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The HydroMID is indicated for short term access (

The HydroMID catheter is a short term (

This document is a 510(k) Pre-Market Notification from the FDA, specifically concerning the HydroMID intravascular catheter. It details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the device in question is a physical medical device (intravascular catheter), not an AI/ML powered medical device. Therefore, the information requested in the prompt regarding acceptance criteria, study details, human reader improvement, multi-reader multi-case studies, ground truth establishment for AI/ML models, and sample sizes for training/test sets for AI/ML models is not applicable to this document.

The document describes the non-clinical testing performed for the HydroMID catheter to demonstrate its substantial equivalence to predicate devices. This testing primarily focuses on physical and performance characteristics relevant to a catheter, rather than the diagnostic or interpretation capabilities of an AI/ML algorithm.

Here's what can be extracted from the document regarding the device's performance and supporting studies, framed within the context of a physical medical device's acceptance rather than an AI/ML one:

1. Acceptance Criteria and Device Performance (for a physical medical device):

The "acceptance criteria" for a physical medical device like the HydroMID catheter are typically met by demonstrating comparable performance and safety to existing legally marketed predicate devices, along with meeting relevant industry standards.

2. Sample Size and Data Provenance for Device Testing (Non-Clinical):

The document does not specify sample sizes for the non-clinical tests. It refers to "in vitro and in vivo models" for thrombus accumulation and states that "Non-Clinical Test Conclusion" indicates that "the non-clinical testing of the proposed device was leveraged from the reference device."

• Data Provenance: The studies are pre-clinical (in vitro and in vivo models). Explicit geographical provenance is not given, but the manufacturer is based in Bedford, Massachusetts, USA. The studies are assumed to be prospective in design (i.e., conducted specifically for this submission).

3. Number of Experts and Qualifications for Ground Truth:

This is not applicable as the document describes a physical medical device, not an AI/ML system that requires expert interpretation for ground truth establishment.

4. Adjudication Method:

This is not applicable for the same reason as above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This is not applicable as the device is a physical catheter, not an AI/ML diagnostic aid for human readers.

6. Standalone Performance:

While not framed as "algorithm-only performance," the document describes standalone physical testing of the HydroMID catheter itself for characteristics like power injection flow rate, length, and potentially the repeated EO/ECH residuals test. The studies on thrombus accumulation ("in vitro and in vivo models") were also standalone performance evaluations of the device's material properties.

7. Type of Ground Truth Used:

For a physical device, "ground truth" refers to established scientific and engineering principles, material properties, and performance standards.

• Engineering Specifications/Standards: The device was tested against "Internal product specification," and according to FDA Guidance Documents, EN ISO 10555-1:2013, and EN ISO 10555-3:2013.
• Biological/Physiological Models: In vitro and in vivo models were used to evaluate thrombus accumulation. The "effectiveness in reducing thrombus accumulation" is the specific performance claim being substantiated.
• Reference Device Data: A significant portion of the supporting data (e.g., sterility, biocompatibility, MRI compatibility) was "leveraged" from the previously cleared HydroPICC device (K193015), which serves as a form of "ground truth" or a validated baseline for those shared characteristics.

8. Sample Size for Training Set:

This is not applicable as it's a physical device, not an AI/ML model.

9. How Ground Truth for Training Set was Established:

This is not applicable as it's a physical device, not an AI/ML model.

In summary, the document details the substantial equivalence of a physical medical device (intravascular catheter) to predicate devices through non-clinical performance testing against established standards and internal specifications, rather than the evaluation of an AI/ML-powered diagnostic tool.

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