(198 days)
The EagleRay Long Sheath and EagleRay Access Catheter are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The EagleRay Long Sheath and EagleRay Access Catheter, hereinafter referred to as EagleRay Catheters, are 0.014"-0.038" guidewire compatible single lumen catheters that provide access to peripheral, coronary and neuro vasculature which allows insertion of other interventional devices.
The catheters are comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. Additionally, an angled distal tip facilitates smoother tracking past vessel branches. The distal tip also has a radiopaque marker to provide the user with clear visual confirmation of the distal tip location under fluoroscopy.
The EagleRay Catheters will be offered with various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1 below.
All EagleRay Catheters are packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.
The 0.088" ID EagleRay Long Sheath is packaged with an additional accessory, a short, retractable Catheter Introducer. This accessory is intended to prevent damage to the EagleRay Long Sheath when advancing it through the hemostasis valve on the access site introducer sheath.
In addition to the supplied accessories discussed above, the adjunctive devices and supplies listed below are intended to be used with the EagleRay Catheters. All of these accessories are also commonly used with the predicate devices.
- Guidewires
- Support/Diagnostic Catheters
- Introducer Sheaths
The provided text is a 510(k) premarket notification summary for a medical device (EagleRay Long Sheath and EagleRay Access Catheter). It describes the device, its intended use, comparison to predicate devices, and various performance tests to demonstrate substantial equivalence.
Based on the information provided, here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally phrased as specifications that the device shall meet or be comparable to competitive/predicate devices. The reported performance is summarized as "Pass" for all tests, indicating the device met these criteria.
| Test Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional/Performance Testing (Table 3) | ||
| Delivery, Compatibility, and Retraction (Trackability) | The catheter shall be able to be delivered, deployed, and retracted per the IFU within a simulated neurological model without incurring any damage to the catheter. | Pass (implied, as "test results were reviewed and found to demonstrate that any differences...do not significantly impact...performance parameters...") |
| Flexibility and Kink Resistance | There shall be no kinking of shaft (permanent deformation) after simulated use. Also, comparable to competitive products and allow for easily tracking the device. No kinking after wrapping around anatomically relevant bend radii. | Pass |
| Compatibility with other devices (external) | The catheters shall be able to be delivered through the minimum introducer sheath or guide catheter size indicated in the product labeling. | Pass |
| Guidewire compatibility | The catheters shall be able to be delivered over the maximum size guidewire indicated in the product labeling. | Pass |
| Interventional device compatibility (internal) | The catheters shall be able to accommodate other interventional devices (e.g., support catheter, diagnostic catheter) up to the maximum size indicated in the product labeling. | Pass |
| Luer compatibility | Devices and accessories shall be compatible with standard syringe luer fittings per ISO 80369-7. | Pass (implicitly, as part of "Accessory compatibility") |
| Accessory compatibility | Devices shall be compatible with catheter introducer and RHV. | Pass |
| Catheter Bond Strength | The catheter shall have sufficient bond strengths to remain intact throughout a procedure. | Pass |
| Flowrate - positive (forward) pressure | The catheter lumen shall allow for a minimum flowrate comparable to competitive products. | Pass |
| Freedom from Leakage – positive pressure | No liquid leakage from the hub or catheter shaft at 46psi for 30 seconds. | Pass |
| Freedom from Leakage – negative pressure | No air leakage into a 20cc syringe when vacuum pulled for 15 seconds. | Pass |
| Burst Pressure | Catheter does not burst under pressures that could be seen when performing contrast injections with a standard 10cc syringe. | Pass |
| Catheter Torque Strength | No separation of any portion of the catheter when rotated at least two (2) full rotations (360 degrees). | Pass |
| Pushability | The proximal shaft of the catheters shall have sufficient stiffness that the user can easily push the catheter to the target anatomy without buckling. | Pass |
| Coating - Particulate | The amount of particulate matter that comes off the hydrophilic-coated shaft during simulated use testing shall be determined and compared to competitive products and techniques. | Pass |
| Coating - lubricity | Coating must be lubricious and maintain a minimum lubricity over 15 test cycles. | Pass |
| Corrosion Resistance | No visible corrosion present on devices after saline immersion followed by 30 minutes in boiling water followed by 48 hours in 37°C water bath. | Pass |
| Radiopacity | The radiopaque marker on the catheter can be seen under fluoroscopy during use. | Pass |
| Biocompatibility Testing (Table 4) | ||
| Cytotoxicity: ISO MEM* Elution | Sample extracts must yield cell lysis grade 2 or lower. | Pass, Non-cytotoxic |
| Cytotoxicity: ISO MTT* Assay | The percentage of cells exhibiting lysis should be similar for all test devices. | Pass, No Significant Differences |
| Sensitization: Magnusson-Kligman Method | Test Group shall yield Grade 10% weight loss in 3 or more test animals, Mortality of 2 or more test animals, Toxic signs such as convulsions and prostration in 2 or more test animals. | Pass, Non-Toxic |
