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510(k) Data Aggregation
(134 days)
The Micro Therapeutics, Inc. Over the Wire (OTW) Thrombolytic Brush Catheter is intended for percutaneous dissolution of acute thrombus located in arteriovenous (A-V) fistula. The Over the Wire (OTW) Thrombolytic Brush Catheter is designed to augment the area of interface between clot and pharmacologic augment by simultaneous thrombolysis and clot maceration. Clinical studies demonstrate effective dissolution of thrombus in A-V grafts when this product is used in conjunction with urokinase. The Over the Wire (OTW) Thrombolytic Brush Catheter is not intended for use in native vessels. The device should not be used on patients with a history of significant pulmonary disease of pulmonary hypertension.
The Micro Therapeutics, Inc. Over the Wire (OTW) Thrombolytic Brush Catheter is intended for the percutaneous dissolution of acute thrombus located in artificial The OTW Thrombolytic Brush Catheter is designed to arteriovenous (A-V) fistula. augment the area of interface between clot and pharmacologic agent by simultaneous thrombolysis and clot maceration. The integral system utilizes a catheter with proximal Yconnector, a soft brush attached at the distal end of a hollow drive shaft, and a hand-held battery-powered motor drive.
The provided 510(k) summary (K973664/K973669) describes the Micro Therapeutics, Inc. Over the Wire (OTW) Thrombolytic Brush Catheter. This submission establishes substantial equivalence to a predicate device, the Thrombolytic Brush Catheter (K963925) also manufactured by Micro Therapeutics, Inc., rather than providing a performance study against specific acceptance criteria for a novel device. Therefore, a table with acceptance criteria and reported device performance, and details of studies involving human readers, training sets, and ground truth establishment, are not applicable in the typical sense for this submission.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
Not explicitly provided as acceptance criteria for a novel device. The submission focuses on demonstrating equivalence to a predicate device through a series of tests. The "performance" is inferred to be "equivalent" to the predicate.
| Acceptance Criteria (Implied Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Dimensional characteristics equivalent to predicate device | In vitro tests confirmed dimensional measurements. |
| Bristle and wire cable strength equivalent to predicate device | In vitro tests confirmed bristle and wire cable strength characterization. |
| Motor drive integrity equivalent to predicate device | In vitro tests confirmed motor drive integrity testing. |
| Catheter flow rates equivalent to predicate device | In vitro tests confirmed catheter flow rates. |
| Bond strengths equivalent to predicate device | In vitro tests confirmed bond strengths. |
| Burst pressure equivalent to predicate device | In vitro tests confirmed burst pressure. |
| Performance under simulated conditions equivalent to predicate device | In vitro tests confirmed performance under simulated conditions. |
| Electromagnetic and patient safety equivalent to predicate device | Independent laboratory tests covered electromagnetic and leakage current potential. |
| In vivo performance in dissolving thrombus in A-V fistulas equivalent to predicate device | In vivo animal studies demonstrated OTW Thrombolytic Brush Catheter performed the same as the predicate device. |
| Biocompatibility compliant with standards | All components tested per ISO 10993-1. |
2. Sample Size Used for the Test Set and Data Provenance:
- In Vitro Tests: "Sample sterile devices were subjected to extensive physical bench testing." No specific number of samples is provided.
- In Vivo Tests: "In vivo animal tests were performed..." No specific number of animals is provided for the test set. Given it's animal testing, the data provenance is presumably from the testing facility where the study was conducted; it is not stated as retrospective or prospective in relation to human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The studies performed were bench tests and animal studies, not human clinical studies requiring expert ground truth for interpretation of outcomes.
4. Adjudication Method for the Test Set:
Not applicable. There are no human readers or subjective interpretations that would require an adjudication method. The tests are objective measurements and observations in laboratory and animal settings.
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:
Not applicable. This device is a mechanical catheter and does not involve AI or human image interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm. Its performance is assessed through physical and biological tests.
7. The type of ground truth used:
- In Vitro Tests: The "ground truth" was based on established engineering specifications, physical integrity, and performance metrics for medical devices, implicitly benchmarked against the predicate device's characteristics.
- In Vivo Tests: The "ground truth" was the observed performance of the device in dissolving thrombus in A-V fistulas within the animal model, compared directly to the predicate device's performance.
8. The Sample Size for the Training Set:
Not applicable. This product is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device submission.
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