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Vitrification Kit: These products are intended for ultra-rapid freezing and containment of human blastocysts for Assisted Reproductive Technology (A.R.T.) procedures. This kit is designed for use with Sage IVF's Vitrification Warming Kit (Ref # ART-8030) for optimal recovery of specimens.

Vitrification Warming Kit: These products are intended for the recovery of human blastocysts that have undergone ultra-rapid freezing and containment using Sage IVF's Vitrification Kit (Ref # ART-8025) for Assisted Reproductive Technology (A.R.T.) procedures.

There are five (5) solutions that comprise the two kits, Vitrification Kit and Vitrification Warming Kit.

Vitrification Kit: Consists of two solutions, Equilibration Solution (ES) and Vitrification Solution (VS) that are intended to be used sequentially, for the preparation for, and cryopreservation of, human blastocysts.

Equilibration Solution is used in preparation for freezing and contains dimethyl sulfoxide (DMSO) and ethylene glycol (EG).

Vitrification Solution is to be used during cryostorage and contains DMSO and EG and sucrose.

Vitrification Warming Kit: The three (3) warming solutions, 1.0 M Sucrose Warming Solution, 0.5 M Sucrose Warming Solution and MOPS Solution, are also intended for sequential use in the warming and recovery of cryopreserved human blastocysts.

This document is a 510(k) summary for the SAGE In-Vitro Fertilization Vitrification Kit and Vitrification Warming Kit. It does not contain acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Specifically, the document states:

• "The technological characteristics of the Sage products as compared to the predicate products are similar in the following areas and do not compromise the safety or efficacy of the device:
  • Indications For Use
  • Formulae
  • Performance testing
  • Sterility"

This indicates that SAGE is relying on the established performance and safety of its predicate devices and making a claim of substantial equivalence based on similar characteristics and the absence of new safety or efficacy concerns. A detailed study with acceptance criteria and device performance metrics would typically be submitted to demonstrate conformity to a specific standard or a novel device's performance, which is not the primary purpose of this 510(k) summary for these "reproductive media" devices.

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