(158 days)
Cryotop®US-flash and Cryotop®US-scoop are cryopreservation storage devices that are intended for use in vitrification procedures to contain and maintain human oocytes (MII) and embryos.
This 510(k) covers two subject devices, the Cryotop®US-flash and Cryotop®US-scoop that are modified versions of the predicate device (Cryotop®US, K153027). Both devices are cryopreservation storage devices intended for embryo/oocyte vitrification. Cryotop®US-flash and Cryotop®US-scoop are provided sterile and are for single-use only.
The Cryotop®US-flash is composed of a polypropylene straw and an acrylonitrile butadiene styrene handle with a polyethylene terephthalate fine tip where oocytes or embryos are loaded. The fine device is flat with a triangular-shaped area for oocyte/embryo loading. The Cryotop®US-scoop is composed of a polypropylene straw and a polystyrene handle and fine tip where oocytes or embryos are loaded. The fine tip of this device is U-shaped. After oocyte or embryo loading, the handle of the subject devices is inserted into the straw enclosure. A hermetic seal is created via a tapered handle with a stop location integrated into the handle. As the handle is placed into the straw enclosure it creates a closed system keeping the fine tip isolated from the liquid nitrogen. The straw component of both devices also includes a weight at its distal end to aid in maintaining correct device position during storage in liquid nitrogen.
The provided text describes a 510(k) premarket notification for two new cryopreservation storage devices: Cryotop®US-flash and Cryotop®US-scoop. The submission aims to demonstrate substantial equivalence to a predicate device, Cryotop®US (K153027). The document focuses on non-clinical performance data to support this claim, rather than a clinical study comparing the devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Specific Test / Criterion | Acceptance Criteria | Reported Device Performance (Cryotop®US-flash & Cryotop®US-scoop) |
|---|---|---|---|
| Performance | Cooling Rate | 3,000°C/min | Passed: 3,000°C/min |
| Warming Rate | 44,000°C/min | Passed: 44,000°C/min | |
| Physical/Mechanical | Dimensional Testing | Outer diameter and length per specifications (specific values not provided in this extract) | Passed (implied) |
| Durability Testing | No burst or liquid nitrogen ingress into straw after 30-second immersion | Passed | |
| Mechanical Tensile Testing | Tensile strength to withstand 5N | Passed | |
| Biocompatibility | Bacterial Endotoxins | and ANSI/AAMI ST72:2002/(R)2010 | Passed: |
§ 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.