(470 days)
The CRYOLOCK™ is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos.
The CRYOLOCK™ is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos.
The CRYOLOCK™ cooling rate: -1,494°C/min at -60°C The CRYOLOCK™ warming rate: +21,000°C /min
CRYQLOCK™ is a square shape stick, with 4 flat surfaces. Both the cap and body are produced from the same material (polystyrene medical grade). The cap and body possess the same coefficient of expansion, ensuring an equally secure coupling at room temperature as well as at low cryogenic temperatures facilitating an even temperature conduction from side to side of the device. Body and cap have gaps on their extremes that allow easy grip with forceps during handling.
The provided text describes the CRYOLOCK™ cryopreservation storage device and its submission for 510(k) premarket notification. The document highlights that the device was found to be "substantially equivalent" to predicate devices, meaning it has similar technological characteristics, intended use, and is as safe and effective. However, it does not present specific acceptance criteria in a table format with numerical targets or thresholds for performance, nor does it detail a standalone clinical study on human subjects with a specified sample size, ground truth, or expert involvement to "prove" the device meets such criteria.
Instead, the submission focuses on demonstrating substantial equivalence through non-clinical performance tests and a comparison of technological characteristics with predicate devices.
Here's an analysis of the provided information, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that the CRYOLOCK™ was compared to predicates in several areas and found to have "similar technological characteristics" or that "minor different technological characteristics have been determined to not have any impact on the safety or efficacy."
The key performance indicators implicitly considered and compared to predicates for equivalence are:
| Performance Area | Acceptance Criteria Implied (Comparative) | Reported Device Performance (Comparative) |
|---|---|---|
| Intended Use | Equivalent to predicates | Similar to predicates |
| Principles of Use | Equivalent to predicates | Similar to predicates |
| Fundamental Technology | Equivalent to predicates | Similar to predicates |
| Biocompatibility | Equivalent to predicates | Similar to predicates |
| Tip Marking | Equivalent to predicates | Similar to predicates |
| Single Use | Equivalent to predicates | Similar to predicates |
| Sterility Assurance Level (SAL) | Equivalent to predicates | Similar to predicates |
| Endotoxin Test | Equivalent to predicates | Similar to predicates (Endotoxin titer and interference screening using Kinetic Turbidimetric method conducted) |
| Mouse Embryo Assay (MEA) | Equivalent to predicates (successful embryo development) | Similar to predicates ("One-cell mouse embryo development in extracted 'embryo-tested' culture medium" conducted) |
| Loading Volume | Similar to predicates | Minor differences, but no impact on safety/efficacy |
| Survival Rate (1-cell mouse) | Equivalent to predicates | Similar to predicates ("Comparison of survival of mouse zygotes after vitrification using two closed systems" conducted) |
| Cleavage Rate | Equivalent to predicates | Similar to predicates |
| Blastocyst Rate | Equivalent to predicates | Similar to predicates |
| Cooling Rate | Device specific rate to achieve desired cryopreservation conditions | -1,494°C/min at -60°C (Minor differences from predicates, but no impact on safety/efficacy) |
| Warming Rate | Device specific rate to achieve desired cryopreservation conditions | +21,000°C/min (Minor differences from predicates, but no impact on safety/efficacy) |
| Packaging Integrity | Maintain sterility and protection for shelf life | Achieved through "Accelerated Aging of Sterile Medical Device Packages," "Container and Closure: Bacterial/Immersion Integrity Test," "Transportation and Distribution ASTM D4169-2009," "CRYOLOCK™ Package Integrity - Shelf Life Real Time Aging Protocol" |
| Contamination Assessment | No contamination from device/system | "Contamination Assessment of the Cryopreservation Device, the CRYOLOCK™ Container and Closure Integrity Test for CRYOLOCK™ Device Closed System Using Immersion in Contaminated Liquid Nitrogen" conducted |
| LN Penetration | Prevent LN penetration | "Liquid Nitrogen (LN) Penetration testing" conducted |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions several non-clinical performance tests:
- Mouse Embryo Assay: "One-cell mouse embryo development in extracted 'embryo-tested' culture medium (5 test articles POOLED)". This indicates a test sample of 5 pooled articles, likely involving multiple embryos per pool, but the exact number of embryos is not specified.
- Survival of Mouse Zygotes: "Comparison of survival of mouse zygotes after vitrification using two closed systems." The sample size for this comparison is not explicitly stated.
- Other tests (e.g., sterilization validation, packaging integrity) involve material or device units, not biological samples in a "test set" for performance metrics like accuracy.
Data Provenance: The studies appear to be laboratory-based non-clinical studies. The country of origin for the data is not specified, but the submission is to the US FDA. The studies are prospective in the sense that they were designed and executed to evaluate the device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not describe the use of human experts to establish "ground truth" for the non-clinical performance tests mentioned. These are objective laboratory tests (e.g., measuring temperatures, assessing embryo development through standard biological assays, physical integrity tests). There is no mention of radiologists or similar clinical experts.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of human-expert-based evaluation or adjudication for establishing ground truth in these non-clinical tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes a medical device for cryopreservation, not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant to this submission.
6. Standalone (Algorithm Only) Performance Study
No. This device is a physical cryopreservation tool, not an algorithm. The performance studies are focused on its physical and biological compatibility and function, not on a standalone algorithm's performance.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical studies is based on:
- Biological Endpoints: One-cell mouse embryo development, survival rate, cleavage rate, blastocyst rate (assessed through established biological assays).
- Physical Measurements: Cooling rates, warming rates, endotoxin levels, sterility, package integrity (assessed through calibrated instruments and standardized test methods).
- Comparative Equivalence: Performance similar to predicate devices.
8. Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a "training set." The listed non-clinical tests are for device validation, not model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, 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.