(199 days)
CryoX™ Vitrification Freeze Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
CryoX™ Vitrification Thaw Kit is intended for use in the thawing of virified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
CryoX™ Vitrification Freeze Kit is designed to facilitate dehydration of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos before vitrification via rapid cooling in liquid nitrogen. CryoX™ Vitrification Freeze Kit contains two solutions to be used sequentially during vitrification. Both solutions consist of Medium 199 (M199), human serum albumin (HSA) and gentamicin sulfate. They also contain varying levels of cryoprotectants, including dimethyl sulfoxide (DMSO), ethylene glycol (EG), and sucrose.
CryoX™ Vitrification Thaw Kt contains three solutions to be used sequentially during oocyte and embryo thawing procedures. All three solutions contain M199, HSA, and gentamicin sulfate. They also contain decreasing concentrations of cryoprotectant.
The five solutions in the CryoX™ Vitrification Freeze Kit and Thaw Kt are aseptically filtered and provided in 4.5 mLPETG vials. The solutions in these kits are single-use only. They have a shelf-life of 6 months when stored at 2-8℃
The document you provided is a 510(k) Premarket Notification from the FDA for a device called "CryoX™ Vitrification Freeze Kit / Thaw Kit." It details the device's indications for use, comparison to a predicate device, and a summary of non-clinical performance testing.
Based on the provided text, here's the information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are the product specifications that were tested during shelf-life testing. The reported device performance is indicated by the statement that these specifications "were met at time 0 and after accelerated aging."
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Appearance | Clean, transparent, pink; no impurities | Met (implicitly, as specifications were met) |
| pH (per USP ) | 7.2-7.6 | Met (implicitly, as specifications were met) |
| Osmolality (mOsmol/kg) | ES: 855~1042 (1:2 dilution) | |
| VS: 1916~2477 (1:2 dilution) | ||
| TS: 1653~2430 | ||
| DS: 871~1025 | ||
| WS: 307~318 | Met (implicitly, as specifications were met) | |
| Sterility (per USP ) | No microbial growth | Met (implicitly, as specifications were met) |
| Bacterial Enodtoxin (per USP ) | . |
- Mouse Embryo Assay (MEA): A specific developmental endpoint (≥ 80% expanded blastocyst development) at 96 hours, as per FDA guidance.
These are objective, rather than subjective, ground truths typically established by consensus or pathology.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. Training sets are relevant for machine learning or AI models. This product is a medical device in the category of reproductive media, and its development and validation involve formulation, manufacturing, and performance testing, not algorithmic training.
9. How the Ground Truth for the Training Set Was Established
As the concept of a "training set" does not apply to this device, the question of how its ground truth was established is not applicable.
§ 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.