(267 days)
The Embryo Biopsy Pipette is intended to aspirate a blastomere or trophectoderm to diagnose genetic disorders prior to embryo selection.
The Polar Body Biopsy Pipette is intended to aspirate polar bodies to diagnose genetic disorders prior to embryo selection.
The Testicular Sperm Extraction Pipette is intended to extract sperm cells from biopsied tessue.
The Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes are 970 microns (um) outer diameter borosilicate glass tubing that is bent and tapered. The Embryo Biopsy Pipette is tapered to a flat, smooth tip inner diameter of 30 um and 35 um. It is intended to be used for blastomere or trophectoderm aspiration. The Polar Body Biopsy Pipette is tapered to an inner diameter of 20 um and beveled to a spike to assist in piercing through the zona pellucida to biopsy the polar body. The Testicular Sperm Extraction Pipette is tapered to a flat angle with an inner diameter of 6.5 um. These pipettes are intended to extract sperm cells from biopsied testicular tissue. The device is supplied gamma sterilized and is intended for one-time use.
The document describes three medical devices: Embryo Biopsy Pipette, Polar Body Biopsy Pipette, and Testicular Sperm Extraction Pipette. The acceptance criteria and the studies performed to demonstrate equivalence are detailed as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| MEA (Mouse Embryo Assay) | ≥80% 1-cell stage embryos must develop to blastocyst within 96 hours. | The predetermined acceptance criterion was met. |
| LAL (Limulus Amebocyte Lysate) |
§ 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.