(80 days)
The Cryotop®SC 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.
CryotopSC 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. Extracting embryos from the body can be costly and burdensome process for the patient to go through multiple extraction procedures. As part of the vitrification procedure, the cells to be stored are loaded on the tip of the CryotopSC device for subsequent storage.
The CryotopSC device is composed of an ABS handle shaft with a PET fine tip and a straw enclosure. The fine tip has a flat film area for loading embryos. The CryotopSC device has a "straw" enclosure system for when the unit is placed in the liquid nitrogen. The straw cap is designed to be heat sealed by the user. The straw cap has a weight at the distal end to place the straw cap and the shaft inside of the cap in a correct position in the liquid nitrogen. The CryotopSC device is provided sterile and is for single use only. The CryotopSC device has been designed to maintain the integrity of the human embryos through the freezing and thawing process.
The Aluminum Block is required for use with the CryotopSC device for the vitrification and thawing process and is sold separately. The Aluminum Block is to be used with the CryotopSC device to prevent liquid nitrogen from entering the straw and to assist in stabilizing the manipulation of the straw.
The CryotopSC device conforms to product quality test specifications of our company: appearance, dimension, durability, tensile strength, colorfastness, endotoxin and Mouse Embryo Assay. The sterilization dose of CryotopSC is validated by sterilization to maintain the sterility of the device through anticipated storage and handling.
The provided text describes the 510(k) submission for the Cryotop®SC cryopreservation storage device. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing rather than a study proving the device directly meets acceptance criteria in a clinical context with human users.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cooling Rate | 3,000 °C/min (Passed) |
| Warming Rate | 44,000 °C/min (Passed) |
| Dimensional Specifications | Passes outer diameter and length according to specifications |
| Mechanical Tensile Strength | Withstand 5N (Passed) |
| Endotoxin Level | ≤0.5 EU/device (Conformed) |
| Sterility | No microbial growth (Passed) |
| Mouse Embryo Assay (MEA) Development Rate | ≥80% of 1-cell control embryos develop at 96 hours (Passed) |
2. Sample Size Used for the Test Set and Data Provenance
The document states that the performance testing, Mouse Embryo Assay (MEA), and sterility tests are “all performed on samples from routine manufactured lots”. It does not specify a particular sample size for each test, nor does it provide details on data provenance such as country of origin. The data is retrospective in the sense that it's performed on manufactured lots, but the context is pre-market submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable/not provided in the document. The Cryotop®SC is a physical device for cryopreservation, and its performance is evaluated through material and biological tests, not by human expert assessment of a test set in the way a diagnostic AI would be. The "ground truth" for these tests is based on established scientific and manufacturing standards (e.g., specific cooling/warming rates, mechanical strength thresholds, endotoxin limits, embryo development rates).
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 typically apply to studies where multiple human readers interpret data, and their findings need to be reconciled to establish a ground truth. Since this device is evaluated through objective physical and biological tests, such an adjudication method is not relevant.
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 information is not applicable/not provided. The Cryotop®SC is a physical medical device (cryopreservation storage device) and not an Artificial Intelligence (AI) or software as a medical device (SaMD) that would typically be evaluated in an MRMC study related to human reader performance or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. As explained above, the Cryotop®SC is a physical device, not an algorithm, so a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used
The ground truth used for the performance testing includes:
- Quantitative Thresholds/Specifications: For cooling rate, warming rate, dimensional compliance, mechanical tensile strength, and endotoxin levels. These are objective numerical values that the device must meet.
- Absence of Growth/Contamination: For sterility testing (absence of microbial growth).
- Biological Viability Percentage: For the Mouse Embryo Assay (MEA), typically defined as a certain percentage of embryos reaching a specific developmental stage (≥80% of 1-cell control embryos develop at 96 hours). This is a biological "ground truth" established through a standard assay.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The Cryotop®SC is a physical device, and its development does not involve a "training set" in the context of machine learning or AI. Its design and manufacturing are based on engineering principles and material science.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/not provided for the same reasons 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.