(124 days)
The transfer of the removed blastomere from a holding vessel to a transport vessel. This device is NOT intended for blastomere biopsy from an embryo.
Stripper PGD® Micropipette and associated tip
This document is a 510(k) clearance letter from the FDA for a medical device called "Stripper PGD® Micropipette and associated tip." It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the information requested in the prompt regarding acceptance criteria, device performance, study details, or ground truth.
The letter is a regulatory approval document and focuses on the administrative aspects of device clearance rather than the detailed technical performance or the studies that would demonstrate compliance with acceptance criteria.
Therefore, I cannot extract the requested information from this provided text.
§ 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.