(111 days)
The PROWLER SELECT LP ES Microcatheter is intended for the introduction of embolic devices and infusion of diagnostic agents into the peripheral and neuro vasculature.
The PROWLER XS Microcatheter is intended for the introduction of embolic devices and infusion of diagnostic agents into the peripheral and neuro vasculature.
The PROWLER SELECT LP ES and PROWLER XS Microcatheters have a 3-zone construction that enables smoother transitions to enhance the stability of the microcatheter. The microcatheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. The maximum outer diameter of a guidewire that is allowed inside the subject microcatheter is 0.014 in.
The proximal shaft is reinforced with a stainless-steel braid to aid in pushability. The distal shafts are reinforced with a Platinum/Tungsten coil to provide flexibility. To provide lubricity, the distal 30 cm of the catheter is coated with a hydrophilic coating.
This document is a 510(k) clearance letter for medical microcatheters (PROWLER SELECT LP ES Microcatheter and PROWLER XS Microcatheter). It focuses on demonstrating substantial equivalence to existing predicate devices, not on proving device performance against specific de novo clinical performance acceptance criteria.
Therefore, the information typically requested in your prompt (e.g., acceptance criteria table, sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not present in this type of FDA submission.
Here's why and what can be inferred:
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Substantial Equivalence (510(k)) vs. De Novo Clearance/PMA:
- A 510(k) submission, like this one, aims to show that a new device is as safe and effective as a legally marketed predicate device. This often relies on design comparisons, bench testing (non-clinical performance), and sometimes clinical data if there are new indications or significant technological differences that raise new questions of safety and effectiveness.
- The prompt's questions are typically relevant for novel devices seeking de novo classification or high-risk devices requiring a Premarket Approval (PMA) application, where the device must prove its safety and effectiveness against defined clinical endpoints and acceptance criteria. This usually involves robust clinical trials, often with AI-based devices needing specific performance metrics like AUC, sensitivity, specificity, and comparison to human performance (MRMC studies).
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What this document does state regarding "performance":
- Non-Clinical Performance Testing (Section VII): "No new testing was conducted to support the minor changes subject to this submission, because all relevant testing has been previously submitted to and reviewed by the FDA." This means the manufacturer relied on existing data, presumably from the original clearance of the predicate device or prior versions. They emphasize that minor design changes "do not raise different questions of safety and effectiveness."
- Clinical Performance Data (Section VIII): "No clinical studies were required to support the minor changes." This explicitly states that clinical trials (which would involve human participants, test sets, ground truth establishment, etc.) were not necessary for this specific submission.
- Ground Truth: The concept of "ground truth" as it pertains to AI/diagnostic performance (expert consensus, pathology, outcomes data) is not applicable here because this is a physical medical device (microcatheter) and the submission doesn't involve an AI component or complex diagnostic performance evaluation. The "ground truth" for a microcatheter's performance is typically established through engineering bench testing (e.g., burst pressure, material integrity, flexibility, guidewire compatibility) and often in vivo animal studies or ex vivo models for more complex functional aspects like navigability, not human clinical consensus on images or diagnoses.
In summary, based on the provided document:
- Acceptance Criteria Table: Not applicable. The "acceptance" is substantial equivalence to a predicate device, demonstrated through non-clinical data already on file. Performance criteria would be engineering specifications (e.g., burst pressure, tensile strength, lubricity), but these specific values are not detailed in this public summary.
- Study that proves the device meets acceptance criteria: The document states "No new testing was conducted" and "No clinical studies were required." The "proof" relies on the existing non-clinical data for the predicate and the manufacturer's assertion that minor changes do not impact safety or effectiveness.
- Sample size for test set / Data provenance: Not applicable for a typical clinical trial. Non-clinical testing would have sample sizes for different mechanical tests, but these are not disclosed.
- Number of experts / Qualifications / Adjudication: Not applicable, as no human expert review for establishing ground truth on a diagnostic test set was performed or required.
- MRMC comparative effectiveness study: No.
- Standalone performance: No.
- Type of ground truth used: Not applicable in the context of diagnostic performance. For physical device performance, ground truth would be established through engineering metrology and standardized test methods.
- Training set sample size / Ground truth for training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring training data.
This 510(k) clearance is for a conventional medical device, not an AI/ML device or one requiring de novo clinical validation against complex diagnostic endpoints.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).