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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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System for maturing immature oocytes of infertile women undergoing in vitro fertilization who for medical reasons cannot or choose not to undergo conventional ovarian stimulation using drugs.

Oocyte Washing Medium: This medium is used for washing immature oocytes contained within cumulus-oocyte complexes (COCs), collected from the follicles before maturation in culture.

Oocyte Maturation Medium: This medium is used for maturation in culture of immature oocytes in an incubator.

Embryo Maintenance: This medium is used for embryonic culture following insemination by intracytoplasmic sperm injection (ICSI).

Oocyte Washing Medium is a balanced salt solution containing nutrients, amino acids and vitamins to maintain immature oocytes during their collection and washing.

Oocyte Maturation Medium is a balanced salt solution containing nutrients, amino acids and vitamins for the in vitro culture of immature oocytes.

Embryo Maintenance Medium is a balanced salt solution containing nutrients and amino acids for maintaining embryos in culture.

This document is a 510(k) summary for reproductive media (Oocyte Washing Medium, Oocyte Maturation Medium, and Embryo Maintenance Medium) and does not describe an AI medical device. Therefore, it does not contain the information required to answer your questions regarding acceptance criteria and studies proving a device meets those criteria for an AI device.

Specifically, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:

1. Formula
2. Indications for Use
3. Performance Testing (though the details of this testing are not provided in the excerpt, it's mentioned as an area of comparison).

The submission is for an "IVM System" (In-Vitro Maturation System) consisting of chemical media, not a software algorithm or AI. As such, concepts like "test set," "ground truth," "experts," "adjudication method," "MRMC study," "standalone performance," or "training set" for an AI device are not applicable to the information provided in this document.

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