(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 Erectile 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 document is a 510(k) premarket notification approval letter for the "Boss-2000-2 Vacuum Erection Device." It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
This letter primarily focuses on the regulatory determination of substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market the device. It outlines general regulations and responsibilities but does not detail performance data, study designs, or acceptance metrics.
Therefore, I cannot provide the requested information based on the given input text.
§ 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.