(164 days)
The G-Vitri™ Vitrification Straw is a cryopreservation storage device intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell embryos, and blastocyst stage embryos.
Not Found
The provided document is an FDA 510(k) clearance letter for the G-Vitri™ Vitrification Straw, a medical device used in assisted reproduction. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment typically found in a clinical study report or a detailed validation study.
The letter primarily focuses on:
- Stating that the device is substantially equivalent to legally marketed predicate devices.
- Outlining regulatory requirements and general controls for the device.
- Defining the Indications for Use for the G-Vitri™ Vitrification Straw.
Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design validation report, or a clinical study report submitted as part of the 510(k) application.
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.