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.

AI/ML Overview

The UroMed Patch is a single-use, disposable foam pad with an adhesive gel coating used to prevent or decrease urine leakage in women with stress urinary incontinence.

Here's an analysis of its acceptance criteria and the study proving its effectiveness:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not explicitly state acceptance criteria in terms of specific thresholds for improvement or statistical significance for each performance parameter. However, the study results, all achieving a p-value of 0.0001, strongly suggest that the observed improvements were considered statistically significant and indicative of efficacy. The improvements themselves can be interpreted as the de-facto acceptance criteria for clinical effectiveness.

Parameter	Implied Acceptance Criteria (Demonstrated Improvement)	Reported Device Performance (Improvement vs. Control)	p-value
Mean Number of Leakage Episodes per week	Significant decrease (e.g., >60%)	65.5%* decrease	0.0001
Perceived Severity of Leakage	Significant decrease (e.g., >70%)	71.1% decrease	0.0001
Impact on Quality of Life	Significant decrease (e.g., >70%)	71.4% decrease	0.0001
Leakage (grams/hour)	Significant decrease (e.g., >60%)	61.1% decrease	0.0001

*Note: The submission mentions an average improvement of 60% when reviewing leakage episodes at weeks 9, 13, and 17, compared to the initially reported 65.5% at 12 weeks. Both are substantial improvements.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size (number of participants) for the clinical testing. It only states that the UroMed Patch has been "extensively tested for its safety and efficacy."

The data provenance (country of origin, retrospective/prospective) is not explicitly stated. However, given the context of a 510(k) submission to the FDA, it is highly likely that the data was collected in a prospective clinical study, most likely within the United States, or at least following good clinical practice (GCP) guidelines.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not provided in the submission. The clinical study focused on patient-reported outcomes (leakage episodes, perceived severity, quality of life) and objective measurements (leakage in grams/hour). These do not typically involve experts establishing a "ground truth" in the same way an imaging device might (e.g., radiologist consensus).

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided, as the study does not involve image interpretation or similar tasks requiring expert adjudication. The primary data points were quantitative measurements and patient self-assessment collected during a standard clinical trial.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. The UroMed Patch is a therapeutic device for incontinence, and its efficacy is measured by objective physiological parameters and patient-reported outcomes, not by human interpretation of diagnostic cases. Therefore, the concept of human readers improving with or without AI assistance is not relevant here.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

The concept of "standalone performance" (algorithm only) is not applicable to the UroMed Patch. This device is a physical product directly used by patients, not a diagnostic algorithm. Its performance is assessed through its direct physical effect on reducing urine leakage and its impact on the user.

7. Type of Ground Truth Used:

The ground truth for the clinical study was established using a combination of:

Objective Physiological Measurements: Leakage measured in grams per hour.
Patient-Reported Outcomes (PROs):
- Mean number of leakage episodes per week (self-reported).
- Perceived severity of leakage (patient-rated scale).
- Impact on Quality of Life (patient-rated scale).

These measures collectively served as the "ground truth" for assessing the device's efficacy.

8. Sample Size for the Training Set:

This information is not applicable as the UroMed Patch is a physical medical device, not an AI/ML algorithm that requires a "training set." Its development would involve engineering, material science, and possibly in-vitro testing, but not an algorithmic training set in the AI sense.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no "training set" in the context of this physical device. The "ground truth" for its development would involve established engineering standards, material properties, and biocompatibility testing criteria (e.g., ISO 10993 for biocompatibility), rather than a statistically derived ground truth for an algorithm.

Summary

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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

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 12Weeks	Improvement	p-value
Mean Number of Leakage Episodes per week	14.18	4.89*	65.5%*	0.0001
Perceived Severity of LeakageScale: 0=not at all; 3=severe:13 activities rated - total possible score of 39	11.02	3.18	71.1%	0.0001
Impact on Quality of LifeSubjects rated degree to which urinary leakagehad a negative effect on 26 activities for amaximum possible score of 78(0 = not at all, 3 = severe)	10.42	2.98	71.4%	0.0001
Leakage(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 (800) 638-2041 or (301) 796-7100 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)

Over-The-Counter Use /

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

Regulation Number and Section

§ 876.5160 Urological clamp.

(a)
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.(b)
Classification. Class I (general controls). Except when intended for internal use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.