UROMED PATCH

K974600 · Uromed Corp. · MNG · Mar 31, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K974600
• Device Name: UROMED PATCH
• Applicant: Uromed Corp.
• Product Code: MNG · Gastroenterology, Urology
• Decision Date: Mar 31, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5160
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The UroMed Patch is indicated for the prevention or decrease of episodes of urine leakage in women with stress urinary incontinence.

Device Story

UroMed Patch is a single-use, disposable foam pad coated with adhesive gel; worn over urethra between urinations; prevents urine escape; replaced after each urination. Device intended for OTC use by patients for self-management of stress urinary incontinence. Clinical benefit includes reduction in leakage frequency and severity, and improved quality of life. Healthcare providers use clinical data to confirm safety and efficacy; patients use device independently based on provided instructions.

Clinical Evidence

Clinical study evaluated safety and efficacy in women with incontinence. Results showed significant improvement: mean leakage episodes per week decreased from 14.18 to 4.89 (p=0.0001, 65.5% improvement). Perceived severity score improved by 71.1% (p=0.0001). Quality of life impact score improved by 71.4% (p=0.0001). Leakage (grams/hour) decreased by 61.1% (p=0.0001). Safety evaluations of bladder function, microbiology, and dermatology showed no clinically significant changes; minor irritation reported. Self-screening and labeling studies confirmed patient ability to self-diagnose and correctly apply the device.

Technological Characteristics

Single-use, disposable foam pad with adhesive gel coating. Designed for urethral occlusion. Materials tested for biocompatibility per ISO 10993 standards (toxicity, cytotoxicity, bacteriostasis, skin sensitivity). Non-powered, mechanical device.

Indications for Use

Indicated for women with stress urinary incontinence to prevent or decrease episodes of urine 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

• Miniguard Patch (Impress Softpatch) (Advanced Surgical Intervention K954215)

Submission Summary (Full Text)

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K 974600
143

# 510(k) Summary of Safety and Effectiveness UroMed Patch

#### Company Name

MAR 3 | 1998

UroMed Corporation 64 A Street Needham, MA 02194

#### Official Contact

Frederick Tobia Director, Clinical and Regulatory Affairs

#### Device Name

| Proprietary Name: | UroMed Patch |
|-------------------------|----------------------------------------------|
| Common Name: | Urethral Patch |
| Classification Name(s): | Device, urethral occlusion, for incontinence |

#### Predicate Devices used for Substantial Equivalence

Miniguard Patch (Impress Softpatch)

Advanced Surgical Intervention K954215 Now UroMed Corporation

#### Intended Use

The UroMed Patch is indicated for the prevention or decrease of urine leakage in women with stress urinary incontinence.

#### Indications for Use

The UroMed Patch is indicated for the prevention or decrease of episodes of urine leakage in women with stress urinary incontinence.

#### Description

The UroMed Patch is a single use, disposable foam pad that is coated on one side with an adhesive gel. The patch is worn over the urethra between times of unination. The product is intended to prevent unine form escaping the environs of the urethra, and is replaced each time the patient urinates.

UroMed Patch - OTC 510(k) 03/25/98

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#### Summary of Standards Achieved

The UroMed Patch was designed and tested to meet the following standards: ISO 10993

## Summary of Testing

#### In-Vitro Testing

The UroMed Patch and the component materials have been tested for biocompatibility, toxicity, cytotoxicity, bacteriostasis, and skin sensitivity. The testing exceeds the guidelines set forth in ISO 10993 for a chronically used mucosal membrane devices. The results indicate the materials and product are biocompatible, non-toxic and well tolerated by subcutaneous tissue.

#### Clinical Testing

The UroMed Patch has been extensively tested for its safety and efficacy in decreasing the number of urinary leakage episodes in women with incontinence. In addition, the UroMed Patch has been tested to ensure the device can be used outside the supervision of a licensed practitioner. and adequate directions for use have been prepared.

| Parameter | Control | After 12<br>Weeks | Improvement | p-value |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------|-------------|---------|
| Mean Number of Leakage Episodes per week | 14.18 | 4.89* | 65.5%* | 0.0001 |
| Perceived Severity of Leakage<br>Scale: 0=not at all; 3=severe:<br>13 activities rated - total possible score of 39 | 11.02 | 3.18 | 71.1% | 0.0001 |
| Impact on Quality of Life<br>Subjects rated degree to which urinary leakage<br>had a negative effect on 26 activities for a<br>maximum possible score of 78<br>(0 = not at all, 3 = severe) | 10.42 | 2.98 | 71.4% | 0.0001 |
| Leakage<br>(grams/hour) | 1.31 | 0.51 | 61.1% | 0.0001 |

The following observations were noted in regards to product efficacy:

*NOTE: In reviewing the average number of leakage episodes reported by the patients at weeks 9, 13 and 17 (5.69 leakage episodes) as compared with the control period (14.18 leakage episodes), there was an improvement of 60%.

To provide clinical safety assurance of the UroMed Patch, the effects of use on bladder function, microbiology and dermatology were evaluated. There were no clinically significant changes noted. The sole event which may be associated with use of the UroMed Patch was a minor increase in the incidence of subject reported symptoms of irritation, characteristic of minor intitation associated with use of any topical device.

Labeling and self screening studies were conducted to assure patients could self-diagnose the type of incontinence, and correctly place the device by using instructions for use.

UroMed Patch - OTC 510(k) 03/25/98

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# Conclusion

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Based on these data the UroMed Patch has been shown to be safe and effective for its intended use.

ਹੈ। ਹਵਾਲੇ ਸਾਹਿਤ ਕਿ ਇਕ ਸਾਰੀ ਦੇ ਸਿੰਘ ਸੀ। ਉਹ ਸੀ। ਉਸਦੀ ਵੀ ਵੀ ਵੀ ਵੀ ਵੀ

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UroMed Patch - OTC 510(k) 03/25/98

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

# APR 2 6 2010

Mrs. Nancy C. MacDonald Manager, Clinical & Regulatory Affairs UroMed Corporation 65 A Street NEEDHAM MA 02194

Re: K974600

Trade/Device Name: UroMed Patch Regulation Number: 21 CFR§ 876.5160 Regulation Name: Urological clamp for males Regulatory Class: I Product Code: MNG Dated: March 9, 1998 Received: March 10, 1998

Dear Mrs. MacDonald:

This letter corrects our substantially equivalent letter of March 31. 1998.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, 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 practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 Ms. Nancy C. MacDonald K974600

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Janine M. Morris

Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Premarket Notification UroMed Patch

510(k) Number (if known): K974600

Device Name: UroMed Patch

#### Indication for Use:.

The UroMed Patch is indicated for the prevention or decrease of episodes of urine leakage in women with stress urinary incontinence.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

OR

Over-The-Counter Use /

ij

Robert D Rathbun

inn Sion-Off on of Reproductive, Abdominal, ENT, and Radiological Devices 4600 510(k) Number.

UroMed Patch - OTC 510(k) 03/25/98