UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)

K971992 · Uromed Corp. · FHA · Aug 1, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971992
• Device Name: UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)
• Applicant: Uromed Corp.
• Product Code: FHA · Gastroenterology, Urology
• Decision Date: Aug 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5160
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The UroMed ABC device is intended to prevent or reduce episodes of male urinary incontinence.

Device Story

UroMed ABC is a urological clamp for male urinary incontinence; occludes urethra to prevent leakage. Unlike traditional shaft-placed clamps, this device attaches to the glans of the penis to provide equivalent continence with reduced compression. Device is applied by the patient; provides mechanical occlusion. Adhesive properties ensure reliable adherence to skin. Benefits include effective management of incontinence symptoms through non-invasive mechanical means.

Clinical Evidence

Bench testing only. Evaluated tack force and peel force of the device adhesive. Compared tack force against another commercially available male incontinence device; results demonstrated consistent and reliable adherence. Peel force evaluated on human skin.

Technological Characteristics

Urological clamp; glans-placement design. Materials evaluated per ISO-10993. Adhesive performance tested per ASTM D2979-88. Mechanical occlusion principle. No energy source or software.

Indications for Use

Indicated for the prevention or reduction of male urinary incontinence episodes.

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

• Cap-Aid Continence Device (K964580)
• C3 Male Continence Device (K885323)
• Male Assistant (K952841)
• Cunningham Clamp (pre-amendment)

Submission Summary (Full Text)

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K971992

142

#### 510(k) Summary of Safety and Effectiveness UroMed Alternative Bladder Control Continence Device

### Company Name and Address

.

UroMed Corporation 64 A Street Needham, MA 02194

AUG - I 1997

# Official Contact

Nancy MacDonald Manager, Clinical & Regulatory Affairs

### Device Name

| Proprietary Name: | UroMed Alternative Bladder Control Continence Device (ABC) |
|----------------------|------------------------------------------------------------|
| Common Name: | Penile Clamp/Urological Clamp |
| Classification Name: | 21 CFR § 876.5160 Urological Clamp for Males<br>(Class I) |

## Predicate Devices used for Substantial Equivalence

The following are predicate devices used for substantial equivalence. The devices are currently marketed with either pre-amendment status or current PreMarket notification numbers:

| Product Name | Manufacturer | 510(k) # |
|---------------------------|-----------------------|---------------|
| Cap-Aid Continence Device | NEBL Inc. | K964580 |
| C3 Male Continence Device | Dacomed Corp. | K885323 |
| Male Assistant | Insight Medical Corp. | K952841 |
| Cunningham Clamp | Bard | pre-amendment |

# Intended Use

The UroMed ABC device is intended to prevent or reduce episodes of male urinary incontinence. Please refer to Section 7 for the device Instructions for Use.

# Indications for Use

The UroMed ABC device is indicated to prevent or reduce episodes of male urinary incontinence.

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2971992
242

## Design Description

The UroMed ABC device is a urological clamp designed to significantly reduce the leakage of urine by occluding the urethra. The ABC device is clamped on the glans of the penis to provide less compression, yet the same continence as those urological clamps that are placed on the shaft of the penis.

## Summary of Standards Achieved

ISO-10993: "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing".

ASTM D2979-88: "Standard Test Method for Pressure Sensitive Tack of Adhesives Using an Inverted Probe Machine".

## Performance Data

Bench tests were conducted to evaluate the tack force and the peel force of the ABC device adhesive. The tack force of the adhesive for the ABC device was compared with adhesive for another commercially available male incontinence device. The results indicate that the tack of the UroMed ABC device adhesive provides a consistent and reliable adherence. The peel force of the ABC device adhesive was evaluated on human skin. Tests results indicate that. . . .

### Summary

In summary, the UroMed ABC device a type of urological clamp as defined by 21 CFR \$876.5160 and is substantially equivalent to the following devices: Cap-Aid Continence Device, the C' Male Continence Device, the Male Assistant and the Cunningham Incontinence Clamp. All five (5) devices have the same intended use: to prevent urinary leakage in males. Information presented in the 510(k) demonstrates that the UroMed ABC device does not raise new questions of safety or effectiveness and is as safe and effective as other legally marketed devices. Therefore, UroMed believes that FDA should determine that the ABC device is substantially equivalent to other legally marketed devices.

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Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - I 1997

Ms. Nancy C. MacDonald Manager, Clinical & Regulatory Affairs UroMed Corporation 64 A Street Needham, Massachusetts 02194

Re: K971992 UroMed® Alternative Bladder Control Device .... Dated: May 28, 1997 Received: May 29, 1997 Regulatory class: I 21 CFR §876.5160/Product code: 78 FHA

Dear Ms. MacDonald:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.foa.gov/odrh/dsmamain.html".

Sincerely yours.

W.J.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): __ K 971992

Alternative Bladden Device Name: Un Med

Indications For Use:

prevent or reduce episodes 70 urindry incontinence

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluatio (Division Sigh Off Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number Frescription lise ાવ Over-Tne-Counte: Use :Per 21 CFR 801.109) (Optional Format 1-2-96)