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The CVC WAND™ Safety Introducer with Valved Peelable Sheath is indicated for use in percutaneous insertion of catheters into the venous system.

The CVC WAND™ Safety Introducer with Valved Peelable Sheath (hereafter CVC WAND™) is a catheter introducer device that is virtually identical to the predicate device, the CVC WAND™ Safety Introducer with Valved Peelable Sheath, cleared for commercial distribution under 510(k) K131148. When assembled for use, it is an all-inone preassembled intravascular catheter introducer, that provides the clinician with a simple and accelerated approach to the Seldinger Technique for placing in-dwelling intravascular catheters. The device is composed of the following key components:

• Introducer Needle
• Guidewire
• Dilator
• Valved Peelable Sheath Introducer

The CVC WAND™ includes a 21-gauge microaccess needle, nylon tissue dilator, FEP peelable sheath and Nitinol guidewire. This device has an integrated valve within the body of the Peelable Sheath Introducer hub which is designed to reduce inflow of air into the bloodstream and outflow of blood when the guidewire, introducer needle and dilator are removed, but it is not a hemostasis valve. The device also has a blood flashback window proximal to the needle's tip which allows the clinician to observe blood flashback upon entering the vessel with the Safety Introducer. The microaccess needle is echogenic and provides the pathway for the guidewire insertion, while the dilator facilitates placement of the peelable sheath and ultimately catheter placement.

The CVC WAND™ is individually packaged in a PETG. glvcol modified polyethylene terephthalate, plastic tray. The tray is heat sealed with a Tyvek® lid. The device is provided 'STERILE' (ethylene oxide gas) and is for 'single-use' only.

The FDA 510(k) summary for "The CVC WAND Safety Introducer with Valved Peelable Sheath" (K182243) does not describe a study involving AI or human readers. The summary focuses on validating a material change in a component of the device (from silicone to thermoplastic elastomer in the valve of the peelable sheath introducer) and demonstrating its substantial equivalence to a previously cleared predicate device (K131148). Therefore, many of the requested categories are not applicable to this submission.

Here's a breakdown of the information provided based on your request, with an emphasis on what is not applicable due to the nature of the device and the submission:

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

The document describes various tests conducted and generally states that the results "satisfied the acceptance criteria of the relevant ISO 10993 standards" or "satisfy acceptance criteria identified in applicable standards and/or the device design specification." However, specific numerical acceptance criteria or detailed performance metrics are not explicitly provided in a table format as requested. The document primarily lists the tests performed and a high-level outcome of meeting criteria.

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 explicitly stated for any of the individual tests. The submission describes conducting "designed verification testing."
• Data Provenance: The document indicates that tests were conducted according to ISO and ASTM standards, and some were GLP (Good Laboratory Practice) compliant. This suggests controlled laboratory settings. It doesn't specify a country of origin for the data or whether the data was retrospective or prospective, though performance testing is inherently prospective for the device being tested.

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)

This is not applicable. The device is a medical instrument (catheter introducer), not a diagnostic imaging device or an AI algorithm requiring expert ground truth for its performance assessment. Its performance is evaluated through physical, chemical, and biological tests against established standards.

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

This is not applicable. See the explanation for point 3.

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 is not applicable. This device is a physical medical instrument, not an AI system.

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

This is not applicable. This device is a physical medical instrument, not an AI algorithm.

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

For the biocompatibility and performance testing, the "ground truth" or reference for comparison are established international standards (ISO, ASTM, USP) and the device's own design specifications for functional requirements. For example, for biocompatibility, the reference is what constitutes a non-toxic or non-irritating response according to ISO 10993. For mechanical tests, it's meeting specified engineering tolerances.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI system with a training set.

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

This is not applicable. See the explanation for point 8.

In summary, the K182243 submission focuses on demonstrating the safety and performance of a modified medical device through standard engineering and biocompatibility testing, rather than the evaluation of an AI-powered diagnostic tool. Therefore, many of your questions related to AI studies and their methodologies are not relevant to this particular FDA submission.

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The CVC WAND™ Safety Introducer with Valved Peelable Sheath is indicated for use in percutaneous insertion of catheters into the venous system.

The CVC WAND™ Safety Introducer with Valved Peelable Sheath (hereafter CVC WAND™) is a catheter introducer device that is virtually identical to the predicate device. the PICC WAND® Peelable Safety Introducer (K111138). When assembled for use, it is an all-in-one preassembled intravascular catheter introducer, that provides the clinician with a safe, simple, and accelerated approach to the Seldinger Technique for placing in-dwelling intravascular catheters. The device is composed of the following key components:

• Introducer Needle
• Guidewire
• Dilator
• Valved Peelable Sheath Introducer
  Some of the components of the predicate device have been modified to facilitate the specific clinical requirements for peripheral access for the placement of a Central Venous Catheter (CVC). The primary modification to the predicate device is the addition of a valve within the body of the Peelable Sheath Introducer Hub. When the Guidewire, Needle and Dilator are removed from the Valved Peelable Sheath Introducer, as part of performing the Accelerated Seldinger Technique procedure, the valve in the hub is actuated (in the closed position) thus preventing air from entering into the venous circulatory system and conversely preventing blood from leaking out. The valve is designed to allow passage of the CVC through it into the central venous circulatory system. This valve provides a similar function as the Bard AirGuard™ Valved Introducer, the other predicate device (K042036). After confirmation of the proper CVC placement, the Valved Peelable Sheath Introducer is removed by breaking apart the Sheath Introducer hub and peeling the sheath off the CVC in the identical manner as the predicate PICC WAND® Peelable Sheath Introducer.
  The CVC WAND™ Safety Introducer is individually packaged in a PETG, glycol modified polyethylene terephthalate, plastic tray. The tray is heat sealed with a Tyvek® lid. The device is provided 'STERILE'(ethylene oxide gas) and is for 'single-use` only.

Here's a breakdown of the acceptance criteria and study information for the CVC WAND™ Safety Introducer with Valved Peelable Sheath, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text outlines the types of tests performed and states that the results "satisfied acceptance criteria as identified in applicable standards and the device design specification." However, it does not provide specific numerical acceptance criteria or the reported device performance metrics for these tests. It only lists the tests themselves.

Here's a table summarizing the tests, categorizing them implicitly based on the context:

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

The document does not explicitly state the sample sizes (number of units) used for the prospective bench testing (Table 5.3) or the biocompatibility testing (Table 5.1).

Data provenance is not mentioned beyond the fact that the tests were conducted. There's no indication of country of origin or whether the studies were retrospective or prospective, though the term "Prospective testing" is used for the performance testing in Table 5.3.

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

This information is not applicable to the provided document. The studies described are bench tests and biocompatibility tests, not clinical studies involving expert assessment of images or patient data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish ground truth for a test set, which is not the case here.

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

No MRMC comparative effectiveness study was mentioned. The studies focus on device performance characteristics and biocompatibility, not on the comparative effectiveness of human readers with or without AI assistance.

6. Standalone (Algorithm Only) Performance

This information is not applicable. The device is a physical medical introducer, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the tests performed can be considered the established scientific/engineering principles, validated test methods (e.g., ISO standards), and the device design specifications. For example:

• For biocompatibility, the ground truth is that the device material should not elicit adverse biological reactions as defined by ISO 10993.
• For performance tests like "Valve Liquid Leakage," the ground truth would be that the valve should prevent leakage beyond a specified (but unstated) limit.

8. Sample Size for the Training Set

This information is not applicable. There is no AI component mentioned, and thus no "training set" in the context of machine learning. The studies described are physical device testing.

9. How Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for an AI/algorithm.

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