CAP-AID (IMPROVED)

K964580 · Nebel, Inc. · FHA · Jan 10, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964580
• Device Name: CAP-AID (IMPROVED)
• Applicant: Nebel, Inc.
• Product Code: FHA · Gastroenterology, Urology
• Decision Date: Jan 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5160
• Device Class: Class 1
• 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.

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)

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 [phone]
Fax: [phone]

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.

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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