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The HLM Tubing Sets with Softline Coating are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.

The HLM Tubing Sets with Softline 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 HLM Tubing Sets with Softline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Softline Coating is to connect the patient to the heart-lung machine and its components. The HLM Tubing Sets with Softline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours. The Softline Coating improves the physical surface properties of products for the extracorporeal circulation system.

The provided document, K090533, describes a Special 510(k) Device Modification for HLM Tubing Sets with Softline Coating. The document confirms that the device is substantially equivalent to predicate devices based on evaluations in integrity, performance, biocompatibility, and sterility. However, it does not provide detailed acceptance criteria or study results in the format requested. The document primarily focuses on regulatory approval based on demonstrating substantial equivalence to already marketed devices.

Therefore, I cannot fulfill most of the requested information (points 1-9) as the detailed study data regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness with human readers are not present in the provided text.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "The following areas have been evaluated: Integrity, Performance, Biocompatibility, Sterility" but does not list specific acceptance criteria or performance metrics.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. This device is a medical accessory, not an AI/diagnostic device that would require expert-established ground truth in the way described.
4. Adjudication method for the test set: Not applicable/provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI diagnostic device.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI diagnostic device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI diagnostic device.

The document states:
"Evaluation on safety and effectiveness was executed to demonstrate that the HLM-Tubing Set with Softline Coating described in this submission is substantially equivalent to the HLM-Tubing Set with Bioline Coating (K080592) as a custom tubing pack and to the Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating (K082117) with regards to the Softline Coating."

This implies that standard evaluations for medical device safety and effectiveness in the areas of integrity, performance, biocompatibility, and sterility were conducted to show equivalence to predicate devices, but the specific details of these evaluations are not included in the provided text.

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