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FertiCult™ Flushing medium are intended for in vitro procedures involving human gametes (sperm and oocytes), including washing of gametes, sperm swim-up procedures, intra-uterine insemination (IUI) of the spermatozoa and sperm injection during intracytoplasmic sperm injection (ICSI). FertiCult™ Flushing medium can also be used human embryo washing and holding, and for embryo transfer (ET) in the uterine cavity. The medium is NOT intended for oocyte pick-up and follicle flushing. FertiCult Flushing medium is used during assisted reproductive Technology (ART) procedures of patients and couples undergoing infertility treatments.

FertiCult Flushing medium and FertiCult Flushing medium with phenol red and gentamicin intended for in vitro procedures involving human gametes (sperm and oocytes), including washing of gametes, sperm swim-up procedures, intra-uterine insemination (IUI) of the spermatozoa and sperm injection during intracytoplasmic sperm injection (ICSI). FertiCult Flushing media can also be used for human embryo washing and holding, and for embryo transfer (ET) in the uterine cavity.

The base formulation contains Water, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Sulphate Heptahydrate, Sodium Dihydrogen Phosphate Dihydrate, Sodium Pyruvate, Glucose Monohydrate, Sodium Lactate, Sodium hydrogen carbonate, HEPES, Human Serum Albumin.

A FertiCult Flushing media variant contains Phenol red and Gentamicin.

The products can be used up to 7 days after opening, when sterile conditions are maintained, and the products are stored at 2-8°C.

The provided FDA 510(k) clearance letter pertains to the FertiCult Flushing medium and FertiCult Flushing medium with phenol red and gentamicin. This document demonstrates the substantial equivalence of the new device to a predicate device, as required for FDA clearance.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria listed are primarily for the physical, chemical, and biological properties of the media, ensuring its quality and suitability for use in Assisted Reproductive Technology (ART) procedures.

• Historically accepted biological performance indicators: Mouse Embryo Assay (MEA) results (development to expanded blastocyst), as specified by the 2021 FDA guidance.
• Observed physical and chemical characteristics: Absence of precipitates.

These are objective, quantifiable, or universally accepted biological endpoints, rather than expert consensus on a subjective interpretation.

8. The Sample Size for the Training Set

Not applicable. This device is a culture medium, not an AI/ML algorithm that requires a training set. The performance testing described validates the manufacturing quality and biological compatibility of the product.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/ML device requiring a training set.

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InActiv Blue is intended for the stabilization, transportation and inactivation of upper respiratory specimens suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens at refrigerated (2-8°C) or ambient temperatures (20-25°C). SARS-CoV-2 RNA in the specimens is stabilized for 7 days at these specified temperatures. Specimens collected and stored in an InActiv Blue collection tube are suitable for use with legally marketed molecular diagnostic devices.

InActiv Blue is a virus-inactivating and lysis solution that abrogates the infectious potential of the collected material without affecting the integrity of the RNA. Two milliliters of InActiv Blue solution are provided in a polypropylene flat bottom collection tube with a high-density polyethylene (HDPE) cap (product code IB TUB). The device is non-sterile, single use. Secondary Packaging for the collection tube configuration includes racks of 50 collection tubes and cardboard boxes with either 400 or 1200 collection tubes.

Sample types intended for collection with the device include upper respiratory swab samples. Swabs are not provided with the InActiv Blue collection tubes.

The active components of the InActiv Blue solution are guanidine thiocyanate, Nlauroylsarcosine sodium salt and EDTA. These components are formulated in a sodium phosphate buffered solution containing methylene blue.

This document describes the performance of the InActiv Blue device, a microbial nucleic acid storage and stabilization device, for stabilizing and inactivating SARS-CoV-2 in upper respiratory specimens.

Here's the breakdown of the acceptance criteria and the study results:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The provided document does not explicitly delineate a "test set" in the context of an algorithm or AI device as it describes a physical collection device. However, the sample sizes and data provenance for the performance studies are detailed:

• Shelf-Life Stability: At least eight lots of InActiv Blue were used. Samples were stored at room temperature (15-25°C). The study appears to be retrospective in terms of analyzing existing product lots over time. The country of origin of the data is not specified, but the applicant (FertiPro NV) is based in Belgium.
• Limit of Detection (LOD):
  • Preliminary LOD: SARS-CoV-2 at 5 concentrations (5, 15, 45, 135, 405 particles/mL), each performed in triplicate. Total 15 preliminary tests.
  • Confirmatory LOD: For each concentration (15 and 45 particles/mL), 20 replicates were evaluated. Total 40 confirmatory tests.
  • The matrix used was "nasopharyngeal clinical matrix" spiked with SARS-CoV-2. The data provenance (country, retrospective/prospective) is not explicitly stated.
• Sample Stability Study: Six replicate samples containing nasopharyngeal matrix were used for each of the four lots of InActiv Blue tested (newly manufactured, middle-aged, near/recently expired, and stressed). Three replicates from each lot were stored at 2-8°C and three at 20-25°C. Total of 24 replicates (4 lots x 6 replicates). The matrix was "nasopharyngeal matrix" spiked with SARS-CoV-2. Data provenance is not explicitly stated.
• Viral Inactivation: Three lots of InActiv Blue (near expiration) were used. For each lot, the study involved mixing virus stock 1:1 with InActiv Blue and incubating for 1, 2.5, and 5 minutes. No specific "sample size" of individual viral samples is mentioned beyond the use of 3 lots and multiple exposure times for each. Data provenance is not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the device is a physical sample collection and stabilization device, not an AI or imaging device requiring expert interpretation for ground truth establishment. The ground truth for the performance studies (e.g., viral load, RNA integrity) is established through laboratory assays (e.g., Roche cobas SARS-CoV-2 assay) and cell culture methods.

4. Adjudication Method for Test Set

This information is not applicable. The studies described are laboratory performance studies, not clinical studies requiring adjudications of diagnoses or interpretations by experts.

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

This information is not applicable. This device is not an AI or imaging device used by human readers, so an MRMC comparative effectiveness study is not relevant.

6. Standalone (Algorithm Only) Performance

This information is not applicable. The InActiv Blue is a physical medical device, not an algorithm, so the concept of "standalone performance" for an algorithm does not apply.

7. Type of Ground Truth Used

The ground truth used for these studies is scientific and laboratory-based:

• Shelf-Life Stability: Physical and chemical properties of the solution (pH, osmolarity, visual inspection, evaporation) against predefined specifications.
• Limit of Detection: Quantification of viral particles (SARS-CoV-2) using a legally marketed molecular diagnostic device (Roche cobas SARS-CoV-2 assay) and determining the concentration at which a specified percentage of positive results are achieved.
• Sample Stability: Detection and quantification of SARS-CoV-2 RNA using a molecular diagnostic device (Roche cobas SARS-CoV-2 assay) and monitoring the change in Ct values over time, demonstrating RNA integrity.
• Viral Inactivation: Measurement of residual infectivity of SARS-CoV-2 using cell culture (Vero E6 cells) and determining the cytopathic effect and TCID50 (Tissue Culture Infectious Dose 50%) via the Reed and Muench method to quantify log reduction in infectivity.

8. Sample Size for the Training Set

This information is not applicable. This device is a physical collection and stabilization device and does not involve AI or machine learning models that require a training set. The development of such a device relies on chemical formulation, engineering, and manufacturing process control, rather than data-driven algorithm training.

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.

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