Search Results

The Jostra HLM Tubing Set with Safeline Coating is indicated for use in surgical procedures requiring extracorporeal support for up to six hours. The Safeline coating is used to reduce the surface tension on blood contact surfaces.

The Jostra HLM Tubing Sets with Safeline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the Jostra HLM Tubing Sets with Safeline Coating are used in combination with the heartlung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the Jostra HLM Tubing Sets with Safeline Coating is to connect the patient to the heartlung machine and it's components. The Jostra HLM Tubing Sets with Safeline Coating are therefore a component in the extracorporeal perfusion circulation system, for the oxygenation of blood and the removal of carbon dioxide. The utilization period of the use of the tubing sets is restricted to six hours.

The provided document does not contain any data, tables, or studies that prove the device meets acceptance criteria.

The document is a 510(k) premarket notification for the Jostra HLM Tubing Sets with Safeline Coating. It describes the device, its intended use, and states that its performance data are comparable to the uncoated version. It also outlines a risk analysis (FMEA) performed to assess the impact of the Safeline coating. The conclusion is that the device is safe and effective for its intended use and substantially equivalent to predicate devices.

However, it does not provide quantitative acceptance criteria or detailed study results to demonstrate this. The key statement regarding performance is: "The performance data of the Jostra HLM Tubing Sets with Safeline Coating are comparable with the performance data of the Jostra HLM Tubing Sets without the Safeline Coating."

Here's a breakdown of why I cannot answer your request based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: This information is not present. The document states comparability but doesn't list criteria or specific performance metrics.
• 2. Sample size used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• 4. Adjudication method for the test set: Not mentioned.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a medical device (tubing sets) and not an AI-assisted diagnostic tool involving human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not explicitly stated, as there are no detailed studies presented. The "ground truth" here would likely be the established performance and safety profiles of the predicate, uncoated device.
• 8. The sample size for the training set: Not applicable and not mentioned, as this is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable and not mentioned.

The document focuses on substantiating that the addition of the "Safeline Coating" does not negatively impact the established safety and performance of the existing Jostra HLM Tubing Sets. The evidence provided is primarily through:

• Statement of Technical Comparison: The device has the same intended use, design, principles of operation, and performance as the predicate, with the only difference being the coating.
• Non-clinical Testing: All tests from the predicate 510(k) (K0503025) are deemed applicable. This implies that the new device would pass those same tests, but the results are not detailed here.
• Risk Analysis (FMEA): This identified potential hazards related to the coating (biological, functional, interaction with other coatings), and states that "Design verification tests were performed as a result of this risk analysis assessment" and that "The evaluation and test results do not show any kind of risk potential." Again, the specific tests and their quantitative results are not provided in this summary.

In summary, the document asserts comparability and safety through risk analysis and reliance on previous clearances, rather than presenting new, detailed performance study data against explicit acceptance criteria.

Ask a specific question about this device