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The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is used for:

1. Continuous or intermittent drug infusions
2. Central venous blood pressure monitoring (CVP)
3. Acute hyperalimentation
4. Blood sampling
5. Delivery of whole blood or blood products
6. Simultaneous, separate infusion of drugs for multi-lumen catheters only
   The device is a short-term use catheter, intended for less than 30 days.
   The Cook dilator is used for dilating puncture sites or catheter tracts.
   The Cook Unimpregnated Central Venous Catheter (Non-Power Injectable) is intended for adult and pediatric populations.

The Cook Unimpregnated Central Venous Catheter with power injection is used for:

1. Continuous or intermittent drug infusions
2. Central venous blood pressure monitoring (CVP)
3. Acute hyperalimentation
4. Blood sampling
5. Delivery of whole blood or blood products
6. Simultaneous, separate infusion of drugs for multi-lumen catheters only
7. Power injection of contrast media*
   *The flow rate may not exceed 3 mL/sec for 4.0 and 5.0 French catheters and 10 mL/sec for 7.0, 8.0, 9.0, and 10.0 French catheters. Verify prior to use that the maximum safety cut-off pressure limit is set at or below 250 psi for 4.0 and 5.0 French catheters and 325 psi for 7.0, 8.0, 9.0, and 10.0 French catheters.
   The device is a short-term use catheter, intended for less than 30 days.
   The 9.0 and 10.0 French catheters include an inner catheter to facilitate insertion of the main catheter.
   The Cook dilator is used for dilating puncture sites or catheter tracts.
   The Cook Unimpregnated Central Venous Catheter with power injection is intended for adult and pediatric populations.

The Cook Unimpregnated Central Venous Catheter is a single use sterile intravascular catheter designed to be inserted into a patient's vascular system. The CVC is inserted into the vasculature using the Seldinger technique. The tip of the catheter is then advanced until it is above the superior vena cava-right atrium (SVC-RA) junction. The CVC configurations include a single, dual, triple, or five-lumen shaft manufactured from polyethylene, ethylene-vinyl acetate, or polyurethane tubing. The CVC is manufactured with an outside diameter between 2.5 and 10 French and has a length between 5 and 40 centimeters dependent on the configuration. Single lumen CVCs are designed with a premolded winged hub on the proximal end. Dual, triple, and five-lumen CVCs are designed with a manifold assembly, which is comprised of a winged manifold connected to extension tubes. Each extension tube has a slide clamp and is manufactured with a proximal winged hub. Certain CVC configurations are power injectable. The CVC may be packaged as a convenience kit with various other components which may include a dilator, inner catheter, wire guide, access needle, injection caps, clamps, catheter securement device, connecting tube, and other convenience accessories. The subject device inner catheter, supplied with the 9 and 10 French subject device catheters, is used to assist advancement of the main catheter over the wire guide. The inner catheter, manufactured from nylon, is designed to lock with the hub of the polyurethane catheter. The subject device dilator, used to dilate the access site during the procedure, is designed with a radiopaque extruded polyethylene shaft and a pre-molded polyethylene proximal hub. It is manufactured with an outside diameter ranging from 3.5 to 12.0 French and has a length between 6 and 11 centimeters.

