(90 days)
Used to micromanipulate, hold, or transfer gametes or embryos for assisted hatching, intsacytoplasmic sperm injection (ICSI) or other assisted reproduction methods
The basic design is a borosilicate glass tube, drawn to form a microinjection and/or microholding holding instrument. Each is angled towards the tip end to allow the instrument to be parallel to the surface of the dish. By apply suction the holding pipette is able to hold the cell in place, and the micro injection tool may pull cells into the hollow middle and then inject these cells into a larger cell mass.
The provided text is a 510(k) Premarket Notification for the genX Microtools (specifically ICSI Microtools, Holding Micro Pipettes, and ICSI Micro Pipettes) submitted to the FDA. Unfortunately, this document does not contain acceptance criteria or study data that proves the device meets specific performance criteria.
Instead, the document focuses on:
- Device Identification and Classification: Name, manufacturer, classification, and procode.
- Intended Use: Micromanipulation, holding, or transfer of oocytes/embryos for assisted reproductive methods like ICSI, holding, or assisted hatching.
- Sterilization Procedures: Describes gamma radiation and related standards.
- Substantial Equivalence Statement: Asserts that the
genXMicrotools are substantially equivalent in design and intended use to legally marketed predicate devices (Humagen and Cook IVF). - FDA Response Letter: Confirms substantial equivalence based on the information provided, allowing the device to be marketed.
- Indications for Use Statement: Reiterates the intended use.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information about specific studies, ground truth, sample sizes, or expert qualifications, as these data points are not present in the provided text.
The statement regarding "performance standards" explicitly states: "Performance Standards under Section 514 of the ACT have not been developed for this device. However, Special controls have been identified by the FDA to provide reasonable assurance of safety and effectiveness of the device in assisted reproductive procedures." This indicates that formal quantitative performance acceptance criteria, as one might find for a more directly measurable diagnostic device, are not detailed in this submission. The approval relies on the concept of substantial equivalence to predicate devices.
§ 884.6150 Assisted reproduction micromanipulators and microinjectors.
(a)
Identification. Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or expulsion of the contents of an assisted reproduction microtool.(b)
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.