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CentroVena Central Venous Catheter (CVC)

Acute central venous catheters are indicated to provide short term access (

Vena Central Venous Catheters are power-injectable, constructed of medical grade polyurethane and designed for insertion into the central venous system. The central venous catheters are radiopaque and have a soft tip that is more pliable than the catheter body. Each catheter is provided in a sterile package with other applicable insertion kit accessories.

The CentroVena One Insertion System integrates the essential components for placing central venous catheters. It combines an introducer needle with a passive needle tip safety mechanism, syringe, guidewire, and self-dilating catheter into one unit. The device is preassembled and also has an integrated drape clip permanently attached to the guidewire designed to keep the system organized in the sterile field and prevent guidewire embolism.

The provided document is a 510(k) clearance letter for a medical device: CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System.

Important Note: The document is primarily a regulatory approval and comparison to a predicate device. It lists numerous "acceptance criteria" through reference standards and tests, but it does not provide the specific numerical results or performance metrics that demonstrate the device quantitatively meets these criteria. It also doesn't detail specific study designs for these tests beyond listing the reference standards.

Therefore, the following information will be extracted where explicitly stated or inferable from the document. Many aspects of a detailed study design (like sample sizes for performance tests, expert qualifications, adjudication methods, or specific effect sizes for human performance improvement with AI) are not typically included in a 510(k) summary for a physical medical device like a catheter and related insertion system as they are more relevant to AI/software as a medical device studies.

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria

The CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System underwent various performance and safety tests to demonstrate substantial equivalence to its predicate device, the BD Acute Central Line (K190855). The acceptance criteria for the device are primarily derived from compliance with recognized industry consensus standards and FDA guidance documents. The studies involved functional performance testing, biocompatibility testing, and evaluation of the insertion system.

1. Table of Acceptance Criteria (as indicated by reference standards) and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each of the numerous tests conducted. The testing described is typical for physical medical devices and usually involves a statistically relevant number of units/components for each specific test to ensure robust results.

The data provenance is not explicitly stated beyond the fact that these are tests conducted by Becton Dickinson Inc. (BD) to support their 510(k) submission. These would generally be pre-market, prospective tests conducted in a controlled laboratory environment. The country of origin of the data is not mentioned but would presumably be where BD's testing facilities are located.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable and not provided in the document. The device is a physical catheter and insertion system, not an AI/software device that requires expert labeled ground truth for image interpretation or diagnosis. The "ground truth" for these tests would be the established scientific and engineering principles outlined in the reference standards themselves.

4. Adjudication Method

This information is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in studies where human readers are interpreting images or data and their decisions need to be reconciled to establish a ground truth, often for AI performance evaluation. This is not relevant for the type of bench and performance testing documented here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done or is mentioned. This type of study is specifically designed for evaluating the performance of diagnostic devices, especially those involving human interpretation (e.g., radiology AI aids), and comparing human performance with and without AI assistance. This device is a physical medical instrument, not a diagnostic AI.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical instrument, not an algorithm or software requiring standalone performance testing.

7. Type of Ground Truth Used

The "ground truth" for the various performance tests is established by:

• Established Industry Consensus Standards: Such as ISO 10993, ISO 10555, ASTM F640, etc. These standards outline methodologies and acceptable performance limits for specific characteristics of medical devices.
• FDA Guidance Documents: Which also provide testing recommendations and performance expectations for device types.
• Engineering Specifications and Design Requirements: The device must meet its own design specifications, which are based on the intended use and safety considerations, often derived from the above standards.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/machine learning model that requires a training set. The tests performed are for verification and validation of the manufactured device.

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

Not applicable. As there is no training set for this type of device, no ground truth needs to be established for it.

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