(85 days)
The RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The RapidCross PTA Rapid Exchange Balloon Dilatation Catheter (RapidCross catheter) is a rapid exchange (RX) coaxial catheter compatible with 0.014" guidewires, with a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip. The distal portion of the catheter has a lubricious coating. The manifold includes an inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon. On the 150 mm and 210 mm devices, two additional marker bands denote the middle of the balloon body. A guidewire lumen starts at a guidewire port located 35 cm from the catheter tip and extends to the distal tip. The 90 cm useable length devices have proximal depth marks printed on the proximal shaft at lengths of 55 cm and 65 cm from the distal tip while the 170 cm useable length devices have depth marks at 90 cm and 100 cm to serve as a reference during catheter insertion.
The RapidCross catheter is available in balloon sizes ranging from 2 mm to 4 mm in diameter and 20 mm to 210 mm in length; and, all sizes are compatible with 4 F sheaths.
The provided document is a 510(k) summary for the RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter. It focuses on establishing substantial equivalence to predicate devices based on bench testing and biocompatibility, rather than clinical studies with human subjects or AI-based performance metrics. Therefore, many of the requested categories are not applicable.
Here's an analysis of the available information:
Acceptance Criteria and Device Performance
The document states that "The RapidCross catheter met all acceptance criteria for the bench testing with results similar to the predicates." It also lists various bench tests performed.
| Acceptance Criteria Test | Reported Device Performance |
|---|---|
| Crossing Profile | Met acceptance criteria; similar to predicates |
| Balloon Burst Strength | Met acceptance criteria; similar to predicates |
| Balloon Compliance | Met acceptance criteria; similar to predicates |
| Balloon OD | Met acceptance criteria; similar to predicates |
| Inflation/Deflation Time | Met acceptance criteria; similar to predicates |
| Balloon Fatigue | Met acceptance criteria; similar to predicates |
| Bond Tensile Strength | Met acceptance criteria; similar to predicates |
| Kink | Met acceptance criteria; similar to predicates |
| Device Tracking | Met acceptance criteria; similar to predicates |
| Insertion Force | Met acceptance criteria; similar to predicates |
| Balloon Pull-back Force | Met acceptance criteria; similar to predicates |
| Repeat Inflations (In Stent) | Met acceptance criteria; similar to predicates |
| Torque Strength | Met acceptance criteria; similar to predicates |
| Radiopacity | Met acceptance criteria; similar to predicates |
| Presence of Coating | Met acceptance criteria; similar to predicates |
| Coating Durability | Met acceptance criteria; similar to predicates |
| Particle Generation | Met acceptance criteria; similar to predicates |
| Pushability | Met acceptance criteria; similar to predicates |
| Support Wire Securement | Met acceptance criteria; similar to predicates |
| Tip ID / RX Port ID | Met acceptance criteria; similar to predicates |
| Tip / Lesion Entry Profile | Met acceptance criteria; similar to predicates |
| Re-Insertion Force | Met acceptance criteria; similar to predicates |
| Catheter Working Length | Met acceptance criteria; similar to predicates |
| RX Port Length | Met acceptance criteria; similar to predicates |
| RX Port OD | Met acceptance criteria; similar to predicates |
| Biocompatibility (ISO 10993-1) | Met acceptance criteria for short duration contact with blood (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, complement activation, thromboresistance, partial thromboplastin time, and platelet/leukocyte count). |
Study Information:
This document describes a premarket notification for a medical device (RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter) seeking substantial equivalence. The "study" referenced is a series of non-clinical, bench-top tests and biocompatibility assessments, not a clinical trial or AI model validation study.
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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):
- Sample Size: Not specified for each individual bench test. The number of devices tested for each parameter is not provided.
- Data Provenance: The tests were "internal Risk Analysis procedures" and "bench testing." This likely refers to in-house laboratory testing by the manufacturer (ev3 Inc. in Plymouth, MN, USA). The data is prospective in the sense that the tests were conducted specifically for this submission.
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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):
- Not Applicable. This is a physical device and the "ground truth" for its performance is determined by established engineering and materials science standards and test methods (e.g., measuring burst pressure, dimensions, tracking force). There were no human experts establishing ground truth in the context of diagnostic interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This concept is relevant for studies involving human interpretation or clinical endpoints. For bench testing of physical properties, the results are typically quantitative measurements against predefined specifications.
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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:
- Not Applicable. This device is a physical medical instrument (a balloon catheter), not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI-related effectiveness metrics are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. See above. There is no algorithm being tested in standalone mode.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Specifications and Biocompatibility Standards. The "ground truth" for this device's performance is its adherence to internal design specifications, industry standards for medical devices (e.g., ISO 10993-1 for biocompatibility), and comparability to legally marketed predicate devices.
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The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not Applicable. See above.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).