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cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrification procedures to contain and maintain human oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The cryo-GO Vitrification Device is a sterile, single-use, closed assisted reproduction storage device for use in vitrification procedures to contain and maintain oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The cryo-GO Vitrification Device is composed of an injection molded body with an extended loading tip (4.45 inches long with a 0.65 inch loading tip), an injection molded cap (1.76 inches), and a total device combined length of 5.05 inches. Visible marks are on the distal loading tip, body, and at the opening of the cap, to indicate the location of the tip, the upright orientation of the device and the opening of the cap, respectively. The body and cap include a taper design that create a seal when assembled prior to plunging the device in liquid nitrogen for vitrification and for subsequent storage. The device is provided in five different colors: red, yellow, green, blue, and purple. The subject devices are radiation sterilized to a sterilization assurance level of 10-6 and have a one-year shelflife.

A detailed response outlining acceptance criteria and device performance based on the provided text for the cryo-GO Vitrification Device (K241341):

Acceptance Criteria and Device Performance for cryo-GO Vitrification Device (K241341)

The provided documentation, a 510(k) Summary, focuses on demonstrating substantial equivalence to a predicate device (VitriGuard, K200815) rather than explicitly stating pre-defined, quantitative acceptance criteria for all aspects of performance with a dedicated clinical study. However, some functional performance criteria are implicitly accepted through comparison with the predicate device or established standards. The non-clinical performance data section presents the studies undertaken to support the device's safety and effectiveness.

Here’s a breakdown based on the categories requested:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of the Study Proving Device Meets Acceptance Criteria:

The "cryo-GO Vitrification Device" underwent non-clinical performance testing to demonstrate its safety and effectiveness, supporting its substantial equivalence to the predicate device. The studies were primarily bench testing and in-vitro biological assays.

2. Sample Size and Data Provenance for Test Set:

The provided document describes non-clinical performance testing rather than a "test set" in the context of AI/machine learning or a clinical trial with patient data. Therefore, the concept of sample size and data provenance as typically applied to such studies does not directly align.

• Sample Size: Not explicitly stated as a single "test set" sample size. The testing involved multiple units of the device for various engineering and biological tests (e.g., numerous devices for sterility validation, package integrity, shelf-life testing, and a sufficient number of mouse embryos for the MEA).
• Data Provenance: The data comes from laboratory testing performed by the manufacturer, FUJIFILM Irvine Scientific, Inc. The nature of the studies implies that they were prospective bench and in-vitro experiments designed to evaluate the device's physical, chemical, and biological performance. There is no indication of country of origin of "data" in the sense of patient data, as this was a non-clinical submission.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This was a submission for a physical medical device (cryopreservation device), not an AI/software device requiring expert human readers to establish ground truth for image interpretation or diagnosis. The "ground truth" for performance was established through standardized laboratory testing methods (e.g., ISO, ASTM, USP, FDA guidance documents).

4. Adjudication Method for Test Set:

Not applicable. As noted above, this was non-clinical bench and in-vitro testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI performance evaluations to reconcile discrepancies among human readers or expert panels.

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

Not applicable. This device is not an AI algorithm or a diagnostic imaging tool that would involve human readers interpreting cases. Therefore, an MRMC study and analysis of AI assistance improving human readers were not performed.

6. Standalone (Algorithm Only) Performance:

Not applicable. The "cryo-GO Vitrification Device" is a physical medical device for cryopreservation, not a software algorithm.

7. Type of Ground Truth Used:

The ground truth for evaluating the device's performance was based on:

• Standardized Laboratory Test Results: Measurements and observations against established industry standards (e.g., ISO 11137 for sterility, ASTM standards for package integrity and accelerated aging, USP for endotoxin).
• Biological Activity/Functionality: The Mouse Embryo Assay (MEA) provides a biological "ground truth" for the device's non-toxicity and suitability for embryo culture, as defined by the "≥ 80% expanded blastocyst within 96 hours" criterion endorsed by the FDA guidance.

8. Sample Size for Training Set:

Not applicable. This is a physical device, not an AI/machine learning model, so there is no concept of a "training set."

