(230 days)
Sydney IVF Cryopreservation Kit is intended for use during in vitro fertilization procedures for cryopreservation of 1-cell to 8-cell embryos.
Sydney IVF Thawing Kit is intended for use during in vitro fertilization procedures for thawing of 1-cell to 8-cell embryos.
The Sydney IVF Cryopreservation and Thawing Kits are intended for cryopreservation and thawing of 1-cell to 8-cell human embryos. The Sydney IVF Cryopreservation and Thawing Kits provide users with the ability to cryopreserve supernumerary embryos created during the in vitro fertilization procedure and then to thaw them for use at a future point in time.
The Sydney IVF Cryopreservation Kit consists of three solutions containing increasing concentrations of cryoprotectant (both propanediol and sucrose are used). These buffers were designed to be used sequentially in order to remove water from embryos prior to cryopreservation. The removal of water prevents ice crystal formation inside the embryo thereby limiting damage and improving viability. It contains 12 mg/mL Human Serum Albumin (HSA) and 0.01mg/mL Gentamicin. Sydney IVF Cryopreservation Kit is designed for use with Sydney IVF Thawing Kit.
The Sydney IVF Thawing Kit consists of four solutions with decreasing concentrations of cryoprotectants (propanediol and sucrose) which are used sequentially throughout the thawing process. It contains 12 mg/mL Human Serum Albumin (HSA) and 0.01mg/mL Gentamicin. It is designed for use with Sydney IVF Cryopreservation Kit.
Sydney IVF Cryopreservation and Thawing Kits are provided in glass vials with Fluorotec coated rubber stoppers held in place with a tamper evident seal. Sydney IVF Cryopreservation Kit is packaged in a carton box containing 2 x 10mL and 1 x 20mL solutions per kit. The Sydney IVF Thawing Kit is packaged in a carton box containing 4 x 10mL solutions per kit.
The document provided is a 510(k) premarket notification for the Sydney IVF Cryopreservation Kit and Sydney IVF Thawing Kit. It outlines the similarities and differences with a predicate device and provides performance data primarily related to stability and shelf life, rather than clinical performance or a comparative effectiveness study.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Device) | Reported Device Performance (Sydney IVF Kits) |
|---|---|
| pH 7.3 - 7.5 | pH 7.3 - 7.5 |
| Osmolality 285 - 295 mOsm/kg | Osmolality 285 - 295 mOsm/kg |
| 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.