(145 days)
Pacific Andrology, Inc. Microtools are a family of precision pipettes that are used for assisted reproduction procedures. They are designed, for use to denude, micromanipulate, inject, hold or transfer human gametes or embryos for assisted hatching, ICSI, or other assisted reproduction methods.
ICSI micropipettes are used for the intracytoplasmic single sperm injection of oocytes.
Assisted hatching micropipettes are used to effect a hole in the zona pellucida by chemical means.
The Holding Micropipettes are used to hold the oocyte in position during single sperm injection with the Intracytoplasmic sperm injection (ICSI) Micropipette, to hold the embryo during the assisted hatching or during partial zona dissection procedures.
Partial zona dissection micropipettes are used to facilitate assisted hatching by mechanically creating a hole in the zona pellucida.
The Denuding Pipettes are used to remove cumulus cell layers from oocytes.
Microtools are a family of precision pipettes.
I am sorry, but based on the provided document, there is no information available regarding acceptance criteria, device performance results, study details (like sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods), MRMC studies, or standalone algorithm performance. The document is a 510(k) clearance letter for "Assisted Reproduction Microtools" and an "Indications For Use" statement. It does not contain the kind of technical performance study reporting that your request outlines.
§ 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.