9. How Ground Truth for Training Set Was Established:

Not applicable, for the same reason as point 8.

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SSS-NX is intended for use in assisted reproductive technology (ART) procedures which include gamete and embryo manipulation and culture. These procedures include the use of SSS-NX as a supplement for ART media.

SSS-NX (Serum Substitute Supplement-NX) is an assisted reproduction media supplement consisting of a combination of human serum proteins (approximate protein content 50 mg/mL, 5% w/v) in a saline solution. Of this, ≥83% is albumin and ≤17% is globulins. The product is supplied as a ready to use liquid in 10 mL containers distributed in a twelve (12) x 10 mL kit and a 100 mL liquid packaged in a 125 mL container.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: SSS-NX (Serum Substitute Supplement-NX)
Device Type: Assisted reproduction media supplement
Predicate Device: Serum Substitute Supplement (SSS)
510(k) Number: K233764

1. Table of Acceptance Criteria and Reported Device Performance

Note: While the "Indications for Use" statement differs between the subject and predicate devices, the "Intended Use" is considered the same: for manipulation of gametes and embryos and for culture use. The differences in device materials do not raise different questions of safety and effectiveness. The subject device has a more stringent endotoxin limit than the predicate, which is considered an improvement and does not raise different safety and effectiveness concerns. The shorter shelf life for the subject device is noted but not presented as a failure of acceptance criteria, as it was supported by testing.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes testing for a reproductive media supplement, not a diagnostic or AI-powered device. Therefore, the concept of a "test set" in the context of imaging or algorithm performance is not applicable here.

• Sample Size: The document does not specify the exact sample size for each test (e.g., how many batches for sterility, how many embryos for MEA). It implies that testing was performed on sufficient samples to meet the specified criteria.
• Data Provenance: Not applicable in the traditional sense for this type of product. The data is generated through laboratory testing of the manufactured product (SSS-NX). There is no mention of country of origin of data or retrospective/prospective clinical data for human subjects because it is a manufacturing component, not a device directly used in a patient.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. As this is a reproductive media supplement, the "ground truth" is established through standardized laboratory assays and physical/chemical property measurements, not clinical expert consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable. Ground truth for this product is determined by objective laboratory tests and adherence to specified ranges (e.g., pH, osmolality, sterility) and biological performance (MEA). There would be no expert adjudication in the manner of diagnostic interpretation.

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

Not applicable. This type of study is relevant for AI-assisted diagnostic devices involving human readers interpreting medical images or data. SSS-NX is a laboratory reagent.

6. Standalone Performance Study (Algorithm Only)

Not applicable. SSS-NX is a physical product (a liquid supplement), not an algorithm or software. Its performance is measured directly by laboratory tests.

7. Type of Ground Truth Used

The ground truth for this device is based on:

• Laboratory Assay Results:
  • Sterility (absence of microbial growth per USP )
  • Endotoxin levels (per USP )
  • pH (per USP )
  • Osmolality (per USP )
  • Mouse Embryo Assay (MEA) performance (percentage of 1-cell embryos developing to expanded blastocyst at 96 hours). This is a biological performance test to ensure the media supports embryo development.
• Physical/Chemical Properties: Clarity and Color.
• Standards Adherence: ISO 13408-1:2008, ISO 13408-2:2018, ASTM F1980-21, ASTM D4169-22.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of algorithm development.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this product.

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PRIME-XV FreezIS DMSO-Free MD is for use in human ex vivo tissue and cell culture processing applications.

PRIME-XV Freez/S DMSO-Free MD is a liquid medium intended for use in human ex vivo tissue and cell culture processing applications.

It is a chemically defined cryogenic preservation solution for human cells for use in a professional Healthcare Facility that performs cell culture and cell handling. It has comparable post-thaw cell viability as solutions containing dimethyl sulfoxide (DMSO), maintains potency of stem cells throughout cryopreservation, eliminates the risk of DMSO in stem cell therapy applications, is animal componentfree, enables cell preservation at -80°C to -196°C environments and is manufactured under cGMP conditions.

