(269 days)
FertiCult™ Flushing medium are intended for in vitro procedures involving human gametes (sperm and oocytes), including washing of gametes, sperm swim-up procedures, intra-uterine insemination (IUI) of the spermatozoa and sperm injection during intracytoplasmic sperm injection (ICSI). FertiCult™ Flushing medium can also be used human embryo washing and holding, and for embryo transfer (ET) in the uterine cavity. The medium is NOT intended for oocyte pick-up and follicle flushing. FertiCult Flushing medium is used during assisted reproductive Technology (ART) procedures of patients and couples undergoing infertility treatments.
FertiCult Flushing medium and FertiCult Flushing medium with phenol red and gentamicin intended for in vitro procedures involving human gametes (sperm and oocytes), including washing of gametes, sperm swim-up procedures, intra-uterine insemination (IUI) of the spermatozoa and sperm injection during intracytoplasmic sperm injection (ICSI). FertiCult Flushing media can also be used for human embryo washing and holding, and for embryo transfer (ET) in the uterine cavity.
The base formulation contains Water, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Sulphate Heptahydrate, Sodium Dihydrogen Phosphate Dihydrate, Sodium Pyruvate, Glucose Monohydrate, Sodium Lactate, Sodium hydrogen carbonate, HEPES, Human Serum Albumin.
A FertiCult Flushing media variant contains Phenol red and Gentamicin.
The products can be used up to 7 days after opening, when sterile conditions are maintained, and the products are stored at 2-8°C.
The provided FDA 510(k) clearance letter pertains to the FertiCult Flushing medium and FertiCult Flushing medium with phenol red and gentamicin. This document demonstrates the substantial equivalence of the new device to a predicate device, as required for FDA clearance.
Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria listed are primarily for the physical, chemical, and biological properties of the media, ensuring its quality and suitability for use in Assisted Reproductive Technology (ART) procedures.
| Acceptance Criteria | Reported Device Performance (from "Shelf-life testing" and "In-use testing") |
|---|---|
| Appearance | All solutions should be without precipitates (Met at Time 0, during shelf-life, and after 7 days of in-use testing) |
| pH (USP ) | 7.3-7.9 (Met at Time 0, during shelf-life, and after 7 days of in-use testing) |
| Osmolality (USP ) | 270-290 mOsmol/kg (Met at Time 0, during shelf-life, and after 7 days of in-use testing) |
| Sterility (USP ) | No microbial growth (Met at Time 0, during shelf-life, and after 7 days of in-use testing) |
| Bacterial Endotoxin (USP ) | for pH, for Osmolality, for Sterility, for Bacterial Endotoxin), ISO standards (e.g., ISO 13408, ISO 11137, ISO 17665, ISO 10993 series), ASTM D4169-22. |
- Historically accepted biological performance indicators: Mouse Embryo Assay (MEA) results (development to expanded blastocyst), as specified by the 2021 FDA guidance.
- Observed physical and chemical characteristics: Absence of precipitates.
These are objective, quantifiable, or universally accepted biological endpoints, rather than expert consensus on a subjective interpretation.
8. The Sample Size for the Training Set
Not applicable. This device is a culture medium, not an AI/ML algorithm that requires a training set. The performance testing described validates the manufacturing quality and biological compatibility of the product.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device requiring a training set.
§ 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.