(219 days)
The Vitrolife Culture Dish 60 mm, Vitrolife Culture Dish 40 mm and Vitrolife Centre Well Dish are intended for IVF, suitable for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other reproduction procedures.
The Vitrolife 5 Well Culture Dish is intended for preparing, storing, manipulating or transferring human gametes or embryos for in vitro fertilization (IVF), or other in vitro fertilization techniques.
The Vitrolife ICSI Dish is intended for IVF, suitable for holding oocytes and sperm during fertilization via intracytoplasmic sperm injection (ICSI).
The Vitrolife Micro Droplet Culture Dish is intended for IVF. It may be used with sperm and for the culturing of embryos using drop culture.
The HertART disposable dishes are injection molded. The dishes are supplied with a lid. The polymers used for the dishes are virgin crystal grade polystyrene, which has successfully passed the USP class VI test for cytotoxicity, as well as 1-cell embryotoxicity test. The HertART dishes are packed in sleeves of x units in a box for a total of y units, as defined below:
Vitrolife Culture Dish 60 mm: Round dish with lid: ø63 x 15,15 mm One round well 60 mm in diameter Well Volume: 24,00 mL
Vitrolife Culture Dish 40 mm: Square dish with lid; 65,96 mm x 65,96 mm x 13,20 mm One round well: 40 mm in diameter, Well volume of 12,56 mL
Vitrolife 5-well Culture Dish: Square dish with lid: 65,96 mm x 65,96 mm x. 13,20 mm 5 round wells, Well Volume: 1,7 mL
Vitrolife Centre Well Dish: Square dish with lid: 65,96 mm x 65,96 mm x 13,20 mm 1 well, round bottom, oval opening.
Vitrolife ICSI Dish: Square dish with lid: 65,96 mm x 65,96 mm x 11,70 mm 1 square well with rounded corners
Vitrolife Micro-droplet Culture Dish: Square dish with lid: 65,96 mm x 65,96 mm x 13,20 mm 12 round wells holds drops up to 50 µL Well Volume: 12.5 µL
The dishes are terminally sterilized by gamma irradiation to achieve a SAL of 10 °. The dishes are non-pyrogenic as tested by LAL, and non-embryotoxic as tested by 1-cell Mouse Embryo Assay (MEA). The dishes are disposable and intended for single use.
The provided text describes a 510(k) summary for various IVF dishes and primarily focuses on demonstrating substantial equivalence to predicate devices. It does not contain information related to acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), study designs (e.g., MRMC, standalone), sample sizes for test/training sets, data provenance, ground truth establishment, or expert involvement typically associated with AI/software medical device studies.
The document details the physical characteristics, intended use, and material composition of the Vitrolife Culture Dishes and compares them feature-by-feature to existing predicate devices. The "Discussion" sections within each comparison consistently state that the differences do not impact safety or effectiveness and therefore support substantial equivalence.
Specifically, the studies mentioned are not performance studies in the AI/software sense, but rather tests to assure material compatibility and safety:
- USP class VI test for cytotoxicity: This is a standard biocompatibility test for materials that will come into contact with the body.
- 1-cell embryotoxicity test (MEA): This is a biological assay used to assess the potential toxicity of materials to embryos. The document notes that the subject device uses a "more sensitive 1-cell MEA assay" compared to the predicate's 2-cell MEA, but this is a test of the material's safety, not a measure of the device's diagnostic or predictive performance.
- LAL test (Limulus Amebocyte Lysate): This is a test for bacterial endotoxins (pyrogens).
Therefore, I cannot fulfill the request as the provided text does not contain the necessary information to describe acceptance criteria, device performance, or study details relevant to AI/software medical devices. The document is a regulatory submission for physical medical devices used in IVF, focusing on substantial equivalence based on material and design characteristics, not on the performance of a diagnostic or assistive AI algorithm.
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.