(98 days)
The Reverse Medical Microcatheter is intended for use in neuro, peripheral and coronary vasculature for the infusion of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils.
The Reverse Medical Microcatheter is a single lumen, flexible stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The Reverse Medical Microcatheter dimensions are included on the individual device labels. The Reverse Medical Microcatheter inner lumen can accommodate guidewires up to 0.018 inches in diameter to access distal tortuous vasculature. Dual radiopaque markers at the distal portion of the catheter facilitate fluoroscopic visualization. The Reverse Medical Microcatheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter is provided sterile, non-pyrogenic, and is intended for single use only.
The provided text describes the 510(k) submission for the Reverse Medical Microcatheter. Here's a breakdown of the requested information, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally not explicitly stated with specific numerical thresholds (e.g., "flexibility must be X N/m"). Instead, the report indicates that the device "Met established criteria" for each test. This implies qualitative or pre-defined quantitative criteria that were assessed for conformance.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility (2. of 7 tests listed) | Materials must be biocompatible | Met established criteria |
| Cytotoxicity | Pass L929 MEM Elution Test | Met established criteria |
| Sensitization | Pass Kligman Maximization | Met established criteria |
| Intracutaneous Reactivity (Irritation) | Pass Intracutaneous Injection Test | Met established criteria |
| Systemic Toxicity (Acute) | Pass ISO Acute Systemic Injection Test | Met established criteria |
| Hemocompatibility (Complement Activation) | Pass Complement Activation Test | Met established criteria |
| Hemocompatibility (Hemolysis) | Pass Hemolysis Test | Met established criteria |
| Hemocompatibility (Inactivated Partial Thromboplastin Time Test) | Pass Inactivated Partial Thromboplastin Time Test | Met established criteria |
| Hemocompatibility (In vivo thrombogenicity) | Pass in vivo thrombogenicity Test | Met established criteria |
| Pyrogenicity | Pass USP Material Mediated Rabbit Pyrogen Test | Met established criteria |
| EtO Residuals | Ethylene oxide and Ethylene chlorohydrins residuals | Met established criteria |
| Sterilization | Sterility Assurance Level (SAL) of 10⁻⁶ | Met established criteria |
| Design Verification (Bench-Top Testing) | ||
| Dimensional and Visual Inspection | Meet established criteria (e.g., dimensions, visual integrity) | Met established criteria |
| Coating Lubricity | Meet established criteria | Met established criteria |
| Tip Buckling | Meet established criteria | Met established criteria |
| Flexibility/Shaft Stiffness Test | Meet established criteria | Met established criteria |
| Flow Rate Test - 100 psi and 300 psi | Meet established criteria | Met established criteria |
| Priming Volume Test | Meet established criteria | Met established criteria |
| Kink Resistance Test | Meet established criteria | Met established criteria |
| Guidewire Compatibility | Meet established criteria | Met established criteria |
| Guide Catheter Compatibility | Meet established criteria | Met established criteria |
| Catheter Leak Test (Air leakage distal end plugged) | Meet established criteria | Met established criteria |
| Catheter Leak Test (Liquid leakage) | Meet established criteria | Met established criteria |
| Dynamic Pressure Test | Meet established criteria | Met established criteria |
| Static Burst Test | Meet established criteria | Met established criteria |
| Torque Strength (Turns to Failure) | Meet established criteria | Met established criteria |
| Tensile Strength Test | Meet established criteria | Met established criteria |
| Corrosion Resistance | Meet established criteria | Met established criteria |
| USP Particulate Test | Meet established criteria | Met established criteria |
| Navigation Capabilities, Accessibility/Pushability Capabilities, Therapeutic Agents Deliverability (Coils and Stents) | Meet established criteria | Met established criteria |
| In vivo Tests | ||
| System Deliverability, Compatibility, and Visibility | Meet established criteria | Met established criteria |
| Biocompatibility Testing | Meet established criteria | Met established criteria |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each bench-top or in-vivo test. It states, "All testing was performed on units that were sterilized and met all inspection criteria." The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). This is a 510(k) submission, which typically relies on pre-clinical data (bench-top and potentially animal studies for in vivo testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document describes a medical device's physical, mechanical, and biological performance testing, not an AI or diagnostic device that requires expert-established ground truth.
4. Adjudication method for the test set
Not applicable, as this is not an AI/diagnostic device and does not involve human readers for ground truth establishment.
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 medical device for physical intervention (microcatheter), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device; there is no "algorithm only" performance concept in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance criteria in this context is defined by industry standards, engineering specifications, and established scientific methods for evaluating medical device properties (e.g., ISO standards, USP tests, internal design control procedures). For example, biocompatibility uses established biological assay methods, and mechanical tests rely on engineering principles.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of medical device submission.
§ 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).