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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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Turbo-Flo® Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for venous pressure monitoring, blood sampling and administration of drugs and fluids.

The 4 and 5 Fr Turbo-Flo® PICC Sets with single or double lumen configurations are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted over-the-wire or through a Peel-Away® introducer. The set components may include the PICC, obturator, Peel-Away® introducer, entry needles, wire guide, and other convenience components. The set is supplied sterile and is intended for one-time use.

This document describes a 510(k) premarket notification for the Cook Incorporated Turbo-Flo® PICC Sets. The submission aims to demonstrate substantial equivalence to a predicate device (Turbo-Flo® PICC, K041849). It's important to note that the document explicitly states no performance testing was required or conducted for this specific submission because the modifications were deemed minor. Therefore, there are no acceptance criteria or study results demonstrating performance to those criteria for this specific device in this document.

However, based on the provided text, I can infer the context and provide a table reflecting the changes made and the justification for not requiring new performance criteria/studies.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not list explicit quantitative acceptance criteria or corresponding measurement results for the Turbo-Flo® PICC Sets. Instead, it relies on the argument of "substantial equivalence" to a previously cleared predicate device. The changes made (ink type and removal of power injection indication) were considered minor and adequately addressed by previous clearances or by their nature not to introduce new safety or effectiveness concerns.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. No dedicated performance or clinical testing was conducted for this submission. The rationale for substantial equivalence explicitly states "no testing is warranted" and "no performance testing is required for this submission."
• Data Provenance: Not applicable. As no new testing was performed, there is no new test set data. The justification for substantial equivalence relies on the characteristics of the previously cleared predicate device (Turbo-Flo® PICC K041849) and reference device (Turbo-JeCT PICC K072625).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Number of Experts: Not applicable. No new test set requiring expert ground truth establishment was conducted for this submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No new test set requiring adjudication was conducted for this submission.

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

• MRMC Study: Not applicable. This device is a physical medical device (catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

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

• Standalone Performance: Not applicable. This is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable for new testing in this submission. The "ground truth" for the device's safety and effectiveness relies on the prior extensive testing and regulatory clearance of the predicate device (Turbo-Flo® PICC K041849) and the reference device (Turbo-JeCT PICC K072625). For the changes specifically, the ground truth is essentially the established performance of the new ink in the reference device and the inherent safety evaluation of removing a feature.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable. As above, this is a physical medical device, not an AI/machine learning model.

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The Spectrum Turbo-JeCT PICC is indicated for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheterrelated bloodstream infections (CRBSIs). The Spectrum Turbo-JeCT PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for power injectors used with the Spectrum Turbo-JeCT PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

The Spectrum Turbo-JeCT catheter is a radiopaque polyurethane peripherally inserted central venous catheter impregnated with antimicrobials and intended for short- or longterm use. The Spectrum Turbo-JeCT PICCs are 60 cm in length and available in 4 and 5 Fr single lumen and 5 Fr double lumen configurations.

The set components include an introducer needle, wire guide, locking Peel-Away introducer, 12cc syringe, drape, injection cap, catheter fixation device, tape measure, safety scalpel, and a hydrophilic-coated wire guide obturator for non-over-the-wire versions.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Spectrum® Turbo-JeCT™ PICC device:

The provided text is a 510(k) summary for a medical device (PICC catheter), which primarily focuses on demonstrating substantial equivalence to predicate devices and lists the types of tests performed. It does not contain the detailed information required to populate all the requested fields, especially concerning the acceptance criteria for each test, specific numerical results against those criteria, or complex study designs like MRMC studies or ground truth establishment for AI systems. This is typical for a 510(k) summary, which is a high-level overview.

However, I can extract what is present and indicate where information is missing.

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

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

• Sample Size: Not specified in the provided summary for any of the tests.
• Data Provenance: Not specified, but likely from in-house laboratory testing (prospective, non-clinical). The equipment used for flow rates (Medrad Stellant® CT injector system) is a commercial product. The "Omnipaque 300®" contrast is a commercial product (Amersham Health, New Jersey).

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

• This question is not applicable. The device is a physical medical device (PICC catheter), not an AI/software device requiring expert interpretation of diagnostic images or data for ground truth establishment. The "ground truth" here is the physical performance of the catheter itself against engineering and physiological requirements.

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

• This question is not applicable. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments, not for physical 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

• This question is not applicable. This device is a physical catheter, not an AI or software device intended for diagnostic interpretation or to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

• This question is not applicable. This device is a physical catheter, not an algorithm or software. "Standalone performance" in this context would refer to the catheter's physical performance, as evaluated by the listed tests, independent of human operators (though human operators would be involved in setting up the tests). The tests performed are effectively "standalone" in this physical sense.

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

• The "ground truth" for the physical performance tests would be defined by engineering specifications, regulatory standards, and established physiological requirements for central venous catheters. For example:
  • Flow rate ground truth: The measured flow rate through the catheter compared against the specified maximum flow rate for safe and effective contrast delivery.
  • Pressure ground truth: The pressure the catheter can withstand compared against the maximum allowed pressure for power injectors.
  • Material integrity ground truth: Absence of leakage, breakage, or degradation under specified conditions.
  • Biocompatibility ground truth: Absence of cytotoxic effects, sensitization, irritation, etc., as per ISO 10993 standards.

8. The sample size for the training set

• This question is not applicable. This device is a physical catheter, not an AI/machine learning model that requires a "training set" of data.

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

• This question is not applicable for the same reason as #8.

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