(150 days)
The iVitri®Straw is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.
The iVitri® Straw device is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. The iVitri® Straw device consists of a square-shaped polystyrene stick and acrylonitrile butadiene styrene (ABS) cap. As part of the vitrification procedure, the embryos are loaded on the tip of the stick, and capped for subsequent storage following vitrification. The tip of the storage device is curved to aid in maintaining and securing the embryos during handling procedures. The stick and cap include a tapered design that creates a hermetic seal, forming a closed storage system. Markings on the stick and tip of the device are used to aid in the proper orientation during embryo loading procedures. The device is provided sterile and is for single use only.
Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided FDA 510(k) summary for the iVitri® Straw.
Acceptance Criteria and Device Performance for iVitri® Straw
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cooling Rate | Not explicitly stated as a separate acceptance criterion, but implicitly comparable to predicate. | -3,022°C/min (Predicate: -3,020°C/min - considered comparable) |
| Warming Rate | Not explicitly stated as a separate acceptance criterion, but implicitly comparable to predicate. | +40,976°C/min (Predicate: +40,694°C/min - considered comparable) |
| Sterility Assurance Level (SAL) | 10⁻⁶ (as per ISO 11137-1:2006(R)2011 and ISO 11137-2:2013) | 10⁻⁶ |
| Endotoxin | ≤0.5 EU/device (per USP ) | ** |
§ 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.