(267 days)
Vitrification Freeze Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
Vitrification Thaw Kit is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos.
The Vitrification Freeze Kit is intended for use in the vitrification of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos during the in vitro assisted reproduction. The Vitrification Freeze Kit includes two solutions: Equilibration Solution (ES) and Vitrification Solution (VS). Both solutions contain ethylene glycol, dimethyl sulfoxide (DMSO), human serum albumin, and Quinn's Advantage® Medium with HEPES. The VS also contains additional sucrose to confer intracellular and extracellular cryoprotective effects. The solutions are available in three specifications: 2 mL, 4.5 mL, and 5 mL, all packaged in polypropylene (pp) vials. The kit includes one vial of each solution.
The Vitrification Thaw Kit is intended for use in the thawing of vitrified oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos, and blastocyst stage embryos during in vitro assisted reproduction. The Vitrification Thaw Kit includes 4 solutions: Thawing Solution 1 (TS1), Thawing Solution 2 (TS2), Thawing Solution 3 (TS3), and Thawing Solution 4 (TS4). All four solutions contain human serum albumin and Quinn's Advantage® Medium with HEPES. TS1 and TS2 also contain sucrose. The solutions are available in three specifications: 2 mL, 4.5 mL, and 5 mL, and 5 mL, all packaged in polypropylene (pp) vials. Model RFD-0201 includes one vial of each solution in the kit, and Model RFD-0202 contains two vials of TS1 and one vial of TS2, TS3, and TS4 each in the kit.
The provided FDA 510(k) clearance letter and summary describe the Vitrification Freeze Kit (RFD-0101) and Vitrification Thaw Kit (RFD-0201, RFD-0202) manufactured by Jiangsu Ruifuda Medical Device Co., Ltd. This device falls under the classification of Reproductive Media and Supplements (Regulation Number: 21 CFR 884.6180, Product Code: MQL).
This document focuses on the in vitro performance of the device rather than a clinical study involving human readers or a standalone AI algorithm. Therefore, many of the typical acceptance criteria and study elements associated with AI-driven medical devices (like MRMC studies, ground truth established by expert consensus, and human reader performance improvement) are not applicable here.
The device's performance is demonstrated through a series of non-clinical performance tests designed to show that it meets specific quality and functional criteria, ensuring its safety and effectiveness for its intended use in assisted reproduction.
Here's a breakdown of the acceptance criteria and study that proves the device meets them:
Acceptance Criteria and Reported Device Performance
The device's performance was assessed against specific product specifications through shelf-life testing. The criteria are outlined below:
| Acceptance Criteria (Specification) | Reported Device Performance (at Time 0 and after Real-Time Aging) |
|---|---|
| Appearance | Met (implicitly, as pH, osmolality, endotoxin, and MEA were tested, suggesting visual appearance was acceptable) |
| pH (USP ) | 7.30-7.70 (Met) |
| Osmolality (USP ) (mOsm/kg) | |
| Equilibration Solution (ES) | 700±70 (1:3 dilution) (Met) |
| Vitrification Solution (VS) | 1000±80 (1:5 dilution) (Met) |
| Thawing Solution 1 (TS1) | 1500-1900 (Met) |
| Thawing Solution 2 (TS2) | 840-920 (Met) |
| Thawing Solution 3 (TS3) | 240-300 (Met) |
| Thawing Solution 4 (TS4) | 240-300 (Met) |
| Endotoxin testing (USP ) | )** |
Study Details
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Sample size used for the test set and data provenance:
This is not a clinical study involving a "test set" in the traditional sense of patient data. The "samples" refer to batches of the manufactured media. The document doesn't specify the exact number of batches or vials tested for each assay (e.g., how many vials for pH, how many embryos for MEA).- Data Provenance: The studies were conducted by the manufacturer, Jiangsu Ruifuda Medical Device Co., Ltd., in China, as indicated by the contact details. The data is prospective, generated from testing the manufactured product.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. The "ground truth" for this in vitro diagnostic/media device is established by the results of standardized laboratory assays (pH, osmolality, endotoxin, sterility, and Mouse Embryo Assay), not by expert human interpretation of images or observations. These assays have predefined acceptance criteria based on scientific and regulatory standards (e.g., USP and ISO standards). -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no human interpretation requiring adjudication was involved. The tests are quantitative laboratory measurements. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a vitrification and thawing media kit, not an AI or imaging device that would involve human readers. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. There is no algorithm involved with this device. Its performance is chemical and biological. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is based on standardized laboratory assay results and biological functionality (specifically, the Mouse Embryo Assay, which demonstrates the media's ability to support embryo development). These methods are scientifically accepted ways to assess the quality and performance of reproductive media. -
The sample size for the training set:
Not applicable. This device does not involve a "training set" for an algorithm. Its development and validation are based on chemical formulation and in-house laboratory testing. -
How the ground truth for the training set was established:
Not applicable. No "training set" as understood in a machine learning context. The product formulation and manufacturing processes are established through standard chemical and biological development protocols, and validated against the performance criteria listed above.
§ 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.