(15 days)
The MicroCatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature.
The Micrus Microcatheter consists of 4 major components:
- A flexible shaft with a lubricious liner extruded from Teflon. The liner is reinforced with a metal wire made from stainless steel. The outer shaft jacket is made from Pebax,
- An atraumatic distal flexible tip containing two radiopaque marker bands. The marker bands are useful in tracking catheter tip position and during placement of detachable embolic coils.
- A standard luer hub insert, which is molded onto the flexible shaft.
- A hydrophilic coating, which covers the distal 100 centimeters of the Microcatheter.
This 510(k) submission (K032624) is for a medical device called the "Micrus Microcatheter," which is a diagnostic and therapeutic intravascular catheter. The submission primarily relies on demonstrating substantial equivalence to a predicate device (K960806, Tracker Excel 14 Microcatheter) rather than presenting a study with specific acceptance criteria and performance metrics for the new device.
Therefore, many of the requested sections related to acceptance criteria, device performance, ground truth, and specific study designs (MRMC, standalone algorithm) do not apply directly to this type of regulatory submission as described in the provided text. This submission focuses on non-clinical testing and comparison to an already cleared device to establish safety and effectiveness.
Here's a breakdown of the information that can be extracted or deduced from the provided text, and where the requested details are not applicable:
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A table of acceptance criteria and the reported device performance
This information is not provided in the document. This 510(k) submission doesn't detail specific performance criteria or a study with numerical performance results for the Micrus Microcatheter itself. Instead, it states that based on non-clinical testing and comparison to a predicate device, it is considered substantially equivalent in safety and effectiveness. The "non-clinical testing" is not further elaborated upon for specific acceptance criteria.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. As no clinical study results are presented, there is no mention of a test set, sample size, or data provenance. The submission refers to "non-clinical testing," which typically includes bench testing (e.g., mechanical, material properties) rather than human subject data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. There is no mention of ground truth establishment or expert involvement for evaluating device performance in a clinical setting.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. No adjudication method is described, as there is no clinical test set or human evaluation of diagnostic results.
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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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices. The Micrus Microcatheter is a physical medical device (catheter) and is not an AI algorithm.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This type of study is relevant for AI-powered diagnostic devices. The Micrus Microcatheter is a physical medical device (catheter) and is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. As there is no clinical study assessing diagnostic or intervention outcomes, no ground truth type is defined.
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The sample size for the training set
This information is not provided in the document. There is no training set mentioned, as this is not an AI or machine learning device.
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How the ground truth for the training set was established
This information is not provided in the document. There is no training set or ground truth establishment relevant to the type of device.
Summary based on the provided text:
The submission for the Micrus Microcatheter primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (Tracker Excel 14 Microcatheter, K960806). The basis for this equivalence is stated as:
- Design, materials, function, and intended use of the new device being comparable to the predicate.
- Non-clinical testing performed by Micrus Corporation. While the specifics of this testing are not detailed in the provided excerpts, it would typically involve bench testing for material biocompatibility, mechanical properties (e.g., tensile strength, kink resistance, pushability, trackability), and fluid dynamics, ensuring these properties are equivalent or superior to the predicate device.
Crucially, this 510(k) does not contain information about clinical studies with human subjects, diagnostic performance metrics, or AI algorithm evaluation. The FDA's letter (K032624) confirms the finding of substantial equivalence based on the information provided in the premarket notification.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).