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Recommended for introduction of balloons, catheters and other diagnostic and interventional devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

The NuMED D'VILL Introducer is recommended for introduction of balloons, catheters and other diagnostic and interventional devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The introducer consists of a dilator and sheath with hemostasis valve and side port on the proximal end of the sheath assembly. There is a single image band embedded in the distal end of the sheath tubing for imaging purposes. The sheath is Pebax braided with stainless steel and a PTFE liner and will accommodate a 0.035" guidewire. The dilator is LDPE. The D'VILL is available in 10, 12 and 14F sizes in both 30 and 85cm lengths, as well as, 12 and 14F in a 65 cm length.

The provided text describes a 510(k) premarket notification for a medical device called the "D'Vill Introducer." This submission is a "Special 510(k)" to obtain marketing clearance for an additional size (65cm length) of an already cleared device, the D'VILL Introducer – K171206.

The crucial information to understand here is that a Special 510(k) is typically used for modifications to a manufacturer's own legally marketed device where the modification does not alter the fundamental scientific technology of the device and does not raise new questions of safety and effectiveness. This often means that the performance testing is focused on demonstrating that the new modification performs equivalently to the existing device within the established parameters, rather than proving the overall safety and effectiveness of a completely new device from scratch.

Therefore, the "acceptance criteria" and "study" described in this document are not a clinical study with human patients, but rather bench testing to demonstrate that the new size performs similarly to the predicate device.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance for the D'Vill Introducer (New 65cm Length)

The device in question is an additional size (65cm length) of an already cleared product. The performance testing focused on demonstrating substantial equivalence to the predicate device rather than establishing entirely new safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify the precise number of units tested for each performance test. It only states, "A complete list of tests performed are provided below. All tests met their acceptance criteria and specifications."
• Data Provenance: This is bench testing of a medical device, not a human study. The data is prospective, generated from testing newly manufactured devices. The country of origin for the testing is not explicitly stated, but given the FDA submission, it would typically be conducted in a controlled environment, often by the manufacturer or a contracted lab.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not applicable as the ground truth for this type of device modification (addition of a new size) is established through engineering and materials testing standards, not clinical expert consensus. The "ground truth" is adherence to established physical and mechanical performance specifications.

4. Adjudication Method for the Test Set

• Not applicable. Bench testing results are typically measured against predetermined specifications, not adjudicated by experts in the context of diagnostic interpretation.

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

• No. An MRMC study is relevant for diagnostic devices that involve human interpretation of images or other data. This device is a catheter introducer, a physical medical device, and its performance is evaluated through engineering and materials testing, not diagnostic accuracy by human readers.

6. Standalone (Algorithm Only) Performance

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

7. Type of Ground Truth Used

• The ground truth used for this type of device is based on engineering specifications, material properties, and established industry standards for the performance of introducer catheters. This includes measurements of physical dimensions, force tolerance, leak resistance, and biocompatibility (by equivalence to predicate materials).

8. Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm or a diagnostic tool that requires a "training set" in the machine learning sense. The "training" for the device's development involves engineering design, material selection, and manufacturing processes honed over time, implicitly incorporating knowledge from previous designs and testing.

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

• Not applicable. See point 8. The "ground truth" (or design principles) for manufacturing such a device is established through biomedical engineering principles, regulatory standards (like ISO standards for medical devices), and a history of manufacturing similar devices.

Summary of the Study:

The "study" was a series of in-vitro (bench) performance tests designed to demonstrate that the new 65cm length of the D'Vill Introducer performs equivalently to the existing, predicate D'Vill Introducer (K171206). The tests covered physical dimensions, mechanical strength, and functional integrity (e.g., leakage, kink resistance). All tested parameters met the prespecified acceptance criteria, leading to the conclusion of substantial equivalence for the new size. Biocompatibility was addressed by stating that the materials and manufacturing processes are identical to the predicate device.

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Recommended for introduction of balloons, catheters and other diagnostic and interventional devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

The NuMED D'VILL Introducer is recommended for introduction of balloons, catheters and other diagnostic and interventional devices. The introducer consists of a dilator, and sheath with hemostasis valve and side port on the proximal end of the sheath assembly. There is a single image band embedded in the distal end of the sheath tubing for imaging purposes. The sheath is Pebax braided with stainless steel and a PTFE liner and will accommodate a 0.035" guidewire. The dilator is LDPE. The D'VILL is available in 10, 12 and 14F sizes and 30 and 85cm lengths.

The document provided is a 510(k) summary for the D'Vill Introducer, a medical device. It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information about a study proving the device meets specific acceptance criteria based on performance data.

The "Performance Testing" section on page 4 lists several tests performed:

• Surface Inspection
• Size Designation – Sheath and Dilator
• Freedom from Leakage – Sheath and Hemostasis Valve
• Peak Tensile Force - 3 locations
• Strength of Union Between Hub and Dilator
• Dimensional Requirements – Sheath, Stopcock, and Dilator
• Luer Hub Testing
• Kink/Flexibility Testing – Sheath and Dilator
• Sterilization Testing
• Biocompatibility Evaluation – Short duration contact with circulating blood (< 24 hours)
• Shelf Life Testing

The document states, "All tests met their acceptance criteria and specifications." However, it does not provide the specific acceptance criteria for each test or the reported results.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample size, ground truth, experts, or comparative effectiveness studies, as this information is not present in the provided text.

The information requested, such as specific performance metrics (e.g., leakage rate, tensile strength values, specific dimensions) and their acceptance thresholds, as well as the actual test results, would typically be found in a more detailed test report or design verification document, which is not included in this 510(k) summary. These summaries focus on demonstrating substantial equivalence rather than providing detailed raw performance data.

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