(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.
§ 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.