(75 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.
Not Found
The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for the "NANMA Adjustable Constriction Ring." These documents do not contain information about:
- Acceptance criteria and reported device performance.
- The specifics of any study conducted to prove the device meets acceptance criteria.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from these documents. The provided text is purely a regulatory clearance notice based on substantial equivalence, not a summary of performance study results.
§ 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.