(46 days)
For freezing and thawing human blastocysts.
BlastFreeze™: For freezing of human blastocysts.
BlastThaw™: For thawing of human blastocysts.
BlastFreeze™ and BlastThawTM, Cat.No. 10532010 and 10542010. BlastFreeze and BlastThaw are based on Earle's Balanced Salts Solution and differing concentrations of sucrose. BlastFreeze contains glycerol as the cryprotectant.
Here's a breakdown of the acceptance criteria and study information for the BlastFreeze™ and BlastThaw™ devices, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterility | Product testing controls are reported, and a Certificate of Analysis is available for each batch. (Specific results not given) |
| pH | Product testing controls are reported, and a Certificate of Analysis is available for each batch. (Specific results not given) |
| Endotoxin | Endotoxin tested ≤ 0.1 EU/ml (USP). A Certificate of Analysis confirms this for each batch. |
| Mouse Embryo Assay (2-cell) | Blastocyst rate µ 80 %. A Certificate of Analysis confirms this for each batch. |
| Survival Rate (clinical) | Around 80% after freezing and thawing of human blastocysts. |
| Implantation Rate | 15% after freezing and thawing of human blastocysts. |
| Abortion Rate | 14% in IVF patients and 0% in ICSI patients. (Lowered compared to other methods). |
| Adverse Events | No registered complaints and no evidence of serious adverse events since commercialization in Europe (April 2002). |
Study Details
The provided document describes a clinical documentation approach supported by a substantially equivalent argument to a predicate device (K991471). It does not outline a formal, prospective clinical trial in the traditional sense with specific statistical endpoints to meet acceptance criteria. Instead, it relies on accumulated clinical experience and comparison to existing products.
Here's what can be inferred and what is not explicitly stated:
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "clinical documentation" and "daily clinical practice" but does not give a specific number of cases or patients included in the reported survival, implantation, and abortion rates.
- Data Provenance: The document states, "BlastFreeze and BlastThaw were marketed in Europe in April 2002. There has been no registered complaints and no evidence that the product has been the cause of any serious adverse events in connection with its intended use." This suggests the clinical data is retrospective and derived from real-world usage in Europe.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Given that the data is presented as aggregated clinical outcomes from "daily clinical practice," it's highly unlikely that a formal ground truth establishment process with a defined number of experts was conducted for this submission. The outcomes (survival, implantation, abortion) are typically documented by treating clinicians in a standard IVF clinic setting.
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Adjudication method for the test set:
- Not applicable/Not mentioned. There is no indication of an adjudication method as would be used in a blinded, prospective study. The clinical outcomes are likely recorded as part of routine patient care.
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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. This is a medical device for freezing/thawing blastocysts, not an AI-powered diagnostic device. Therefore, an MRMC study and AI-related effectiveness are not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a cryopreservation solution used by human embryologists/clinicians with human intervention. It is not an algorithm that performs tasks independently.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the clinical performance metrics (survival rate, implantation rate, abortion rate) is based on patient outcomes data collected during routine clinical practice (IVF/ICSI cycles).
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The sample size for the training set:
- Not applicable. The "study" here is not an algorithm a's training. It's a submission for a medical device (cryopreservation media) that relies on clinical performance data and substantial equivalence to a predicate device.
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How the ground truth for the training set was established:
- Not applicable. As stated above, there is no "training set" in the context of an algorithm. The clinical data supports the observed performance of the product in human embryology procedures. The document does reference "Ménézo. Y and Veiga.A. 1997" for similar results, suggesting a comparison to published literature or internal data used to inform the observed performance.
§ 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.