(109 days)
Biopsy Medium is intended for blastomere biopsy of cleavage stage embryos for PGD (preimplantation genetic diagnosis)
MediCult Biopsy Medium is a defined sterile media used by professionals within assisted reproduction and designed for blastomere biopsy of cleavage stage embryos for pre-implantation genetic diagnosis (PGD). The formulation is based on a HEPES-buffered HTF solution added SSR (Synthetic Serum Replacement: ART supplement), human serum albumin (HSA) and amino acid but without calcium and magnesium ions to facilitate the process of biopsy. The absence of calcium and magnesium ions reversibly reduces the cellular connection between the blastomeres making it easy to excise a blastomere from the embryo without fatal trauma.
Biopsy Medium is supplied in 10 ml polyethylene plastic vials with screw top closures.
The provided text describes a 510(k) submission for the MediCult Biopsy Medium. It includes details about the device's intended use, technological characteristics, and performance data. However, the document is a regulatory submission and approval letter, not a detailed study report. Therefore, it lacks specific information typically found in a scientific study.
Based on the provided information, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the device as meeting its intended use but does not present a table with explicit acceptance criteria or quantitative performance metrics that would typically be found in a study for medical devices requiring specific performance measurements.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implied Acceptance Criteria | |
| Effective for intended use (blastomere biopsy) | "The results showed that the product is effective for its intended use." |
| No serious adverse events | "no evidence of any serious adverse events in connection with the intended use." |
| No registered complaints | "no registered complaints" |
| Cytotoxicity | "Biopsy Medium has been cytotoxicity tested." (Implicitly passed, as it was deemed effective and safe) |
| Stability | "Stability studies have been performed." (Implicitly passed, as it was deemed effective and safe) |
| Sterility (Ph. Eur. and USP) | "Each batch is tested according to Ph. Eur. and USP for sterility..." (Implicitly passed for each batch) |
| Osmolality | "...osmolality..." (Implicitly passed for each batch) |
| pH | "...pH..." (Implicitly passed for each batch) |
| Endotoxin | "...endotoxin..." (Implicitly passed for each batch) |
| MEA (Mouse Embryo Assay, implied for ART products) | "...and MEA." (Implicitly passed for each batch) |
Note: The acceptance criteria are largely implied by the statements that the product is "effective," "safe," and has "no serious adverse events" or "registered complaints." Specific numerical thresholds or pass/fail criteria are not detailed in this document.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions a "human study" but does not provide the number of participants or embryos involved in this study.
- Data Provenance: The human study was conducted in a European context, as it states the device "has been marketed in Europe since 2002." It is implied to be retrospective reporting of clinical experience rather than a prospective trial designed to specifically test the device's performance in a controlled manner, though the exact study design is not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This information is not provided in the document. For a product like a biopsy medium, "ground truth" would likely relate to embryo viability, successful biopsy, or genetic diagnosis outcomes, which would be assessed by embryologists, geneticists, or other ART professionals. However, the document does not specify how these outcomes were assessed or by whom.
4. Adjudication Method for the Test Set
N/A. The document does not describe any specific adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is typically relevant for diagnostic imaging devices where human readers interpret results with and without AI assistance. This device is a culture medium used in a laboratory procedure, not an imaging device with human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
N/A. This question is not applicable as the device is a biopsy medium, not an AI algorithm. Its performance is intrinsically tied to its use by human embryologists/technicians in a laboratory setting.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the efficacy of the biopsy medium would indirectly relate to:
- Successful blastomere excision without fatal trauma to the embryo.
- Viability and further development of the biopsied embryo.
- Accuracy of subsequent PGD results (though the medium itself doesn't directly perform diagnosis, it facilitates the sample collection).
The document states, "The results showed that the product is effective for its intended use." This implies that the human study observed positive outcomes related to these aspects, but the specific metrics and how ground truth was established (e.g., through embryo development rates, successful genetic diagnosis, etc.) are not detailed.
8. The Sample Size for the Training Set
N/A. The concept of a "training set" is typically associated with machine learning or AI models. This device is a chemical medium, not a software algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
N/A. As there's no training set for this type of device, this question is not applicable.
§ 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.