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510(k) Data Aggregation
(183 days)
The Stockert V142 Series Venous Cannulae with Lighthouse Tip are intended to be used for cannulating the major venous vessels during cardiopulmonary bypass surgery.
The Stockert V142 Series Venous Cannulae with Lighthouse Tip are intended to be used for cannulating the superior or the inferior vena cava during standard cardiopulmonary bypass surgery.
The Stockert V142 Series Venous Cannulae with Lighthouse Tip are sterile, non-pyrogenic devices, for single use only, and are not to be resterilized by the user. The devices are single stage, wire reinforced venous cannulae with a distal open lighthouse tip. They are intended to be used to can, ulate the venous vessels during cardiopulmonary bypass surgery.
The product will be offered for sale in various french sizes ranging from 28 Fr to 36 Fr.
The Stockert Venous Cannulae with Lighthouse Tip are composed of two components, the cannula tube and the lighthouse tip. Encapsulated within the cannulae outer wall is a helically wound stainless steel wire which allows the cannula tube to resist kinking. The length of the device is, 40 cm.
The provided text describes a 510(k) Pre-Market Notification for the Stockert Venous Cannulae with Lighthouse Tip. This type of notification establishes substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new, de novo device. Therefore, a direct table of acceptance criteria and reported device performance, as one might find for a novel device with defined thresholds, is not present. Instead, the study aims to demonstrate that the new device performs similarly to an already-approved predicate device.
Here's an analysis based on the provided text, addressing your questions where applicable within the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
The text does not explicitly state numerical acceptance criteria or detailed reported device performance in a table format. Instead, it lists the tests performed to demonstrate substantial equivalence to the predicate device, the Baxter Research Medical Inc. Single Stage Venous Return Cannula Wire Reinforced with Lighthouse Tip. The implicit "acceptance criteria" for a 510(k) submission like this is that the new device's performance in these tests is comparable to or better than the predicate device, thereby not raising new questions of safety or effectiveness.
| Test Performed | Implicit Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (Summary from text) |
|---|---|---|
| 1. Pressure Drop | Performance (e.g., flow rate vs. pressure drop characteristics) should be comparable to or better than the predicate device, ensuring adequate blood flow during cardiopulmonary bypass. The specific values would be held to be within a pre-defined range of the predicate device's performance. | The study included this test to show substantial equivalency. No specific performance data (e.g., "X mmHg pressure drop at Y L/min flow") is provided, but the FDA's clearance implies that the results were satisfactory for claiming substantial equivalence. |
| 2. Blood Trauma | The device should not cause significantly more blood cell damage (e.g., hemolysis) than the predicate device. | The study included this test to show substantial equivalency. No specific performance data (e.g., "hemolysis rate of X%") is provided, but the FDA's clearance implies that the results were satisfactory for claiming substantial equivalence. |
| 3. Leak | The device should be leak-free under conditions similar to or exceeding physiological and operational stresses. | The study included this test to show substantial equivalency. No specific performance data (e.g., "no leakage observed at X pressure") is provided, but the FDA's clearance implies that the results were satisfactory for claiming substantial equivalence. |
| 4. Kink Resistance | The device should resist kinking to a degree comparable to or better than the predicate device, ensuring continuous and unobstructed flow. | The device description explicitly states it has an "helically wound stainless steel wire which allows the cannula tube to resist kinking." The study included a "Kink Resistance" test to demonstrate this property is comparable to the predicate. No specific performance data is provided, but the FDA's clearance implies satisfactory results. |
| 5. Bond Strength | All bonded components (e.g., cannula tube to lighthouse tip) should maintain structural integrity under intended use conditions, comparable to or better than the predicate device. | The study included this test to show substantial equivalency. No specific performance data (e.g., "bond strength of X Newtons") is provided, but the FDA's clearance implies that the results were satisfactory for claiming substantial equivalence. |
| 6. Dimensional Inspection Post-sterilization and Post-aging | The device dimensions should remain within specified tolerances after sterilization and accelerated aging processes, demonstrating stability and integrity over its intended shelf life. | The study included this test to show substantial equivalency. No specific performance data is provided, but the FDA's clearance implies that the results were satisfactory for claiming substantial equivalence, ensuring the device remains within functional dimensional limits after sterilization and aging. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes for any of the tests performed (Pressure Drop, Blood Trauma, Leak, Kink Resistance, Bond Strength, Dimensional Inspection).
The data provenance is implicitly from the manufacturer's internal testing (Stockert Instrumente GmbH / COBE Cardiovascular, Inc.), conducted to support the 510(k) submission. The exact country of origin for the testing itself isn't specified, but the manufacturer is based in Germany and the applicant in the USA. Given this is product testing, it would be considered prospective data generation for the purpose of demonstrating substantial equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of submission for a medical device (venous cannula) does not involve establishing ground truth through expert review in the sense of image interpretation or diagnostic accuracy. The "ground truth" here is the objective physical and mechanical performance of the device against established engineering and biological standards, and comparison to a predicate device. Therefore, no experts were used to establish ground truth in this context. The "experts" involved would be the engineers and scientists who conducted the testing and evaluated the results against the predicate and relevant standards.
4. Adjudication Method for the Test Set
Not applicable. As explained in point 3, this is not a study requiring adjudication of expert opinions for a test set. The evaluation is based on objective measurements from physical and mechanical tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are typically used to assess the diagnostic performance of imaging devices or algorithms, often comparing human readers with and without AI assistance. This submission is for a physical medical device (venous cannula) and does not involve diagnostic interpretation or AI.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context is the objective, measurable physical and mechanical performance characteristics of the device (e.g., actual pressure drop, actual blood trauma, actual bond strength values) as determined by laboratory testing. These values are then compared to the known or established performance of the legally marketed predicate device (Baxter Research Medical Inc. Single Stage Venous Return Cannula Wire Reinforced with Lighthouse Tip). The underlying "ground truth" for the predicate device would also be its objectively measured performance.
8. Sample Size for the Training Set
Not applicable. This submission is for a physical medical device and does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained in point 8, there is no training set involved.
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