K142355 is an FDA 510(k) clearance for the Vaginal Tactile Imager. Classified as Perineometer (product code HIR), Class II - Special Controls.
Submitted by Advanced Tactile Imaging, Inc. (Trenton, US). The FDA issued a Cleared decision on May 28, 2015 after a review of 276 days - an extended review cycle.
This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 884.1425 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.
View all Advanced Tactile Imaging, Inc. devices
NCT01111916
Completed
Observational
Industry-sponsored
Development Study Using Vaginal Tactile Imager
A Development Study Using Vaginal Tactile Imager to Assess the Elasticity Properties of the Vaginal Wall and Surrounding Connective Tissue
| Condition studied |
Pelvic Organ Prolapse |
| Eligibility |
Female only
· 21 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Vladimir Egorov, PhD |
| Sponsor |
Artann Laboratories
(industry)
|
Started 2010-03-01
→
Primary completion 2010-09-01
Primary outcome
To determine whether there is a detectable difference in 3-D elasticity images provided by Vaginal Tactile Imager for the patients with presence or absence of prolapse.
Study completed - no results published.
This trial concluded in 2010 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov