(197 days)
The Reverse Medical Microcatheter-027 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-027 is a single lumen, flexible stiffness composite catheter. The catheter shaft has a hydrophilic coating to reduce friction during use. The Reverse Medical Microcatheter-027 dimensions are included on the individual device labels. The Reverse Medical Microcatheter-027 inner lumen can accommodate guidewires up to 0.025 inches inner diameter to access distal tortuous vasculature. Dual radiopaque markers at the distal portion of the catheter facilitate fluoroscopic visualization.
Each Reverse Medical Microcatheter-027 is provided with accessories, which include a shaping mandrel and peel away introducer within a Tyvek™ pouch.
The shaping mandrel allows the catheter tip to be steam shaped by the physician for proper adjustment to the anatomy prior to use. Test data is presented in this submission for both the 027 and 021 Reverse Medical Microcatheters to support the inclusion of the shaping mandrel and the peel away introducer.
The Reverse Medical Microcatheter-027 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Reverse Medical Microcatheter-027:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence through non-clinical (bench-top) testing. There isn't a comprehensive "device performance" section in the way one might expect for a clinical study with sensitive/specific metrics. Instead, the performance is reported against established engineering or safety criteria.
| Test Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity (L929 MEM Elution) | Grade 0 (No cell lysis) per ISO 10993-5. | Non-Cytotoxic (Grade 0) |
| Sensitization (Kligman Maximization) | Grade 0 (no visible change) per ISO 10993-10. | Non-Sensitizing (Grade 0) |
| Systemic Toxicity (Acute) | Score 0, no toxicity or animal weight loss for cottonseed oil and saline extracts per ISO 10993-11. | Non-Toxic (Score 0) |
| Hemocompatibility (Complement Activation) | No greater biological response than corresponding control. | Met criteria |
| Hemolysis | Hemolytic grade score of zero, considered non-hemolytic. | Non-Hemolytic (Score 0) |
| Inactivated Partial Thromboplastin Time | Minimal activator of intrinsic coagulation pathway; passed test (clotting time 290 seconds vs. 300 seconds for negative/reference). | Non-Activator |
| In vivo Thrombogenicity | No adverse effects or clinical signs. | Non-Thrombogenic |
| Pyrogenicity (USP Material Mediated) | Non-pyrogenic; no individual rabbit temperature rise >= 0.5 deg. C per ISO 10993-11. | Non-Pyrogenic |
| EtO Residuals | Met criteria in accordance with ISO 10993-7 Part 7. | Passed, acceptable limits |
| Genotoxicity (Bacterial Reverse Mutation) | No statistically significant increase in revertant colonies compared to negative controls. | Non-Mutagenic |
| Genotoxicity (Mouse lymphoma) | Did not produce significantly more revertant colonies than negative controls. | Non-Mutagenic |
| Genotoxicity (In vivo micronucleus) | No statistically significant increase in micronucleus in test article extract vs. negative control. | Non-Mutagenic |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 according to ANSI / AAMI / ISO 11135. | Validated ($10^{-6}$ SAL) |
| Design Verification (Bench-Top) | ||
| Dimensional/Visual Inspection | Per test protocol rev B. | Pass |
| Tip Buckling Test | Perform the same or better than predicate devices (95/90 confidence/reliability). | Pass |
| Coating Lubricity Test | Frictional force; Coating Length (95/90 confidence/reliability). | Pass |
| Flexibility/Shaft Stiffness Test | Distal tip and proximal shaft flexibility comparable or better than predicate. | Pass |
| Priming Volume Test | For comparison to predicate; equal to or better than predicate. | Pass |
| Flow Rate Test | For comparison to predicate; equal to or better than predicate. | Pass |
| Guidewire Compatibility Test | Free movement of appropriately sized guidewires; Frictional force (95/90 confidence/reliability). | Pass |
| Guide Catheter Compatibility Test | Free movement inside appropriately sized Guide Catheter; Frictional force measurement (95/90 confidence/reliability). | Pass |
| Catheter Air Leakage Test | Per ISO 10551-1. | Pass |
| Catheter Liquid Leakage Test | No leaks in accordance with protocol. | Pass |
| Dynamic Pressure Test | No leaks due to dynamic pressure test; Peak Pressure. | Pass |
| Static Pressure Test | Burst pressure in accordance with protocol (95/90 confidence/reliability). | Pass |
| Kink Resistance Test | Distal kink resistance (95/90 confidence/reliability). | Pass |
| Torque Strength Test | X revolutions without failure. | Pass |
| Corrosion Resistance | No corrosion on metallic components. | Pass |
| USP Particulate Testing | Report total of particles; Compare to predicate devices (USP 788). | Pass |
| Tensile Strength | Distal/medial; medial/proximal; proximal/hub (95/90 confidence/reliability). | Pass |
| Navigation/Accessibility/Pushability | Comparable to predicate devices. | Pass |
| Micro-devices Compatibility | Comparable to predicate devices. | Pass |
| With Steam-Shaping Capabilities | ||
| Dimensional and Visual Inspection | Per test protocol rev B. | Pass |
| Steam Shaping Capabilities | No Damage; Shape Inspection (at various angles). | Pass |
| Coating Lubricity Test - Post Steam Shaping | Frictional force (Pass/Fail). | Pass |
| Static Pressure Test - Post Steam Shaping | Burst pressure (95/90 confidence/reliability). | Pass |
| Tensile Strength - Post Steam Shaping | Distal/Medial; Medial/Proximal; Proximal/Hub (95/90 confidence/reliability). | Pass |
| Navigation/Accessibility/Pushability | Comparable to predicate. | Pass |
| Micro-devices Compatibility | Can allow uses of other micro-devices, in simulated flow model. | Pass |
2. Sample Size for Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each bench-top test. For some tests (e.g., Tip Buckling, Coating Lubricity, Guidewire Compatibility, Guide Catheter Compatibility, Static Pressure, Kink Resistance, Tensile Strength), the acceptance criteria mention "95/90," which typically refers to a 95% confidence level with 90% reliability, implying a statistically significant sample size was used for those specific tests. However, the absolute number of devices tested is not provided.
- Data Provenance: All data presented is from pre-clinical (bench-top) testing. The document does not indicate any human data or provide country of origin, as it's not a clinical study. It's internal testing conducted by Reverse Medical Corporation.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
This information is not applicable to the provided document. The "ground truth" for this submission is based on established engineering standards (ISO, USP, internal protocols) and comparison to predicate devices, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. This document describes bench-top engineering tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This submission focuses on the substantial equivalence of a medical device (microcatheter) through non-clinical testing, not on the performance of an AI algorithm or human reader improvement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study in the context of an AI algorithm was not done. The device is a physical microcatheter, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the tests is derived from:
- Established international and national standards (e.g., ISO, USP).
- Internal test protocols and specifications.
- Performance of legally marketed predicate devices, against which the new device's performance is compared for substantial equivalence.
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, for the same reason as point 8.
§ 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).