The provided text describes a medical device, PRIME-XV FreezIS DMSO-Free MD, which is a tissue culture medium. It presents the device's indications for use, technological characteristics, and a comparison to predicate devices, but it does not contain information about an AI-powered device or a study involving human readers or a test set to establish ground truth for performance metrics like sensitivity or specificity.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance data for an AI device. The document is a 510(k) summary for a biological/chemical product, not a software device or an AI diagnostic tool.

The acceptance criteria provided in the document relate to the quality and performance of the tissue culture medium itself, such as:

• High cell viability, robust cell expansion post-cryopreservation, maintenance of cell function, phenotype and differentiation potential: To demonstrate lack of potential toxicity and support of tissue/cell growth.
• **Endotoxin testing per USP , mycoplasma testing per USP **: To demonstrate lack of endotoxin or pyrogen contamination.
• Compliance with GMP requirements regarding aseptic processing: For validation of Aseptic Processing and Sterility Assurance Level (SAL).
• Incoming raw materials are of high quality and are lot-tested for identity and purity: To demonstrate chemical purity.
• 24-month shelf life when stored at 2 – 8 °C: Based on stability testing confirming pH, osmolality, non-cytotoxicity, and protection against microbial contamination.

These are established through laboratory testing directly on the medium and its interaction with cells, not through studies involving expert readers or ground truth adjudication as would be relevant for an AI diagnostic device.

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Vit Kit - Freeze NX (Vitrification Freeze Kit) is intended for use in the vitrification of oocytes (MI) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

Vit Kit - Warm NX (Vitrification Warm Kit) is intended for use in the thawing of vitrified occytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The five media products that comprise the two kits, Vit Kit - Freeze NX and Vit Kit -Warm NX, consist of a basal media of Continuous Single Culture Medium (CSCM) which utilizes MOPS, HEPES and sodium bicarbonate buffers, 20% (v/v) DSS, 10μg/mL gentamicin and varying levels of cryoprotectants, including dimethyl sulfoxide (DMSO), trehalose, and ethylene glycol (EG).

The two freeze media in the Vit Kit – Freeze NX are intended to be used sequentially for the preparation and cryopreservation of oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

The three media in the Vit Kit - Warm NX are intended for sequential use in the thawing and recovery of cryopreserved oocytes (MII) and pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

This document describes a 510(k) premarket notification for Vit Kit - Freeze NX and Vit Kit - Warm NX, which are reproductive media for vitrification (freezing) and thawing of oocytes and embryos.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the non-clinical performance data and the comparison to the predicate device. The document states that "The subject device passed the predefined acceptance criteria for these tests," confirming that the reported device performance met these criteria.

Note: The document only states "The subject device passed the predefined acceptance criteria for these tests" without providing specific numerical results for each test for the subject device. The table above uses the predicate's specifications or general qualitative criteria as a proxy for the acceptance criteria, which the subject device is stated to have met.

2. Sample Sized Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample sizes used for each non-clinical test (e.g., number of vials tested for pH, number of embryos for MEA).
• Data Provenance: The document does not explicitly state the country of origin. The study appears to be a lab-based non-clinical performance evaluation, not involving human subjects or patient data. It is a non-clinical performance data study, retrospectively conducted for the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable to this type of device and study. This 510(k) pertains to reproductive media, not an AI or imaging device requiring expert interpretation of results to establish ground truth. The "ground truth" for media performance is established through standardized laboratory assays (pH, osmolality, endotoxin, sterility, mouse embryo assay).

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective, laboratory-based measurements, not subjective human interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, often with and without AI assistance. This 510(k) is for IVF media, which does not involve human reader interpretation in its intended use or performance evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done

No, a standalone algorithm performance study was not done. This concept is specific to AI/machine learning devices where the algorithm's performance is evaluated independently. This product is a biological medium, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance evaluations was established through objective laboratory measurements and standardized biological assays:

• Chemical assays (pH, Osmolality)
• Microbiological assays (Endotoxin, Sterility)
• Biological assays (Mouse Embryo Assay - MEA)

These are empirical measurements against predefined quality control specifications, rather than expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/machine learning device that requires a "training set." The device is a manufactured chemical product.

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

This information is not applicable given that the device is not an AI/machine learning product and does not have a "training set."

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