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The intended use is to provide access to the vascular system to administer fluids intravenously. The device is also suitable for sampling blood and monitoring blood pressure.

The subject catheter is a single use intravascular administration set of various gauges and lengths which is designed to provide access to the vascular system. It is stainless steel needle set with butterfly wings and a short extension set.

The provided text is related to a 510(k) premarket notification for K970259, an Intravascular Administration Set. This is a medical device application for a physical product (infusion set), not a software or AI-based diagnostic device.

Therefore, the concepts of "acceptance criteria," "device performance," "sample size for test/training sets," "ground truth," "experts," "adjudication methods," and "MRMC comparative effectiveness studies" as they relate to algorithm or AI performance are not applicable to this submission.

The submission focuses on demonstrating substantial equivalence to a predicate device for an existing physical product, primarily by clarifying the "intended use."

Here's how to interpret the provided information in the context of a physical device:

1. A table of acceptance criteria and the reported device performance: Not applicable in the AI sense. For a physical device, acceptance criteria would typically relate to manufacturing specifications (e.g., material strength, flow rate, sterility, dimensions), and device performance would be confirmed through testing those physical characteristics. The document states "The device is unchanged," implying it already meets the established physical performance criteria of the predicate device.

2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of data in the AI sense. Any testing would be physical product testing, not data analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context would be physical specifications or clinical outcomes, not expert labeling of images or data.

4. Adjudication method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for assessing AI's impact on human readers, not a physical infusion set.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used: Not applicable in the AI sense. For a physical device, "ground truth" would be established physical standards, material properties, sterility testing results, etc.

8. The sample size for the training set: Not applicable. There is no AI model to train.

9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The submission K970259 for the Intravascular Administration Set (E-Z SET® and Saf-T E-Z SET®) is a physical medical device 510(k) application. It is not an AI or software device. The primary purpose of this submission is to clarify the intended use of an unchanged device, adding suitability for blood sampling and pressure monitoring. Substantial equivalence is claimed based on the fact that the device itself has not changed from its previously marketed predicate. Therefore, the questions posed about AI-specific acceptance criteria, study methodologies, and performance metrics are not relevant to this document.

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