(128 days)
VitriGuard 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.
VitriGuard 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 VitriGuard device is composed of a two-piece polystyrene assembly that includes a hexagonal shaped stick and cap. As part of the vitrification procedure, the embryos to be stored are loaded on the tip, also referred to as the leaf, and capped with a pre-cooled cap for subsequent storage following vitrification. The leaf has a trough area for loading. maintaining, and securing the embryos. The stick and cap include a taper design that creates a hermetic seal, forming a closed system. Markings at the stick and the tip of the device provide visual aid for proper device orientation. The device is provided sterile and is for single use only. The VitriGuard has been designed as a cryopreservation storage device to maintain the integrity of human 4-8 cell and blastocyst stage embryos throughout the cooling. storage, and warming processes.
Here's the information about the acceptance criteria and the study that proves the device meets them, extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Gamma Sterilization Validation | (Implicit: Meets ISO 11137-1:2006/(R)2010 and 11137-2:2013) | Passed |
| Shipping and Distribution Testing | (Implicit: Meets ISTA 3A 2008) | Passed |
| Package Integrity Testing | (Implicit: Meets ASTM F1980-07(2011), AAMI/ANSI/ISO 11607-1:2006/A1:2014, 11607-2:2006/A1:2014, ASTM F929-15, ASTM F88/F88M-15, and ASTM F1886/F1886M-09(2013)) | Passed |
| Endotoxin Evaluation | ≤2.0 EU/device (Implicit: Meets ANSI/AAMI ST72:2011/(R)2016 and USP ) | ≤2.0 EU/device (Passed) |
| Mouse Embryo Assay (MEA) | ≥80% blastocyst at 96 hours (1-cell) | ≥80% blastocyst at 96 hours (1-cell) (Passed) |
| Thermal Profile Evaluation (Cooling/Warming Rates) | Warming and cooling rates must be substantially equal to (or greater than in absolute value) to the predicate device. | Met acceptance criteria (Subject device cooling: -2,271°C/min; warming: 36,377°C/min; Predicate cooling: -1,494°C/min; warming: 21,000°C/min, indicating faster rates for the subject device) |
| Mouse Embryo Survival Evaluation | Survival rate must be ≥80% for all embryo stages. | Met acceptance criteria (≥80% survival rate for all embryo stages) |
| Mouse Embryo Development Evaluation | Blastocyst development rate must be ≥80% for all embryo stages. | Met acceptance criteria (≥80% blastocyst development rate for all embryo stages) |
| Container and Closure Integrity - Bacterial/Immersion | Negative for growth of the challenge organism. | Met acceptance criteria (Negative for growth) |
| Container and Closure Integrity Bacterial Contaminated LN2 | Test samples do not show presence or growth of the challenge organism; no leakage of LN2. | Met acceptance criteria (No presence/growth; no leakage) |
| Durability Testing | Must not exhibit any cap expulsion during the process; no leakage of LN2. | Met acceptance criteria (No cap expulsion; no leakage) |
| Product Evaluation | Device passes the predetermined design requirements. | Met acceptance criteria |
| Shelf Life Testing (Accelerated Aging) - MEA | ≥80% blastocyst at 96 hours (1-cell) | (Implicitly passed by passing overall MEA for aged samples) |
| Shelf Life Testing (Accelerated Aging) - Container and Closure Integrity Bacterial/Immersion | Negative for growth of the challenge organism. | (Implicitly passed by passing overall CCI for aged samples) |
| Shelf Life Testing (Accelerated Aging) - Container and Closure Integrity Bacterial Contaminated LN2 | Test samples do not show presence or growth of the challenge organism; no leakage of LN2. | (Implicitly passed by passing overall CCI for aged samples) |
| Shelf Life Testing (Accelerated Aging) - Durability Testing | Must not exhibit any cap expulsion during the process; no leakage of LN2. | (Implicitly passed by passing overall Durability for aged samples) |
| Shelf Life Testing (Accelerated Aging) - Product Evaluation | Device passes the predetermined design requirements. | (Implicitly passed by passing overall Product Evaluation for aged samples) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample size (e.g., number of embryos or devices) used for each test. However, it indicates that "various mouse embryos" were used for the Mouse Embryo Survival and Development evaluations.
The data provenance is not explicitly detailed in terms of country of origin. The studies appear to be prospective in nature, as they involve conducting tests on the VitriGuard device according to specified protocols to evaluate its performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of human experts to establish ground truth for the test set. The ground truth for the performance tests (e.g., survival rates, development rates, integrity checks) is established by direct measurement against predefined criteria or by observation of biological outcomes (mouse embryo survival/development).
4. Adjudication Method for the Test Set
Not applicable, as the evaluation methods described are objective measurements or biological assays rather than subjective human assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The studies described are performance tests of the device itself, comparing its physical and biological performance characteristics to predefined criteria and to a predicate device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The VitriGuard is a cryopreservation storage device, not an AI algorithm. Its performance is evaluated through non-clinical laboratory testing.
7. The Type of Ground Truth Used
The ground truth used for the performance studies is a combination of:
- Direct Measurement/Objective Criteria: For parameters like cooling/warming rates, endotoxin levels, sterility, and physical integrity (e.g., no leakage, no cap expulsion).
- Biological Outcomes Data: Specifically for the Mouse Embryo Assay (MEA), Mouse Embryo Survival Evaluation, and Mouse Embryo Development Evaluation, where the "ground truth" is the observed biological response (e.g., percentage of blastocyst formation, survival rate). These are quantitative biological endpoints.
8. The Sample Size for the Training Set
Not applicable. The VitriGuard is a physical medical device, not an AI/machine learning algorithm 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.