← Product Code [FHA](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA) · K964580 # CAP-AID (IMPROVED) (K964580) _Nebel, Inc. · FHA · Jan 10, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K964580 ## Device Facts - **Applicant:** Nebel, Inc. - **Product Code:** [FHA](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA.md) - **Decision Date:** Jan 10, 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 NEBL CAP-AID (Improved) is designed to effectively occlude the male meatus thereby preventing urinary leakage. ## Device Story External penile clamp; occludes distal urethra to prevent urinary leakage. Device adheres to glans penis via medical-grade pressure-sensitive adhesive; shallow closed-ended trough occludes meatus. Patient-operated; device removed for voiding and replaced with new unit post-void. Intended for home use by male patients. ## Clinical Evidence No clinical data; substantial equivalence determination not based on performance data. ## Technological Characteristics External penile clamp; materials: Kraton Thermoplastic elastomer G-2706, C-Flex Thermoplastic elastomer, and medical-grade pressure-sensitive skin adhesive (Dow Corning Bio PSA 7-4500). Sterile, disposable, single-use device. ## 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 - NEBL Inc. CAP-AID ([K954959](/device/K954959.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} JAN 10 1997 K964580 8192 # 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is: K964580 Submitted By: Jeffrey A. Dann, M.D. President NEBL Inc. 44 Terrace Drive Worcester, MA 01609 Phone (508) 342-2224 Fax: (508) 345-0137 Date Prepared: 11/14/96 ## Device Name Proprietary Name: NEBL, Inc. CAP-AID (Improved) Common Name: Male Incontinence Cap Classification Name: Penile Clamp ## Substantial Equivalence The NEBL CAP-AID (Improved) is exactly similar in indications, design and features to NEBL's original CAP-AID device. ## Device Description The CAP-AID (Improved) is exactly similar in indications, design and features to the original CAP-AID device. Only the materials are different. The material changes requested in the "Improved" version allow additional comfort and ease of use for the patient. ## Intended Use The NEBL CAP-AID (Improved) is designed to effectively occlude the male meatus thereby preventing urinary leakage. {1} Indications for Use K964580 p292 The product prevents urinary leakage in men with urinary incontinence. ## Substantial Equivalence Comparison | | NEBL Inc. CAP-AID (Improved) | NEBL Inc. CAP-AID (original) K954959 | | --- | --- | --- | | Indication | Prevent urine leakage in male incontinence | Prevent urine leakage in male incontinence | | Mode of Operation | External device which occludes the distal urethra | External device which occludes the distal urethra | | Application | 1. adheres to the glans penis 2. a shallow closed ended trough occludes the meatus 3. Patient removes device to void and re-applies a new device after each void | 1. adheres to the glans penis 2. a shallow closed ended trough occludes the meatus 3. Patient removes device to void and re-applies a new device after each void | | Material | 1. Kraton Thermoplastic elastomer G-2706 2. C-Flex Thermoplastic elastomer - CPT Technologies 3. medical grade pressure sensitive skin adhesive Dow Corning Bio PSA 7-4500 | 1. Kraton Thermoplastic elastomer G-2705 2. medical grade pressure sensitive skin adhesive Polyken Technologies #DFPE 170 or 3M Healthcare polyethylene film #1509 | | Sterility | Sterile/disposable | Sterile/disposable | The determination of substantial equivalence is not based on an assessment of any performance date, clinical or non-clinical. Submitter's Signature Date ![img-0.jpeg](img-0.jpeg) ![img-1.jpeg](img-1.jpeg) --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K964580](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K964580) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com