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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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Turbo-Flo® Peripherally Inserted Central Venous Catheters (PICC) are 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 maximum pressure setting/limit of power injectors used with the Turbo-Flo PICC may not exceed 300 psi for the 5 Fr single lumen and 200 psi for the 4 Fr single lumen and 5 Fr double lumen. The Turbo-Flo PICC is indicated for a single injection of contrast media through a power injection.

Turbo-Flo® PICCs are polyurethane peripherally inserted central venous catheters 60 cm in length, available in 4 & 5 Fr single lumen and 5 Fr double lumen for short and long-term use. Catheters are inserted using an obturator version or an over-the-wire version.

The provided document describes a Premarket Notification (510(k)) for the Cook Turbo-Flo® PICC, a peripherally inserted central venous catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving de novo safety and effectiveness through clinical trials. Therefore, the information requested about acceptance criteria and a study proving those criteria are met, particularly in the context of AI/MRMC studies, ground truth establishment, and training sets, is not fully applicable or present in this document.

However, I can extract the relevant information regarding the device's performance claims and the testing conducted to support its substantial equivalence.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present explicit, quantifiable acceptance criteria with corresponding performance metrics in a tabular format as would be seen in a de novo approval or a study with predefined endpoints. Instead, it states that the device "has undergone testing which provide reasonable assurance of safety and effectiveness for its intended use equivalent to predicate devices."

The types of testing conducted are listed:

Note: The FDA letter explicitly adds a limitation based on these tests: "The safe and effective use of the 4 Fr Single Lumen and 5 Fr Double Lumen Turbo-Flo PICC catheters with power injector pump pressure settings above 200 psi has not been established." This indicates that while the device was tested, the performance at higher pressures for these specific configurations was not deemed sufficiently proven.

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

• Sample Size: Not specified. The document states "Testing included tensile, flow rate, leakage, stability, and biocompatibility," but does not detail the number of units tested for each.
• Data Provenance: Not specified. It can be assumed these were laboratory (bench) tests conducted by Cook Incorporated, likely in the US (Bloomington, IN). The data is retrospective in the sense that it was generated prior to the 510(k) submission.

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

Not applicable. This is a medical device 510(k) Pre-Market Notification, not a study evaluating expert performance or AI. The "ground truth" for the device's physical and mechanical properties would be established by standard engineering and materials science testing methodologies, not by expert consensus in diagnostic interpretation.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study involving human interpretation of data where adjudication would be necessary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This document is for a physical medical device (catheter), not an AI algorithm for diagnostic imaging, and therefore, human reader performance with or without AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This document is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the tests mentioned (tensile, flow rate, leakage, stability, biocompatibility) would be based on:

• Engineering Specifications/Standards: Established industry standards (e.g., ASTM, ISO), internal Cook specifications, or regulatory guidelines for medical device materials and performance.
• Physical Measurements: Direct measurements of tensile strength, flow rates, leakage volumes, and material stability through laboratory instrumentation.
• Biological Assays: For biocompatibility, established in vitro and/or in vivo biological testing methods according to standards like ISO 10993.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device 510(k) for a physical product, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for a physical medical device.

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