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The Groshong® NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.

Groshong™ NXT Peripherally Inserted Central Catheters are made from specially formulated and processed medical grade materials in a tray with accessories for reliable long- (greater than 30 days) or short- (less than 30 days) term vascular access.

Groshong™ Valve Function

The Groshong™ catheter incorporates the patented, 3-position, pressure-sensitive Groshong™ valve. The valve is located near the rounded, closed, radiopaque catheter tip and allows fluid infusion and blood aspiration. When not in use, the valve restricts blood backflow and air embolism by remaining closed.

The Groshong™ valve is designed to remain closed between -7- and 80-mm Hg. Since the normal central venous pressure range in the superior vena cava is 0 to 5 mm Hg, the valve remains closed at normal central venous pressure. Pressure in the superior vena cava must exceed 80 mm Hg to open the valve inward. Also, negative pressure (vacuum) will cause the valve to open inward, allowing blood aspiration.

Positive pressure into the catheter (gravity, pump, syringe) will open the valve outward, allowing fluid infusion. The need for the anticoagulant effect of heparin is eliminated because the closed valve prevents blood from entering the catheter and clotting. If the catheter is aspirated, pulling the valve inward, it must be flushed with normal saline to clear blood from the lumen and allow the valve to return to its normal, closed position.

The provided text is a 510(k) summary for the Groshong™ NXT PICC Catheter. It outlines the device's characteristics, its similarities to a predicate device, and the testing performed to demonstrate substantial equivalence. However, it does not contain detailed acceptance criteria, specific reported device performance values, or information about a study proving the device meets these criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a predicate device (also named Groshong™ NXT PICC Catheter, K034020), rather than establishing and meeting novel acceptance criteria for the new device and then detailing a study specifically proving the new device's performance against them. The premise is that because the new device is largely similar to the predicate and differences have been evaluated not to raise new safety/effectiveness concerns, its performance is considered substantially equivalent.

Therefore, many of the requested items cannot be extracted from this document, as it's designed for a different purpose (510(k) clearance based on substantial equivalence) than a detailed clinical or performance study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided directly from the text. The document lists performance tests and reference standards (e.g., ISO 10555-1, ASTM F640), but it does not specify quantitative acceptance criteria or the reported performance values for the "subject device" against these criteria. It only states that the tests were "conducted per guidance documents, industry standards, and in-house protocols to establish the performance of the device, thereby leading to a conclusion of substantial equivalence."

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

• Cannot be provided. The document mentions "Verification and validation tests" and "Performance tests for Subject Device," but does not specify sample sizes for these tests, the country of origin of the data, or whether the data was retrospective or prospective. These would typically be detailed in a separate test report, not the 510(k) summary.

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 / Cannot be provided. This type of information is relevant for studies involving expert review, such as image analysis for AI devices. The Groshong™ NXT PICC Catheter is an intravascular catheter, and the performance tests mentioned (e.g., biocompatibility, sterility, radiopacity) do not typically involve human expert interpretation in the way an AI diagnostic device would.

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

• Not applicable / Cannot be provided. Similar to point 3, adjudication methods are typically used in studies involving human interpretation or outcome assessment, not for the technical performance testing of a catheter.

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 device is a medical catheter, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a medical catheter, not an algorithm.

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

• Limited information. For the physical and material tests, the "ground truth" would be the established scientific principles and specifications defined by the referenced ISO and ASTM standards. For example, for biocompatibility, the ground truth is adherence to ISO 10993-1. For radiopacity, it's meeting the criteria of ASTM F640. There isn't "expert consensus" or "pathology" in the sense of a diagnostic outcome for this type of device performance testing.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

• Not applicable. As above, no training set is involved.

Summary of what is available from the text:

The document describes the Groshong™ NXT PICC Catheter and states that its technological characteristics are substantially equivalent to a predicate device (K034020) with the same name. The key differences evaluated were:

• A change to the inner lumen geometry (from round to rectangular).
• A material and formulation change to the catheter silicone and catheter silicone colorant.

These differences were evaluated through risk assessment and performance tests. The document asserts these changes "do not raise new or different questions of safety or effectiveness."

Performance Tests Conducted (Verification / Validation Method and Reference Standards):

• Performance:
  • ISO 10555-1:2013/Amd 1:2017: Intravascular Catheters - Sterile and Single-Use Intravascular Catheters - Part 1: General Requirements
  • ISO 10555-3:2013: Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters
  • ASMT F640-12: Standard Test Methods for Determining Radiopacity for Medical Use
  • ASTM F2119-07: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
  • ASTM F2182: Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging
  • ASTM F2052-15: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
  • ASTM F2213-17: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
• Biocompatibility Evaluations:
  • ISO 10993-1:2018: Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process
  • USP: Particulate Matters in Injections (method 1 Light Obscuration Particle Count Test)
• Sterilization:
  • ANSI AAMI ISO 11135:2014C: Sterilization of Health Care Products - Ethylene Oxide - Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices.

In conclusion, while the document confirms tests were done according to established standards to support substantial equivalence, it does not provide the detailed study information or quantitative acceptance criteria and results as typically found in a clinical study report for an AI device.

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