(250 days)
iMedium Single Step media are intended to be used as culture media for gametes and embryos from fertilization through day 5/6 of development. iMedium Single Step media are not intended for embryo transfer procedures.
The Kitazato iMedium Single Step media are culture media used in assisted reproductive procedures. The iMedium Single Step media are designed for development of the embryo from fertilization through day 5/6 until the embryo transfer, in a continuous and uninterrupted culture system without the need to change media. The iMedium Single Step media are provided in three variants: without protein (Model: IM-S), with human serum albumin (HSA; Model: IM-SS), and with recombinant human albumin (rHA; Model: IM-SC). All variants contain gentamicin, an antibiotic agent that suppresses bacterial growth. Each iMedium Single Step solution is offered in three volumes (10mL, 50mL and 100mL). Each iMedium Single Step solution is a colorless and clear fluid. The product is single-use only, provided aseptically-filtered in a container sterilized by gamma irradiation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the iMedium Single Step device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Specification) | Reported Device Performance |
|---|---|
| pH | 7.2-7.6 |
| Endotoxin | ≤ 0.25 EU/mL |
| 1-Cell Mouse Embryo Assay (MEA) | ≥ 80 % embryos developed to expanded blastocyst at 96 hours |
| Sterility | No growth |
| Appearance | Passed (Implicitly, as it passed all testing) |
| Osmolarity | Passed (Implicitly, as it passed all testing) |
| Shelf-life | Met at 4 months (real-time aged samples) |
| Transportation Testing | Passed |
| Sterilization Validation | Passed |
2. Sample Size and Data Provenance
The document does not specify the sample sizes used for the non-clinical tests (e.g., number of mouse embryos for MEA, number of batches for sterility, etc.).
Data provenance: The testing was conducted by Kitazato Corporation, the manufacturer, as internal non-clinical tests. The country of origin for the data is Japan, based on the manufacturer's address (Kitazato Corporation, Japan). The data is retrospective as it was collected before the 510(k) submission.
3. Number of Experts and their Qualifications
This information is not provided in the document. The non-clinical tests described are laboratory-based and do not inherently involve human expert interpretation in the way a diagnostic imaging device might.
4. Adjudication Method
This information is not applicable as the non-clinical tests described do not involve human interpretation or subjective assessment that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a culture medium, not a diagnostic imaging or interpretive aid that would typically involve human readers.
6. Standalone Performance Study
Yes, a standalone performance study was done. The non-clinical performance data described (pH, endotoxin, MEA, sterility, etc.) represents the performance of the algorithm/device (the culture medium itself) without human intervention during the actual performance measurement. The purpose of these tests was to demonstrate the inherent safety and effectiveness characteristics of the iMedium Single Step media.
7. Type of Ground Truth Used
The ground truth for the non-clinical tests was established through:
- Laboratory measurements/standards: For pH (USP ), Endotoxin (USP ), Sterility (USP ), and Osmolarity (freezing point depression method), the ground truth is based on established scientific and regulatory standards for these measurements.
- Biological assay outcomes: For the 1-Cell Mouse Embryo Assay (MEA), the ground truth is the biological outcome of embryo development to the expanded blastocyst stage within 96 hours. This is a recognized biological endpoint for assessing the suitability of reproductive media.
- Engineering/Quality standards: For shelf-life, transportation testing (ASTM D4169-16), and sterilization validation (ISO 13408-1:2008 / A1:2013, ISO 13408-2:2018), the ground truth refers to meeting the specified parameters and requirements outlined in these engineering and quality standards.
8. Sample Size for the Training Set
This information is not applicable/not provided. This device is a medical device (culture medium) and not an AI/ML algorithm that requires a training set in the conventional sense. The development of the medium would involve formulation scientists and biologists, rather than an AI training process.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for the same reasons mentioned in point 8.
§ 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.