(234 days)
V-VITFREEZE is intended for use in the vitrification of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
V- VITWARM is intended for use in the thawing of vitrified of oocytes (MI), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
V-VITFREEZE AND V-VITWARM include a set of five media intended for use in the vitrification and thawing of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos as part of InVitro Fertilization (IVF) procedures.
V-VITFREEZE (2mL vials) includes two media components, Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol, trehalose (only in VS), and dimethyl sulfoxide. During the vitrification process, embryos are first exposed to ES and then to VS.
Using this methodology, the permeating cryoprotectants can replace water in the oocyte or PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen.
V-VITWARM (4mL vials) is composed of three media used stepwise for thawing and removing cryoprotectants from vitrified oocytes and PN through blastocyst stage embryos. It is composed of Thawing Solution (TS), Diluent Solution (DS) and Washing Solution (WS).
The base medium for the vitrification and thawing media includes water, salts, buffering agents, minerals, chelating agents, energy substrates, amino acids, hydroxypropyl cellulose, polymeric substance, gentamicin, and phenol red. Cryoprotectants in the media include ethylene glycol, (7.5% in ES and 15% in VS), DMSO (7.5% in ES and 15% in VS), and trehalose in VS, TS, and DS.
The five solutions in the V-VITFREZE and V-VITWARM kit are aseptically filtered (storage vials sterilized by radiation) and provided in polypropylene vials with high density polyethylene screw caps. They have a shelf-life of 12 months when stored at 2-8℃. Media in the vials can be used for up to seven days after vial opening.
This is an FDA 510(k) clearance letter for the V-VITFREEZE and V-VITWARM devices, which are reproductive media and supplements. The document describes the device, its intended use, and a comparison to a predicate device. It also summarizes non-clinical performance testing.
However, the provided text does not contain detailed acceptance criteria and the results of a specific study in the format requested (e.g., a table of acceptance criteria and reported device performance with statistical metrics like sensitivity, specificity, accuracy). It focuses on physical and biological characteristics of the media rather than performance metrics of an AI or diagnostic device.
Therefore, I cannot fulfill all parts of your request exactly as specified because the document does not describe the acceptance criteria and a study in the context of an AI or diagnostic device's performance in the way you've outlined.
The document does list certain specifications for the media and the tests conducted to ensure the media meets those specifications, which are a form of acceptance criteria for manufacturing and quality control. I will extract these details.
Here's the information that can be extracted relevant to acceptance criteria and testing, adapted to the context of the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance (as per non-clinical testing of the media):
| Test/Characteristic | Acceptance Criteria | Reported Device Performance (Implied by "met" without specific data) |
|---|---|---|
| Appearance | All solutions pink to rose color without precipitates | Met (demonstrated through shelf-life testing) |
| pH (WS, DS, TS) | 7.20 - 7.45 | Met (demonstrated through shelf-life testing) |
| pH (VS) | 7.50 - 7.70 | Met (demonstrated through shelf-life testing) |
| pH (ES) | 7.30 - 7.60 | Met (demonstrated through shelf-life testing) |
| Osmolality (ES) | 2300-3100 mOsm/kg (1:10 dilution) | Met (demonstrated through shelf-life testing) |
| Osmolality (VS) | 4600-6150 mOsm/kg (1:20 dilution) | Met (demonstrated through shelf-life testing) |
| Osmolality (TS) | 1250-1600 mOsm/kg (1:4 dilution) | Met (demonstrated through shelf-life testing) |
| Osmolality (DS) | 730-930 mOsm/kg (1:2 dilution) | Met (demonstrated through shelf-life testing) |
| Osmolality (WS) | 240-300 mOsm/kg (No dilution) | Met (demonstrated through shelf-life testing) |
| Sterility | No microbial growth | Met (demonstrated through shelf-life testing and aseptic filtration/filling validation) |
| Bacterial Endotoxin | ). |
* **Bacterial Endotoxin:** Defined by Limulus Amebocyte Lysate (LAL) test standards (e.g., USP ).
* **Mouse Embryo Assay (MEA):** Defined by the specified FDA guidance for ART devices, where successful development of a certain percentage of embryos to expanded blastocyst within 96 hours is the benchmark.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established:
- 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.