(196 days)
"THE STRIPPER®" MICROPIPET FAMILY'S INDICATION FOR USE IS T0 MANIPULATE AND TRANSFER ZYGOTES AND EMBRYOS DURING IVF AND ICSI PROCEDURES.
"THE STRIPPER®" MICROPIPETS ARE USED IN THE TISSUE CULTURE TECHNIQUES PERFORMED BY EMBRYOLOGISTS WHEN PREPARING OOCYTES FOR IVF, ICSI AND ASSISTED HATCHING TECHNIQUES PRIOR TO RE-IMPLANTATION.
"THE STRIPPER®" MICROPIPETS ARE TOOLS USED IN PROCEDURES THAT HAVE BEEN DEVELOPED TO AID INFERTILE COUPLES ACHIEVE PREGNANCY.
REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE FOR CONFIRMATION OF FERTILITY DURING IVF.
REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE PRIOR TO ICSI PROCEDURES.
USED TO TRANSFER EMBRYOS AND OOCYTES THROUGH VARIOUS MEDIA AND SOLUTIONS DURING THE IVF PROCEDURE.
"THE STRIPPER®" micropipetter is a hand held device used to create the vacuum necessary for "THE STRIPPER®" micropipetter tips to aspirate and dispense fluid and cellular material. Its' components include an aluminum barrel that houses a stainless steel plunger and spring, an aluminum plunger shaft with finger pad, o-rings, washer and collet for securing "THE STRIPPER®" tips.
"THE STRIPPER®" micropipette tips are fabricated from polycarbonate tubing wherein one end of the tube is pulled to a much smaller dimension to produce tips of varying internal dimensions.
The provided document describes the "THE STRIPPER®" Micropipetter and Micropipetter Tips, a device used in In Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) procedures. The document includes information on the device's testing procedures and, by extension, its acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mouse Embryo Bioassay (Toxicity Testing) | |
| % Development to Blastocyst at 96 hours (Test Article) | > 70% |
| % Development to Blastocyst at 96 hours (Control Medium) | > 70% (Indicates a valid assay) |
| Sterility Testing | |
| Sterility Assurance Level (SAL) | 10⁻⁶ |
| Minimum Radiation Dose (for sterilization) | 15 kGy (Established by AAMI Method I, SIP) |
| Maximum Radiation Dose (for sterilization) | 25 kGy |
| Endotoxin Testing (Limulus Amebocyte Lysate Assay) | |
| Endotoxin Level per device |
§ 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.