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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.

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • 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.

   • 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.

2. 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.

3. 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.

4. 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.

5. 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).

6. 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).

7. 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.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set was used for an AI/machine learning model.

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The Rapid-i™ Kit is a cryopreservation device designed to contain 4-8 cell and blastocyst stage human embryos.

Rapid-iTM Kit, a cryopreservation device designed to contain, vitrify and maintain 4-8 cell and blastocyst stage human embryos, consists of the following three items:
• 80 mm PMMA stick (Rapid-iTM)
• 135 mm Mediprene straw equipped with a stainless steel weight, (RapidStraw)
• 115 mm stainless steel rod inserted in the RapidStraw

Here's an analysis of the acceptance criteria and supporting studies for the Rapid-i™ Kit, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

*   **Sterilization:** No specific sample size given, but validation was performed according to ISO 11737-2:2009. (Page 5)
*   **Data Provenance:** Likely internal lab studies by Vitrolife Sweden AB, prospective.

• Design Validation (Comparative Studies, predicate device K090832):

  • "Effects of sealing before and after vitrification": Compared post-seal Rapid-i™ (predicate), pre-seal Rapid-i™ and HSV straw. No specific sample counts for embryos, but compared "different non-liquid nitrogen (LN2) contact vitrification methods of previously frozen day 1 embryos." (Page 8)
  • "A comparative mouse study": Compared post-seal Rapid-i™ (predicate), pre-seal Rapid-i™ and HSV straw, using "fresh F1 mouse embryos." (Page 8)
  • "A comparative Swiss outbred study": Compared post-seal Rapid-i™ (predicate) and pre-seal Rapid-i™ using "Swiss outbred mice." (Page 8)
  • "A vitrification study": No embryos used; visually verified vitrification of media. (Page 8)
  • Data Provenance: These were studies related to the predicate device (K090832) for design validation and likely conducted by or for Vitrolife. The nature of the studies suggests prospective experimental designs.

• Clinical Testing (Blastocyst Vitrification):

  • Patients: 426 patients with embryo transfer. (Page 10)
  • Data Provenance: Conducted at four sites. It appears to be retrospective collection of results from historical clinical use, stating "The clinical pregnancy rates range between 32% and 47%, and to date, birth of 124 children." and "Clinical blastocyst vitrification was conducted at four sites..." (Page 10)

3. Number of Experts and Qualifications for Ground Truth

• Nonclinical & Shelf-Life Testing (MEA, Endotoxin, Sterilization): No independent experts are explicitly mentioned for establishing ground truth for these tests. These are standard laboratory assays with predefined control samples and acceptance criteria.
• Design Validation (Comparative Studies on Mice/Embryos): No external experts are mentioned. Ground truth was based on defined measurable outcomes like blastocyst development, cell count, and visual assessment of vitrification.
• Clinical Testing: This section references "standard procedures" for embryo assessment and "clinical pregnancy rates" and "birth of 124 children." While embryologists and clinicians are inherently experts, the document does not specify how many or their specific qualifications for establishing ground truth in terms of a consensus panel for this specific submission. The "ground truth" here is objective clinical outcomes (pregnancy, live birth, survival rates) as reported by the clinics.

4. Adjudication Method

• There is no mention of an adjudication method (e.g., 2+1, 3+1) in the document. This type of adjudication is typically for subjective assessments (e.g., image interpretation). Given the nature of these tests (laboratory assays, survival rates, clinical outcomes), such a method would not commonly be applied.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this device. This type of study is more common for diagnostic imaging devices where human readers interpret data, and the comparison is how AI assistance changes their diagnostic accuracy. The Rapid-i™ Kit is a cryopreservation device, not a diagnostic tool requiring human interpretation for its primary function.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. The Rapid-i™ Kit is a hardware device for cryopreservation, not an algorithm. Therefore, "algorithm only" performance is not applicable.

7. Type of Ground Truth Used

• Nonclinical & Shelf-Life Testing: Objective laboratory measurements (e.g., growth in MEA, endotoxin levels, sterility confirmation).
• Design Validation: Objective experimental outcomes (e.g., blastocyst development rate, cell count, visual assessment of vitrification).
• Clinical Testing: Objective clinical outcomes (embryo survival rate, clinical pregnancy rate, live birth). This is a form of outcomes data.

8. Sample Size for the Training Set

• The concept of a "training set" is not applicable here as the Rapid-i™ Kit is a medical device (hardware) rather than an AI/ML algorithm that requires training data. The studies performed are for validating the product's functional performance and safety.

9. How Ground Truth for the Training Set Was Established

• As the device is not an AI/ML algorithm, there is no "training set" or ground truth for it in that context. The "ground truth" for evaluating the device's performance as a cryopreservation tool is established through the objective measurements and clinical outcomes described above.

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