(136 days)
cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrification procedures to contain and maintain human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
The cryo-GO Vitrification Device is a sterile, single-use, closed assisted reproduction storage device for use in vitrification procedures to contain and maintain oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
The cryo-GO Vitrification Device is composed of an injection molded body with an extended loading tip (4.45 inches long with a 0.65 inch loading tip), an injection molded cap (1.76 inches), and a total device combined length of 5.05 inches. Visible marks are on the distal loading tip, body, and at the opening of the cap, to indicate the location of the tip, the upright orientation of the device and the opening of the cap, respectively. The body and cap include a taper design that create a seal when assembled prior to plunging the device in liquid nitrogen for vitrification and for subsequent storage. The device is provided in five different colors: red, yellow, green, blue, and purple. The subject devices are radiation sterilized to a sterilization assurance level of 10-6 and have a one-year shelflife.
A detailed response outlining acceptance criteria and device performance based on the provided text for the cryo-GO Vitrification Device (K241341):
Acceptance Criteria and Device Performance for cryo-GO Vitrification Device (K241341)
The provided documentation, a 510(k) Summary, focuses on demonstrating substantial equivalence to a predicate device (VitriGuard, K200815) rather than explicitly stating pre-defined, quantitative acceptance criteria for all aspects of performance with a dedicated clinical study. However, some functional performance criteria are implicitly accepted through comparison with the predicate device or established standards. The non-clinical performance data section presents the studies undertaken to support the device's safety and effectiveness.
Here’s a breakdown based on the categories requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric/Test | Acceptance Criteria (Implicitly Accepted) | Reported Device Performance |
|---|---|---|
| Sterility | Sterility Assurance Level (SAL) of 10⁻⁶ (in accordance with ISO 11137-1:2018, 11137-2:2015, and 2024 FDA guidance) | Achieved SAL of 10⁻⁶ |
| Package Integrity (Shipping) | Withstand rigors of shipping and maintain sterile barrier over one-year shelf-life (demonstrated by ASTM D4169-22, visual inspection, ASTM F1929-23, ASTM F88/F88M-21) | Devices withstood simulated transportation and maintained sterile barrier, demonstrating the ability to function within the stated shelf-life. |
| Shelf Life (General) | Maintained performance for newly manufactured and after one year accelerated aging per ASTM F1980-21 | Devices maintained performance after one year of accelerated aging. |
| Cooling Rate | (Comparison to predicate: -2,271°C/min; subject device found to have a lower rate but deemed not to raise different S&E questions) | -1,650°C/min |
| Warming Rate | (Comparison to predicate: +36,377°C/min; subject device found to have a lower rate but deemed not to raise different S&E questions) | +16,500°C/min |
| Dimensional Stability | Maintained dimensions after one year of accelerated aging. | Testing confirmed dimensional stability. |
| Durability (LN₂ Exposure) | No cracks, deformation, discoloration, or other damage after exposure to liquid nitrogen. | Testing demonstrated device integrity after LN₂ exposure. |
| Seal Integrity/Leakage (LN₂ ) | No leakage after exposure to liquid nitrogen. | Testing confirmed seal integrity and no leakage. |
| Capping and De-capping Force | Maintained appropriate force for capping and de-capping after one year of accelerated aging. | Testing confirmed acceptable capping and de-capping force. |
| Ink Marker Resistance | Ink markers remained resistant after one year of accelerated aging. | Testing confirmed ink marker resistance. |
| Endotoxin Test | ≤ 2 EU/device (according to USP, ) | ≤ 2 EU/device |
| Mouse Embryo Assay (MEA) | ≥ 80% expanded blastocyst within 96 hours (in accordance with 2021 FDA guidance) | ≥ 80% expanded blastocyst within 96 hours |
Summary of the Study Proving Device Meets Acceptance Criteria:
The "cryo-GO Vitrification Device" underwent non-clinical performance testing to demonstrate its safety and effectiveness, supporting its substantial equivalence to the predicate device. The studies were primarily bench testing and in-vitro biological assays.
2. Sample Size and Data Provenance for Test Set:
The provided document describes non-clinical performance testing rather than a "test set" in the context of AI/machine learning or a clinical trial with patient data. Therefore, the concept of sample size and data provenance as typically applied to such studies does not directly align.
- Sample Size: Not explicitly stated as a single "test set" sample size. The testing involved multiple units of the device for various engineering and biological tests (e.g., numerous devices for sterility validation, package integrity, shelf-life testing, and a sufficient number of mouse embryos for the MEA).
- Data Provenance: The data comes from laboratory testing performed by the manufacturer, FUJIFILM Irvine Scientific, Inc. The nature of the studies implies that they were prospective bench and in-vitro experiments designed to evaluate the device's physical, chemical, and biological performance. There is no indication of country of origin of "data" in the sense of patient data, as this was a non-clinical submission.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This was a submission for a physical medical device (cryopreservation device), not an AI/software device requiring expert human readers to establish ground truth for image interpretation or diagnosis. The "ground truth" for performance was established through standardized laboratory testing methods (e.g., ISO, ASTM, USP, FDA guidance documents).
4. Adjudication Method for Test Set:
Not applicable. As noted above, this was non-clinical bench and in-vitro testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI performance evaluations to reconcile discrepancies among human readers or expert panels.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is not an AI algorithm or a diagnostic imaging tool that would involve human readers interpreting cases. Therefore, an MRMC study and analysis of AI assistance improving human readers were not performed.
6. Standalone (Algorithm Only) Performance:
Not applicable. The "cryo-GO Vitrification Device" is a physical medical device for cryopreservation, not a software algorithm.
7. Type of Ground Truth Used:
The ground truth for evaluating the device's performance was based on:
- Standardized Laboratory Test Results: Measurements and observations against established industry standards (e.g., ISO 11137 for sterility, ASTM standards for package integrity and accelerated aging, USP for endotoxin).
- Biological Activity/Functionality: The Mouse Embryo Assay (MEA) provides a biological "ground truth" for the device's non-toxicity and suitability for embryo culture, as defined by the "≥ 80% expanded blastocyst within 96 hours" criterion endorsed by the FDA guidance.
8. Sample Size for Training Set:
Not applicable. This is a physical device, not an AI/machine learning model, so there is no concept of a "training set."
9. How Ground Truth for Training Set Was Established:
Not applicable, for the same reason as point 8.
§ 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.