(150 days)
The Cryotop®US is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos.
CryotopUS is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 4-8 cell and blastocyst stage embryos. As part of the vitrification procedure, the cells to be stored are loaded on the tip of the CryotopUS device for subsequent storage.
The CryotopUS device is composed of an acrylonitrile butadiene styrene (ABS) handle shaft with a polyethylene terephthalate (PET) film tip and a polypropylene straw enclosure. The fine tip has a flat film area for loading embryos. The CryotopUS device has a "straw" enclosure system for when the unit is placed in the liquid nitrogen. The handle shaft is designed with a "stop" for inserting the film tip/shaft handle into the straw enclosure. A hermetic seal is created via a tapered shaft handle with a stop location integrated into the handle is placed into the straw enclosure this creates a closed system keeping the film tip isolated from the liquid nitrogen. The straw enclosure system has a weight at the distal end to place the straw and the shaft inside in a correct position in the liquid nitrogen. The CryotopUS device is provided sterile and is for single use only. The CryotopUS device has been designed to maintain the integrity of the human embryos through the freezing and thawing process.
The provided document describes the performance testing of the Cryotop®US cryopreservation storage device. Here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Cooling Rate | 3,000 °C/min (Passed) |
| Warming Rate | 44,000 °C/min (Passed) |
| Dimensional | Passes outer diameter and length according to specifications |
| Durability | No burst or liquid nitrogen inside the straw after 30 second immersion |
| Mechanical Tensile | Tensile strength to withstand 5N |
| Endotoxin | ≤0.5 EU/device (Conforms to the value) |
| Sterility | No microbial growth from sterility testing |
| Mouse Embryo Assay (MEA) | ≥80% of 1-cell control embryos develop at 96 hours |
| Shelf Life | Test performed, outcome implies satisfactory (Passed) |
| Package Integrity | Test performed, outcome implies satisfactory (Passed) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size used for each "test set." It mentions that the performance testing, Mouse Embryo Assay (MEA), and sterility tests are "all performed on samples from routine manufactured lots." This suggests that the testing is ongoing quality control rather than a single, fixed sample size for a specific study.
The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. Given that it's for a new device attempting to prove substantial equivalence, the testing would generally be prospective, conducted by the manufacturer (KITAZATO BioPharma Co., Ltd. from JAPAN).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The tests performed are objective physical and biological assays (e.g., cooling rate, biochemical levels, embryonic development), and their results are typically assessed against pre-defined numerical thresholds or standards rather than expert consensus on a "ground truth" as might be seen for diagnostic imaging interpretation.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as the acceptance criteria are based on objective measurements and established standards, not on subjective interpretations by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance data comparing the device to a predicate device based on technical characteristics and objective performance tests, not human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (cryopreservation storage device), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed is based on:
- Established Standards/Specifications: For parameters like cooling/warming rates, dimensional requirements, tensile strength, endotoxin levels, and sterility, the ground truth is defined by pre-determined numerical specifications or industry standards that the device must meet.
- Biological Outcomes: For the Mouse Embryo Assay, the ground truth is the successful development of embryos to a certain stage (≥80% of 1-cell control embryos develop at 96 hours), which is a direct biological efficacy measure.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This device is a physical medical device and does not involve machine learning or AI, thus there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided as there is no training set for this type of device.
§ 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.