(254 days)
'Cook Sydney IVF Blastocyst Vitrification Kit' is intended for the vitrification of Human blastocysts for ART procedures. This kit is designed for use with Cook Sydney IVF Blastocyst Vitrification Warming Kit
'Cook Sydney IVF Blastocyst Warming Kit' is intended for the recovery of Human blastocysts that have undergone vitrification using Cook Sydney IVF Blastocyst Vitrification Kit for ART procedures.
Blastocyst Warming Kit is intended for the recovery of human blastocysts that have Diastooyst Warming This Internet Sydney IVF Blastocyst Vitrification Kit (K-SIBV-5000) for ART procedures.
Blastocyst Vitrification Kit is intended for the vitrification of human blastocysts for assisted Diastooyot . This sit is designed for use with Blastocyst Warming Kit (K-SIBW-5000)
Cook Sydney IVF Blastocyst Vitrification and Warming Kits are intended for the vitrification, containment and re-warming of human blastocysts as part of human ART procedures. Vitrification involves the rapid freezing of the embryo and is defined as the solidification of a solution at a temperature below its glass transition temperature by extreme elevation in viscosity using high cooling rates (15 000 to 30 000 °C/min) rather than crystallisation. The Cook Sydney IVF Vitrification and Warming Kits are comprised of HEPES buffered solutions containing physiological salts and the cryoprotectants ethylene glycol, DMSO and trehalose.
The provided document describes the Cook Sydney IVF Blastocyst Vitrification Kit and the Cook Sydney IVF Blastocyst Warming Kit. It is a 510(k) summary for these devices, which are reproductive media and supplements. The document focuses on demonstrating substantial equivalence to a predicate device, Vit Kit Freeze/Vit Kit Thaw (K060168) manufactured by Irvine Scientific Sales.
The document does not detail specific acceptance criteria with quantifiable metrics (e.g., minimum percentage of viable blastocysts, maximum contamination levels) that the device must meet, nor does it present a formal study report with detailed device performance statistics against such criteria. Instead, it relies on a comparison to a predicate device and mentions "satisfactory safety" determined through bench testing and "clinical efficacy" supported by clinical practice at Sydney IVF, but without specific data.
Therefore, much of the requested information cannot be extracted from this document as it is not a performance study report in the typical sense for a medical device with measurable outcomes like accuracy or sensitivity.
Here's an attempt to answer the questions based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|
| Bench Testing: | |
| - pH testing | The vitrification and warming media passed all the requirements. (Specific pH range not given, but "satisfactory safety" determined.) |
| - Osmolality | The vitrification and warming media passed all the requirements. (Specific osmolality range not given, but "satisfactory safety" determined.) |
| - Two-cell mouse embryo assay (MEA) | The vitrification and warming media passed all the requirements. (Specific pass/fail criteria for MEA not given, but "satisfactory safety" determined.) |
| - Bacterial endotoxin (LAL) | The vitrification and warming media passed all the requirements. (Specific endotoxin limits not given, but "satisfactory safety" determined.) |
| Clinical Efficacy: | |
| - Safety and Efficacy | "The results in clinical practice support the safety and efficacy of the product, returning a suitable pregnancy rate." (Specific pregnancy rate or comparison to predicate/standard not provided. This is a general statement of positive outcome.) |
| Technological Characteristics | Similar to the predicate device (Irvine Scientific Vitrification K060168) in principal of operation, intended use (with minor wording difference), formulation (though some differences in specific components exist), and packaging. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for any of the tests mentioned (bench testing or clinical practice).
- Data Provenance:
- Bench testing (pH, osmolality, MEA, LAL): The location where these were conducted is not specified, but the manufacturer is Cook Australia.
- Clinical Efficacy: "Clinical practice at Sydney IVF, Sydney, Australia." This indicates retrospective clinical data from Australia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The "clinical practice at Sydney IVF" suggests that experts (e.g., embryologists, reproductive specialists) were involved in the ART procedures and assessment of outcomes, but their specific role in establishing a formal "ground truth" for a study is not described.
4. Adjudication method for the test set
- No formal adjudication method is described for either the bench tests or the clinical efficacy claims.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was conducted. This device is a medical product (vitrification/warming kits), not an AI-based diagnostic or assistive device that would involve human readers/interpreters. Therefore, this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is related to AI/software performance. This device is not an algorithm or AI-based system. Therefore, this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For bench testing, the "ground truth" or reference was likely established by standard laboratory methods and specifications for pH, osmolality, MEA, and LAL assays.
- For clinical efficacy, the "ground truth" for "safety and efficacy" and "suitable pregnancy rate" would be based on clinical outcomes data from human ART procedures, as assessed by the clinicians and embryologists at Sydney IVF.
8. The sample size for the training set
- This device does not involve a "training set" in the context of machine learning or AI. The product's formulation and protocols were developed based on scientific understanding of cryopreservation and clinical experience, not through a data-driven training process.
9. How the ground truth for the training set was established
- This question is not applicable as there is no "training set" for this type of medical device. The "ground truth" for the development of such media is typically based on fundamental biological and chemical principles, previous research in cryopreservation, and iterative refinement through laboratory and eventually clinical testing.
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.