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Kit, Conception-Assist, Home Use

Page Type
Product Code
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
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.5250
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5250 Cervical cap

§ 884.5250 Cervical cap.

(a) Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.

(b) Classification. Class II (performance standards).

Kit, Conception-Assist, Home Use

Page Type
Product Code
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
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.5250
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.5250 Cervical cap

§ 884.5250 Cervical cap.

(a) Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.

(b) Classification. Class II (performance standards).