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The VISER™ penile tumescence monitor is a noninvasive monitoring device used to measure intracavernosal pressure (ICP) and blood flow in the penis. This monitoring assists the physician in the diagnosis of erectile dysfunction. VISERTM is a prescriptive device to be used under the direction of a physician or other authorized health care professional.

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This document is a 510(k) clearance letter for the VISER™ Penile Tumescence Monitor. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

The provided text does not include details about acceptance criteria, device performance from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set information. These details are typically found in the 510(k) submission itself, which is not fully included here.

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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the FDA did not require a new clinical study to establish safety and effectiveness, but rather determined that the new device is as safe and effective as a device already on the market. Therefore, the detailed study information requested is not present in this clearance letter.

Without the actual 510(k) submission, it's impossible to answer the specific questions about acceptance criteria and study details.

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