(263 days)
The C3® External Male Bladder Control Device is intended to be used for the management of urinary incontinence in males.
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 provided text describes a 510(k) premarket notification for a medical device, the C3® External Male Bladder Control Device. However, it explicitly states that no functional or safety testing was repeated for this device because it is identical to a previously marketed prescription device (K885323). The submission relies on the substantial equivalence of the new Over-The-Counter (OTC) device to this predicate and to other unclassified OTC penile constriction rings.
Therefore, the input text does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria for the K974040 submission. It merely asserts that the device is identical to a previously cleared device, with the only difference being the labeling for OTC use.
Based on the provided text, here's what can be stated about the acceptance criteria and the study that "proves" the device meets acceptance criteria (which, in this case, is a claim of substantial equivalence without new testing for this specific submission):
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated or defined within the provided text for the K974040 submission. The core "acceptance criterion" for this 510(k) is substantial equivalence to existing predicate devices, implying that the safety and efficacy demonstrated by those predicates are met.
- Reported Device Performance: No new performance data is reported as no functional or safety testing was repeated for this 510(k) submission. The device performance is presumed to be identical to the predicate device K885323.
| Acceptance Criteria (Inferred from 510(k) Goal) | Reported Device Performance (Claimed) |
|---|---|
| Substantial Equivalence to predicate device K885323 in design, function, materials, and intended use. | Device is identical to K885323. |
| No new questions of safety and efficacy compared to predicate devices. | Claimed no new questions of safety and efficacy. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable, as no new test set or functional/safety testing was conducted for this 510(k) submission (K974040).
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable, as no new test set requiring expert ground truth was established for this 510(k) submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable, as no new test set requiring adjudication was conducted for this 510(k) submission (K974040).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done for this 510(k) submission. The device is a physical bladder control device, not an AI-assisted diagnostic or imaging system where MRMC studies are typically performed.
- Effect Size of Human Readers with/without AI: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance Study: No, a standalone performance study was not done for this 510(k) submission. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Not applicable for the K974040 submission, as no new performance data or ground truth establishment was described. The submission relies on the established safety and efficacy of the predicate devices.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set: Not applicable. This device is a physical medical device, not an AI/ML algorithm.
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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
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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).
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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
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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)
§ 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.