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
| Device Type ID | 4052 |
| Device Name | Kit, Conception-assist, Home Use |
| 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; |
| 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 |
| Target Area | Sperm, Uterine Horn, Vagina And Embryo (if Any) Have The Potential To Be Affected By This Device. |
| Regulation Description | Cervical Cap. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| 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) |
| CFR Regulation Number | 884.5250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OBB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4052 |
| Device | Kit, Conception-assist, Home Use |
| Product Code | OBB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cervical Cap. |
| CFR Regulation Number | 884.5250 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
RINOVUM WOMEN'S HEALTH, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |