(205 days)
The Nanma adjustable constriction rings are external penile rigidity devices used for the treatment or management of erectile dysfunction/impotence. The Nanma adjustable constriction ring can be used alone or with a vacuum pump. This device is intended for over-the-counter use (OTC)
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I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria, the study that proves the device meets the acceptance criteria, or any details about a clinical study.
The document is a 510(k) clearance letter from the FDA to Nanma Manufacturing Co., Ltd. for their "Nanma Adjustable Constriction Rings." This letter indicates that the device has been found substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
The document does NOT contain:
- A table of acceptance criteria or reported device performance.
- Information on sample size, data provenance, number of experts, adjudication methods for a test set.
- Details about a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- Information on the type of ground truth used or the sample size and establishment of ground truth for a training set.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, which often relies on comparative performance, materials, and intended use, rather than extensive new clinical studies with detailed acceptance criteria as one might find for a novel or higher-risk device PMA submission.
§ 876.5020 External penile rigidity devices.
(a)
Identification. External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.(b)
Classification. Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.