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510(k) Data Aggregation
K Number
K112200Device Name
FOCUS TOUCH CONCEPTION SYSTEM
Manufacturer
Date Cleared
2012-09-06
(402 days)
Product Code
Regulation Number
884.5250Why did this record match?
Applicant Name (Manufacturer) :
INTIMATE BRIDGE 2 CONCEPTION, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Focus Touch Conception System is indicated for assisted insemination in instances where low sperm count, sperm immobility, or hostile vaginal environment has been diagnosed. The system (cervical cap in a condom-like silicone sheath) is used to collect semen into a cervical cap, and then deliver the cap to the outside of the cervix as an aid to conception. It is to be used at home following physician instruction. The Focus Touch Conception System should not be left in place for longer than 6 hours.
Device Description
The Focus Touch™ Conception System includes detailed Instructions for Use, one Conceptacle and one plastic applicator. The system can be purchased packaged in a quantity of one (1) or three (3) individually packaged systems.
Once the couple has decided to attempt to become pregnant, the Focus Touch™ Conception System Instruction for Use recommends using the device during female's most fertile days in a given month. During sexual intercourse, semen will be collected using the Conceptacle, a cervical cap that is pre-inserted into a condom-like sheath. The male removes the Conceptacle from the penis by rolling it down and separating it from the penis. After removal, the rim of the cervical cao is lightly pinched so that the Condom-like Sheath can be separated. (The Cervical Cap and Condom-like Sheath are separated in two separate parts). The semen is contained in the cervical cap and its reservoir. The second component, the Applicator, is used for ease of transition of the Cervical Cap to the cervix. The applicator seals the Cervical Cap and contains the semen for transition through the vaginal tract, assisting the female in guiding the cap to the cervix and releasing the semen and the cap in front of the cervical cap is loaded onto the applicator (while it is still outside of the Retainer locks onto the Cervical Cap and is delivered with the Cervical Cap intravaginally. The Retainer also has a removal cord that is attached for withdrawal. The Cervical Cap and Retainer then remain in place for up to 6 hours.
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