(52 days)
The RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter is intended to dilate stenoses 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. This device is also indicated for stent post-dilatation in the peripheral vasculature.
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
The provided text describes a 510(k) summary for the RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility testing, not on clinical acceptance criteria or a study proving performance against such criteria in the context of diagnostic or AI-driven systems.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this type of device submission. This is a premarket notification for a physical medical device, not a diagnostic algorithm or image analysis software.
Here's a breakdown of the relevant (and non-relevant) information based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document states that "The RapidCross catheter met all acceptance criteria for the bench testing with results similar to the predicates." However, specific numerical acceptance criteria for each test (e.g., "Balloon Burst Strength must be > X psi") are not detailed in this summary.
- Reported Device Performance: The document lists the types of tests performed. It doesn't provide specific numerical results, but rather states that the device performed "similar to the predicates" and "met all acceptance criteria."
| Test Performed | 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 (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, complement activation, thromboresistance, partial thromboplastin time, platelet/leukocyte count) | Met acceptance criteria (per ISO 10993-1 for short duration contact); similar to predicates |
2. Sample sized 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 any of the bench tests.
- Data Provenance: The testing was "Bench testing" and "biocompatibility testing." This is laboratory/engineering data, not clinical data from patients. Country of origin is not relevant for this type of testing.
3. 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 relates to physical device performance and biocompatibility, not diagnostic interpretation requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This applies to clinical data interpretation, not bench testing.
5. 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 is a physical medical device, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For bench testing, the "ground truth" is typically defined by engineering specifications, validated test methods, and industry standards (e.g., ISO, ASTM). For biocompatibility, it's defined by ISO 10993-1.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device.
§ 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).