(88 days)
The Jostra Arterial Cannulae (adults) are designed to be used as perfusion cannulae during extracorporeal circulation during cardiopulmonary bypass up to 6 hours or less.
The Jostra Adult Arterial Cannulae are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to return arterial blood to the patient via the antic root or other large artery during extracorporeal circulation. to the cannulae are made from polyvinyl chloride (PVC) and range in size from 20fr. to 24fr. with a variety of tips, with or without attached connectors. The cannulas are specifically designed for use on patients requiring more than 3L/Min. of blood flow.
The Jostra Adult Arterial Cannulae is a medical device designed for use in cardiopulmonary bypass procedures. The device's acceptance criteria and performance were assessed through a non-clinical testing study to demonstrate substantial equivalence to a predicate device, the Medtronic DLP Adult Arterial Cannulae.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Tested to demonstrate substantial equivalence to the predicate device. |
| Flow-Pressure curves | Performance testing included. |
| Kink Resistance | Performance testing included. |
| Bond Strength | Performance testing included. |
| Leakage Test | Performance testing included. |
| Effects on cellular components | In-vitro testing performed. |
| Safety and Effectiveness | Comparative testing demonstrated that differences from the predicate device do not affect safety and effectiveness. |
2. Sample Size and Data Provenance:
The document does not specify the exact sample sizes used for each individual performance test (Flow-Pressure curves, Kink Resistance, Bond Strength, Leakage Test, and in-vitro testing for cellular effects). The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given it is a premarket notification for a new device, the testing would typically be prospective, carried out by the manufacturer.
3. Number of Experts and Qualifications:
Not applicable. This was a non-clinical performance and biocompatibility study, not a clinical study involving expert judgment for ground truth.
4. Adjudication Method:
Not applicable. Adjudication methods are typically relevant for clinical studies involving multiple reviewers; this was non-clinical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The study focused on technical performance and biocompatibility rather than human reader performance with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone study of the device's performance was done. The non-clinical testing evaluated the device's physical properties and biocompatibility as a standalone entity. There is no mention of human-in-the-loop performance since the device is a physical cannula, not an AI or imaging diagnostic tool.
7. Type of Ground Truth Used:
The "ground truth" for this type of device is established through engineering and biological standards. For example:
- Performance Tests: The ground truth for flow-pressure curves, kink resistance, bond strength, and leakage tests would be established by validated engineering specifications and industry standards for cardiopulmonary bypass cannulae. The "truth" is whether the device meets these pre-defined physical and functional requirements.
- Biocompatibility: The ground truth is compliance with relevant biological safety standards (e.g., ISO 10993 series) and demonstration that the device material does not cause adverse biological reactions or affect cellular components.
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical instrument, not an AI/machine learning model, so there is no "training set" in that context. The testing involved samples of the manufactured device.
9. How Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device. The "ground truth" for evaluating the performance and biocompatibility of the Jostra Adult Arterial Cannulae was based on established engineering principles, industry standards, and biological safety guidelines for similar medical devices. The predicate device (Medtronic DLP Adult Arterial Cannulae) also served as a benchmark for comparison.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).