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510(k) Data Aggregation
(179 days)
The ECLIPSE 2L is indicated for use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired. These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms.
ECLIPSE 2L is indicated for use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic devices, such as embolization coils.
ECLIPSE 2L is also indicated for neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic devices, such as DMSO based embolization materials, that have been approved for use in the neurovasculature and are compatible with the diameter of the ECLIPSE 2L.
ECLIPSE 2L balloon catheters are catheters with dual lumen arranged in a parallel configuration. The guidewire lumen or the working lumen is DMSO compatible and can be used for infusion/delivery of diagnostic and therapeutic devices. The inflation lumen is used for the inflation and deflation of the balloon. The inflation of the balloon can be achieved independently of the presence of the guidewire. ECLIPSE 2L balloon catheter is equipped with a non-detachable low inflation pressure super compliant balloon welded to the distal end of the catheter.
The ECLIPSE 2L balloon catheter incorporates 3-4 radiopaque markers. The radiopaque marker bands are located at the distal end of the working lumen and at either end of the balloon to facilitate fluoroscopic visualization during procedure. The short nose (SN) variant has an additional proximal marker located 3 cm from the distal tip of the catheter to aid in positioning detachable coils. The ECLIPSE 2L also has distal purge air from the balloon prior to use. The catheter and the outer surface of the balloon is coated with hydrophilic coating to reduce friction and increase lubricity. An introducer sheath is provided with the device as an accessory.
The document provides acceptance criteria and study results for the ECLIPSE 2L device. Here is the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Bench Testing | ||
| Corrosion Resistance | All test samples meet acceptance criteria. | All test samples met acceptance criteria. |
| Particulate Matter Characterization | All test samples meet acceptance criteria. | All test samples met acceptance criteria. Particulate matter characterization of the Subject Device was comparable to Predicate Device. |
| Coating Integrity and Adherence | All test samples meet acceptance criteria. | All test samples met acceptance criteria. |
| Compatibility and Coil Remodeling | No coating particulate shall be observed during and post simulated use. | All test samples met acceptance criteria. |
| Simulated Use/Coating Lubricity and Durability | No coating particulate shall be observed during and post simulated use. Overall performance comparable or better than competitor devices. | All test samples met the acceptance criteria. The overall performance of the Subject Device is equivalent or better than the Predicate Device. |
| Flow Rate | (For reference only) | Testing was conducted for reference only. |
| Dynamic Burst | Catheter hub and shaft junctions shall not burst. | All test samples met the acceptance criteria. |
| Liquid Leak | No liquid shall be leaking from hub and catheter shaft under pressure. | All test samples met the acceptance criteria. |
| Air Leak | Air bubbles shall not leak into the hub assembly during aspiration via syringe. | All test samples met the acceptance criteria. |
| Static Burst | Guidewire lumen shall not burst per specification. | All test samples met the acceptance criteria. |
| Torque Strength | Comparison of torque strength to Predicate Device. | All test samples met the acceptance criteria. The torque strength of the Subject Device is equivalent or better to the Predicate Device. |
| Physical Attributes | Dimensions inspect and measure per product specification. | All test samples met the acceptance criteria. |
| Dead Space Volume | (For reference only) | Testing was conducted for reference only. |
| Balloon Deflation Time | Determine time required to deflate balloon from rated burst volume. | All test samples met the acceptance criteria. |
| Balloon Compliance | Measure balloon OD while inflating incrementally to max rated inflation volume. | All test samples met the acceptance criteria. |
| Balloon Fatigue | No leakage or rupture after 20 inflation/deflation cycles to rated burst volume. | All test samples met the acceptance criteria. |
| Balloon Burst Volume | Determine burst volume by incrementally inflating until burst failure. | All test samples met the acceptance criteria. |
| Kink Resistance | No OD change or kinking when wrapped with appropriate pin gauge (180° turn), comparable to Predicate Device. | All test samples met the acceptance criteria. The kink resistance performance of the Subject Device is equivalent or better to the Predicate Device. |
