(270 days)
V-HYADASE is intended for the enzymatic removal of cumulus and corona radiata cells from oocytes prior to intracytoplasmic sperm injection (ICSI) procedures.
V-HYADASE is an assisted reproduction medium intended for the enzymatic removal of cumulus and corona radiata cells from oocyte prior to Intracytoplasmic Sperm Injection (ICSI) procedures. The medium is aseptically filtered and provided in a volume of 1 mL in pre-sterilized 2 mL polypropylene copolymer (PPCO) bottles with PPCO caps. V-HYADASE has a shelf-life of one-year when stored at 2-8°C and can be used for up to seven days after bottle opening.
Here's an analysis of the acceptance criteria and study information for the V-HYADASE device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria (Subject Device, V-HYADASE) | Reported Device Performance (Implied by "met at time 0 and after accelerated aging") |
|---|---|---|
| Clarity/Color | Pink rose color, no precipitates | Met |
| pH (per USP) | 7.2-7.4 | Met |
| Osmolality (per USP) | 257-273 mOsm/kg | Met |
| Endotoxin (per USP ) | )** | No growth |
| Hyaluronidase Activity | 50-120 IU/mL | Met |
| Shelf Life | 1 Year (7 days after bottle opening) | Met |
Note: The document explicitly states that the product specifications were "met at time 0 and after accelerated aging," indicating that the device performance for these criteria was within the defined acceptance limits.
Regarding the other requested information, the provided document does not contain the following details:
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 an MEA (Mouse Embryo Assay) but does not specify the number of embryos or test repetitions used for this specific test within the context of the device's performance validation.
- No information is provided about data provenance (country of origin, retrospective/prospective).
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 type of information is not relevant to the non-clinical performance testing described for this device, which involves laboratory assays and physical/chemical property measurements, not expert interpretation of outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication methods are typically associated with human-read studies or studies where subjective assessments are involved. This is not applicable to the non-clinical tests described.
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
- No MRMC study was conducted. This device is a reproductive media, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone performance is not applicable to this device, as it is a chemical solution used in a laboratory procedure, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the non-clinical tests is established by the assay parameters themselves (e.g., pH meter readings, osmolality readings, microscopic observation of embryo development according to pre-defined criteria, sterility culture results, hyaluronidase activity assays).
- For the MEA, the "ground truth" is the observed development of embryos to the expanded blastocyst stage within the specified timeframe and percentage.
8. The sample size for the training set
- There is no "training set" in the context of this device's non-clinical performance testing. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set mentioned.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The device, V-HYADASE, underwent a series of non-clinical performance tests to demonstrate its safety and effectiveness and substantial equivalence to a predicate device (Origio A/S SynVitro Hyadase K200680). The studies included:
- Sterile Filtration and Aseptic Fill Validation: Conducted per ISO 13408-1:2008 and ISO 13408-2:2018. This ensured the sterility of the final product.
- Shelf-Life Testing: This was a critical study to support the claimed 12-month shelf-life and 7-day open-vial stability. The testing involved demonstrating that all the acceptance criteria listed in the table above (Clarity/Color, pH, Osmolality, Endotoxin, MEA, Sterility, Hyaluronidase Activity) were met at the initial time point (time 0) and after accelerated aging (in accordance with ASTM F1980-21). Additionally, tests were performed on aged samples that had undergone 7 days of simulated use conditioning after bottle opening to verify the open-vial stability.
- Transportation Testing: Performed according to ASTM D4169-22 and USP to ensure the product's integrity during transport.
The conclusion drawn from these studies is that the "results of the performance testing described above demonstrate that V-HYADASE is as safe and effective as the predicate device and support a determination of substantial equivalence." This implies that all the stated acceptance criteria were successfully met during these non-clinical evaluations.
§ 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.