(214 days)
Cryopreservation device intended to be used to contain, vitrify and maintain human embryos and/or oocytes (MI).
Rapid-i™ Kit is a modified version of the predicate device (K140207). This device is a cryopreservation storage device intended for embryo/oocyte vitrification. Rapid-i™ Kit is provided sterile and is for single-use only. This device consists of the following items:
- Rapid-i Stick – A 80 mm long Polymethyl methacrylate (PMMA) stick with a 0.4 mm diameter hole located near the distal tip of the device. The hole on the stick is used to hold one to five embryos or oocytes for vitrification in a 30 nL drop of vitrification medium. Users suspend samples across the hole via surface tension. Therefore, the medium containing the samples only touches the periphery of the hole. The stick has one flat side that aids in correct orientation of the device during oocyte/embryo loading procedures.
- RapidStraw A 130 mm long Mediprene straw equipped with a stainless steel weight to maintain device orientation in liquid nitrogen (LN). The straw has a flared open end to allow for insertion of the Rapid-i Stick. This component functions as a protective sleeve around the Rapid-i Stick to prevent direct contact with LN during loading and after sealing the open end with an ultrasonic sealing device.
- Stainless steel rod - This 115 mm long stainless steel rod resides within RapidStraw during pre-cooling procedures in LN. It aids in keeping RapidStraw straight in LN during pre-cooling. Rod removal occurs 20-30 seconds prior to Rapid-i Stick loading into the RapidStraw.
Here is a breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided FDA 510(k) summary for the Rapid-i™ Kit (K181461).
Acceptance Criteria and Reported Device Performance
The device is a cryopreservation system for human embryos and oocytes. The acceptance criteria are implicitly tied to maintaining the viability and developmental potential of these biological materials after cryopreservation, demonstrated through various post-thaw outcomes.
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived) | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance | ||
| Dimensional Testing | Conformance to predefined design specifications. | Device passed. |
| Bacterial Endotoxin Testing | and ANSI/AAMI ST72:2002/(R)2010. | Device passed. |
| Mouse Embryo Assay (MEA) | ≥80% of 1-cell embryos developed to blastocysts at 96 hours. | Device passed. |
| Shelf-life Testing (Package) | Proper package integrity (dye penetration, seal strength, visual inspection). | Device passed. |
| Shelf-life Testing (Device) | Maintenance of acceptable dimensional, endotoxin, and MEA results over shelf-life. | Device passed. |
| Clinical Performance (2PN Embryos) | ||
| Embryo Survival Rate (2PN) | High survival rate after warming (no explicit threshold stated, but strong performance expected). | 90.1% (1458/1618) |
| Clinical Pregnancy Rate (2PN) | Acceptable clinical pregnancy rates after embryo transfer (no explicit threshold stated). | 25.1% for embryos cultured 1-3 days (418 transfers). |
| 36.3% for embryos cultured 4-5 days (92 transfers). | ||
| Clinical Performance (Oocytes) | ||
| Oocyte Survival Rate | High survival rate after warming (no explicit threshold stated, but strong performance expected). | Study 1: 94% (555/593). |
| Study 2: 93.7% | ||
| Published Article: 90.5% (374/413) | ||
| Fertilization Rate (Oocytes) | Acceptable fertilization rates (no explicit threshold stated). | Study 1: 78% (434/555 of survived oocytes). |
| Study 2: 58.5%. | ||
| Published Article: 64.2% (240/374 of survived oocytes). | ||
| Cleavage Rate (Oocytes) | Acceptable day 2 cleavage rates (no explicit threshold stated). | Study 1: 95% (414/434 of fertilized oocytes). |
| Published Article: 90.4% (217/240 of fertilized oocytes). | ||
| Blastulation Rate (Oocytes) | Acceptable day 5 blastulation rates (no explicit threshold stated). | Study 1: 24% (102/434 of fertilized oocytes). |
| Clinical Pregnancy Rate (Oocytes) | Acceptable clinical pregnancy rates after embryo transfer (no explicit threshold stated). | Study 1: 50% (27/54 blastocyst transfers). |
| Study 2: 40% (16/40 embryo transfers). | ||
| Published Article: 40.9% (18/44 embryo transfers). |
Study Details:
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Sample sizes used for the test set and the data provenance:
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2PN Embryos:
- N = 1618 vitrified 2PN embryos.
