(263 days)
No
The device description and summary of performance studies indicate a purely mechanical, externally applied device with no mention of AI/ML components or data processing.
No
The device manages a condition (urinary incontinence) but does not treat, cure, or prevent it as expected from a therapeutic device. It's a control device, not a therapeutic one.
No
Explanation: The device is intended for the management of urinary incontinence, not for diagnosing a condition. It is a control device as indicated by its name and description.
No
The device description clearly states it is a "disposable, externally applied occlusive device" and a "clamp," indicating it is a physical hardware device, not software.
Based on the provided information, the C3® External Male Bladder Control Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The C3® device is an externally applied mechanical device that physically occludes the urethra. It does not involve testing any biological samples.
- Intended Use: The intended use is for the "management of urinary incontinence in males," which is a physical management of a condition, not a diagnostic test.
Therefore, the C3® External Male Bladder Control Device falls under the category of a non-IVD medical device.
N/A
Intended Use / Indications for Use
The C3® External Male Bladder Control Device is intended to be used for the management of urinary incontinence in males.
Product codes (comma separated list FDA assigned to the subject device)
FHA
Device Description
The C3® External Male Bladder Control Device is a disposable, externally applied occlusive device intended to manage urinary incontinence in males. The male urethra is occluded by applying an external force on the base of the dorsal side of the penile shaft by means of a clamp.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
male urethra, penile shaft
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Because the C3® External Male Bladder Control Device is identical to Timm Research Company's currently marketed prescription C3® Male Continence Device, no functional or safety testing was repeated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
K974040 ાત્વન
510(k) Summary A.
510(K) SUMMARY
| SUBMITTER: | Timm Research Company |
|---|---|
| CONTACT PERSON: | Mr. David Anderson |
| Director of Engineering | |
| Timm Research Company | |
| 6541 City West Parkway | |
| Eden Prairie, MN 55344 | |
| DATE PREPARED: | October 23, 1997 |
| TRADE NAME: | C3® External Male Bladder Control Device |
| CLASSIFICATION NAME | Urological Clamp for Males |
| and NUMBER: | Class I, 21 CFR 876.5160 |
| PRODUCT CODE: | FHA |
| PREDICATE DEVICE(S): | The C3® External Male Bladder Control Device is |
| identical to Timm Research Company's C3® Male | |
| Continence Device, which is a prescription only, | |
| urological clamp for males for the management of |
urinary incontinence (K885323). The OTC C3® Device is identical to Timm Research Company's prescription C3® Device (K885323) in design, function, materials, and intended use. The only difference between the OTC C3® Device and the
In addition, the OTC C3® Device is substantially equivalent to the penile constriction rings (external
unclassified) in the risks from being an OTC device,
prescription C3® Device is the labeling.
penile rigidity devices; product code LKY;
the design of the labeling, and the general
Systems Corporation (K844445).
mechanism of action. Therefore, the OTC C3® Device does not raise any new questions of safety and efficacy. An example of an OTC constriction ring is the Revive System manufactured by Revive
_ page 9
1
DEVICE DESCRIPTION:
INTENDED USE:
FUNCTIONAL &
SAFETY TESTING:
The C3® External Male Bladder Control Device is a disposable, externally applied occlusive device intended to manage urinary incontinence in males. The male urethra is occluded by applying an external force on the base of the dorsal side of the penile shaft by means of a clamp.
The C3® External Male Bladder Control Device is intended to be used for the management of urinary incontinence in males.
Because the C3® External Male Bladder Control Device is identical to Timm Research Company's currently marketed prescription C3® Male Continence Device, no functional or safety testing was repeated.
CONCLUSION: The C3® External Male Bladder Control Device is identical to Timm Research Company's C3® Male Continence Device, which is a prescription only, urological clamp for males for the management of urinary incontinence (K885323). The OTC C3® Device is identical to Timm Research Company's prescription C3® Male Continence Device (K885323) in design, function, materials, and intended use. The only difference between the OTC C3® Device and the prescription C3® Device is the labeling.
In addition, the OTC C3® Device is substantially equivalent to the penile constriction rings (external penile rigidity devices; product code LKY; unclassified) in the risks from being an OTC device, the design of the labeling, and the general mechanism of action. Therefore, the OTC C3® Device does not raise any new questions of safety and efficacy. An example of an OTC constriction ring is the Revive System manufactured by Revive Systems Corporation (K844445).
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K974040
C3 External Male Bladder Control Device - OTC Dated: May 8, 1998 Received: May 14, 1998 Regulatory Class: I 21 CFR 876.5160/Procode: 78 FHA
Dear Mr. Way:
Mr. Ron Way
Regulatory Affairs
Timm Research Company
6541 City West Parkway
Eden Prairie, MN 55344
JUL 1 4 1998
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, 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 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 subsantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 542 of the Act for devices under the Electronic Product 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 predication 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.fda.gov/cdrb/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| Page | of |
|---|---|
| ------ | ---- |
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
6, 2017 - 11:
The C3® External Male Bladder Control Device is intended to be used for the management of urinary incontinence in males.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of ODRH, Office of Device Evaluation (ODE)
Roler R. Ratling/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 974040 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)