(147 days)
BlastGen™ is for the culture of embryos from the 4-8 cell stage through to the blastocyst stage. BlastGen™ can also be used for embryo transfer.
BlastGen™ is based on ORIGIO® Sequential Blast™ (K133387) with the supplement of Leukine (Sargramostim) granulocyte macrophage colony-stimulating factor (GM-CSF).
BlastGen™ is a colorless, non-viscous solution contained in 3mL 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. BlastGen™ is a ready to use by professionals for assisted reproduction.
BlastGen™ is quality control tested before release for pH, sterility, Mouse Embryo Assay, endotoxin, osmolality, GM-CSF concentration (by ELISA), GM-CSF potency (TF-1 cell assay) and human serum albumin (HSA) concentration (by ELISA).
Here's an analysis of the acceptance criteria and study data for the BlastGen™ device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly state formal "acceptance criteria" in a tabular format for direct comparison with reported device performance. Instead, it presents various performance and safety data points that demonstrate equivalence to a predicate device. The implicit acceptance criterion for a 510(k) is "substantial equivalence" to a legally marketed predicate device.
However, based on the non-clinical and clinical evidence provided, we can infer some performance aspects that were evaluated.
| Performance Characteristic | Implicit Acceptance Criterion (vs. Predicate/Control) | Reported Device Performance (BlastGen™) |
|---|---|---|
| Biocompatibility | Demonstrate safety (Non-cytotoxic, non-sensitizing, non-irritating) | "results demonstrated that BlastGen™ was safe." |
| Sterility | Achieve sterility assurance level (SAL) of 10⁻³ | "SAL of 10⁻³." |
| Shelf-Life (Unopened) | Maintain product specifications (pH, osmolality, sterility, MEA, endotoxin, GM-CSF conc., GM-CSF potency, HSA conc.) | "26-week shelf-life" (Under recommended storage conditions) |
| Shelf-Life (Opened) | Maintain product specifications (pH, osmolality, sterility, MEA, endotoxin, GM-CSF conc., GM-CSF potency, HSA conc.) | "7-day stability" (After bottle opened) |
| Blastocyst Rate | Comparable to or improved over control/predicate (G1/G2) | "trend towards higher blastocyst rate" (vs. G1/G2, not statistically significant in one study) |
| Pregnancy Rate | Comparable to or improved over control/predicate | "trend towards higher pregnancy...rates" (vs. G1/G2 in one study) |
| Ongoing Implantation Rate | Comparable to or improved over control/predicate | "trend towards higher...ongoing implantation rates" (vs. G1/G2 in one study) |
| Embryo Development to Blastocyst | Increased proportion relative to control | "increased the proportion of embryos that developed to the blastocyst stage from 30 to 76%." |
| Developmental Competence (Hatching/Attachment) | Improved relative to control | "improved by GM-CSF" |
| Apoptotic Nuclei in Blastocysts | Reduced relative to control | "50% fewer apoptotic nuclei" (in 2 ng/ml GM-CSF vs. control) |
| Viable Inner Cell Mass Cells | Increased relative to control | "30% more viable inner cell mass cells" (in 2 ng/ml GM-CSF vs. control) |
2. Sample Size Used for the Test Set and Data Provenance
The primary clinical evidence mentioned is:
- Sample Size: "a prospective randomized sibling zygote pilot study (n=371 zygotes)"
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as "prospective randomized sibling zygote pilot study." The names of authors (Nakajyo, Sjöblom) suggest international research, but the specific source country of the embryos/patients is not mentioned in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This document describes a device (reproductive media) for culturing embryos, not a diagnostic device that requires expert-established ground truth for performance evaluation in the same way an imaging AI would. The "ground truth" for embryology outcomes (e.g., blastocyst formation, pregnancy) is typically based on biological observation and clinical outcomes. Therefore, the concept of "experts establishing ground truth for a test set" with specific qualifications (like radiologists) does not apply directly here. The "truth" is the biological outcome observed by embryologists/clinicians.
4. Adjudication Method for the Test Set
Not applicable in the context of this type of device and study. The outcomes (e.g., blastocyst formation, pregnancy) are objective biological assessments rather than subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
- This type of study is relevant for diagnostic devices where human readers interpret images or data, and the comparison is between human interpretation alone versus human interpretation with AI assistance. BlastGen™ is a culture medium, not a diagnostic imaging AI tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone "algorithm only" study was not done because BlastGen™ is a culture medium, not an algorithm or AI. Its performance is evaluated through biological outcomes in a laboratory and clinical setting, which inherently involves human embryologists and clinicians interacting with the embryos and patients.
7. Type of Ground Truth Used
The ground truth used for evaluating BlastGen's performance is biological and clinical outcomes, specifically:
- Embryo development: Blastocyst formation rate, proportion of embryos reaching the blastocyst stage.
- Embryo quality indicators: Apoptotic nuclei count, viable inner cell mass cell count.
- Clinical outcomes: Pregnancy rate, ongoing implantation rates.
- Pre-clinical tests: Mouse Embryo Assay (MEA), pH, osmolality, sterility, endotoxin, GM-CSF concentration, GM-CSF potency, and HSA concentration.
8. Sample Size for the Training Set
This information is not provided. The provided studies are performance evaluations of the final product, not related to the training of an algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as BlastGen™ is a culture medium and not an algorithmic/AI device that requires a "training set" with established ground truth in the AI sense. Its formulation and development would be based on scientific research and biological principles, rather than machine learning training.
§ 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.