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The OuickCat™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

The QuickCat™ Extraction Catheter is a single use, disposable, dual lumen catheter with associated accessories consisting of a 30 ml. vacuum syringe, extension tubing with stopcock, and an independent 40-micron filter basket. The 145 cm working length and is compatible with 6F guiding catheters with an inner diameter (I.D.) > 0.068" (1.73 mm) and 0.014" (0.36 mm) diameter guidewires. The extraction lumen of the catheter facilitates removal of emboli and thrombi via the attached tubing assembly, stopcock and vacuum syringe. The atraumatic distal tip, which incorporates a radiopaque marker for visibility under fluoroscopy, provides for smooth passage in the arterial system. The catheter consists of three segments. The stiffer proximal segment and more flexible distal segments provide the required structural integrity and flexibility to navigate tortuous vasculature. The distal segment consists of a dual lumen to allow for "rapid exchange" attachment to the guidewire. The catheter's distal portion has a hydrophilic coating to enhance deliverability. A 40-micron pore filter basket is supplied to assist in filtering of blood and thrombotic material for visual or laboratory analysis.

I am sorry, but based on the provided document, there is no acceptance criteria or a study described that proves the device meets specific performance criteria in the way you've outlined.

This document is a 510(k) premarket notification approval letter for the QuickCat Extraction Catheter. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through detailed clinical or statistical studies as would be required for a novel device or a PMA submission.

Here's a breakdown of why the requested information cannot be extracted from this document:

1. Table of acceptance criteria and reported device performance: This document does not contain any specific performance metrics (e.g., sensitivity, specificity, accuracy, success rates) or acceptance criteria for those metrics. The "Non-Clinical Summary" merely states that "Results of this testing indicate that the QuickCat design meets all specifications and intended use," which is a general statement and not a table of specific criteria and results.

2. Sample size used for the test set and data provenance: No information is provided about a "test set" in the context of performance evaluation. The document mentions "in-vitro bench testing and biocompatibility testing" but does not give details about the sample sizes or the origin of any data used in these tests.

3. Number of experts and qualifications for ground truth: Since there are no specific performance claims or clinical study results beyond the general statement of meeting specifications, there's no mention of experts establishing ground truth for a test set.

4. Adjudication method for the test set: Not applicable, as no information on a test set or expert evaluation is provided.

5. Multi-reader multi-case (MRMC) comparative effectiveness study: This document does not describe any MRMC study, nor does it refer to AI assistance. The device is a physical catheter, not an AI-powered diagnostic tool.

6. Standalone performance (algorithm only): Not applicable. The device is a physical medical device, not an algorithm.

7. Type of ground truth used: Not applicable, as detailed performance studies generating ground truth are not described. The basis for substantial equivalence is primarily the comparison of technological characteristics and intended use to a predicate device, along with verification through bench and biocompatibility testing.

8. Sample size for the training set: Not applicable. The device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided FDA 510(k) approval letter (K073519) for the QuickCat Extraction Catheter focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting detailed performance acceptance criteria and study results in the manner requested for AI/software-as-a-medical-device (SaMD) products.

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The QuickCat™ Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

The QuickCat™ Extraction Catheter is a single use, disposable, dual lumen catheter with associated accessories consisting of a 30 ml. vacuum syringe, extension tubing with stopcock, and an independent 40-micron filter basket. The 145 cm working length and is compatible with 6F guiding catheters with an inner diameter (I.D.) ≥ 0.068" (1.73 mm) and 0.014" (0.36 mm) diameter guidewires. The extraction lumen of the catheter facilitates removal of emboli and thrombi via the attached tubing assembly, stopcock and vacuum syringe. The atraumatic distal tip, which incorporates a radiopaque marker for visibility under fluoroscopy, provides for smooth passage in the arterial system. The catheter consists of three segments. The stiffer proximal seqment and more flexible distal segments provide the required structural integrity and flexibility to navigate tortuous vasculature. The distal segment consists of a dual lumen to allow for "rapid exchange" attachment to the quidewire. The catheter's distal portion has a hydrophilic coating to enhance deliverability. A 40-micron pore filter basket is supplied to assist in filtering of blood and thrombotic material for visual or laboratory analysis.

This document, a 510(k) summary for the QuickCat™ Extraction Catheter, details the device's characteristics and its substantial equivalence to predicate devices, but it does not provide specific acceptance criteria or an explicit study proving performance against those criteria in the way a clinical trial or performance study report would. It focuses on establishing equivalence for regulatory clearance.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This information is NOT explicitly provided in the 510(k) summary. The document states that "Design verification testing was performed on the QuickCat™ Extraction Catheter to confirm that the design inputs meet the design outputs," and "Comparison bench testing was performed... regarding performance characteristics to demonstrate equivalency." However, it does not list specific quantitative acceptance criteria (e.g., "Device must extract X% of emboli") or the specific performance results against such criteria. It only asserts that equivalency was demonstrated.

2. Sample Size for the Test Set and Data Provenance

This information is NOT explicitly provided. The summary mentions "Performance Testing - Bench" and "Comparison bench testing," but does not specify the sample sizes (e.g., number of catheters tested, number of simulated emboli used) or the data provenance (e.g., country of origin, retrospective/prospective). This type of detail would typically be in a separate, more comprehensive test report, not usually in a 510(k) summary.

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

This information is NOT applicable/provided. The testing mentioned (biocompatibility and bench testing) does not involve human expert assessment for establishing "ground truth" in the way a clinical study using diagnostic imaging would. Ground truth in this context would likely refer to objective measurements of device performance (e.g., extraction force, flow rate, navigability).

4. Adjudication Method for the Test Set

This information is NOT applicable/provided. As the document describes bench testing and biocompatibility, there is no expert adjudication method like 2+1 or 3+1 typically used in clinical imaging studies.

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

No, a MRMC comparative effectiveness study was NOT done/reported in this document. The document discusses "Comparison bench testing" to demonstrate equivalency to predicate devices, but this refers to comparing physical performance characteristics, not comparing human reader performance with and without AI assistance. This device is a physical medical device (catheter), not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study was NOT done/reported in this document. This is a physical medical device, not an algorithm. Therefore, "algorithm only" performance is not relevant.

7. Type of Ground Truth Used for the Test Set

For the bench testing, the "ground truth" would likely be objective measurements and engineering specifications of the catheter's performance characteristics (e.g., successful extraction of simulated thrombi, navigability, guidewire compatibility, lumen integrity, material properties). For biocompatibility, the ground truth is established through adherence to ISO 10993 standards and FDA guidelines, indicating the absence of adverse biological reactions.

8. Sample Size for the Training Set

This information is NOT applicable/provided. As this is a physical medical device, not an AI or machine learning model, there is no "training set" in the computational sense. The design and validation of the catheter would involve engineering principles, material science, and physical testing, not data training.

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

This information is NOT applicable/provided. No training set exists for this type of device. The "ground truth" for the device's design and manufacturing would be established through engineering design specifications, material standards, and quality control processes.

In summary:

The provided 510(k) summary for the QuickCat™ Extraction Catheter is for a physical medical device and primarily focuses on demonstrating "substantial equivalence" to predicate devices through biocompatibility and bench testing. It clearly lacks the specific details about acceptance criteria, quantifiable performance results against those criteria, sample sizes for test sets, and the methodologies related to expert review or AI model validation that would be found in a performance study for a diagnostic algorithm or a clinical trial report. The context of the questions (e.g., "number of experts," "MRMC study," "training set," "algorithm only performance") strongly suggests inquiry into an AI/ML powered device, which this catheter is not.

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