(166 days)
The Esperance Aspiration Catheter with the Medela Dominant Flex Surgical Suction Pump and Wallaby Aspiration Tubing set is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within internal carotid, middle cerebral - Ml and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Esperance Aspiration Catheter System is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device system includes 5F and 6F catheters with inner diameters of 0.055" and 0.071", respectively, designed with three different working lengths for both sizes: 115 cm, 125 cm, and 131 cm. The device is supplied as a kit with Wallaby Aspiration Tubing Set provided with a single catheter. The distal tip of each catheter is visible under fluoroscopy and the distal shaft of each catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of each catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. Each catheter has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy. The Esperance Aspiration Catheter System is a non-active, surgically invasive device intended for short term use within the vasculature.
The document describes the acceptance criteria and supporting studies for the Esperance Aspiration Catheter System.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a single format. Instead, it lists various tests with outcomes indicating that the device "met all pre-defined acceptance criteria" or "performs as intended and met all pre-defined acceptance criteria." For some tests, there's also a comparison to a predicate device, noting the subject device "demonstrates equivalency" or its results "were evaluated and compared to the predicate in the same test conditions and deemed substantially equivalent."
Below is a summary derived from the "Design Verification Testing - Bench" and "Biocompatibility" sections, which outlines the tests performed and the general performance statements provided. Since specific numerical acceptance criteria are not detailed in the provided text, the performance is reported as meeting these (unspecified) criteria or being comparable to the predicate device.
Table of Acceptance Criteria (Inferred) and Reported Device Performance:
| Test Category | Specific Test | Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|---|
| Bench Testing | Visual Inspection | Device meets all visual inspection requirements. | The device met all pre-defined acceptance criteria. |
| Dimensional Inspection (ID, OD, Length, etc.) | Device meets all dimensional requirements. | The device met all pre-defined acceptance criteria. | |
| Aspiration Rate | Saline flow rate meets pre-defined criteria. | The device met all pre-defined acceptance criteria. | |
| Simulated Use (preparation/assembly, interaction, lubricity, kink, clot removal) | Device performs as intended under simulated use conditions. | Device performs as intended and met all pre-defined acceptance criteria under simulated use conditions. | |
| Physician Validation (simulated clot retrieval) | Device performs as intended and is equivalent to predicate under simulated use conditions. | Device performs as intended and demonstrates equivalency to its predicate device under simulated use conditions. | |
| Delivery and Retrieval Forces | Device meets pre-defined acceptance criteria; comparable to predicate. | The device met all pre-defined acceptance criteria. Results were evaluated and compared to the predicate in the same test conditions and deemed substantially equivalent. | |
| Tip Stiffness | Device tip deflection force meets acceptance criteria; comparable to predicate. | The device met acceptance criteria. Results were evaluated and compared to the predicate in the same test conditions and deemed substantially equivalent. | |
| Tip Shaping | Shaped tip meets pre-defined acceptance criteria. | The device met the pre-defined acceptance criteria. | |
| System Tensile (hub, shaft, tip) | System meets minimum tensile requirement. | The device met all predefined acceptance criteria. | |
| Elongation to Failure | Device meets pre-defined acceptance criteria. | The device met all pre-defined acceptance criteria. | |
| Torque Strength | Device torque response meets acceptance criteria. | The device met acceptance criteria. | |
| Coating Integrity | Coating integrity maintained after insertion/retrieval. | The device met all pre-defined acceptance criteria. (6F results utilized for 5F as worst-case). | |
| Coating Lubricity | Frictional forces meet pre-defined acceptance criteria. | The device met all pre-defined acceptance criteria. | |
| Catheter Burst (Pressure) | Device does not leak, burst, and is compatible with accessories (per ISO 10555-1, ISO 594-1). | The device met acceptance criteria. | |
| Leak (Liquid & Air) | Device does not leak. | The device (catheter and tubing set) met acceptance criteria. | |
| Kink Resistance | Device resists kinking around bends with clinically relevant radii. | The device met acceptance criteria. | |
| Vacuum Resistance | Device resists lumen collapse under vacuum. | The device (catheter and tubing set) met all pre-defined acceptance criteria. | |
| Particulate | Particulate generation comparable to predicate. | The device met acceptance criteria. (6F results utilized for 5F as worst-case). | |
| Corrosion Resistance | Device is corrosion resistant per ISO 10555-1. | The catheter is corrosion resistant per ISO 10555-1. | |
| Radiopacity | Marker band is visible under fluoroscopy. | The device met the pre-defined acceptance criteria during the animal study. | |
| Tubing Set Bench | Set Tensile (Luer, suction connector) | Connectors meet minimum tensile requirement. | The tubing set connectors met all predefined acceptance criteria. |
| Tubing Set Functionality & Label Verification | Functionality and labeling perform as intended. | Tubing set met all pre-defined acceptance criteria. | |
| Luer Hub Bench | ISO 80369-7 & 80369-20 (Dimension, Leakage, Stress Cracking, Separation, etc.) | Luer hub dimensions, leakage resistance, stress cracking resistance, and resistance to separation/overriding meet standard requirements. | The device Luer hub met the pre-defined specifications for all listed ISO tests. |
| Biocompatibility | Cytotoxicity (MTT – L-929) | No cytotoxic potential. | Non-cytotoxic. |
| Irritation (ISO Intracutaneous) | Non-irritant. | Non-irritant. | |
