(114 days)
ICSI injection micropipettes are used for injecting spermatozoa into the . cytoplasm of an oocyte during intracytoplasmic sperm injection (ICSI). -
- Holding micropipettes are used to anchor the oocyte under vacuum during . intracytoplasmic sperm injection (ICSI).
- Assisted hatching micropipettes are used to direct Tyrode's solution onto the . zona of an oocyte, thus creating a hole and enabling the oocyte to hatch.
- Denuding pipettes are used to strip the cumulus from oocytes prior to . intracytoplasmic sperm injection (ICSI).
ICSI injection micropipette (spiked and non-spiked) ICSI holding micropipette Assisted hatching / zona drilling micropipette Denudation pipette
There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) clearance letter from the FDA for a set of micropipettes, confirming that the devices (K991261) are substantially equivalent to legally marketed predicate devices. It discusses regulatory classification, general controls, and good manufacturing practices, but does not include any performance data or study details.
Therefore, I cannot provide the requested information.
§ 884.6130 Assisted reproduction microtools.
(a)
Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.