(112 days)
Not Found
No
The device description and performance studies describe a physical patch with adhesive, not a software or algorithm-based technology. There are no mentions of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes
The device is indicated for the prevention or decrease of urine leakage in women with stress urinary incontinence, which addresses a medical condition and aims to improve health outcomes.
No
The UroMed Patch is indicated for the prevention or decrease of urine leakage, which is a treatment or management function, not a diagnostic one.
No
The device description clearly states it is a "single use, disposable foam pad that is coated on one side with an adhesive gel," indicating it is a physical hardware device, not software.
Based on the provided information, the UroMed Patch is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- UroMed Patch Function: The UroMed Patch is a physical device applied externally to the body (over the urethra) to prevent urine leakage. It does not analyze any biological specimens.
- Intended Use: The intended use is to physically prevent or decrease urine leakage, not to diagnose or monitor a condition through the analysis of a sample.
- Device Description: The description clearly states it's a "foam pad that is coated on one side with an adhesive gel" and is "worn over the urethra." This is a physical barrier, not a diagnostic tool.
Therefore, the UroMed Patch falls under the category of a physical medical device used for managing a symptom (urine leakage) rather than an IVD used for diagnostic purposes.
N/A
Intended Use / Indications for Use
The UroMed Patch is indicated for the prevention or decrease of urine leakage in women with stress urinary incontinence.
The UroMed Patch is indicated for the prevention or decrease of episodes of urine leakage in women with stress urinary incontinence.
Product codes (comma separated list FDA assigned to the subject device)
MNG
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra
Indicated Patient Age Range
women
Intended User / Care Setting
outside the supervision of a licensed practitioner.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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), showed 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean Number of Leakage Episodes per week (Control: 14.18, After 12 Weeks: 4.89*, Improvement: 65.5%*, p-value: 0.0001)
Perceived Severity of Leakage (Scale: 0=not at all; 3=severe: 13 activities rated - total possible score of 39) (Control: 11.02, After 12 Weeks: 3.18, Improvement: 71.1%, p-value: 0.0001)
Impact on Quality of Life (Subjects rated degree to which urinary leakage had a negative effect on 26 activities for a maximum possible score of 78 (0 = not at all, 3 = severe)) (Control: 10.42, After 12 Weeks: 2.98, Improvement: 71.4%, p-value: 0.0001)
Leakage (grams/hour) (Control: 1.31, After 12 Weeks: 0.51, Improvement: 61.1%, p-value: 0.0001)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
K974600
2 of 3
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
Weeks | Improvement | p-value |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------|-------------|---------|
| Mean Number of Leakage Episodes per week | 14.18 | 4.89* | 65.5%* | 0.0001 |
| Perceived Severity of Leakage
Scale: 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 Life
Subjects rated degree to which urinary leakage
had a negative effect on 26 activities for a
maximum 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
2
Conclusion
K974600
3 of 3
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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three faces in profile overlapping each other. The figure is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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.
4
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
5
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