(454 days)
The Cryotop®CL 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.
CryotopCL 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.
The CryotopCL device is composed of PET plastic shaft with a fine tip and a straw cap. The fine tip has 5 rounded depressed areas for loading embryos. The CryotopCL 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 protective straw cap has a weighted end to allow proper alignment in the storage container. The CryotopCL device is provided sterile and is for single use only. The device is also provided with a pushing straw to aid in loading the sample holding component of the device into the "straw" enclosure system.
The CryotopCL 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 CryotopCL is validated by sterilization validation to maintain the sterility of the device through anticipated storage and handling.
Acceptance Criteria and Device Performance Study for Kitazato's Cryotop®CL
This document describes the acceptance criteria and the study used to demonstrate that Kitazato's Cryotop®CL device met these criteria, based on the provided 510(k) summary (K112695).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cooling Rate Testing | 3,000 °C/min (for the device to function as intended) | 3,000 °C/min Passed |
| Warming Rate Testing | 40,000 °C/min (for the device to function as intended) | 40,000 °C/min Passed |
| Dimensional Testing | Outer diameter, length, width of shaft, and spacing of embryo holding locations according to specifications | Passed specifications |
| Mechanical Tensile Testing | Withstand 5N | Withstood 5N |
| Endotoxin Testing | ≤0.5 EU/device | ≤0.5 EU/device |
| Sterility Testing | No microbial growth, SAL 10^-6^ | No microbial growth, SAL 10^-6^ |
| Mouse Embryo Assay (MEA) | ≥80% of 1-cell control embryos develop at 96 hours | ≥80% of 1-cell control embryos developed at 96 hours |
| Overall Performance | All specifications met acceptance criteria | All specifications met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the specific sample sizes used for each individual test (e.g., number of devices tested for cooling rate, endotoxin, etc.). However, it indicates:
- Test Set Description: The "Non-Clinical Testing" section lists various tests performed on the CryotopCL device.
- Sample Size: Not explicitly stated as a single number for all tests. For the Mouse Embryo Assay, the acceptance criteria relates to the percentage of 1-cell control embryos that develop, implying a sample of embryos within a test.
- Data Provenance: Retrospective, as the testing was performed during the development and validation phase of the device prior to submission. The origin of the data is from KITAZATO BioPharma Co., Ltd. in Japan, as they are the submission sponsor and manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of external experts or a ground truth panel to establish the "ground truth" for the non-clinical performance tests. The tests performed are objective, quantitative measurements (e.g., temperature rates, physical dimensions, endotoxin levels, sterility checks) or standardized biological assays (Mouse Embryo Assay). These types of tests typically rely on established protocols and measurement standards rather than expert consensus on a "ground truth" definition for individual cases.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the non-clinical tests are objective and quantitative; therefore, an adjudication method for conflicting expert opinions is not relevant. The results are compared directly against predefined numerical or qualitative acceptance criteria.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate devices." Therefore, no study involving human readers (with or without AI assistance) was conducted to assess improvement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The Cryotop®CL is a physical medical device (cryopreservation storage device) and not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.
7. Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is defined by:
- Predefined physical specifications: For dimensional and mechanical tests.
- Established scientific thresholds: For cooling/warming rates, endotoxin levels, and sterility (e.g., no microbial growth, SAL 10^-6^).
- Standardized biological assay outcomes: For the Mouse Embryo Assay, the ground truth is the viability/development of 1-cell control embryos at 96 hours as observed in the assay.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.