(211 days)
The IVF ICSI dish is intended for holding oocytes and sperm during fertilization via intracytoplasmic sperm injection (ICSI).
The IVF ICSI Dish is an injection molded polystyrene dish with a single dish-sized well. The dish has overall outside dimensions of 1.999" (50.77 mm) diameter and 0.340" (8.64 mm) height without the lid. Addition of the lid increases overall height to 0.384" (9.75 mm). The dish has a fluid capacity of 12.5 ml, if filled to the top of the sidewall; however, individual IVF clinics typically use a small fraction of that potential volume. The polystyrene used for the dish and lid are virgin crystal-grade polystyrene, which has successfully passed the USP 32 Class VI test for in vivo cytotoxicity and USP 32 for in vitro cytotoxicity. The dish is designed in such a way that when the lid is mounted on the dish, dishes can be stacked. The lid can be removed with one hand. The IVF ICSI Dish is packed in strips of 3 dishes with lids and 40 strips in a box for a total of 120 units. The IVF ICSI Dish is terminally sterilized by gamma irradiation to achieve an SAL of 10 °. The dish is non-pyrogenic as tested by LAL, and non-embryo toxic as tested by one-cell mouse embryo assay (MEA), The IVF ICSI dish is disposable and intended and labeled for single use.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the IVF ICSI Dish:
1. Table of Acceptance Criteria and Reported Device Performance
The submission functions as a 510(k) Premarket Notification, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with explicit numerical acceptance criteria and results. Therefore, the device performance is described in terms of meeting established standards and comparison to the predicate, rather than measured against specific quantitative acceptance metrics.
| Acceptance Criteria (Inferred from 510(k) Text) | Reported Device Performance (IVF ICSI Dish) |
|---|---|
| Sterility Assurance Level (SAL): 10⁻⁶ | Sterile (SAL 10⁻⁶), via gamma radiation |
| Non-pyrogenic: Negative LAL test | Tested non-pyrogenic by LAL |
| Non-embryotoxic: Supports embryonic development | Passed 1-cell mouse embryo test at ≥80% expanded blastocysts at 96 hours |
| Biocompatibility (in vivo): USP Class VI | Polystyrene material successfully passed USP 32 Class VI test for in vivo cytotoxicity |
| Biocompatibility (in vitro): USP | Polystyrene material successfully passed USP 32 for in vitro cytotoxicity |
| Material Composition: Virgin crystal-grade polystyrene | Virgin crystal-grade polystyrene |
| Physical Design: Single well, stackable, one-hand lid removal, optically clear flat bottom | Single dish-sized well, lid can be removed with one hand, dishes can be stacked, flat and optically clear bottom. |
| Manufacturing Process: Injection molded | Injection molded |
| Disposability: Single use | Disposable and intended and labeled for single use |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not detail specific "test set" sample sizes in the context of a clinical trial or performance study with human subjects. The evaluations related to the device's material and biological safety (sterility, pyrogenicity, embryotoxicity, cytotoxicity) are laboratory-based tests.
- Mouse Embryo Assay (MEA): This is a biological assay. The standard practice for MEA involves a statistically significant number of mouse embryos, typically in the range of 20-30 embryos per group (test and control) across multiple replicates, to achieve statistical power for the a ≥80% expanded blastocyst rate. The document doesn't specify the exact number of mouse embryos used.
- USP Cytotoxicity Tests: These tests follow established protocols, which involve specific cell culture setups and replicates. Sample sizes are specified by the USP monographs, but not detailed here.
- LAL Test: This test is performed on extracts from the device, not on a "sample set" of devices in the same way clinical data is collected.
Data Provenance: The data primarily comes from laboratory testing performed by the manufacturer (Thermo Fisher Scientific) or qualified contract laboratories. There is no mention of country of origin for the data or whether it's retrospective or prospective, as it pertains to internal product quality and safety testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the technical and biological safety tests described for this device. The "ground truth" for these tests (e.g., whether a device is sterile, non-pyrogenic, or non-embryotoxic) is established by the well-defined protocols and acceptance criteria of the respective assays (e.g., USP standards, MEA protocols). Expert interpretation is involved in executing and verifying these lab tests, but it's not a consensus-based scoring of a "test set" in the way it would be for diagnostic imaging.
4. Adjudication Method for the Test Set
Not applicable. The tests performed (sterility, LAL, MEA, cytotoxicity) have objective endpoints and established analytical methods, not subjective assessments requiring adjudication by multiple readers or experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
Not applicable. This is a medical device (labware), not an AI/software-as-a-medical-device (SaMD) that assists human readers in making diagnostic decisions. Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable, as this device is a piece of labware, not an algorithm or AI.
7. The Type of Ground Truth Used
The ground truth for the various tests is established by:
- Established biological assay standards: For embryotoxicity (MEA) and pyrogenicity (LAL), the ground truth is defined by the performance of control groups and the established threshold for acceptable biological response (e.g., ≥80% blastocyst development, absence of pyrogenic response).
- Chemical/physical material standards: For material composition and cytotoxicity, the ground truth is based on the chemical properties of the polystyrene and the results of standardized USP tests.
- Microbiological standards: For sterility, the ground truth is defined by the absence of microbial growth as detected by sterility testing, demonstrating the SAL.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning algorithm; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.