(64 days)
The UroMed ABC device is intended to prevent or reduce episodes of male urinary incontinence.
The UroMed ABC device is indicated to prevent or reduce episodes of male urinary incontinence.
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.
This K971992 document describes the UroMed Alternative Bladder Control Continence Device (ABC), a Class I urological clamp. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with defined endpoints.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided document. The 510(k) submission for the UroMed ABC device does not articulate specific acceptance criteria for performance metrics (such as efficacy in preventing urine leakage or comfort levels) nor does it report device performance against such criteria. The submission primarily relies on demonstrating substantial equivalence to existing predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided for efficacy or clinical performance. The document only mentions "Bench tests were conducted to evaluate the tack force and the peel force of the ABC device adhesive." It does not specify the sample size for these bench tests, nor does it provide details on data provenance beyond stating "on human skin" for the peel force. There is no information about a test set for clinical performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable/not provided. There is no mention of a clinical test set requiring expert-established ground truth for the UroMed ABC device. The submission relies on bench testing and substantial equivalence to market approval.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. No clinical test set requiring adjudication is described in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as described in the provided document. The submission focuses on substantial equivalence based on device design and intended use, not on comparing human reader performance with and without AI assistance. The device is a physical medical device, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable/not provided. The UroMed ABC is a physical medical device and does not involve an algorithm or AI. Therefore, a standalone performance study in the context of AI algorithms is not relevant.
7. Type of Ground Truth Used
For the bench tests on adhesive performance, the "ground truth" would be the direct measurements of tack force and peel force. However, for the overall effectiveness of the device in preventing urinary incontinence, the document does not refer to any specific ground truth method applied to a clinical study. Instead, it relies on the established safety and effectiveness of its predicate devices through the substantial equivalence pathway.
8. Sample Size for the Training Set
This information is not applicable/not provided. The UroMed ABC device is not an AI/ML algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
This information is not applicable/not provided. As the device is not an AI/ML algorithm, there is no training set or associated ground truth establishment process.
In Summary:
The K971992 submission for the UroMed ABC device is a Class I 510(k) submission, which typically relies on demonstrating substantial equivalence to legally marketed predicate devices. This type of submission generally does not require extensive clinical trials with detailed performance acceptance criteria, test sets, or ground truth establishment in the same manner as novel, higher-risk devices or AI/ML-driven diagnostics. The provided document details the device's design, intended use, and a summary of bench tests for adhesive properties, with the primary argument being substantial equivalence to existing penile clamps.
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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(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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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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)
§ 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.