(88 days)
The intended use of the device is to assist users in achieving a full erection, i.e., to create an erection in men with Erectlle dysfunction by means of an applied vacuum to the penis, which draws blood to the penile corpora cavernosa, causing the penis to become erect and rigid. The constriction bands are then placed around the base of the erect penis to restrict the flow of venous blood leaving the penis.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called the "SE-200 Vacuum Erection Device." It addresses the regulatory and marketing aspects of the device, including its classification, substantial equivalence to predicate devices, and general controls.
However, the document does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance. These details are typically found in the scientific and clinical evidence submitted in a 510(k) application, which is not part of this clearance letter.
Therefore, I cannot provide the requested information based on the given input.
§ 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.