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U.S. Department of Health and Human Services

Product Classification

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Device kit, conception-assist, home use
Regulation Description Cervical cap.
Definition 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.
Physical State The Kit consists of : conception (cervical) caps (1 for practice insertions); 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. All device contents have been previously cleared through pre-market notifications; however, the condom and cervical cap have new indications for use (semen collector and collection cap respectively).
Technical Method During sexual intercouse, sperm is collected in a polyurethane semen collection device (condom). Immediately thereafter, this sperm is transferred to the bowl of a cervical cap (made of silicone elastomers). This cap is placed on the cervix for up to 6 hours, so as to improve the chances of insemination.
Target Area Sperm, uterine horn, vagina and embryo (if any) have the potential to be affected by this device.
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeOBB
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(k)
Regulation Number 884.5250
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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