(240 days)
VitaVitro® Fertilization Medium is intended for preparation and handling of human gametes and for in vitro fertilization.
VitaVitro® Gamete Buffer Medium is intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI).
VitaVitro® Flushing Buffer Medium is intended for use during ovarian follicle flushing and oocyte collection procedures for use in in vitro fertilization procedures.
This submission includes three media products:
- . VitaVitro® Fertilization Medium is intended for preparation and handling of human gametes and for in vitro fertilization. Media provided in volumes of 30 ml and 60 ml.
- . VitaVitro® Gamete Buffer Medium intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI). Media provided in a single volume of 60 ml.
- . VitaVitro® Flushing Buffer Medium intended for use during in vitro fertilization procedures for follicle flushing and oocyte collection. Media provided in volumes of 60 ml and 125 ml.
All devices are aseptically filled into radiation-sterilized PETG bottles, are single-use only, and have a shelf-life of six-months when stored as recommended at 2-8°C.
The device in question consists of three media products: VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, and VitaVitro® Flushing Buffer Medium. The provided document is a 510(k) Summary, which is a premarket notification to demonstrate that the device is substantially equivalent to legally marketed predicate devices. This type of submission focuses on comparing the new device against existing ones rather than providing a standalone clinical study for efficacy against a disease endpoint. Therefore, the information regarding acceptance criteria and studies is framed within the context of demonstrating substantial equivalence.
Here's the breakdown of the acceptance criteria and the studies performed to meet them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| pH | 7.20 - 7.60 | Met (tested at time 0 and after accelerated aging) |
| Osmolality | 260 - 290 mOsm/kg | Met (tested at time 0 and after accelerated aging) |
| Endotoxin | ) | Met (tested at time 0 and after accelerated aging) |
| Shelf-life Verification | Product specifications (pH, Osmolality, Endotoxin, MEA, Sterility) met after accelerated aging equivalent to six months | Met |
| Transportation | Conforms to ASTM D4169-2016 Protection Level 1 (Severe) | Not explicitly detailed performance, but testing was conducted to confirm adequate protection. |
| Sterilization Validation | Conforms to ISO 13408-1:2015 and ISO 13408-2:2018 | Not explicitly detailed performance, but validation was conducted to ensure aseptic processing and sterile filtration. |
| Biocompatibility (Flushing Buffer Medium only) | Non-cytotoxic, non-sensitizing, non-irritating | Test demonstrated non-sensitizing and non-irritating (cytotoxicity not explicitly stated as passed, but implied by overall positive conclusion) |
| Cytotoxicity (ISO 10993-5:2009) | No cytotoxic effects observed | Implied as "tested" and overall conclusion of safety and effectiveness. |
| Sensitization (ISO 10993-10:2010) | No sensitization observed | Non-sensitizing (reported) |
| Irritation (ISO 10993-10:2010) | No irritation observed | Non-irritating (reported) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for each test conducted. It states that "The testing... apply to each of the subject media products," indicating that tests were performed on samples of each of the three media.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. However, as it's part of a 510(k) submission, the testing would have been conducted by or for the manufacturer (Shenzhen VitaVitro Biotech Co., Ltd., China) as part of their premarket activities. These were non-clinical performance studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the non-clinical performance studies described. The "ground truth" for these tests refers to the established scientific and regulatory standards (e.g., USP monographs, ISO standards, ASTM standards, FDA guidance documents) for chemical, biological, and physical properties of the media. The "experts" would be the scientists and technicians conducting the validated assays and interpreting results against predefined quantitative specifications.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, quantitative laboratory assays with predefined acceptance criteria. There is no subjective interpretation or need for expert adjudication in the way typically seen in image or clinical diagnostic studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is not relevant for this type of medical device (reproductive media). These studies are typically used to assess the diagnostic performance of software or imaging devices where human readers interpret results.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, in a sense. The studies described are standalone performance evaluations of the physical and biological characteristics of the media products themselves. There is no "human-in-the-loop" component to the performance of these media, as they are chemical formulations used in assisted reproduction, not diagnostic tools interpreted by humans in real-time. The in-vitro performance (e.g., MEA) demonstrates the intrinsic function of the media in supporting embryo development.
7. Type of Ground Truth Used
The ground truth for these non-clinical studies is based on:
- Established scientific and regulatory specifications: pH, Osmolality, Endotoxin limits are set by pharmacological and regulatory standards.
- Biological performance standards: MEA (Mouse Embryo Assay) is a standard biological assay used to assess the suitability of media for supporting embryo development. The "ground truth" here is the observed blastocyst development rate in comparison to established benchmarks (≥80%).
- Sterility and Biocompatibility Standards: Ground truth is defined by the absence of microbial growth and the lack of adverse biological reactions (cytotoxicity, sensitization, irritation) as determined by validated test methods (e.g., USP , ISO 10993 series).
8. Sample Size for the Training Set
Not applicable. These are finished medical products (media formulations), not algorithms or AI models that require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for these media products.
§ 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.