K Number
K974215
Manufacturer
Date Cleared
1998-02-19

(101 days)

Product Code
Regulation Number
876.5020
Panel
GU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use of the device is to assist men who have difficulty in achieving an erection by using the vacuum device and maintaining a satisfactory erection by using the constriction rings.

For men who are able to achieve an erection but not maintain it, the application of a constriction ring at the base of the penis can sufficiently reduce venous leak to maintain the erection. In this instance, they may not be required to use the vacuum device.

Device Description

Vacuum Device and Constriction Ring Set

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a medical device (VET-Co OTC Vacuum Device and Constriction Ring Set). This type of document is a regulatory approval and does not include detailed studies, acceptance criteria, or performance data in the format requested.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976... A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement... and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions."

This means the device was approved based on its substantial equivalence to existing, legally marketed predicate devices, not on a new clinical study demonstrating specific performance against predefined acceptance criteria. The detailed study information requested would typically be found in a clinical trial report or a performance study summary, which are not part of this 510(k) clearance letter.

Therefore, I cannot extract the requested information (acceptance criteria, specific study details, sample sizes, expert qualifications, etc.) from this document. The document only provides the intended use of the device: "to assist men who have difficulty in achieving an erection by using the vacuum device and maintaining a satisfactory erection by using the constriction rings."

§ 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.