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The RI MSC is intended to prepare sperm by migration-sedimentation method for the assisted reproduction techniques of intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI).

The Research Instruments Migration Sedimentation Chamber (RI MSC) is sterile, non-pyrogenic proven by Limulus Amebocyte Lysate and non-toxic to sperm proven by Human Sperm Survival Assay (HSSA). The RI MSC is disposable and labelled for single use, individually packaged in medical pouches and sold in boxes of twenty (x20) units. The RI MSC is manufactured from medical grade polystyrene and its surfaces are untreated. It is injection moulded as a completed unit, housing a central well with a surrounding gallery. The cylinder is 74 mm in height with a top OD of 16.5 mm and fluid capacity of 6 ml (approx) if completely filled; however, during recommended procedures it accommodates 1-2 ml of culture medium. The RI MSC facilitates the migration sedimentation technique. The migration sedimentation technique utilizes the innate 'swimming' ability of sperm to separate vigorous, A-motile sperm from non-motile or abnormal sperm and ejaculate debris.

The provided 510(k) summary for the Research Instruments Migration Sedimentation Chamber (RI MSC) details non-clinical testing performed to demonstrate its substantial equivalence to a predicate device. It primarily focuses on material safety and performance for sperm compatibility.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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