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Blastocyst Vitrification Kit is intended for the vitrification of human blastocysts for assisted reproduction technologies (ART). This kit is designed for use with Blastocyst Warming Kit (K-SIBW-5000).

Blastocyst Warming Kit is intended for the warming of human blastocysts that have undergone vitrification using COOK Sydney IVF Vitrification Kit (K-SIBV-5000) for ART procedures.

COOK Sydney IVF Blastocyst Vitrification and Warming Kits are intended for the vitrification and warming of human blastocysts as part of human ART procedures. The COOK Sydney IVF Blastocyst Vitrification and Warming Kits provide users with the ability to cryopreserve supernumerary embryos created during the in vitro fertilization procedure and then to re-warm them for use at a future point in time.

The COOK Sydney IVF Blastocyst Vitrification Kit (K-SIBV-5000) consists of a series of 2-[4-(2-hydroxyethyl)piperazin1-yl] ethanesulfonic acid (HEPES)-buffered, physiological solutions containing increasing concentrations of functional cryoprotectants to which the embryo is sequentially exposed during cryopreservation. The first three solutions in the kit are all based upon the same formulation (known as "Cryobase buffer"), which is a 10 mM HEPES buffered media containing 20 mg/mL Human Serum Albumin (HSA) and 0.01 mg/mL Gentamicin. The fourth solution in the kit is dimethyl sulfoxide (DMSO) and does not contain HSA or Gentamicin. The DMSO is provided for the practitioner to add to Solution 2 and Solution 3 of the vitrification kit, as described in the Instructions for Use.

COOK Sydney IVF Blastocyst Warming Kit (K-SIBW-5000) consists of three solutions which are used sequentially throughout the warming process. The three media in the kit are all based upon the same formulation of Cryobase buffer, a 10 mM HEPES buffered media containing 20 mg/mL HSA and 0.01 mg/mL Gentamicin.

The COOK Sydney IVF Blastocyst Vitrification and Warming Kits are single use, sterile (aseptic filtration) devices.

These solutions contact the blastocyst during the vitrification and re-warming process. The solutions are removed by washing prior to embryo transfer back to the patient and are therefore non-patient contacting.

The provided document describes the COOK Sydney IVF Blastocyst Vitrification Kit and COOK Sydney IVF Blastocyst Warming Kit, and its comparison to a predicate device (K082363). The primary purpose of the submission is to justify an extended shelf-life from 8 weeks to 20 weeks for the updated device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance specifications that are considered acceptance criteria for the device. The reported performance of the proposed device is stated to be the same as the predicate device for these parameters.

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