K103695 is an FDA 510(k) clearance for the PREPEX SYSTEM. Classified as Clamp, Circumcision (product code HFX), Class II - Special Controls.
Submitted by Circ Medtech (Chalotte, US). The FDA issued a Cleared decision on January 10, 2012 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.
This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.
NCT01150370
Completed
Interventional
A Pivotal Study to Assess the Safety and Efficacy of The PrePex System, a Male Circumcision Device and Methodology for Rapid Scale up of Painless and Bloodless National Circumcision Programs, in Urban and Remote Rural Settings
| Condition studied |
Male Circumcision; HIV Prevention; HIV Infections |
| Study design |
Single group |
| Eligibility |
Male only
· 18 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Dr. Jean Paul Bitega, M.D. |
| Sponsor |
Ministry of Health, Rwanda
|
Started 2010-06-01
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Primary completion 2010-12-01
Primary outcome
The efficacy and safety of The PrePex System for adult male circumcision in Rwanda
Secondary outcome
Operational scalability to mass scale up program
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510(k) Summary PDF or remain unpublished.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