The provided text describes the acceptance criteria and the results of various performance tests for the Cook Unimpregnated Central Venous Catheter. It is a submission for a 510(k) premarket notification to demonstrate substantial equivalence to a predicate device, not an AI or algorithm-driven device. Therefore, many of the requested categories (such as sample size for test set, data provenance, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable to this document.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• ≥ 5 N for 2.5 and 3 Fr catheters
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Sideport Tensile (Aged) | Peak tensile load for the sideport section of the catheter shall be:
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Shaft-to-Hub Tensile (Aged) | Peak tensile load for the shaft-to-hub section of the catheter shall be:
• ≥ 5 N for 2.5 and 3 Fr catheters
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Shaft-to-Manifold Tensile (Aged) | Peak tensile load for the shaft-to-manifold section of the catheter shall be:
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Manifold-to-Extension Tube Tensile (Aged) | Peak tensile load for the manifold-to-extension tube section of the catheter shall be:
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Extension Tube-to-Hub Tensile (Aged) | Peak tensile load for the extension tube-to-hub section of the catheter shall be:
• ≥ 10 N for 4 and 5 Fr catheters
• ≥ 15 N for catheters > 5 Fr
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Catheter Liquid Leakage (Aged) | No part of the catheter shall leak liquid when tested in accordance with Annex C of BS EN ISO 10555-1. | The acceptance criterion was met. |
  | Catheter Air Leakage (Aged) | No air shall enter the hub when tested in accordance with Annex D of BS EN ISO 10555-1. | The acceptance criterion was met. |
  | Catheter Kink Radius (Aged) | The catheter shall not kink (flowrate reduced by 50%) at a specified kink (circumferential) length when tested in accordance with Annex B of BS EN 13868. | The acceptance criterion was met. |
  | Catheter Gravity Flow Rate (Time-Zero) | The flow rate of the test articles will be characterized when tested in accordance with Annex E of BS EN ISO 10555-1. | The acceptance criterion was met. |
  | Catheter Static Burst (Aged) | The catheter failure pressure during static burst was characterized for the test articles when tested in accordance with Annex F of BS EN ISO 10555-1. | The acceptance criterion was met. |
  | Catheter Hub Pressure (Power Injection) (Aged) | The peak hub pressure of the power injectable lumen for each specimen type for the test articles when tested in accordance with Annex G of BS EN ISO 10555-1. | The acceptance criterion was met. |
  | Inner Catheter Shaft Tensile (Time-Zero) | Peak tensile load for the shaft section of the inner catheter shall be:
• ≥ 5 N for 3 Fr catheters
• ≥ 10 N for 4 Fr catheters
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Inner Catheter Hub-to-Shaft Tensile (Time-Zero) | Peak tensile load for the hub-to-shaft section of the inner catheter shall be:
• ≥ 5 N for 3 Fr catheters
• ≥ 10 N for 4 Fr catheters
  (In accordance with BS EN ISO 10555-1:2013) | The acceptance criteria were met. |
  | Dilator Hub-to-Shaft Tensile (Aged) | Peak tensile load for the hub-to-shaft section of the dilator shall be:
• ≥ 5 N for 3.0 Fr dilators
• ≥ 10 N for 3.5, 4.0, 5.0, and 5.5 Fr dilators
• ≥ 15 N for dilators > 5.5 Fr
  (In accordance with BS EN ISO 11070) | The acceptance criterion was met. |
  | Dilator and Wire Guide Compatibility Analysis | Each unique dilator French size shall be compatible with the correlating wire guide. | The acceptance criteria were met (implied by "The acceptance criterion was met"). |
  | Catheter Hub Luer Compatibility Analysis | Tested in accordance with the test methods specified in ISO 594-1:1986 and ISO 594-2:1998. | The acceptance criterion was met (implied by "The acceptance criterion was met"). |
  | Packaging: Dye penetration testing | Per ASTM F1929-15. | Performed (stated "Performed to assure design and performance"). |
  | Packaging: Seal strength testing | Per ASTM F88/F88M-15. | Performed (stated "Performed to assure design and performance"). |
  | Sterilization validation testing | Per ISO 11135-1:2014. | Performed (stated "Performed to assure design and performance"). |
  | Biocompatibility Testing | Testing for cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, and hemocompatibility were performed per ISO 10993-1 and FDA guidance. | Performed (stated "Performed to ensure the biocompatibility of the subject device set"). |

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each performance test. It mentions "each specimen type" for some tests, implying multiple samples were tested for each variation. Data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but these are laboratory-based performance tests, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document describes laboratory performance testing of a physical medical device, not a diagnostic or AI-driven system that requires expert ground truth.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, this is about the mechanical and material performance of a central venous catheter, not a diagnostic or AI system.

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

Not applicable, as this is not an algorithm or AI device.

7. The type of ground truth used

For the performance tests, the "ground truth" is defined by the objective physical and chemical standards and test methods specified by the referenced international standards (e.g., BS EN ISO 10555-1, BS EN 13868, ISO 594-1, ISO 594-2, ASTM F1929-15, ASTM F88/F88M-15, ISO 11135-1, ISO 10993-1). These standards outline the methods to objectively measure and verify the device's characteristics.

8. The sample size for the training set

Not applicable, as this is not an AI or algorithm-driven device that requires a training set.

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

Not applicable.

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