(47 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
I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria for the POS-T-VAC (IVP-600) Vacuum Erection Device or any studies conducted to prove it meets such criteria.
The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. This letter primarily focuses on the regulatory authorization to market the device and its indications for use. It does not contain detailed performance data, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.
Therefore, I cannot provide the requested table or answer the specific questions about the study design, ground truth, or expert involvement based solely on this document.
§ 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.