(74 days)
The Jostra Two-Stage Venous Cannulas are designed to be used as perfusion cannulae to divert venous blood from the patient during surgery requiring extracorporeal circulation for up to 6 hours.
The Jostra Two-Stage Venous Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to divert blood from the patient to the extracorporeal circuit by draining blood simultaneously from the Right atrium and the Inferior vena cava. The cannulae are made from polyvinyl chloride (PVC) and range in size from 32Fr./40Fr. to 36Fr./51Fr. with a variety of tips and with or without attached connectors.
This document describes the 510(k) submission for the Jostra Dual-stage Venous Cannulae (K013944), a medical device used in cardiopulmonary bypass surgery. The submission focuses on demonstrating substantial equivalence to a predicate device, the Medtronic DLP Two-Stage Venous Cannulae.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the nature of the tests performed to demonstrate "substantial equivalence" to the predicate device. The goal is to show comparable performance. The document does not explicitly state numerical acceptance criteria for each test but rather describes the types of tests conducted and their stated outcome.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Performed, demonstrating substantial equivalency to predicate device. |
| Flow-Pressure curves | Performed, demonstrating substantial equivalency to predicate device. |
| Kink Resistance | Performed, demonstrating substantial equivalency to predicate device. |
| Bond Strength | Performed, demonstrating substantial equivalency to predicate device. |
| Leakage Test | Performed, demonstrating substantial equivalency to predicate device. |
| Effects on cellular components (in-vitro) | Performed, demonstrating substantial equivalency to predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each of the performance tests (Flow-Pressure curves, Kink Resistance, Bond Strength, Leakage Test, and in-vitro cellular effects). The data provenance is likely from laboratory testing conducted by the manufacturer, Jostra AG, in Germany. The tests are described as in-vitro and performance testing, implying a controlled laboratory setting rather than human or animal studies. The data is retrospective in the sense that it was collected as part of the device development and verification process to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a submission for a physical medical device (venous cannulae) and the tests are in-vitro performance and biocompatibility studies, there is no "ground truth" in the traditional sense established by human experts in the way it would be for an AI/algorithm-based diagnostic device. The "ground truth" for compliance with acceptance criteria is based on objective measurements and established industry standards for device performance and safety, as evaluated by engineers and technical specialists.
4. Adjudication Method for the Test Set
Not applicable. This is not an imaging or diagnostic device that requires expert adjudication of results. The performance of the device is assessed through objective physical and biological tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI algorithms where human interpretation is involved. The Jostra Dual-stage Venous Cannulae is a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm or AI system. Its performance is inherent in its physical and material properties.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective, measurable physical and biological parameters established through engineering and laboratory testing. This includes:
- Physical measurements (e.g., flow rates, pressure resistance, bond strength).
- Mechanical properties (e.g., kink resistance).
- Biocompatibility assessments (e.g., in-vitro effects on cellular components).
- Comparison to the established performance characteristics of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The device is a physical product.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for a physical medical device of this nature.
§ 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).