(316 days)
Dewin Reproductive Media consists of Dewin Fertilization Medium (with HSA and without HSA) and Dewin Cleavage Medium (with HSA and without HSA). The indications for use for the Dewin Fertilization Medium and Dewin Cleavage Medium are as follows:
Dewin Fertilization Medium is intended for use during in vitro fertilization (IVF) procedures and culture to the two pronuclei (zygote) stage of development. Dewin Fertilization Medium is also intended for washing sperm and collected oocytes after aspiration prior to IVF procedures. Dewin Fertilization Medium is not intended for use in intrauterine insemination procedures.
Dewin Cleavage Medium is intended for culture of embryos from the two pronuclei (zygote) stage of embryo development. Dewin Cleavage Medium is also intended for use in the transfer of cleavage stage embryos into the uterine cavity.
Dewin Reproductive Media includes two products (Dewin Fertilization and Dewin Cleavage Medium). Dewin Fertilization Medium is intended for use in washing sperm and oocytes for use in in IVF procedures. Dewin Cleavage Medium, is intended for use in culturing embryos from the zygote stage to the 8-cell stage of development and can also be used for embryo transfer procedures.
Dewin Reproductive Media are comprised of salts, energy substrates, anti-oxidant, nutrient supplements, amino acids, EDTA, gentamicin, and phenol red. Dewin Reproductive Media are offered with and without Human Serum Albumin (HSA).
The Dewin Reproductive Media are aseptically filtered and filled into glass bottles with polypropylene caps. The devices are provided in 25 mL and 50 mL volumes. Dewin Reproductive Media have a fourmonth shelf-life when stored as recommended and are for single-use only.
The medical device in question is Dewin Reproductive Media, which includes Dewin Fertilization Medium and Dewin Cleavage Medium. This document is a 510(k) Summary, which typically compares a new device to a legally marketed predicate device to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text lists acceptance criteria and performance for several non-clinical tests. It doesn't explicitly present a comparative table of acceptance criteria vs. specific reported device performance values for all criteria, but it states that "Results confirm that the design inputs and performance specifications for the device are met." and for specific tests, it states the acceptance criteria (e.g., pH target, MEA success rate).
| Test/Parameter | Acceptance Criteria (Design Input/Performance Spec) | Reported Device Performance (as stated in sections 9 & 10) |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating | "The testing demonstrated the Dewin Cleavage Medium formulations to be non-cytotoxic, non-sensitizing, and non-irritating." |
| Sterile filtration & Aseptic fill | Conformance to ISO 13408-1:2008 and ISO 13408-2:2018 | (Stated as conforming, no specific numerical results given) |
| Shelf-Life (4 months) | Product specifications met at time 0 and after accelerated aging | "demonstration that the product specifications (shown below) were met at time 0 and after accelerated aging" |
| Appearance | Clear, particle-free | (Stated as conforming, no specific numerical results given) |
| pH | 7.2–7.5 (per USP ) | (Stated as conforming, no specific numerical results given) |
| Osmolality | 260–295 mOsm/kg (per USP ) | (Stated as conforming, no specific numerical results given) |
| Endotoxin | ) | (Stated as conforming, no specific numerical results given) |
| MEA (Fertilization Medium) | One-cell system: ≥80% embryos developed to expanded blastocyst at 96 hours after 24-hour exposure | (Stated as conforming, no specific numerical results given beyond meeting the ≥80% criterion) |
| MEA (Cleavage Medium) | One-cell system: ≥80% embryos developed to expanded blastocyst at 96 hours after 48-hour exposure | (Stated as conforming, no specific numerical results given beyond meeting the ≥80% criterion) |
| Sterility | No microbial growth (per USP ) | (Stated as conforming, no specific numerical results given) |
| Transportation Testing | Conformance to ASTM D4169-16 | (Stated as conforming, no specific numerical results given) |
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 mentions "non-clinical performance testing" and describes the types of tests (biocompatibility, shelf-life, MEA, etc.). However, it does not specify the sample sizes used for these tests nor does it provide information on the data provenance (country of origin, retrospective/prospective). For MEA (Mouse Embryo Assay), a specific number of embryos would be used, but this is not detailed.
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 section is not applicable as the device is a reproductive medium (solution), not an AI/imaging device requiring expert interpretation for ground truth establishment. The performance is assessed through laboratory assays (e.g., cell development, chemical properties, sterility).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as point 3. The performance evaluation is based on objective laboratory measurements and biological assays, not subjective expert reviews requiring adjudication.
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
This section is not applicable as the device is a reproductive medium and not an AI-assisted diagnostic or imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a reproductive medium and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" or reference standard is based on:
- Established scientific and regulatory standards: e.g., ISO standards for biocompatibility and aseptic filling, USP standards for pH, osmolality, endotoxin, and sterility, ASTM standards for transportation.
- Biological assay endpoints: For the Mouse Embryo Assay (MEA), the endpoint is the percentage of embryos developed to the expanded blastocyst stage within a specified timeframe (e.g., ≥80% development). This is an objective, measurable biological outcome.
- Chemical and physical properties: Measured parameters like pH, osmolality, and endotoxin levels are compared against predefined numerical specifications.
8. The sample size for the training set
This is not applicable as the device is a reproductive medium and does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
This is not applicable as the device is a reproductive medium and 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.