(105 days)
Denudation Pipettes are used for the removal of cumulus oocyte complexes (COC) from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) as well as for the handling of gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART).
Denudation Pipettes are not intended for biopsy of cells from oocytes or embryos.
The Denudation Pipettes are extruded polycarbonate capillary tubes that are pulled at one end to form a tapered tip. They have an outer diameter (OD) of 0.9mm at the proximal end and fit into an actuating device. All tips are approximately 90mm in length and depending on the size of the pipette have a volumetric capacity of 18.6-21.9µl.
The Denudation Pipettes are supplied in a range of inner diameter (ID) sizes at the distal end as shown below:
- 80μm, 130μm, 140μm, 150μm, 160μm, 170μm, 180μm, 190μm, 210μm, 230μm, 250μm, 270μm, 290μm.
The Denudation Pipettes are radiation sterilized and provided in a sterile pouch, supplied in two packaging options. Each pouch contains 5 or 10 pipettes. All pipettes are intended for single use and disposable.
This 510(k) clearance letter is for Denudation Pipettes, a Class II medical device used in assisted reproductive technologies. This type of device is an instrument and does not fit the typical format for AI/ML-enabled devices so I have focused on the relevant mechanical and biological performance characteristics.
Acceptance Criteria and Device Performance
There is no single study described that proves the device meets all acceptance criteria. Instead, a series of non-clinical performance tests were conducted.
Here's a table summarizing the acceptance criteria and the reported device performance for the Denudation Pipettes:
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|---|---|
| Biocompatibility/Embryo Safety | One-cell Mouse Embryo Assay (MEA) | ≥ 80% embryos developed to expanded blastocyst at 96 hours | ≥ 80% embryos developed to expanded blastocyst at 96 hours | Meets criteria. The subject device's MEA assessment time (96h) is shorter than the predicate (120h), but it's noted as the standard assessment time for this assay. |
| Material Toxicity | Endotoxin (LAL, USP) |
§ 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.