- N = 510 embryo transfers (418 transfers for embryos cultured 1-3 days, 92 transfers for embryos cultured 4-5 days).
- Data provenance: Not explicitly stated beyond "Data from clinical studies using the Rapid-i™ Kit were used..." This suggests it could be retrospective collection from fertility clinics where the device was in use, but without further detail, it's difficult to confirm. The document does not specify country of origin for this particular dataset.
- Study type: Prospective or retrospective collection based on the wording "Data from clinical studies." It is not described as a controlled clinical trial.
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Oocytes:
- Study 1: N = 593 vitrified oocytes; N = 54 blastocyst stage embryo transfers.
- Study 2: Data on survival, fertilization rates, and N = 40 embryo transfers. (Exact N of vitrified oocytes not stated for this study, only percentages).
- Published Article (Gook et al. 2016): N = 413 vitrified oocytes; N = 44 embryo transfers.
- Data provenance: Similar to 2PN embryos, "Data from clinical studies." The published article indicates a clinical setting. The Gook et al. 2016 paper is from Australia. Thus, at least some of the oocyte data likely originates from Australia.
- Study type: Prospective or retrospective collection from clinical practice.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a medical device for assisted reproduction purposes. The "ground truth" (i.e., successful cryopreservation, pregnancy outcomes) is established through standard clinical and laboratory procedures performed by trained embryologists, reproductive endocrinologists, and other healthcare professionals in fertility clinics. This is not a diagnostic device where image interpretation by experts creates a "ground truth." The outcomes (survival, fertilization, pregnancy) are objective biological results.
- Therefore, the concept of "experts used to establish ground truth" in the way it applies to AI diagnostic tools (e.g., radiologists annotating images) is not directly applicable here. The data points themselves (e.g., number of embryos surviving, number of pregnancies) are the ground truth, generated by the normal operations of an IVF clinic.
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Adjudication method for the test set:
- Not applicable in the context of this type of device and study design. Adjudication methods like "2+1" are typically used for establishing ground truth in diagnostic studies where there might be inter-reader variability in interpreting data (e.g., medical images). Here, the outcomes measured are direct biological results.
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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:
- No. This is not an AI-assisted diagnostic device that involves human readers interpreting output. It is a cryopreservation device. The study is evaluating the device's performance in preserving reproductive cells, not assisting human interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (cryopreservation kit), not an algorithm or software. Its performance is inherent to its design and material properties in facilitating the cryopreservation process. Human interaction is required for its use (loading, vitrifying, warming).
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The type of ground truth used:
- Clinical Outcomes and Biological Performance Markers: The ground truth is established by the observed biological outcomes of human embryos and oocytes after being processed with the device. This includes:
- Survival rates post-warming.
- Fertilization rates for oocytes.
- Developmental rates (cleavage, blastulation) for embryos.
- Clinical pregnancy rates following embryo transfer (which are typically confirmed by ultrasound).
- For non-clinical tests, ground truth was established by laboratory standards and assays (e.g., bacterial endotoxin testing, mouse embryo assay).
- Clinical Outcomes and Biological Performance Markers: The ground truth is established by the observed biological outcomes of human embryos and oocytes after being processed with the device. This includes:
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The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set. The "training" for such a device would be its iterative design and manufacturing process, combined with quality control and verification, rather than a data-driven training set in the AI sense.
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How the ground truth for the training set was established:
- Not applicable, as no training set was used for an AI/machine learning model.
§ 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.