(242 days)
RapidVit™ Blast is indicated for vitrification of human blastocyst stage embryos
RapidWarm™ Blast is indicated for warming of vitrified human blastocyst stage embryos
RapidVit™ Blast and RapidWarm™ Blast is a device used for vitrification and warming of human blastocysts. The cryoprotectants 1,2-propanediol and ethylene glycol are used together with sucrose for dehydration of the embryo before cryopreservation.
RapidVit™ Blast consists of three different solutions with increasing concentrations of cryoprotectants intended to prepare the human blastocysts for vitrification by reducing the intracellular water content and increasing the osmolality. Also RapidWarm™ Blast consists of three different solutions with decreasing concentrations of sucrose to restore the water content and osmolality in embryo during warming after vitrification storage.
The provided text describes the 510(k) summary for Vitrolife Sweden AB's RapidVit™ Blast and RapidWarm™ Blast devices, intended for the vitrification and warming of human blastocysts.
No explicit acceptance criteria are stated in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices and presenting nonclinical and clinical study results without defining specific performance thresholds for acceptance.
However, based on the nonclinical and clinical study results that "showed good survival, development and hatching rate of the blastocysts" and that "the majority of the blastocysts survive vitrification," we can infer the implied acceptance criteria: demonstrated equivalent or improved survival, development, and hatching rates of vitrified/warmed blastocysts compared to predicate devices or established clinical norms, with no adverse effects.
Here's an analysis of the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Good survival, development, and hatching rate of vitrified blastocysts. | Nonclinical Studies: "All studies showed good survival, development and hatching rate of the blastocysts." One study also included fluorescence in situ hybridization analysis for chromosomal abnormalities and reported "no significant differences in abnormal cells than non vitrified fresh blastocysts." |
| Clinical Studies: "the majority of the blastocysts survive vitrification" using RapidVit™ Blast and RapidWarm™ Blast. | |
| Can be used with good results in the daily treatment of IVF patients. | Clinical Studies: "vitrification using RapidVit™ Blast and RapidWarm™ Blast can be used with good results in the daily treatment of IVF patients." |
| Pregnancy rate with vitrified and warmed blastocysts. | Clinical Studies: "Reported pregnancy rate is 43.0% per embryo transfer." |
| Live births from vitrified and warmed blastocysts. | Clinical Studies: "So far 43 healthy babies have been born from vitrified and warmed blastocysts after the use of RapidVit™ Blast." |
| No adverse effects or complications. | Clinical Studies: "No adverse effects or complications were reported during the Study." |
| Results similar to other FDA-approved devices. | Clinical Studies: "Reports are similar to results with other FDA approved devices." |
| Safe, efficient, and performs as well as similar FDA-approved devices (Conclusion on Nonclinical and Clinical studies). | Conclusions: "RapidVit™ Blast and RapidWarm™ Blast has showed to be as safe, efficient and performs as well as similar FDA approved devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Nonclinical studies: "Three studies have been performed with vitrified surplus human blastocysts using RapidVit™ Blast and RapidWarm™ Blast." The exact number of blastocysts in these three studies is not specified. The data provenance is human blastocysts, implying clinical or research settings where surplus embryos were available. It is inferentially retrospective for the samples. The country of origin is not explicitly stated.
- Clinical studies: "All patients undergoing IVF and included in the data analysis." The exact number of patients or blastocysts included in the clinical study is not specified, but it yielded "43 healthy babies." This appears to be a prospective clinical investigation. The country of origin is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth in either the nonclinical or clinical studies. The assessment of survival, development, hatching rates, and pregnancy outcomes would typically be performed by trained embryologists, clinicians, and medical staff.
4. Adjudication Method for the Test Set
The document does not detail any specific adjudication methods (e.g., 2+1, 3+1, none) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned, nor is there any discussion of human readers improving with or without AI assistance. This device is a cryopreservation solution, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a cryopreservation medium, not an algorithm or software. It does not operate without human intervention.
7. The Type of Ground Truth Used
- Nonclinical Studies: The ground truth for blastocyst survival, development, and hatching rates was established through direct observation and laboratory analysis of the blastocysts. Additionally, one study used "fluorescence in situ hybridisation analysis for chromosomal abnormalities" as a ground truth for genetic integrity.
- Clinical Studies: The ground truth for effectiveness was established by clinical outcomes: survival of blastocysts post-warming, successful embryo transfer, reported pregnancy rates, and the birth of healthy babies.
8. The Sample Size for the Training Set
The concept of a "training set" is not relevant here, as this device is a medical solution for cryopreservation, not an AI/machine learning algorithm that requires a training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.