510(k) K112200

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

September 6, 2012

Date Received

August 1, 2011

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Kit, Conception-Assist, Home Use

Device Class

Class II

Regulation Number

884.5250

Review Panel

OB

Submission Type

The kit is intended for assisted insemination in situations in which low sperm count , sperm immobility, or hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception. It is to be used at home following physician instruction. The Cap should not be left in place for more than 6 hours. The kit consists of: conception (cervical) caps; 3 polyurethane condoms; 24 ovulation predictors; 3 pregnancy test kits; 3 "sperm friendly" moisturizer samples (Pre Lubricant); 1 conception journal; 1 instruction manual; 2 conception wheels (1 in English and 1 in French); 1 medical provider envelope.