(348 days)
V-HEPES PLUS is intended for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity.
V-HEPES PLUS is a medium for oocyte collection, intracytoplasmic sperm injection (ICSI) fertilization, and oocyte and embryo washing and handling procedures. V-HEPES PLUS is also intended for transfer of embryos to the uterine cavity. The medium is aseptically filtered and provided in a volume of 100 mL in pre-sterilized PETG bottles. V-HEPES PLUS has a shelf-life of 12 months when stored at 2-8°C and can be used for up to seven days after bottle opening.
Here's a breakdown of the acceptance criteria and study information for the V-HEPES PLUS device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specification) | Reported Device Performance (V-HEPES PLUS (K213293)) | Predicate Device (K142991) |
|---|---|---|
| Sterility | No growth | Sterile (SAL 10-3) |
| pH | 7.0-7.4 | 7.2-7.4 |
| Osmolality (mOsm/kg) | 257-273 | 260-270 |
| Mouse Embryo Assay (MEA) | 1-Cell MEA: ≥80% developed to expanded blastocysts at 96 h after 120-minute exposure | 1-Cell MEA: ≥80% developed to expanded blastocysts at 96 h after one-hour exposure |
| Endotoxin (EU/mL) | . |
- pH, Osmolality, Endotoxin: Quantitative measurements against specified ranges/limits, per established laboratory methods (e.g., USP for Endotoxin).
- Mouse Embryo Assay (MEA): Defined by the percentage of embryos reaching the expanded blastocyst stage within a specified timeframe, according to FDA guidance.
- Appearance: Visual inspection against an objective description ("Pink rose color, no precipitates").
- Biocompatibility: Results of standardized in vitro (cytotoxicity) and in vivo (sensitization, irritation) tests as per ISO 10993 standards.
8. The Sample Size for the Training Set
This question is not applicable. The V-HEPES PLUS is a biological medium, not an AI model or algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this device.
§ 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.