(126 days)
Erco-Ribbon™ is used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection (either with the aid of a vacuum pump or naturally).
Erco-Ribbon can be used for patients with following conditions:
a) separately:
premature ejaculation
firm but short lasting erection
b) as a part of a vacuum constriction system
Diabetes
Venous leakage
Prostatectomy
Hypertension
Psychogenic condition
Radiation therapy
Spinal cord injury
A constriction ribbon is made of elastic and soft silicone with generally rectangular cross section. A belt with release loop is used for keeping the constrictor in a prearranged tightened position and for unlocking the ribbon.
The material conforms FDA regulation for devices contacting human skin.
For unlocking of the constrictor. the belt's release loop is pulled forward. The belt slips off, allowing easy unwrapping of the constricting ribbon.
A mounting tube comprises a segment of acrylic tube.
For arrangement of Erco-Ribbon™ penile constriction device, the ribbon is wrapped with the tension by multyple turns over the segment of the proximal end of the mounting tube. (or a vacuum chamber, when Erco-Ribbon ™ is used as a part of a vacuum constriction system),
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for the ERCO-RIBBON™ constriction device, primarily focusing on establishing substantial equivalence to previously marketed predicate devices.
Therefore, I cannot provide the requested information in the table or answer the other questions as the data is not present in the given text.
The document describes:
- The intended use of the Erco-Ribbon™.
- A brief description of the device's design and materials.
- A comparison of the Erco-Ribbon™ to predicate constriction rings, highlighting perceived advantages in terms of ease of use and pressure control.
- The FDA's decision of substantial equivalence.
There is no mention of:
- Specific acceptance criteria for performance metrics (e.g., pressure range, material durability, comfort levels).
- Any studies (clinical or benchtop) conducted to demonstrate the device's performance against such criteria.
- Sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or details about training and ground truth for any potential studies.
§ 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.