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The HEALTH LINE CT CVC is indicated for short term (less than 30 days) access to the central venous system for intravenous administration of fluids, medications, blood products, and/or nutritional therapy solutions when prescribed. Blood sampling and power injection of contrast media may also be conducted with the HEALTH LINE CT CVC.

The HEALTH LINE CT CVC is a family of central venous catheters designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies. The catheters, made of radiopaque polyurethane tubing, are inserted in a central vein. Each HEALTH LINE CT CVC has a kink resistant, gradual tapered catheter design. The HEALTH LINE CT CVC kit includes a catheter and introduction components. The catheter is supplied sterile and nonpyrogenic in a variety of kit configurations.

The HEALTH LINE CT CVC is indicated for dwell times shorter than 30 days. The HEALTH LINE CT CVC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi.

The HEALTH LINE CT CVC product line has catheters in 16 G and 14 G single lumen, 5 Fr and 7 Fr dual lumen and 7 Fr triple lumen. Catheters range from approximately 13-30 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment. All HEALTH LINE CT CVC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.

The provided text describes a 510(k) summary for the "Health Line CT CVC" device. This device is a central venous catheter (CVC).

Important Note: The document states that the device is identical to the predicate device (Orion™ II CT CVC, K113622) in its final finished form, with only minor changes to labeling, instructions for use, and the addition of an optional suture wing component. These changes are explicitly stated to not impact the performance or safety and effectiveness of the device compared to the predicate. Therefore, the "study that proves the device meets the acceptance criteria" for this specific 510(k) is primarily based on the demonstration of substantial equivalence to the legally marketed predicate device, leveraging the predicate's existing performance and biocompatibility data.

This is not a typical AI/ML-based device submission that would involve ground truth establishment, reader studies, or detailed algorithm performance metrics. Instead, it's a traditional medical device submission relying on established equivalence principles.

Given this context, I will address the requested points, noting where the information is not applicable due to the nature of this 510(k) submission for a non-AI/ML device.

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission for a physical device, the "acceptance criteria" are primarily met through demonstrating equivalence to the predicate device and compliance with relevant standards. The performance is demonstrated through in vitro testing and biocompatibility.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

For this type of device (non-AI/ML, physical catheter), a "test set" in the context of an algorithm is not applicable. The performance testing is typically in vitro and would involve a sample size of devices tested to demonstrate compliance with specifications (e.g., burst pressure, flow rate, tensile strength). The document states:

• "The HEALTH LINE CT CVC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi."
• "The subject device is identical to the predicate device (K113622) in its final finished form. Therefore, the biocompatibility and performance data were leveraged from the predicate device."

While specific sample sizes for these tests are not provided in this summary, they would typically be determined by recognized standards and statistical rationale for the specific physical and chemical tests performed. The data provenance would be from laboratory testing conducted as part of the device development and validation, likely under GLP conditions. The document does not specify the country of origin for these test results, but implied that it's from existing documentation related to both the predicate and the current device, likely conducted internally or by contract testing labs.

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 applicable. This is not an AI/ML device requiring human expert annotation for ground truth. The "ground truth" for a physical device is derived from engineering specifications, material properties, and relevant performance standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device requiring expert adjudication of image annotations or diagnoses.

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. This is not an AI/ML device; therefore, no MRMC study or human reader improvement assessment was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device with a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" for demonstrating performance is based on:

• Engineering Specifications and Bench Testing: Compliance with defined parameters like burst pressure, flow rates, tensile strength, and material integrity.
• Biocompatibility Standards: Adherence to ISO 10993 series for material safety.
• Sterilization Validation: Compliance with ISO 11135-1 and AAMI TIR 28.
• Demonstrated Performance of Predicate Device: The primary "ground truth" is that the legally marketed predicate device (Orion™ II CT CVC) has already demonstrated its safety and effectiveness for its intended use, and the current device is substantially equivalent.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device requiring a training set with established ground truth.

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