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510(k) Data Aggregation
(112 days)
ThromCat™ Thrombectomy Catheter System is indicated for mechanical removal of thrombus in synthetic hemodialysis access grafts and native vessel dialysis fistulae.
ThromCat Thrombectomy Catheter System is a single-use, disposable device that performs percutaneous maceration and removal of thrombus and restoration of blood flow. The device consists of a 5.5 Fr x 4.5 Fr infusion/extraction catheter, a DC-powered infusion/extraction pump, and an extraction line and bag. The stainless steel helix is enclosed within a radiopaque, atraumatic flexible tip and shaft, preventing direct contact with the vessel wall. The integrated pumps, tubing and 150 cm length catheter provide an infusion flow to "wash' the vessel, while simultaneously providing an extraction flow to remove thrombus.
This document is a 510(k) summary for the Kensey Nash ThromCat™ Thrombectomy Catheter System. It describes the device, its intended use, and provides information on non-clinical testing for substantial equivalence to predicate devices.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria (e.g., performance thresholds like "achieve X% thrombus removal") or quantifiable reported device performance results for the ThromCat™ Thrombectomy Catheter System.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It asserts that "Results of bench testing and animal studies demonstrate ThromCat is as safe and effective as the legally marketed predicate devices." This is a qualitative statement of equivalence rather than a report of specific performance metrics against defined criteria.
To fully answer this question, more detailed testing reports would be needed, which are not present in this 510(k) summary. However, based on the information given, a conceptual table might look like this, with the understanding that specific numerical criteria and results are missing:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence: Consistent with legally marketed predicate devices (X-Sizer® Catheter System & Amplatz Thrombectomy Device) with regard to materials, intended use, principles of operation, and technological characteristics. Any differences do not significantly affect safety and efficacy. | Demonstrated through Non-Clinical Testing:- Biocompatibility: Passed relevant tests (implied, no specific results)- EMC (Electromagnetic Compatibility): Passed relevant tests (implied, no specific results)- Electrical Safety: Passed relevant tests (implied, no specific results)- Mechanical Testing: Passed relevant tests (implied, no specific results)- Animal Studies: Demonstrated safety and effectiveness (implied, no specific results)- In vitro Comparison Testing: Conducted against X-Sizer Catheter, providing reasonable assurance of safety and effectiveness (implied, no specific results)- In vivo Comparison Testing: Conducted against X-Sizer Catheter, providing reasonable assurance of safety and effectiveness (implied, no specific results) |
| Mechanical Removal of Thrombus: Ability to achieve mechanical removal of thrombus from synthetic hemodialysis access grafts and native vessel dialysis fistulae. | This is the intended use, and the non-clinical testing (especially in vitro and in vivo comparison testing) aimed to confirm this capability and its equivalence to predicate devices. No specific "percentage of thrombus removed" or "time to removal" metrics are provided. |
| Prevention of direct contact with vessel wall: The stainless steel helix is enclosed within a radiopaque, atraumatic flexible tip and shaft. | This is a design feature claimed to prevent direct contact. The "animal studies" and "in vivo comparison testing" would implicitly assess the effectiveness of this design in a physiological environment, but no specific data is presented. |
2. Sample Size Used for the Test Set and the Data Provenance
The document mentions "bench testing" and "animal studies" and "in vitro and in vivo comparison testing." However, it does not specify the sample sizes used for these test sets.
- Test Set Sample Size: Not specified.
- Data Provenance: The studies are described as "non-clinical testing," "in vitro," and "in vivo (animal studies)." The country of origin is not specified but implicitly would be related to the submitting company (Kensey Nash Corporation, USA). The studies are not described as retrospective or prospective in a human clinical trial sense, but rather as pre-market, non-clinical evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the 510(k) summary. Non-clinical studies (bench and animal) typically do not involve human "experts" establishing ground truth in the same way clinical studies do (e.g., radiologist reviews). Instead, performance is measured against established scientific principles and metrics in a laboratory or animal model.
4. Adjudication Method for the Test Set
Since this relates to expert review of clinical data, and the studies mentioned are non-clinical (bench and animal), there is no information provided on an adjudication method.
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
No MRMC study was done. The device described is a mechanical thrombectomy catheter system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a mechanical catheter system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "non-clinical testing" including "bench testing" and "animal studies" and "in vitro and in vivo comparison testing," the ground truth would be established by:
- Quantitative measurements of performance parameters (e.g., flow rates, thrombus removal efficiency, force measurements for mechanical tests).
- Histopathological analysis in animal studies to assess tissue damage or healing.
- Direct observation and measurement in controlled in vitro environments.
- Comparison to known performance characteristics of the predicate devices under similar conditions.
There's no mention of expert consensus, pathology in human cases, or human outcomes data for these non-clinical studies.
8. The sample size for the training set
This information is not applicable. This device is a mechanical medical device, not an AI/machine learning system that requires a "training set" in the computational sense.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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