(174 days)
The Rejoyn Penile Support System is intended for use by men who have an inability to engage in sexual intercourse due to a flaccid or partially erect penis resulting from impotence.
The Rejoyn penile support system consists of a semi-rigid split support sleeve molded from medical grade rubber with an attachment strap. The sleeve is placed over the penis with the split side down and the strap is fastened behind the scrotum. The sleeve is approximately 2 1/4" long. The system may also include a lubricated latex cover which may be worn over the sleeve to enhance comfort.
Another version of the Rejoyn system includes a single-use, disposable support sleeve in lieu of the reusable support sleeve. The single-use sleeve is made of the same materials as the reusable sleeve but is removed after use by breaking off one end of the attachment strap at a specified location.
The Rejoyn system will be available in five different package variations: (1) one support sleeve, three covers and one tube of lubricating jelly; (2) one support sleeve and one tube of lubricating jelly; (3) one support sleeve and three covers; (4) three single-use support sleeves, three covers and one tube of lubricating jelly; and (5) three single-use support sleeves and three covers. Replacement covers and lubricating jelly also will be available separately.
This document (K971576) is a 510(k) premarket notification for a medical device called the "Rejoyn Penile Support System." It primarily focuses on demonstrating substantial equivalence to predicate devices and getting FDA clearance to market.
Crucially, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) submission process for this type of device (an external penile support system) in 1997 likely relied on the device's technological characteristics being substantially equivalent to legally marketed predicate devices, rather than requiring extensive clinical performance studies with specific acceptance criteria that would typically involve statistical analysis of efficacy or safety endpoints.
Therefore, I cannot populate the requested table or describe a study that proves the device meets acceptance criteria based on this document. The document describes the device, its intended use, and argues for its substantial equivalence to existing devices.
To answer your request, if this were a document that contained such information, it would typically be found in a "Clinical Study," "Performance Testing," or "Validation Report" section, which is absent here.
§ 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.