(344 days)
072 Aspiration Catheter: As part of the 072 Aspiration System, the 072 Aspiration Catheter with a compatible suction pump is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 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 therapy are candidates for treatment.
Aspiration Tubing: As part of the 072 Aspiration System, the Aspiration Tubing is intended to connect the 072 Aspiration Catheter to a compatible suction pump.
The 072 Aspiration Catheter is a single lumen, variable stiffness catheter. The catheter has a hydrophilic coating to reduce friction during use. The catheter includes radiopaque markers on the distal end for angiographic visualization and a Luer hub on the proximal end allowing attachments for flushing and aspiration. The Delivery Tool is an optional accessory for use with the 072 Aspiration Catheter and should be removed prior to aspiration. The 072 Aspiration Catheter, Delivery Tool. Rotating Hemostasis Valve, and Flow Switch are included in the package. The Aspiration Tubing is provided in a separate package. For the aspiration source, the 072 Aspiration Catheter is used in conjunction with a compatible suction pump with prespecified performance parameters that is connected using the Aspiration Tubing.
Here's a breakdown of the acceptance criteria and study information for the Q'Apel Medical, Inc. 072 Aspiration System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally phrased as meeting "predetermined acceptance criteria" or specific ISO standards. The reported device performance for all bench tests and animal studies is "Pass," indicating that all samples met the defined criteria.
Note: For bench tests, specific numerical acceptance criteria are not detailed in the provided summary, only the general statement that "All samples met the predetermined acceptance criteria." For biocompatibility, the specific numerical acceptance criteria are listed.
| Test Category | Acceptance Criteria (as stated) | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| Visual Surface Requirement | Device meets visual surface requirements. | Pass |
| Packaging Visual Inspection | Packaging meets visual inspection. | Pass |
| Dimensional/Visual Inspection | Device dimensions conform to specifications. | Pass |
| Liquid Leakage Under Pressure | Catheter joint strength meets freedom from leakage requirements of ISO 10555-1:2013, Annex C. | Pass |
| Hub Aspiration Air Leakage | Device passes hub aspiration air leakage test of ISO 10555-1:2013, Annex D. | Pass |
| Simulated Use | Effectiveness of device at retrieval of soft and firm clots and mechanical integrity after multiple passes. | Pass |
| Flex Fatigue | Meets minimum value per specification for multiple passes in the simulated use model. | Pass |
| Track and Advance Force | Test specimens meet track and advance force criteria. | Pass |
| Tip Deflection | Test specimens meet tip deflection forces criteria and compare favorably to predicate catheters. | Pass |
| Torque | Number of revolutions to failure of the Catheter in simulated anatomy meets criteria. | Pass |
| Tip Elongation and Compression | Test specimens meet tip elongation and compression criteria. | Pass |
| Peak Tensile | Tensile strength of catheter sections and bonds meets criteria after simulated use. | Pass |
| Particulates, Coating Integrity | Integrity of hydrophilic coating evaluated after multiple insertion/withdrawal cycles, and particulates measured during simulated use compared to reference device, meet criteria. | Pass |
| Flow Rate | Flow rate through a catheter meets ISO 10555-1, Annex E. | Pass |
| Aspiration Flow Rate | Aspiration flow rate through the aspiration catheter meets criteria when connected to a constant vacuum source. | Pass |
| Kink Resistance | Test specimen segments formed into a defined bend diameter meet kink resistance criteria. | Pass |
| Corrosion Resistance | No visible corrosion immediately after Corrosion Testing procedure based on ISO 10555-1, Annex A. | Pass |
| Radiopacity | Marker band is fluoroscopically visible. | Pass |
| Burst Pressure-Static | Tested per ISO 10555-1:2013, Annex F, after simulated use, meets criteria. | Pass |
| Burst Pressure-Dynamic | Minimum value per specification. | Pass |
| Connectors for Intravascular | Hubs tested per ISO 80369-7. | Pass |
| Lumen Collapse | Aspiration Catheter samples meet lumen patency under maximum applied vacuum pressures. | Pass |
| Manual Syringe Injection Peak Pressure | Measure peak pressure during manual injection of contrast media with a syringe, meets criteria. | Pass |
| Aspiration Tubing Bench Testing | ||
| Dimensional/Visual Inspection | Aspiration Tubing meets all dimensional and visual specifications. | Pass |
| Tensile Strength | Aspiration Tubing meets existing tensile strength specifications. | Pass |
| Simulated Use Test | Aspiration Tubing passes testing specified in the simulated use test protocol. | Pass |
| Resistance to Collapse and Leakage at Maximum Aspiration Pressures | Aspiration Tubing resistance to collapse at maximum aspiration pressure meets testing specified in the test protocol and does not show signs of leakage at maximum aspiration pressure. | Pass |
| Flow Switch Functionality Testing | Flow Control Switch completely and immediately stops fluid flow after a specified number of ON/OFF cycles. | Pass |
| Biocompatibility Testing (072 Aspiration Catheter and Delivery Tool) | ||
| Cytotoxicity - MEM Elution | The achievement of a numerical grade greater than 2 is considered a cytotoxic effect. (Implicit acceptance: numerical grade ≤ 2) | Non-cytotoxic |
| Sensitization | Magnusson and Kligman grades of 1 or greater in the test group generally indicate sensitization, provided grades of less than 1 are seen in control animals. If grades of 1 or greater are noted in control animals, then the reactions of test animals which exceed the most severe reaction in control animals are presumed to be due to sensitization. (Implicit acceptance: no statistically significant sensitization compared to control) | Non-sensitizing |
| Irritation: Intracutaneous Reactivity | The requirements of the test were met if the final test article score was ≤ 1.0. | Non-irritating |
| Acute Systemic Toxicity | If using five animals per group, the test article meets the requirement of the test if: 1. Two or more animals from the test group die. 2. Animal behavior, such as convulsions or prostration, occurs in two or more animals from the test group. 3. A final (end of study) body weight loss > 10% occurs in three or more animals from the test group. (Implicit acceptance: none of these conditions occurred) | Non-toxic |
| Material Mediated Pyrogenicity | The requirements of the test were met if no rabbit showed an individual rise in temperature of 0.5 °C or more above its respective baseline temperature throughout the duration of the test. | Non-pyrogenic |
| ASTM Hemolysis- Direct | The positive control's mean hemolytic index above the negative control must be ≥ 5% for the direct method. The negative control must display a mean hemolytic index of |
§ 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).