Search Results

The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter and as a conduit for retrieval devices.

The Modified HD Guide Catheters are single lumen, braided, variable stiffness shaft catheters designed for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular system. The catheters include a radiopaque marker on the distal and for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing and aspiration. The catheter shaft has a hydrophilic coating to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.

Here's an analysis of the acceptance criteria and study details for the Modified HD Guide Catheter, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document categorizes testing into "Testing and Non-Clinical Performance Data" (bench testing) and "Clinical Performance Data" (review of existing clinical studies and post-market data).

• Non-Clinical Performance Data (Bench Testing):

  • The document states "All samples met acceptance criteria." but does not specify the exact number of samples used for each bench test (e.g., Tip Patency during Aspiration, Lumen Compatibility, etc.). It only implies that multiple samples (denoted by "All samples") were tested for each criterion.
  • Data Provenance: The bench testing utilized a "neurovascular model cast from actual human neurovascular arteries." This is a controlled experimental setup, not data from live patients.
  • Specifically for the expanded indications, "Finished sterilized devices were used for the simulated use testing."

• Clinical Performance Data:

  • TREVO 2 Study: 99 patients where the DAC (Modified HD Guide Catheter) was used.
    • Provenance: Retrospective analysis of an IDE trial ("TREVO 2 study... designed to support FDA clearance of the Trevo Retriever in the U.S."). Enrolled at 26 sites in the United States and one site in Spain.
  • TREVO Study: 30 patients where aspiration through DAC was applied (a subset of 34 patients where DAC was used).
    • Provenance: Retrospective analysis of a post-marketing prospective, multi-center, single-arm study performed at seven sites in Europe.
  • Post-Market Surveillance: A review of product complaints and Medical Device Reports (MDRs) from 2008 to July 31, 2013. The exact number of complaints reviewed is not given, but it is stated that 10 MDRs were filed.
    • Provenance: Real-world post-market data.
  • Literature Review: 15 published articles pertaining to DAC use.
    • Provenance: Published scientific literature.

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

• Non-Clinical (Bench) Testing: The document does not specify the number or qualifications of experts involved in observing and confirming the "Pass" results for the bench tests. It likely involved internal engineering or research staff.
• Clinical Performance Data (TREVO and TREVO 2 Studies):
  • The original TREVO 2 and TREVO studies would have had clinical investigators and potentially core labs or adjudication committees, but their specific roles in establishing "ground truth" for catheter performance (as opposed to primary study endpoints for the Retriever device) are not detailed here.
  • The 510(k) summary states that "None of the procedure related or CEC adjudicated events were related to DAC," implying that a Clinical Events Committee (CEC) was used in the TREVO study to adjudicate events. Their specific qualifications are not provided in this 510(k) summary.

4. Adjudication Method for the Test Set

• Non-Clinical (Bench) Testing: No specific adjudication method is mentioned. Results were simply reported as "Pass" based on visual verification or adherence to specified methods.
• Clinical Performance Data: The TREVO study mentioned events being "CEC adjudicated," indicating a Clinical Events Committee (CEC) was involved in reviewing adverse events. The specific method within the CEC (e.g., 2+1, 3+1) is not detailed. The TREVO 2 study also implies similar clinical oversight.

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

There is no MRMC comparative effectiveness study mentioned, nor is there any AI assistance component to this device. This is a physical medical device (catheter), not an AI-powered diagnostic tool. Therefore, this section is not applicable.

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

Not applicable, as this device is a physical catheter and does not involve an algorithm.

7. The Type of Ground Truth Used

• Non-Clinical (Bench) Testing:
  • For most bench tests, the "ground truth" was based on pre-defined acceptance criteria and direct observation of the device's physical performance characteristics (e.g., patency, resistance, integrity, absence of fracture/leakage) in a simulated environment (neurovascular model).
• Clinical Performance Data (TREVO 2 and TREVO Studies):
  • The "ground truth" in these studies relates to the clinical outcomes of the overall thrombectomy procedure, specifically revascularization rates and the absence of device-specific adverse events. While the primary ground truth would be patient outcomes as assessed by clinicians (e.g., angiography for revascularization, neurological exams for NIHSS), the review here focuses on whether the DAC was implicated in any negative outcomes.

8. The Sample Size for the Training Set

Not applicable. This is a physical device and not an AI/machine learning model that requires a training set. The existing clinical data reviewed served as real-world performance evidence, not a "training set."

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device