K112200 is an FDA 510(k) clearance for the FOCUS TOUCH CONCEPTION SYSTEM. Classified as Kit, Conception-assist, Home Use (product code OBB), Class II - Special Controls.
Submitted by Intimate Bridge 2 Conception, Inc. (Murrysville, US). The FDA issued a Cleared decision on September 6, 2012 after a review of 402 days - an unusually long review period, suggesting complex equivalence evaluation.
This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5250 - the FDA obstetrics and gynecology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.
NCT01564940
Completed
Observational
Industry-sponsored
Human Factors Usability Study of Ib2C Conception System
Human Factors Usability Study of Abbreviated Functional Use of the Intimate Bridge 2 Conception, Inc. Conception System
| Condition studied |
Cervical Cap Insemination |
| Eligibility |
Female only
· 20 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Michael J Pelekanos, OB-GYN |
| Sponsor |
Rinovum Women's Health, Inc.
(industry)
|
Started 2011-09-01
→
Primary completion 2011-09-01
Study completed - no results published.
This trial concluded in 2011 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510(k) Summary PDF or remain unpublished.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