(195 days)
EmbryoAssist™ and EmbryoAssist™ with Phenol Red are for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ and EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3.
EmbryoAssist™ and EmbryoAssist™ with Phenol Red are each a defined sterile media used by professionals within assisted reproduction and intended for fertilization and culture until the 2-8 cell stage. EmbryoAssist™ and EmbryoAssist™ with Phenol Red can also be used for embryo transfer at day 2 or 3. The composition of EmbryoAssist™ and EmbryoAssist™ with Phenol Red are almost identical to The predicate device Embryo Assist™ (K061309), but with an extension of the intended use including a transfer indication. The EmbryoAssist" medium is a salt solution containing SSR (Synthetic Serum Replacement), HSA, amino acids, a stable form of L-glutamine, vitamins and antibiotics. EmbryoAssist™ is supplied in 10 ml and 60 ml polyethylene plastic vials with screw top closures.
The provided 510(k) summary for EmbryoAssist™ and EmbryoAssist™ with Phenol Red describes a medical device, a cell culture medium, rather than a diagnostic AI device. Therefore, many of the requested categories related to AI specific performance, such as sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable to this submission.
However, I can extract the information that is present and relevant to the "acceptance criteria" (implied functional and safety requirements) and the "study that proves the device meets the acceptance criteria" from the provided text.
Acceptance Criteria and Device Performance
The core acceptance criteria for this type of device (reproductive media) revolve around its safety and effectiveness for its intended use, which is fertilization, culture until the 2-8 cell stage, and embryo transfer. The primary way this is demonstrated for a 510(k) submission is through substantial equivalence to a legally marketed predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: No serious adverse events | "During our studies there have been no registered complaints and no evidence that the product has been the cause of any serious adverse events in connection with the intended use." |
| Effectiveness: Capable of supporting fertilization, culture (2-8 cell stage), and embryo transfer successfully. | "The results showed that the product is effective and safe for its intended use." (This is a general statement, relying on comparison to predicate and the human study data.) |
| Quality Control: Meets established physical and biological parameters. | "Each batch is tested according to Ph. Eur. and USP for sterility, osmolality, pH, endotoxin and Mouse Embryo Assay (MEA). Stability studies have been performed." |
| Substantial Equivalence: Similar technological characteristics and intended use to predicate devices. | The device's composition is "almost identical" to a predicate, with an extended intended use (transfer indication). It is concluded to be "substantially equivalent." |
Study Information
As this is a 510(k) for an in vitro diagnostic/culture medium, the "study" is a human clinical study aimed at demonstrating safety and effectiveness, leveraging the concept of substantial equivalence.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text. It mentions "a human study" but does not give the number of participants or embryos.
- Data Provenance: The study was "a human study." The sponsoring company, MediCult a/s, is located in Denmark, suggesting the study may have been conducted there or in a similar regulatory environment, but this is not explicitly stated. It is a prospective study as it states "During our studies there have been no registered complaints," implying current data collection.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a cell culture medium, not an AI diagnostic device where expert ground truth is typically assigned to images or patient data. The "ground truth" here is the biological outcome of the cultures and transfers.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
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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 not an AI device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this type of device, the "ground truth" would be the observed biological outcomes (e.g., successful fertilization, embryo development to the 2-8 cell stage, successful transfer leading to pregnancy/live birth outcomes – although the latter is often not required for 510(k) for culture media, usually focusing on early embryological development and safety). The text specifically states: "The results showed that the product is effective and safe for its intended use." This efficacy is based on the biological performance observed in the human study.
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The sample size for the training set:
- Not Applicable. This is not an AI device, so there is no training set in the AI sense.
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How the ground truth for the training set was established:
- Not Applicable. See point 7.
§ 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.