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510(k) Data Aggregation
(158 days)
Cryotop**®US-flash and Cryotop®**US-scoop
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: |
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