Search Results

Ask a specific question about this device

The Arrow Cannon™ II Plus is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Cannon™ II Plus is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Cannon™ II Plus is intended for use in adult patients.

The Arrow Cannon™ II Plus consists of a double lumen catheter with a detached connector assembly. This allows the catheter tip to be precisely positioned within the vein, similar to single lumen, dual catheters. After the catheter has been positioned, the proximal end of the catheter is tunneled retrograde to the exit site. The connector assembly is then fastened to the proximal end of the catheter using a compression sleeve and compression cap.

Here's an analysis of the provided 510(k) summary for the Cannon™ II Plus Chronic Hemodialysis Catheter, focused on acceptance criteria and supporting studies:

This 510(k) submission, K040078, provides very limited information regarding specific acceptance criteria and detailed study designs. It is a submission for a Class III Medical Device and claims substantial equivalence to a previously marketed device, the Arrow Cannon Catheter™ (K010399). This type of submission generally relies on demonstrating that the new device is as safe and effective as the predicate device by showing similar technological characteristics and performance in relevant tests, rather than establishing de novo performance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, the "acceptance criteria" are implied by the performance tests conducted to demonstrate substantial equivalence to the predicate device. The document does not explicitly state quantitative acceptance limits for these tests.

Conclusion: The document states, "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices." This implies that the device met the unstated acceptance criteria for each test category by performing comparably to the predicate device.

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

• Sample Size: Not specified in the provided documents. The term "test set" in the context of AI/ML models is not directly applicable here as this is a medical device clearance, not an AI/ML algorithm submission. The tests performed are laboratory-based performance tests for a physical device.
• Data Provenance: Not explicitly stated. The tests are described as "laboratory tests," implying they were conducted by Arrow International, Inc. or a contracted lab. There is no mention of country of origin of data or whether it was retrospective or prospective, as these are typically not relevant for bench performance tests of a physical device.

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

• Number of Experts: Not applicable. For a physical medical device, "ground truth" is typically established through objective measurements against engineering specifications or established standards, not expert consensus in the way it's used for AI/ML.
• Qualifications of Experts: Not applicable. The tests would be performed by trained technicians or engineers, not "experts" in the clinical sense of establishing ground truth for disease detection.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human reviewers when establishing ground truth, typically in image interpretation or clinical diagnosis. This is not relevant for the bench performance tests described for this physical device.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC study was not done, and is not applicable to this type of device clearance. MRMC studies are primarily used for evaluating the effectiveness of diagnostic imaging devices or AI-powered algorithms where human interpretation is involved. This submission is for a physical chronic hemodialysis catheter, not a diagnostic tool.

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

• Standalone Performance: Not applicable. This device is a physical medical instrument, not an algorithm. Therefore, "standalone performance" in the context of AI/ML is not relevant.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the "performance tests" listed (flow rate, chemical compatibility, leak, biocompatibility, tensile), the ground truth would be based on:
  • Engineering Specifications/Standards: Each test would have defined parameters and acceptable ranges based on recognized standards (e.g., ISO, ASTM) or internal design specifications. For example, a flow rate test would measure the actual flow rate and compare it to the specified design flow rate.
  • Predicate Device Performance: Crucially, for a 510(k) substantial equivalence claim, the performance of the new device is compared directly to that of the legally marketed predicate device (K010399). The "ground truth" for acceptable performance is what the predicate device achieved.
  • Chemical/Biological Test Results: Biocompatibility would be determined by standard assays (e.g., cytotoxicity, irritation tests) against established pass/fail criteria.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary of the Study and Device Clearance:

The K040078 submission for the Cannon™ II Plus Chronic Hemodialysis Catheter is a traditional 510(k) premarket notification based on substantial equivalence. This means the primary "study" is a set of laboratory performance tests designed to demonstrate that the new device has technological characteristics and performance that are as safe and effective as its predicate device (Arrow Cannon Catheter™, K010399).

The document highlights the following performance tests:

• Flow rate tests
• Chemical compatibility tests
• Leak tests
• Biocompatibility tests
• Tensile tests

The "acceptance criteria" are implicitly met by showing that the Cannon™ II Plus performed comparably to the predicate device in these tests, leading to the conclusion that it is "as safe and effective." This type of submission does not involve clinical trials, AI/ML algorithm validation, or detailed "ground truth" establishment by clinical experts in the way that diagnostic or AI-powered devices might. The focus is on demonstrating equivalent mechanical, material, and functional performance to an already approved device.

Ask a specific question about this device