(75 days)
Sydney IVF Follicle Flush Buffer is intended for use during in vitro fertilization procedures for follicle flushing and oocyte collection.
Sydney IVF Fertilization Medium is intended for use during in vitro procedures for insemination of oocytes.
Sydney IVF Cleavage Medium is intended for use during in vitro fertilization procedures for culture and transfer of cleavage stage embryos.
Sydney IVF Blastocyst Medium is intended for use during in vitro fertilization procedures for extended culture and transfer of embryos.
The Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium and Sydney IVF Blastocyst Medium are used for processing eggs and embryos during in vitro fertilization procedures.
Sydney IVF Follicle Flush Buffer is used to flush the follicles during oocyte recovery. It contains Gentamicin (0.01mg/mL) and is available in 100 mL vials.
Sydney IVF Fertilization Medium maintains oocytes in a 6% CO2 environment until insemination and fertilization is complete. Sydney IVF Fertilization Medium contains Humans Serum Albumin (HSA) (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20, 50 or 100 mL vials.
Sydney IVF Cleavage Medium facilitates the first two days of embryonic growth post fertilization. Sydney IVF Cleavage Medium contains HSA (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20, 50 or 100 mL vials.
Once an embryo has reached the Day 3 (eight-cell) stage, it is then transferred into Sydney IVF Blastocyst Medium. This medium has been metabolically balanced to maximize blastocyst development rates and is suitable for blastocyst transfer. Sydney IVF Blastocyst Medium contains HSA (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20 or 50 mL vials.
The Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium and Sydney IVF Blastocyst Medium 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.
This document describes the FDA 510(k) clearance for Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, and Sydney IVF Blastocyst Medium. It is not a study proving a device meets acceptance criteria through clinical trials or performance metrics of an AI/software device. Instead, it demonstrates substantial equivalence to a predicate device based on similar technological characteristics and performance specifications for the storage and use of IVF media.
Therefore, many of the requested elements are not applicable in this context. Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Specifications) | Reported Device Performance (Validation/Testing) |
|---|---|
| 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.