| Surface Contamination | Entire catheter surface free of particulate under 2.5x magnification. | All test samples met the acceptance criteria. |
| Tensile Force | Peak tensile strength of distal tip ≥ 3N (for OD 0.55mm to 0.75mm); Peak tensile strength of catheter bonds ≥ 5N (for OD 0.75mm to 1.15mm). | All test samples met the acceptance criteria. |
| Gauge Test | Reference conical gauge and port opening align in limit planes; no rocking. | All test samples met the acceptance criteria. |
| Ease of Assembly | Satisfactory fit with inflation and guidewire ports and reference fittings. | All test samples met the acceptance criteria. |
| Unscrewing Torque | Port remains attached to reference fitting after specified unscrewing torque. | All test samples met the acceptance criteria. |
| Resistance to Overriding | Reference fitting does not override threads of port after specified torque. | All test samples met the acceptance criteria. |
| Separation Force | Port remains attached to reference fitting after specified max force. | All test samples met the acceptance criteria. |
| Stress Cracking | No evidence of stress cracks on the hub. | All test samples met the acceptance criteria. |
| Catheter Flexural Fatigue | Acceptable if Simulated Use, Dynamic Burst, Liquid Leakage, Air Leakage, Static Burst tests passed. | All test samples met the acceptance criteria. |
| DMSO Compatibility | Acceptable if Simulated Use, Dynamic Burst, Liquid Leakage, Air Leakage, Static Burst, Balloon Deflation, Balloon Compliance, Balloon Fatigue, Balloon Burst, Tensile Strength tests passed after DMSO Conditioning. | All test samples met the acceptance criteria. |
| Packaging Integrity Test | ||
| Visual Inspection | Packaging free of damage, seals free of defects, labels legible and intact. | All test samples met the acceptance criteria. |
| Bubble Leak Test | All samples must exhibit no leaks. | All test samples met the acceptance criteria. |
| Seal Strength | Perform seal strength test per ASTM F88/F88M-15. | All test samples met the acceptance criteria. |
| Performance Animal Testing | ||
| Animal Testing (GLP) | Evaluate in vivo performance, trackability, handling, radiopacity, and balloon occlusion, comparable to predicate devices. | All test samples met the acceptance criteria. Trackability and handling of the catheter, radiopacity, and the balloon test occlusion were comparable to predicate device. |
| Biocompatibility Testing | ||
| Cytotoxicity - Extraction | Average grade of 0 (no reactivity). | Non-cytotoxic |
| Sensitization - ISO Guinea Pig Maximization Sensitization Test | Sensitization response of “0”. No delayed sensitization. | Did not elicit sensitization response. |
| Irritation or Intracutaneous - ISO Intracutaneous Study in Rabbits | Differences in mean test and control scores of dermal observations ≤ 1.0. | Non-irritant |
| Acute Systemic Toxicity - ISO Acute Systemic Toxicity Study in Mice | No signs of toxicity, body weight changes within acceptable parameters. | Non-toxic |
| Systemic Toxicity - ISO Materials Mediated Rabbit Pyrogen | No temperature rise ≥ 0.5 °C. | Non-pyrogenic |
| Hemocompatibility-Hemolysis (Direct) | Test article in non-hemolytic range. | Non-Hemolytic |
| Hemocompatibility - ASTM Hemolysis (Extract Method) | Test article in non-hemolytic range. | Non-Hemolytic |
| Hemocompatibility – Complement Activation – SC5b-9 | Statistically less activation than predicate device. | Passed |
| Hemocompatibility – Partial Thromboplastin Time (PTT) | Not statistically different from predicate device; clotting times similar. All acceptance criteria met. | Passed |
| Hemocompatibility – Platelet & Leukocyte Counts (PLC) | Not statistically significant (p>0.05) compared to comparison article. | Passed |
| Sterilization | ||
| Original Sterilization Validation and adoption | Validation demonstrated reliable and consistent sterilization to SAL of 10-6. Fractional, half, and full cycles met acceptance criteria. Subject device successfully adopted. | The validation study demonstrated that the sterilization process and equipment are capable of reliably and consistently sterilizing the devices to a minimum SAL of 10-6. Fractional cycles, half cycles, and full cycles met the acceptance criteria. The subject device was successfully adopted to the original sterilization validation by performing one (1) full cycle. |
| EO and ECH Residuals | Below limits specified in ISO 10993-7. | The residual traces of EO and ECH for the subject device are below the limits specified in ISO 10993-7. |
| Bacterial Endotoxin Levels |
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