(249 days)
The Vitrification Kit is indicated for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
The Warming Kit is indicated for use in the thawing of vitrified oocvtes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
The Cryo-straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embrvos.
The Vitrification Kit and Warming Kit are assisted reproduction technology (ART) media products for freezing and thawing oocytes (MII), pronuclear (PN) zygotes through Day 3 cleavage stage embryos, and blastocyst stage embryos.
There are two models for each Vitrification Kit and Warming Kit. The difference is the volume of the solutions in the kits. The solutions in the "A" model for each kit are in 1 ml vials, and the solutions in the "B" model are in 2 ml vials. Each model contains two sets of kit media.
The Vitrification Kit includes three sequential media components, Washing solution (WS), Equilibrium solution (ES), and Vitrification solution (VS), containing the cryoprotectants ethylene glycol, dimethyl sulfoxide, and sucrose. Using this methodology, the permeating cryoprotectants can replace water in the oocyte and PN through blastocyst stage embryos prior to vitrification and storage in liquid nitrogen.
The Warming Kit is composed of three media used sequentially for thawing and removing cryoprotectants from vitrified oocytes and PN through blastocyst stage embryos. The Warming Kit is composed of Thaw solution (TS), Diluent solution (DS), and Washing solution (WS).
All media in the Vitrification Kit and Warming Kit undergo aseptic filtration and are single-use only.
The Cryo-Straw is a single-use, sterile, cryopreservation storage device for holding and maintaining vitrified oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos. There are two models for the Cryo-straws: Type I and Type III, and each has 5 colors: brown, orange, blue, red, green. The Cryo-straws are composed of a rod and sheath with a combined length of 132.5 mm. The Type I model has a flat slide and the Type III model has a curved slide for sample loading. The Cryo-straws are sterilized using gamma radiation.
The provided document is a 510(k) premarket notification for a medical device: Cryo-straw, Warming Kit, and Vitrification Kit. It details the device's indications for use, comparison to a predicate device, and non-clinical performance data.
However, this document does not describe a study involving an AI/Machine Learning (ML) algorithm or human readers aided by AI. The acceptance criteria and performance data presented are for the physical cryopreservation device and its associated media, focusing on biological and physical properties relevant to in vitro fertilization (IVF) and cryopreservation, such as pH, osmolality, sterility, shelf-life, and mouse embryo assay (MEA) results.
Therefore, I cannot provide the requested information about:
- A table of acceptance criteria and reported device performance related to AI/ML. The acceptance criteria listed are for the physical and chemical properties of the cryopreservation media and device.
- Sample size used for the test set and data provenance: No test set involving AI/ML is described.
- Number of experts used to establish ground truth & qualifications: Not applicable to this device submission.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on laboratory assays (e.g., MEA, sterility, endotoxin) and physical testing.
- Sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Acceptance Criteria and Performance (from document):
The document focuses on demonstrating the substantial equivalence of the "Cryo-straw," "Warming Kit," and "Vitrification Kit" to a legally marketed predicate device (Kitazato Corporation's Vitrification Kit and Thawing Kit, K171748). This is achieved through non-clinical performance data addressing the physical, chemical, and biological properties critical for their intended use in cryopreservation of oocytes and embryos.
Here's the relevant information extracted from the document regarding the device's acceptance criteria and reported performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Parameter | Acceptance Specification (Criteria) | Reported Device Performance (Typically stated as "met the requirements" or similar) |
|---|---|---|---|
| Vitrification/Warming Kit | |||
| Sterility | Aseptic processing validation, Sterility per USP | Met ISO 13408-1:2008/Amd1:2013 & ISO 13408-2:2018 requirements; No microbial growth | Met requirements |
| Shelf-life | Supported shelf-life | 6 months (supported by time 0 and real-time aging data) | Supported a 6-month shelf-life |
| pH | per USP | All solutions: 7.2-7.4 | Met specifications |
| Osmolality | per USP | ES: 1391-1590 (1:1 dilution) | |
| VS: 1430-1710 (1:3 dilution) | |||
| TS: 1,650-2,170 | |||
| DS: 850-925 | |||
| WS: 265-295 | Met specifications | ||
| Endotoxin | per USP | equivalent | Met requirements |
| Cryo-straw | |||
| Sterilization | Process & Validation (ISO 11737-1/2, ISO 11137-3) | Sterilization Assurance Level 10-6 | Met ISO standards, SAL 10-6 |
| Shelf-life | Supported shelf-life | 2 years (supported by time 0, real-time aging, or accelerated aging per ASTM F1980-16) | Supported a two-year shelf-life |
| Cooling Rate | (measured) | Type I: 1,539°C/min; Type III: 1,543°C/min | Achieved specified rates |
| Warming Rate | (measured) | Type I: 21,430°C/min; Type III: 21,385°C/min | Achieved specified rates |
| Dimensional | Dimensional testing | Met specifications | Met specifications |
| Durability | Liquid nitrogen immersion | No damage after 30 second immersion in liquid nitrogen | No damage reported |
| Liquid N2 Penetration | Immersion test | No ingress after 24-hour immersion in liquid nitrogen | No ingress reported |
| Endotoxin | per USP |
§ 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.