| Sensitization (ISO Guinea Pig Maximization) | No sensitization response. | Did not elicit sensitization response. | |
| Systemic Toxicity (ISO Acute Systemic) | No abnormal clinical signs of toxicity; alive at 72 hours; acceptable body weight changes. | Non-toxic. | |
| Pyrogenicity (ISO Material Mediated Rabbit) | No rabbit temperature rise >= 0.5°C. | Non-pyrogenic. | |
| Complement Activation (SC5b-9) | Acceptable range compared to control device. | Test article complement activation has similar performance as the control. | |
| Hemolysis (ASTM - Direct Contact & Extract) | Non-hemolytic. | Test device is non-hemolytic. | |
| Platelet & Leukocyte counts | Counts within acceptable ranges and comparable to control. | Counts of test device are within acceptable ranges and similar to control. | |
| Partial Thromboplastin Time (PTT) | Test and predicate device have similar performance; not an activator of intrinsic coagulation pathway. | Test and predicate device have similar performance. Test and control articles are not considered an activator of the intrinsic coagulation pathway. | |
| Thromboresistance Evaluation | No adverse effects or clinical signs; no thrombus score >3 for test or control device. | Thromboresistance of test device is similar to control. | |
| Sterilization & Shelf Life | Sterilization Assurance Level (SAL) | SAL of 10^-6^ in accordance with ISO 11135:2014. | The sterilization cycle was verified to ensure a sterility assurance level (SAL) of 10^-6^. |
| Aging Studies (packaging integrity, seal strength, device functionality) | Catheters and packaging remain functional for labeled use-by date; all acceptance criteria met. | Aging studies were performed and met all acceptance criteria. | |
| Animal Study (6F model) | Safety, Usability, Performance (preparation, sheath interaction, lubrication, kink, device condition) | Demonstrated safety, usability, and substantial equivalence to predicate.Gross necropsy and histopathology show safety. | The subject device is safe, usable, and is substantially equivalent to the predicate device. An interventionalist assessed safety and usability, and safety was evaluated by gross necropsy and histopathology of treated vessels and downstream tissues and organs. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not provide specific numerical sample sizes for most bench tests (e.g., how many catheters were visually inspected or how many were subjected to tensile testing). For the animal study, it mentions a "porcine model" but doesn't specify the number of animals used.
- Data Provenance: The studies were non-clinical bench, animal, and biological compatibility testing, indicating laboratory-generated data (bench tests, biocompatibility assays) and animal study data (porcine model). The country of origin is not explicitly stated, but the submission is to the U.S. FDA. The studies are prospective in the sense that they were conducted for this submission, rather than retrospective analysis of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Bench Testing (Physician Validation): The "Physician Validation" test mentioned that the device was "evaluated in a simulated anatomy model by physicians." The exact number of physicians is not specified, nor are their specific qualifications (e.g., "radiologist with 10 years of experience").
- Animal Study: For the animal study, an "interventionalist assessed the safety and usability of the subject and predicate devices." Again, the specific number and detailed qualifications of this interventionalist are not provided.
- For other tests, ground truth was based on established engineering standards or biological assay protocols, not expert consensus in the same way.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth, especially for the "physician validation" or "interventionalist assessment." The general phrasing "met all pre-defined acceptance criteria" suggests that results were compared against predetermined thresholds or qualitative expectations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The studies focused on technical performance, safety, and equivalence to a predicate device via non-clinical means (bench and animal testing). The comparison involved subjective assessment by physicians/interventionalists in simulated or animal settings, but not in a formal MRMC design to measure human reader improvement with AI assistance. This device is not an AI-powered diagnostic tool, but a medical intervention device.
6. Standalone (Algorithm Only) Performance Study
This question is not applicable. The Esperance Aspiration Catheter System is a physical medical device, not an algorithm or AI software. Therefore, there is no "standalone (algorithm only)" performance to evaluate.
7. Type of Ground Truth Used
- Bench Testing: Ground truth was primarily based on:
- Engineering Specifications: Pre-defined dimensional requirements, tensile strength, burst pressure, flow rates, etc.
- Performance Metrics: Qualitative and quantitative assessments against intended function (e.g., "kink resistance," "lubricity," "clot removal").
- Predicate Device Comparison: Establishing equivalence to the performance of a legally marketed predicate device.
- Biocompatibility Testing: Ground truth was based on:
- Standardized Assay Results: Outcomes of well-established biological tests (e.g., cytotoxicity, irritation, sensitization) conforming to ISO 10993 standards, with defined thresholds for acceptance.
- Control Device Comparison: Comparison to a control or predicate to establish similar biological interaction.
- Animal Study: Ground truth for safety and usability stemmed from:
- Interventionalist Assessment: Expert observation and qualitative evaluation of device handling and performance.
- Pathology/Histopathology: Gross necropsy and microscopic examination of tissues for adverse effects.
8. Sample Size for the Training Set
This question is not applicable. The Esperance Aspiration Catheter System is a physical medical device, not an algorithm that requires a "training set" in the context of machine learning. The term "training set" is usually associated with AI/ML model development.
9. How the Ground Truth for the Training Set Was Established
This question 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).