(232 days)
The manufactured microtools are to be used for Assisted Reproductive Technology (ART) and Reproductive Medicine (RM), and the specific pipette indication is as follows:
Injection Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for intracytoplasmic sperm injection (ICSI)
Holding Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for holding oocyte or embryo during ICSI or biopsy
Biopsy Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s)
Polar Body Biopsy Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of polar bodies from occytes, which may be done in order to perform pre implantation genetic diagnosis on the genetic material in the biopsied cell(s)
Assisted Hatching Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to create a defect in the zona pellucida chemically using Tyrode's acid solution in order to perform assisted hatching of embryos
Denuding Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to denuding cumulus cells from oocytes by delivering enzymes to aid separation
Partial Zona Pipette: tool used in IVF/Assisted Reproduction Technology (ART) laboratories to cut zona pellucida to create a defect in the zona pellucida mechanically in order to perform assisted hatching of embryos mechanically
The following Jieying Microtools are made of glass capillary tubing. They range in sizes and have various degrees of beveled angles as necessary for each individual application. They are gamma radiated and tested for endotoxin and mouse embryo. These devices are assisted reproduction microtools/pipettes that are used in the laboratory to denude, micromanipulate, or hold human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.
- a. Injection pipette;
- b. Holding pipette;
- c. Biopsy pipette;
- d. Polar body biopsy pipette;
- e. Denuding pipette;
- f. Partial zona dissection (PZD) pipette;
- g. Assisted hatching (AH) pipette.
The provided document describes Jieying Laboratory Inc.'s micro-manipulation pipettes and their equivalence to predicate devices, focusing on the safety and performance characteristics for regulatory approval.
Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| LAL (Limulus Amboycte Lysate) Testing: | Each batch performs LAL testing. Level of endotoxin units must be |
§ 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.