(103 days)
The Riptide™ Aspiration System is intended for use in the revascularization of patients with acute iscoke 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) or who fail IV t-PA therapy are candidates for treatment.
The React™ 71 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with a durable polymer outer layer. A lubricious, polytetrafluoroethylene and Engage liner is used to create a structure that has both proximal stiffness and distal flexibility. The React™ 71 Catheter is also designed with an encapsulated radiopaque distal platinum-iridium markerband which is used for visualization under fluoroscopy. The React™ 71 Catheter is introduced into the vasculature through the split y-introducer sheath.
The proximal end of the React™ 71 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The distal end of the React™ 71 Catheter is designed with a hydrophilic coating. The React™ 71 Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion.
Based on the provided text, the Riptide™ Aspiration System (React™ 71 Catheter) is a medical device. The acceptance criteria and the studies performed are detailed in the "510(k) Summary: K182101."
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists numerous tests with their acceptance criteria (implicitly, as the results consistently state "met the acceptance criteria") and the reported device performance. Due to the extensive list, a summarized table is provided below, grouping similar types of tests.
| Test Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | No evidence of cell lysis/toxicity, Grade criteria | Met the acceptance criteria. |
| Bioburden | Met ISO 11737-1 criteria | Met the acceptance criteria. | |
| Packaging | Visual Inspection | Met ASTM F1886 criteria | Met the acceptance criteria. |
| Bubble Leak | Met ASTM F2096 criteria | Met the acceptance criteria. | |
| Seal Strength | Met ASTM F88 criteria | Met the acceptance criteria. | |
| Performance (Bench) | Visual Inspection | Met criteria for x2.5 magnification | Met the acceptance criteria. |
| Dimensional Measurements | Met specified dimensions | Met the acceptance criteria. | |
| Tip Buckling | Withstand maximum compressive force | Met the acceptance criteria. | |
| Kink Resistance | Met maximum kink diameter | Met the acceptance criteria. | |
| Particulate | Met USP criteria | Met the acceptance criteria. | |
| Coating Lubricity | Met average frictional forces criteria | Met the acceptance criteria. | |
| Tensile Strength | Met ISO 10555-1, Annex B criteria | Met the acceptance criteria at hub and shaft. | |
| Liquid Leak | Met ISO 10555-1, Annex C criteria | Met the acceptance criteria. | |
| Corrosion Resistance | Met ISO 10555-1, Annex A criteria | Met the acceptance criteria. | |
| Hub Aspiration Resistance | Met ISO 10555-1, Annex D criteria | Met the acceptance criteria. | |
| Radiopacity | Met criteria for markerband length, wall thickness, and fluoroscopy confirmation | Met the acceptance criteria. | |
| Luer Standards | Met ISO 594-1 and ISO 80369-7 criteria | Met the acceptance criteria. | |
| Torque to Failure | Withstand typical clinical torsional forces | Was able to withstand torsional forces typical of clinical use. | |
| Dynamic Pressure | Withstand typical clinical pressures | Was able to withstand pressures typical of clinical use. | |
| Coating Integrity | Remained coated and lubricious | Remained coated and lubricious. | |
| System Performance | Recanalization | Met specified criteria for recanalization | Met the acceptance criteria. |
| Vacuum Pressure | Met specified criteria for vacuum pressure | Met the acceptance criteria. | |
| Suction Flow Rate | Met specified criteria for suction flow rate | Met the acceptance criteria. | |
| Lumen Collapse | Remained patent | Remained patent. | |
| Usability | Met criteria for maneuverability, flexibility, aspiration, and clot retrieval | Met the acceptance criteria. |
2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state sample sizes for each bench or animal study. It mentions a "canine model" for the thrombogenicity test and a "porcine model" for the animal performance data. Specific numbers of animals or test articles used in these studies are not provided.
The data provenance is non-clinical bench and animal testing. There is no mention of human subject data. Therefore, it is entirely retrospective or prospective non-clinical data performed in a laboratory/animal setting. The country of origin of the data is not specified, but the submission is to the U.S. FDA, suggesting the studies were conducted to meet U.S. regulatory standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the studies are entirely non-clinical (bench and animal testing). The "ground truth" is based on the objective measurements and observations from the physical and biological tests conducted according to established standards (e.g., ISO, ASTM, USP).
4. Adjudication Method for the Test Set:
This information is not applicable as the studies are entirely non-clinical. Adjudication typically refers to expert consensus or review in clinical studies.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device is a physical medical device (catheter), not an AI software. The studies described are non-clinical bench and animal tests, not an MRMC comparative effectiveness study involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used:
The ground truth used for the non-clinical studies is based on:
- Objective Measurements: Such as dimensional measurements, pressure readings, flow rates, tensile strength, Luer standards, etc.
- Standardized Test Methods: Adherence to established international (ISO) and national (ASTM, USP, ANSI/AAMI) standards for evaluating materials, sterility, packaging, and performance.
- Biological Endpoints: In animal models, these include observations for systemic toxicity, sensitization, irritation, pyrogenicity, and direct measurement of thrombogenic potential.
- Visual Inspection and Functional Assessment: E.g., for coating integrity, recanalization, lumen patency, and usability by trained personnel.
8. The Sample Size for the Training Set:
This information is not applicable. This is a submission for a physical medical device. The concepts of "training set" and "testing set" are primarily relevant to machine learning and AI, which are not involved here. The non-clinical studies evaluate the device's inherent physical and biological properties.
9. How the ground truth for the training set was established:
This information is not applicable for the same reasons as #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).