(238 days)
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:
| Acceptance Criteria (Inferred from tests) | Reported Device Performance |
|---|---|
| Tensile strength (ISO 10555-1) | Pass |
| Leakage and tightness (ISO 10555-1) | Pass |
| Flow rate (ISO 10555-1) | Adequate flow of liquid |
| Sterility (SAL 1 x 10^-6) | Achieved via ETO sterilization |
| Shelf life | Established via real-time aging testing |
| Biocompatibility: Cytotoxicity | Complies with EN ISO 10993-1 |
| Biocompatibility: Sensitizing effect | Complies with EN ISO 10993-1 |
| Biocompatibility: Intracutaneous reactivity | Complies with EN ISO 10993-1 |
| Biocompatibility: Systemic (acute) toxicity | Complies with EN ISO 10993-1 |
| Biocompatibility: Blood compatibility | Complies with EN ISO 10993-1 |
| Biocompatibility: Rabbit pyrogenicity | Complies with EN ISO 10993-1 |
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.
§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. 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.(b)
Classification. Class II (performance standards).