(87 days)
Sydney IVF Sperm Medium is intended for use during in vitro fertilization procedures to process sperm.
Sydney IVF Sperm Gradient Kit is intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma.
Sydney IVF Spermient is intended for use during in vitro fertilization procedures to separate motile sperm from seminal plasma.
The Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit and Sydney IVF Spermient are used for processing sperm during in vitro fertilization procedures.
Sperm Medium is used to provide a "liquid" and nutritious environment for the sperm to maintain its motility for the "swim up" procedures and the following fertilization process. The medium contains 10 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. It is available in 20, 50 or 100 mL vials.
Sydney IVF Sperm Gradient Kit is used to separate sperm based on density, using density gradient solutions. Sperm Gradient Kit contains both 40% density solutions and is comprised of silane coated silica particles which are diluted in a HEPES buffer. The sperm gradient has the dual purpose of enriching motile sperm populations and removing sperm inhibitory compounds normally present in the eiaculate. It contains 10 mg/mL HSA and 0.01 mg/mL Gentamicin. Sydney IVF Sperm Gradient Kit is available in 20 or 50 mL vials, packaged in a carton box, consisting of one vial filled with the 40% sperm gradient solution, and a second vial filled with the 80% sperm gradient solution.
Sydney IVF Spermient is intended to separate sperm based on density, using density gradient solutions. This is achieved by diluting the Spermient into various concentrations with a HEPES buffered solution. It contains colloidal silica coated with an inert polymer (silane) and has been formulated to be isotonic. Spermient contains 10 mg/mL HSA and 0.01 mg/mL Gentamicin. It is available in 20 or 100 mL vials.
The Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit and Sydney IVF Spermient are provided in glass vials with Fluorotec® coated rubber stoppers held in place with a tamper evident seal.. These products are single use, sterile (aseptic filtration) devices.
The provided document is a 510(k) summary for the Sydney IVF Sperm Medium, Sydney IVF Sperm Gradient Kit, and Sydney IVF Spermient. This document indicates that the device's main modification from its predicate was an extended shelf-life. The acceptance criteria and the study that proves the device meets them are described in the "PERFORMANCE DATA" section.
Here's the breakdown:
1. A table of acceptance criteria and the reported device performance:
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf-life | 20 weeks at 2-8°C | Validated to 20 weeks at 2-8°C |
| Endotoxin |
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.