(329 days)
BlastAssist® and BlastAssist® with Phenol Red are used for culture of embryos from the 4-8 cell stage through to blastocyst stage. Can also be used for transfer.
BlastAssist® and BlastAssist® with Phenol Red are defined sterile media, used by assisted reproduction professionals and intended for culture of embryos from the 4-8 cell stage to blastocyst stage and for embryo transfer.
The design of BlastAssist® and BlastAssist® with Phenol Red is based on BlastAssist® System Medium 2 ( K003156). The BlastAssist® medium is a salt solution added SSR (Synthetic Serum Replacement), HSA, ethanolamine, amino acids, a stable form of L-glutamine, vitamins and antibiotics.
BlastAssist® is supplied in 10 ml polyethylene plastic vials with screw top closures
The provided document (K080172) is a 510(k) Summary for a reproductive media device (BlastAssist®), not an AI/ML medical device. Therefore, many of the requested details regarding AI/ML device acceptance criteria and performance studies (such as MRMC studies, effect size of human reader improvement with AI, ground truth establishment for training sets, etc.) are not applicable to this submission.
However, I can extract the relevant information regarding the performance data and product testing controls mentioned for this specific device.
Here's the information based on the provided text, tailored to what is applicable for a medical device like BlastAssist®:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (BlastAssist®) |
|---|---|
| Clinical Performance | Effective for its intended use (culture of embryos from 4-8 cell stage to blastocyst stage, and embryo transfer). No complaints and no adverse events registered during the study. |
| Safety | Safe for its intended use. No complaints and no adverse events registered during the study. |
| Sterility | Tested according to Ph. Eur. and USP. |
| Osmolality | Tested according to Ph. Eur. and USP. |
| pH | Tested according to Ph. Eur. and USP. |
| Endotoxin | Tested according to Ph. Eur. and USP. |
| Mouse embryo Assay (MEA) | Performed for each batch. |
| Stability | Stability studies have been performed. |
| Substantial Equivalence | Concluded to be substantially equivalent to the predicate device (MediCult's BlastAssist® System K003156). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document states "BlastAssist® has been tested in a human study." However, the specific sample size (number of embryos, patients, or study participants) for this human study is not provided in the summary.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "human study," implying prospective clinical assessment, but further details are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The performance assessment was based on the effectiveness and safety of the media in embryo culture, likely evaluated by assisted reproduction professionals (e.g., embryologists), but no details on expert panels for 'ground truth' in the AI sense are relevant here.
4. Adjudication method for the test set
- Not applicable and not provided. This is relevant for AI/ML studies where multiple human readers might disagree; for a media product, effectiveness is typically measured by biological outcomes.
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. An MRMC study is not relevant for this type of medical device (embryo culture media) and was not performed. This is an AI/ML-specific study design.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is an embryo culture media, not an algorithm.
7. The type of ground truth used
- The "ground truth" for the device's performance was its demonstrated effectiveness in supporting embryo development to the blastocyst stage and safety (absence of complaints/adverse events) in a human study, and its ability to pass various biochemical and biological quality control tests (sterility, osmolality, pH, endotoxin, MEA, stability).
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The "design" (formulation) was based on the predicate device and modified with new ingredients (vitamins, ethanolamine, stable L-glutamine).
9. How the ground truth for the training set was established
- Not applicable. As above, there is no 'training set' in the AI/ML sense for this product. The development of the media was based on scientific formulation and empirical testing (performance data, product testing controls).
§ 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.