CAP-AID (IMPROVED)
K964580 · Nebel, Inc. · FHA · Jan 10, 1997 · Gastroenterology, Urology
Device Facts
| Record ID | K964580 |
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| Device Name | CAP-AID (IMPROVED) |
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| Applicant | Nebel, Inc. |
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| Product Code | FHA · Gastroenterology, Urology |
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| Decision Date | Jan 10, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 876.5160 |
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| Device Class | Class 1 |
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| Attributes | Therapeutic |
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Intended 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.
Indications for Use
Indicated for men with urinary incontinence to prevent urinary leakage.
Regulatory Classification
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)
Related Devices
- K963950 — BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE · Bioderm, Inc. · Jan 10, 1997
- K971992 — UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) · Uromed Corp. · Aug 1, 1997
- K970308 — MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE · Mentor Urology, Inc. · Apr 2, 1997
- K963265 — PROSYS SAMEC LA · Convatec, A Division of E.R. Squibb & Sons · Oct 25, 1996
- K962900 — SELF RETAINING MALE EXTERNAL URINARY CATHETER · Hollister, Inc. · Sep 16, 1996
Submission Summary (Full Text)
{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
