(221 days)
RapidVit™ Oocyte: Media for vitrification of human oocytes (MII).
RapidWarm™ Oocyte: Media for warming of vitrified human oocytes (MII).
Two sets of media are covered by this 510(k), the RapidVit™ Oocyte for vitrification of oocytes and the RapidWarm™ Oocyte for warming of vitrified oocytes. RapidVit™ Oocyte contains three medium solutions to be used sequentially during oocyte vitrification. RapidWarm™ Oocyte includes four medium solutions to be used sequentially during oocyte warming.
Here's a breakdown of the acceptance criteria and study information for the Vitrolife RapidVit™ Oocyte and RapidWarm™ Oocyte devices, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, it primarily presents data to show that the new device is as safe and effective as the existing one, rather than a full, comprehensive study report with all the details typically found in a clinical trial publication.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are mainly for non-clinical performance and a Mouse Embryo Assay (MEA). The clinical performance is reported as observed rates, not explicitly tied to specific numerical acceptance criteria within the document, although they are presented as evidence of successful function.
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance / Result |
|---|---|---|
| Non-Clinical Performance | ||
| pH Testing | Per USP | N/A (Confirmed compliance, values not provided) |
| Osmolality Testing | Per USP | N/A (Confirmed compliance, values not provided) |
| Aseptic Filling Validation | Per ISO 11137-1:2006 and ISO 11137-2:2013 | N/A (Confirmed compliance) |
| Bacterial Endotoxins Testing | 80% of embryos expand to the blastocyst stage by 96h | N/A (Confirmed compliance, specific percentage not provided in summary) |
| Stability Testing (Shelf-life & Post-opening) | pH, osmolality, sterility, 1-cell MEA, and endotoxin spec. met at end of shelf-life (25 weeks) and 2 weeks after opening. | N/A (Confirmed compliance) |
| Clinical Performance | ||
| Oocyte Survival Rate | (Not explicitly stated as an acceptance criterion in this format, but the observed rate supports device function) | 94% (555/593) |
| Fertilization Rate | (Not explicitly stated) | 78% (434/555) |
| Day 5 Blastulation Rate | (Not explicitly stated) | 24% (102/434) |
| Day 5/6 Utilization Rate | (Not explicitly stated) | 35% (153/434) |
| Clinical Pregnancy Rate (confirmed by fetal heartbeat) | (Not explicitly stated) | 50% (27/54 recipients) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study): 593 oocytes from 64 donors.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is referred to as "A clinical study was conducted," which typically implies a prospective design, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For a medical device like reproductive media, the "ground truth" for clinical performance is generally the observed biological outcomes (survival, fertilization, blastulation, pregnancy), which are objectively measurable laboratory and clinical endpoints rather than subjective expert interpretations of images or data. Therefore, a panel of experts for "ground truth" establishment in the typical sense (e.g., for diagnostic AI) might not be applicable here.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant when human experts are assessing a subjective outcome (e.g., classifying an image, making a diagnosis) and their agreement needs to be established or disagreement resolved. For the clinical outcomes measured in this study (oocyte survival, fertilization, pregnancy rate), the outcomes are objective biological events, not subjective interpretations. Therefore, an adjudication method in this context is not applicable and not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., radiologists interpreting images) changes with or without AI assistance. The device in question is a media (liquid solutions) used in an in-vitro fertilization process, not an AI diagnostic tool or system that assists human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone "algorithm only" performance study was not done. This device is a biological media. Its performance is intrinsically tied to its use in a laboratory setting by human embryologists/clinicians performing the vitrification and warming procedures. The concept of an "algorithm only" performance is not applicable to this type of device.
7. The Type of Ground Truth Used
The ground truth used for the clinical study was based on observed biological and clinical outcomes:
- Oocyte survival post-warming.
- Fertilization rates.
- Embryo development (Day 5 blastulation, Day 5/6 utilization).
- Clinical pregnancy confirmation by fetal heartbeat.
For the non-clinical tests (pH, osmolality, endotoxins, sterility, MEA), the ground truth was based on established laboratory assay results and conformity to specified criteria.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a biological media, not an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is 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.