. Device Name, Classification Name: Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence Trade Name: To be determined FDA Classification: Class I per 21CFR876.5250, Urological Clamp for Males, Code 78FHA. ### 3. Identification of Substantially Equivalent Device Bard Cunningham Incontinence Clamp, #K884426 ### 4. Device Description The Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence is a two piece compression device for males with urinary incontinence. The device consists of a silicone gel filled penile compression wrap for occlusion of the urethra and a silicone ring. It is intended for users who would prefer a reusable soft sided device instead of a rigid clamping device. The device is intended for users with moderate to heavy urinary incontinence to provide a temporary means of urinary continence. ### 5. Indications for Use The Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence is indicated for any male, who has urinary incontinence, either on a temporary or long term basis. It is also indicated for those patients who have an adverse reaction to natural latex rubber. 153 {1} APR 01 '97 01:40PM MENTOR UROLOGY K970308 P.3 p2072 6. Contraindications for Use Clinical contraindications for use of the Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence include: Use on patients with broken or poor skin quality. Use on patients with adverse reactions to any component of the system. 7. Warnings, Precautions Patient skin must be clean and dry before use. The correct size must be used. Physician advise may be helpful. 8. Biological Safety Testing Mentor Urology has performed biological safety testing on all components used in this device. These tests meet or exceed Tripartite and ISO 10993 standards. All tests were satisfactory. 9. Physical Testing, Design Verification Mentor Urology has performed various physical tests on this device and its components to show that the device and its design are adequate for the use intended. 140 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K970308](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K970308) **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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