(94 days)
Renegade HI-FLO FATHOM Kit / System:
The Renegade HI-FLO FATHOM Kit / System is intended for peripheral vascular use. The FATHOM guidewire can be used to selectively introduce and position the Renegade HI-FLO microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.
Renegade HI-FLO Microcatheter and Kit:
The Renegade HI-FLO Microcatheter is intended for peripheral vascular use. The microcatheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels. Diagnostic, embolic, or therapeutic agents to be used in accordance with specifications outlined by the manufacturer.
The Boston Scientific Renegade HI-FLO Microcatheter devices are single lumen, multipurpose catheters intended for use in the peripheral vasculature. The basic operating principle is to advance the microcatheter through a guide catheter and track coaxially over a steerable guidewire in order to access the treatment site. Once the target region has been accessed, the microcatheter can be used to deliver diagnostic, embolic, or therapeutic materials into vessels.
The Renegade Hi-Flo Microcatheter incorporates a taper in its outside diameter along its length from the 3.0F (1.0 mm) proximal outer diameter (OD) to the flexible 2.8F (0.93 mm) distal OD. The inner diameter (ID) of the microcatheter is 0.69 mm (0.027 in) minimally in the proximal and distal regions. The microcatheter lumen is able to accommodate steerable guidewires that are ≤ 0.47 mm (0.018 in) in diameter. The microcatheter is available in 80, 105, 115, 135, and 150 cm usable lengths.
The distal end of the microcatheter is coated with Hydro Pass™ hydrophilic coating for lubricity. The Renegade Hi-Flo Microcatheter has a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The distal tip of the microcatheter is steam shapeable and can be bent to the desired geometry with a steam shaping mandrel accessory packaged with the device. The proximal end of the microcatheter incorporates a hub with a standard luer to facilitate the attachment of accessories.
This document describes the acceptance criteria and study proving the device, Renegade HI-FLO Microcatheters, meets these criteria. The study focuses on non-clinical performance data to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Burst Pressure | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
| Dynamic Burst Test (Infusion Pressure) | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
| Catheter Distal Joint Tensile Strength | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
| Hub to Shaft Tensile Strength | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
| Kink Radius of Curvature | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
| Distal OD Reduction | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
| Distal Tip Flexibility | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
| Proximal Shaft Stiffness | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
| Radiopacity | Not explicitly stated, implied to meet pre-determined criteria for equivalence to predicate. | Met the predetermined acceptance criteria. |
Note: The document states that the devices “met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device.” However, the specific quantitative acceptance criteria for each test are not detailed in the provided text.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each "bench testing" component. The dataProvenance is non-clinical bench testing, implying data was generated in a controlled laboratory setting, not from human or animal subjects. Therefore, there is no country of origin of data or retrospective/prospective classification in the typical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This was a non-clinical bench study. The "ground truth" for the tests would be based on established engineering and materials science principles, and the direct measurements and observations during the bench tests, validated against predetermined acceptance criteria derived from the predicate device's performance.
4. Adjudication Method for the Test Set
Not applicable. As a non-clinical bench study, there is no mention of adjudication by experts for test results. The assessment would involve direct measurement and comparison to predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Performance Data: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a microcatheter, a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for these non-clinical tests was based on engineering specifications and performance data of the predicate device. The tests were designed to ensure the modified device exhibited equivalent physical and mechanical performance characteristics to the already approved predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or algorithm-based system 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.
§ 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).