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Rapid-i™ is a cryopreservation device indicated to be used to contain, vitrify and maintain 4-8 cell stage embryos

Rapid-i™ is a device intended for the vitrification of 4-8 cell stage embryos through vitrification. Rapid-iTM consists of the following two items:

• . A Polymethyl Methacrylate (PMMA) stick, 80 mm long and 2 mm in diameter
• A Polyvinyl Chloride (PVC) straw, 165 mm long and 3 mm in . diameter, equipped with a stainless steel weight
• The two parts are packed in a TYVEK® bag and sterilised by ionizing radiation

I cannot provide acceptance criteria and study details as the input document is a 510(k) premarket notification summary for a medical device (Rapid-i™ cryopreservation container and microtool). This type of document declares substantial equivalence to a predicate device and does not typically include detailed performance studies with acceptance criteria in the manner you've requested for typical AI/ML-based device evaluations. The document focuses on demonstrating that the new device has similar intended use and technological characteristics to an already approved device.

Here's why the information you're asking for is not present or applicable in this context:

• Acceptance Criteria & Reported Device Performance (Table 1): The document affirms that the Rapid-i™ has "similar intended use as the predicate device... and similar technological characteristics related to safety and effectiveness." It doesn't present specific performance metrics (e.g., sensitivity, specificity, accuracy, or a quantitative measure of embryo viability/survival rate) with predefined acceptance criteria. Instead, it relies on the established safety and effectiveness of the predicate device.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Studies, Training Set Details (Points 2-9): These points are highly relevant for modern AI/ML-based medical devices or devices undergoing rigorous clinical performance trials. This 510(k) pertains to a physical microtool used in assisted reproduction. The "study" here is primarily a comparison of material properties, design, and intended use against a legally marketed predicate, rather than a clinical trial generating novel performance data against a ground truth.

What the document does convey regarding "performance" is:

• Substantial Equivalence: The core "finding" or "proof" is the FDA's determination that the Rapid-i™ is substantially equivalent to the predicate device (CryoTip™ K041562). This implies that its performance, as it relates to safety and effectiveness for its intended use, is considered equivalent to a device already on the market.
• Safety Considerations: The document discusses the likelihood of contamination from liquid nitrogen being "very small" due to the device's design (distance from liquid nitrogen surface, air pocket, liquid nitrogen transition to gas). It also states that "samples can not thaw when the straw is sealed after placement in liquid nitrogen if the instructions in the Package Insert are followed." These are statements related to the design features meant to ensure safety and maintain expected performance rather than measured performance results from a study.
• Maintenance of Embryos: The intended use states the device is "intended to be used to contain, vitrify and maintain 4-8 cell stage embryos." The "performance" in this context is the successful vitrification and maintenance of embryos, which is assumed to be equivalent to the predicate device.

In summary, this document is a regulatory submission for a physical medical device demonstrating substantial equivalence, not a performance study for an AI/ML algorithm or a device requiring detailed clinical efficacy data against a ground truth.

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