(59 days)
The RESTORE Vacuum Erection Device consists of two main parts: the vacuum pump and constriction ring. Intended use statements for these are as follows.
Vacuum Pump (intended use) - used to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood into the penile corpora cavernosa causing the penis to become erect and rigid.
Constriction Ring (intended use) - used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the aid of a vacuum pump.
The RESTORE Vacuum Erection Device consists of a vacuum pump, ABS plastic vacuum cylinder, connecting PVC tubing, cylinder end cap, cushion seal, constriction rings, a tube of personal water-based lubricant and a convenient travel case.
The provided text is a 510(k) Premarket Notification summary for the RESTORE Vacuum Erection Device from 1998. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.
Therefore, this document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.
The document states that the RESTORE Vacuum Erection Device is "substantially equivalent" to predicate devices based on:
- Technological Characteristics: The vacuum pump is stated to be substantially equivalent to the Erecaid System Classic (K841257) and Erecaid System / Stay Erec System (K974173). The constriction rings are identical to the Pro-Long rings (K904485).
- Manufacturing: Repro-Med Systems, Inc. manufactured the predicate Osbon products.
- Materials: All component materials are identical to the named predicate devices.
The FDA's letter (K981506) confirms this finding of substantial equivalence, allowing the device to be marketed. This regulatory pathway typically relies on existing data or equivalence to devices already proven safe and effective, rather than new, independent clinical trials with explicit acceptance criteria.
§ 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.