(223 days)
Pre-Seed™ Fertility Lubricant is a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Pre-Seed™ Fertility Lubricant is compatible with sperm, oocytes, and can be used by trying to conceive couples. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
Pre-Seed™ Fertility Lubricant can be used to lubricate genital tissues and devices to facilitate use of diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
Pre-Seed™ Fertility Lubricant is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubrication. The product is also compatible with sperm, oocytes, and embryos, can be used by trying to conceive couples, and can also be used to lubricate diagnostic and therapeutic devices during fertility interventions and reproductive medicine.
Pre-Seed™ Fertility Lubricant is packaged in a High-Density Polyethylene tube with a Polypropylene closure. A foil seal is present over the tube opening under the cap closure. The provided with single-use, piston type, Low Density Polyethylene applicators for delivering the product to the vagina.
The provided document is a 510(k) summary for the Pre-Seed™ Fertility Lubricant. It details the device's characteristics, indications for use, comparison with a predicate device, and the non-clinical performance data used to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Specification | Recommended Acceptance Criteria | Reported Performance (Pre-Seed™ Fertility Lubricant) |
|---|---|---|
| Appearance/Color | Hazy, colorless to slightly yellow, viscous liquid | Met acceptance criteria during shelf-life testing |
| Odor | Characteristic, no off odor (25 °C ± 2) | Met acceptance criteria during shelf-life testing |
| pH | 7.0-7.4 | Met acceptance criteria during shelf-life testing |
| Osmolality | 260-370 mOsm/kg | Met acceptance criteria during shelf-life testing |
| Viscosity | 2800-11500 cps | Met acceptance criteria during shelf-life testing |
| Total Aerobic Microbial Count (TAMC) - USP and | and | |
| Antimicrobial Effectiveness - USP | Bacteria: Not less than 2.0 log reduction from the initial count at 14 days. No increase from 14 days count to 28 days. Yeast & Mold: not increase from the initial calculated count at 14 and 28 days. | Met acceptance criteria during shelf-life testing |
| Endotoxin |
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.