| Hemocompatibility: Complement Activation | The concentrations of C3a and SC5b-9 in the test devices are statistically similar to the predicate device (Penumbra Neuron Max 6F Catheter) and statistically lower than the positive control for all exposure times. | Pass, No Significant Differences, test device had statistically similar or lower concentrations than the predicate and negative controls. |
| Hemocompatibility: Hemolysis (Direct Contact Method) | Sample extracts must be nonhemolytic (≤ 2% hemolytic index). | Pass, Non-hemolytic |
| Hemocompatibility: Hemolysis (Extract Method) | Sample extracts must be nonhemolytic (≤ 2% hemolytic index). | Pass, Non-hemolytic |
| Standard In vivo Thrombogenicity, Ovine Jugular NAVI (ISO) | The device must have similar or lesser thrombogenic potential after 4 hours in vivo when compared to a control device (Penumbra Neuron Max 6F Catheter). | Pass, Minimal Thrombogenic Potential, test device had less thrombogenic potential than the control device. |
| Sterilization Validation (Table 5) | ||
| Positive BI controls must be positive | All positive controls in each cycle read positive. | PASS |
| Fractional cycle requirements | IPCDs equal or less difficult to sterilize than EPCDs; IPCDs and EPCDs may show growth (EPCD equal or more EtO resistant); Product Sterility testing no growth; Bacteriostasis/Fungistasis testing not inhibitory for growth. | PASS |
| Half cycle requirements | IPCDs must show no growth after 7 days; EPCD are expected to show no growth after 7 days (few positives allowed). | PASS |
| Full cycle requirements | IPCDs must show no growth after 7 days; Selected EPCD must show no growth after 7 days; Samples exposed to 2X sterilization cycle must pass EtO residual testing. | PASS |
| Shelf Life and Packaging (Table 6) | ||
| Packaging Visual Inspection | N/A (Standard ASTM F1886 applied) | Pass |
| Pouch Integrity Test - Gross Leak Detection | N/A (Standard ASTM F2096 applied) | Pass |
| Pouch Seal Strength – Peel Strength | N/A (Standard ASTM F88 applied) | Pass |
| Label Integrity | N/A (Company specific TM00071 applied) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact sample sizes (N numbers) for each individual bench or lab test. It states "Bench and Lab (in-vitro) testing were conducted" and "Comparative testing was also performed." For the animal study, it notes "A series of subacute and chronic animal studies were conducted" and "Performed in duplicate" (for Ovine Jugular Thrombogenicity). While the number of animals for the thrombogenicity test is stated as "performed in duplicate," the overall number of animals for the "series" of studies is not explicitly given.
- Data Provenance:
- Country of Origin: Not specified. Standard testing guidelines (ISO, ASTM) are referenced, suggesting internationally recognized methods.
- Retrospective or Prospective: The testing described (bench, lab, animal studies) is inherently prospective in nature, as it involves newly conducted studies to evaluate the new device against defined criteria and predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This document describes pre-market testing for a medical device (catheters), not an AI/software device that requires human expert review for "ground truth" to determine performance characteristics (like sensitivity/specificity for disease detection).
For the animal studies, it states: "Use of the test devices resulted in no significant vascular response during these studies and was found to be comparable to the control devices by the study pathologist and the study director." This indicates at least two experts were involved in interpreting the results of the animal studies. Their specific qualifications (e.g., years of experience) are not detailed beyond "study pathologist" and "study director."
4. Adjudication Method for the Test Set
Not applicable in the context of device performance testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or for AI ground truth establishment where human readers might disagree on findings. Here, the "ground truth" is based on the physical properties of the device and biological responses in animal models, evaluated through standardized tests and expert interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study (MRMC) is relevant for evaluating the impact of an AI system on human reader performance (e.g., radiologists interpreting images). This document describes the performance of a physical medical device (catheter) through bench, lab, and animal testing to demonstrate substantial equivalence to predicate devices, not an AI system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is not an AI device. The described tests are for the standalone performance of the physical catheter itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through a combination of:
- Engineering Specifications and Standards: Compliance with international standards (ISO, ASTM) and internal company protocols for various physical and mechanical properties (e.g., flow rate, burst pressure, bond strength, kink resistance).
- Biocompatibility Testing: In-vitro (cell culture) and in-vivo (animal) studies against established biological endpoints (e.g., cytotoxicity, sensitization, systemic toxicity, hemolysis, thrombogenicity).
- Comparative Performance to Predicate Devices: Performance attributes (e.g., dimensions, flexibility, lubricity, thrombogenic potential) were evaluated for "comparability" to legally marketed predicate devices, which serve as a benchmark for accepted safe and effective performance.
- Expert Interpretation: For the animal studies, pathologist and study director opinions contributed to the ground truth regarding biological response.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a "training set." The testing described is verification and validation for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for 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).