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Indicated for short-or long-term peripheral access to the central venous therapy, including but not limited to the administration of fluids, medications, and nutrients; the sampling of blood; central venous pressure monitoring; and power injection of contrast media.

Rated for maximum power injection flow rate of 3.5ml/s

The HydroPICC peripherally inserted central catheter (PICC) is a 5 French, dual lumen catheter comprised of a radiopaque hydrophilic catheter material with a suture wing, Luer lock hubs, and extension tubes made from materials commonly used in the manufacture of catheters are provided packaged in kit configurations with the appropriate accessories for placement in the appropriate clinical environments. The maximum power injection flow rate for each lumen is indicated on each extension tube clamp.

HydroPICC has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vivo models. Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

This document is a 510(k) summary for the HydroPICC 5F Dual Lumen Catheter. It indicates that the device has undergone performance testing to demonstrate substantial equivalence to a predicate device. However, the document does not contain details about acceptance criteria, reported device performance, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

The provided text focuses on the physical and technological characteristics of the medical device and its predicate, along with the regulatory and biocompatibility testing performed to establish substantial equivalence. It does not describe an AI/ML device or its performance study in the way the request specifies.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's the breakdown of what can be extracted:

1. A table of acceptance criteria and the reported device performance: Not available in the provided text. The document refers to conformance with recognized standards but does not list specific acceptance criteria or performance metrics for the device in a study context.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not available in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not available in the provided text.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available in the provided text.

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 available in the provided text. This device is not an AI/ML product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in the provided text. This device is not an AI/ML product.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available in the provided text. For the type of device (intravascular catheter), "ground truth" would typically refer to physical and mechanical properties, not diagnostic categories.

8. The sample size for the training set: Not available in the provided text. This device is not an AI/ML product.

9. How the ground truth for the training set was established: Not available in the provided text. This device is not an AI/ML product.

What can be extracted from the document regarding "performance testing" related to the device:

The document lists various performance tests conducted to demonstrate conformance with FDA-recognized standards for intravascular catheters. These tests are primarily focused on the physical, mechanical, and safety aspects of the catheter, rather than diagnostic or AI-driven performance.

Study Details (as much as can be inferred/is stated):

• Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth (for diagnostic AI/ML): Not applicable or not provided. The study mentioned for "reducing thrombus accumulation" used "in vivo models," but specific details like sample size, provenance, control groups, or exact endpoints are not given.
• Training Set Sample Size/Ground Truth: Not applicable for this type of medical device submission.

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The HydroMID is indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy, including but not limited to, the administrations, and the sampling of blood and blood products. Therapies not appropriate for midline catheters include continuous vesicant therapy, parenteral nutrition, infusates with pH less than 5 or greater than 9, and infusates with an osmolarity greater than 600mOsm/L.

HydroMID is rated for a Maximum Power Injection Flow Rate of 6mL/sec.

The HydroMID catheter is a short term (< 30 days) peripheral venous access device with a single 4F outer diameter lumen that is 20 cm in length. Midlines are usually placed in an arm vein such as the basilic, brachial, or cephalic and the tip ends below the level of the axillary line. Midline catheters are longer than peripheral IV catheters which are generally 1 to 3 inches long and shorter than peripherally inserted central catheters (PICC) which extend into the superior vena cava. This device provides an alternative to short peripheral IVs and PICCs for certain treatments.

The HydroMID catheter is comprised of radiopaque, hydrophilic base with a suture wing, Luer lock hub, and extension tube made from materials commonly used in the manufacture of catheters. The catheter has a maximum power injection flow rate of 6ml/sec. HydroMID has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vitro and in vivo models. Pre-clinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

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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