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Cannula for Organ Perfusion is a single-use device indicated for hypothermic flushing and replacement of residual blood in donor organs with a legally marketed organ preservation solution at the time of organ removal from the donor during the preparation of these organs for transplantation. This device is indicated for use with gravity flow; no testing has been provided for use with pump systems, such as mechanical perfusion devices.

The Cannula for Organ Perfusion is a device designed and intended as a component to an organ perfusion and transport system / organ preservation solution, used in an organ transplantation procedure. The device is a cannula (available in several different sizes) intended for flushing and replacement of residual blood in donor organs with organ preservation solution during the preparation processes of these organs for transplantation. The cannulas are single use, sterile, non-toxic and nonpyrogenic devices. As a component to an organ perfusion and transport system / organ preservation solution, the Cannula for Organ Perfusion is also a Class II medical device, subject to Product Code KDN and MSB, 21 CFR 876.5880: "This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set." (21 CFR 876.5880(a)).

The Cannulas come in multiple sizes, according to the French catheter scale, including 8F, 10F, 12F, 16F (adjustable to 18F with a slidable ring), 20F (adjustable to 28F with a slidable ring), 25F (adjustable to 34F with a slidable ring). In addition, there is a configuration of the cannula that is intended for "back table" procedures, which is available in a 16F size.

This FDA 510(k) submission describes the "Cannula for Organ Perfusion" device. The document primarily focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide a table of acceptance criteria with corresponding performance metrics for the device in the manner typically seen for algorithmic or diagnostic devices. Instead, it relies on bench testing results and biocompatibility testing to demonstrate safety and effectiveness.

Here's a re-interpretation of "acceptance criteria" based on the performed tests:

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

This information is not provided in the document. The tests performed are bench tests (tensile strength, leakage, flow rate) and biocompatibility tests, which typically do not involve a "test set" in the context of patient data. The "samples" would be individual units of the cannula. There is no mention of country of origin for any data or whether it was retrospective or prospective.

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

This information is not applicable/not provided. The device is a physical medical device (cannula) and the tests performed are physical and biological evaluations, not diagnostic or image-based assessments requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as there is no "test set" requiring adjudication in the context of this submission. The tests are laboratory-based and measure physical properties or biological responses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance

This information is not applicable. The device is a physical cannula for organ perfusion, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

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

This information is not applicable. The device is a physical cannula, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable in the traditional sense of a diagnostic device. For the bench tests, the "ground truth" would be the established engineering and ISO standards against which the device performance is measured (e.g., specific tensile strength values for a "Pass"). For biocompatibility, the "ground truth" is compliance with documented biological safety standards like EN ISO 10993-1, which dictate acceptable levels of biological response.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable as there is no training set.

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EasiSlush™ slushed solution is intended for topical cooling of in-situ, abdominal donor organs during intraoperative recovery from the donor. It is also intended to maintain organ hypothermia during storage and transport to the transplant recipient.

EasiSlush™ slushed solution is used to establish, and maintain hypothermia of donor organs during recovery, storage, and transport.

Organ Recovery

Prior to organ recovery, EasiSlush™ slushed solution is delivered to the open peritoneal cavity of the donor to assist in creating hypothermia by topically cooling external surfaces of organs for recovery.

During organ recovery, if ice crystals are no longer visible, the temperature of the saline solution will begin to rise and additional EasiSlush slushed solution may be delivered per established transplant team procedures. (Temperature rise may be assessed with temperature probes, being careful that the probe is measuring the solution and is not in contact with the organ).

Organ Storage/Transport

For organ storage/transport, EasiSlush™ slushed solution may be used to topically cool external surfaces of a sterile, sealed, primary organ bag containing chilled preservation solution and the organ. In this application, EasiSlush may be added to a secondary bag or to a tertiary hard container to surround the primary organ bag. Once bagged, the organ can be placed in a bed of non-sterile ice in an insulated transport container, which is then closed. Actual use should follow standard practices of the OPO or hospital for transporting and storing specific types of donor organs using sterile, slush solutions.

EasiSlush (Sodium Chloride Solution for Sterile Slush Preparation) is 1.25L sterile 0.9% Sodium Chloride Solution in a 2L bag. It meets the USP 34 monograph for Sodium Chloride Irrigation. It is a sterile, nonpyrogenic, isotonic solution that is chilled for the preparation of slushed solution.

The provided text is a 510(k) summary for EasiSlush™ (Sodium Chloride Solution for Sterile Slush Preparation). It describes the device, its intended use, and a comparison to predicate devices, focusing on the concept of substantial equivalence.

However, the summary does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 of your prompt. The document explicitly states:

• "No clinical testing has been performed on this device." (Page 10)

This means there was no multi-reader multi-case (MRMC) study, no standalone algorithm performance, and no test or training sets with associated ground truth established by experts.

The acceptance criteria and performance data discussed are limited to non-clinical performance testing (biocompatibility, leachables, sterility, and performance bench tests related to temperature and USP standards).

Therefore, I cannot provide a detailed response to your request, as the necessary information regarding clinical study design, acceptance criteria based on clinical outcomes, sample sizes for test/training sets, expert involvement, and ground truth establishment from such studies is absent from this document.

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