(23 days)
The PROWLER® SELECT™ Infusion Catheters are intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the vascular systems (Neuro, Peripheral, Coronary), for Guidewire Exchange/Support, and for superselective angiography of the peripheral and coronary vasculatures.
The PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips are a single lumen catheter featuring a stiff proximal shaft and a flexible distal section. The catheter's inner diameter accommodates guidewires of .014" and smaller depending on the catheter type. The catheter body is radiopaque with one or two distinguishable marker(s) at the distal tip. It includes a hydrophilic coating on the outside of the shaft as well as a PTFE liner on the inner lumen.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PROWLER® SELECT™ Infusion Catheters.
It's important to note that this document is a 510(k) Premarket Notification, which primarily demonstrates substantial equivalence to a legally marketed predicate device. This type of submission relies heavily on non-clinical performance data and often does not involve the extensive clinical trials or human reader studies typically associated with novel AI-powered diagnostic devices.
The information provided describes a medical device (infusion catheters), not an AI/ML-powered diagnostic device. Therefore, many of the requested categories related to AI/ML device studies (like MRMC efficacy, expert-established ground truth for AI, standalone algorithm performance, training set details) are not applicable to this document.
Acceptance Criteria and Study for PROWLER® SELECT™ Infusion Catheters
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a quantified, pass/fail manner for each test. Instead, it states that "Design verification testing showed that the PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips performed as intended" and "No new questions of safety and effectiveness were raised." This implies that the tests were performed and the results met the design specifications and internal performance requirements, which constitute the implicit acceptance criteria for such a device. These are primarily engineering and mechanical performance tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Outer Diameter Dimension meets specifications (pre-coating) | Performed as intended (implies specifications were met). |
| Visual Inspection meets quality standards | Performed as intended (implies standards were met, e.g., no defects, correct markings). |
| Flexible Coil Length / Distal Zone Length meets specifications | Performed as intended (implies specifications were met). |
| Lateral Stiffness meets specifications | Performed as intended (implies specifications were met for proper navigation and support). |
| Trackability meets specifications | Performed as intended (implies specifications were met for smooth advancement through vascular pathways). |
| Joint Pull Strength meets safety specifications | Performed as intended (implies joints did not fail under specified force, preventing detachment of components). |
| Static Burst Pressure tolerance meets safety specifications | Performed as intended (implies the catheter can withstand internal pressure during infusion without bursting). |
| Biocompatibility | All materials used... are biocompatible (implies materials passed relevant biocompatibility tests as per ISO 10993 or equivalent). |
| Substantial Equivalence to Predicate Devices | The PROWLER® SELECT™ 10 and 14 Infusion Catheters with and without pre-shaped tips are substantially equivalent to the predicate devices. (This is the overarching acceptance criterion for the 510(k), demonstrated by the performance testing). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes (number of units) used for each design verification test. It refers generally to "Design verification testing."
- Data Provenance: The tests are described as "Design verification testing," which refers to in-house laboratory testing conducted by the manufacturer (Cordis Neurovascular, Inc.). This is retrospective data collected during the device's design and development phase for regulatory submission. There is no indication of country of origin for the data other than the manufacturer's location in Miami Lakes, Florida, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a physical medical device (catheter), and the "ground truth" for its performance is established through engineering specifications, validated test methods, and industry standards, not by expert consensus on clinical data or images. The "experts" involved would be the design engineers, quality control personnel, and potentially materials scientists from Cordis Neurovascular, Inc.
4. Adjudication Method for the Test Set
- Not Applicable. As the tests are non-clinical engineering and materials performance tests, there is no adjudication process involving multiple human evaluators or a consensus process in the sense of clinical decision-making. The results are based on objective measurements against pre-defined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is not relevant to the evaluation of a physical medical device like an infusion catheter, as it is designed to assess the performance of diagnostic devices or algorithms with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This is not an algorithm or AI-powered device, so standalone algorithm performance testing is not applicable.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on engineering specifications, validated test methods, and compliance with recognized industry standards (e.g., for biocompatibility, material properties, and mechanical performance). It is not pathology, outcomes data, or expert consensus in a clinical diagnostic sense. The ultimate "ground truth" for a 510(k) submission is substantial equivalence to a predicate device.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device, so there is no "training set." Device design and manufacturing processes are refined through iterative development and testing, rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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).