(126 days)
EmbryoGen® is for culture of human embryos until the 2-8 cell stage. EmbryoGen® can also be used for embryo transfer at day 2 or 3.
EmbryoGen® (1204) is a modification of EmbryoGen® (1203) (K120136), where the base medium has been changed from EmbryoAssist® (K080473) to the new ORIGIO Sequential Cleav™ (K133912) medium. EmbryoGen® (1204) contains GM-CSF (Granulocyte macrophage- colony stimulating factor), in the same concentration as EmbryoGen® (1203). EmbryoGen® (1204) is an aseptically filtered, colorless, non viscous solution, which is ready to use by professionals within assisted reproduction. EmbryoGen® (1204) is contained in 3 ml transparent glass bottles with white polypropylene caps, available in a single piece card board box, individually labeled and with instruction for use provided as a package insert.
The provided document is a 510(k) Summary for a medical device called EmbryoGen® (Cat. No. 1204). This device is a reproductive culture medium used for human embryos. The document focuses on demonstrating substantial equivalence to a predicate device, EmbryoGen® (Cat. No. 1203).
The 510(k) summary does not contain acceptance criteria or details of a study designed to prove the device meets specific performance acceptance criteria in the typical sense of a clinical trial for diagnostic or interventional devices with quantifiable outcomes like sensitivity, specificity, accuracy, etc.
Instead, the submission for EmbryoGen® (1204) relies on demonstrating substantial equivalence to a legally marketed predicate device (EmbryoGen® (1203)). This means the "acceptance criteria" are effectively the characteristics and performance of the predicate device. The "study" proving the device meets these criteria is a comparison of technological characteristics and performance data between the new device and the predicate device, as well as another cleared device (ORIGIO® Sequential Cleav™).
Here's an breakdown based on the provided text, addressing your questions where possible:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for substantial equivalence of a culture medium, the "acceptance criteria" are the established specifications and comparable performance parameters of the predicate device and other similar cleared devices. The "reported device performance" are the specifications of the new device.
| Acceptance Criteria (Predicate/Cleared Device Specs) | Reported Device Performance (EmbryoGen® (1204)) |
|---|---|
| Indication for use: Culture of human embryos until 2-8 cell stage; embryo transfer day 2 or 3 | Indication for use: Culture of human embryos until the 2-8 cell stage; embryo transfer at day 2 or 3. (Narrowed from predicate which included fertilization) |
| pH: 7.3-7.5 (EmbryoGen® (1203)); identical to ORIGIO® Sequential Cleav™ | pH: 7.2-7.4 (A little lower than predicate, but identical to ORIGIO® Sequential Cleav™) |
| Osmolality (mOsm/kg): 272-288 | Osmolality (mOsm/kg): 272-288 |
| Endotoxin (EU/mL): 80% | GM-CSF ELISA test: >80% |
| GM-CFS potency (TF-1 cell assay): 80-125% | GM-CFS potency (TF-1 cell assay): 80-125% |
| Protein source: HSA Protein Supplementation 2 mg/mL (EmbryoGen® (1203)); 5 mg/mL (ORIGIO® Sequential Cleav™) | Protein source: HSA Protein Supplementation 5 mg/mL |
| Drugs: Gentamicin sulphate 0.01 mg/mL | Drugs: Gentamicin sulphate 0.01 mg/mL |
| Recombinant human GM-CSF: 2 ng/mL | Recombinant human GM-CSF: 2 ng/mL |
| Base Medium: Similar components as ORIGIO® Sequential Cleav™ (e.g., 21 amino acids, Na Hyaluronate, no SSR) | Base Medium: Identical to ORIGIO® Sequential Cleav™ (e.g., 21 amino acids, Na Hyaluronate, no SSR) |
| Biocompatibility: Pass cytotoxicity, sensitization, irritation tests (ISO 10993-1:2009) | Biocompatibility: Passed cytotoxicity, sensitization, and irritation tests |
| Shelf life: 26 weeks for predicate | Shelf life: Validated to 26 weeks |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" sample size for a typical clinical performance study. The "performance data" section primarily discusses laboratory tests and stability studies, which would involve samples of the culture medium itself, not biological samples from human patients in a clinical trial.
- 1-cell MEA (Mouse Embryo Assay): This is a biological assay using mouse embryos. The document states a performance criterion (≥80%) but does not specify the sample size (e.g., number of mouse embryos, number of batches tested) used to demonstrate this for EmbryoGen® (1204).
- Stability studies: These tests involved multiple batches of the product over time. The sample size (number of batches) is not explicitly stated.
- Data Provenance: Not specified as a clinical trial. The manufacturing company, ORIGIO a/s, is based in Denmark.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device submission. There is no concept of "ground truth" established by human experts in the context of this culture medium's substantial equivalence demonstration. The "ground truth" is essentially the established specifications and safety profile of the predicate device and the general scientific understanding of IVF media components.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no clinical read by human readers that would require an adjudication method.
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
Not applicable. This device is a culture medium, not an AI-powered diagnostic or decision support system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a culture medium, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on:
- Established scientific understanding and regulatory requirements for reproductive media.
- Performance specifications of the predicate device (EmbryoGen® (1203)) and another cleared device (ORIGIO® Sequential Cleav™).
- Standardized laboratory tests for pH, osmolality, endotoxin, specific protein concentrations, and biological assays like MEA (Mouse Embryo Assay), GM-CSF ELISA, and GM-CSF potency (TF-1 cell assay).
- Biocompatibility testing (cytotoxicity, sensitization, irritation) against ISO 10993-1:2009 standards.
There is no "expert consensus" or "pathology" in the sense of interpreting images or clinical findings.
8. The sample size for the training set
Not applicable. This device is a culture medium, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As stated above, this device does not involve a training set.
§ 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.