(109 days)
Conceptions Technologies' Microtools are used in the laboratory as a microtool to denude, micromanipulate, inject, hold or transfer human gametes or embryos for assisted hatching, ICSI, or other assisted reproduction procedures.
Microtools
The provided text is a 510(k) summary from 1999 for a device called "Microtools" which are described as tools for micromanipulation in assisted reproduction procedures. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The document is a regulatory approval letter and an indications for use statement, not a scientific study report.
§ 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.