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510(k) Data Aggregation
(107 days)
Riptide Aspiration System React 68 Catheter
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 Riptide™ Aspiration System React™ 68 Catheter is a single lumen, flexible, variable stiffness composite catheter with a nitinol structure that is jacketed with a durable polymer outer layer. A lubricous, polytetrafluoroethylene liner is used to create a structure that has both proximal stiffness and distal flexibility, and an encapsulated radiopaque distal platinum-iridium markerband which is used for visualization under fluoroscopy. The Riptide™ Aspiration System React™ 68 Catheter is introduced into the vasculature through the split y-introducer sheath.
The proximal end of the Riptide™ Aspiration System React™ 68 Catheter is designed with a thermoplastic elastomer strain relief and a clear hub. The Riptide™ Aspiration System React™ 68 Catheter is designed with a hydrophilic coating. The Riptide™ Aspiration System React™ 68 Catheter is navigated to the intended treatment site and positioned proximal to the site of occlusion.
The document describes the acceptance criteria and supporting studies for the Riptide Aspiration System (React 68 Catheter). However, it's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with specific performance metrics against pre-defined acceptance criteria for a new AI/software device. The device in question is a medical device (catheter) for stroke revascularization, not an AI/software device that typically has performance metrics like sensitivity, specificity, or F1-score.
The acceptance criteria provided in the document are primarily for bench testing and biocompatibility, and the reported "performance" is whether the device "met the acceptance criteria" or specific qualitative observations, rather than a quantitative measurement against a numerical threshold.
Here's the information extracted from the provided text, structured to best fit your request, with an understanding that the device is a physical catheter and not an AI/software product in the context of typical AI acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
For the Riptide Aspiration System (React 68 Catheter), acceptance criteria are primarily related to bench testing, biocompatibility, and animal testing. The reported "performance" is whether the device met these criteria.
| Test Description | Acceptance Criteria (Implied / Explicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity (Elution Method) | No evidence of causing cell lysis or toxicity (grade of zero reactivity) | Test article extract showed no evidence of causing cell lysis or toxicity and had a grade of zero (no reactivity). Considered non-cytotoxic. |
| Sensitization (Guinea Pig Max. Test) | Grade less than two (mild reactivity) | Test article extract met requirements (grade less than two). Does not elicit a sensitization response. |
| Irritation (Intracutaneous Reactivity) | Difference between test article and control extract mean scores = 0.0 | Difference between test article extract overall mean score and corresponding control extract mean score was 0.0. Considered a non-irritant. |
| Acute Systemic Toxicity (Systemic Toxicity) | No mortality or evidence of systemic toxicity; clinically normal animals | No mortality or evidence of systemic toxicity. All animals clinically normal. Does not indicate signs of toxicity. |
| Hemocompatibility (Hemolysis) | Hemolytic index for direct contact blood | Met the acceptance criteria for bacterial endotoxin. |
| Visual Inspection | Met acceptance criteria for visual inspection | Met the acceptance criteria for visual inspection. |
| Dimensional Measurements | Met acceptance criteria for dimensional measurements | Met the acceptance criteria for dimensional measurements. |
| Tip Buckling | Met acceptance criteria for maximum compressive force | Met the acceptance criteria for tip buckling. |
| Kink Resistance | Met acceptance criteria for maximum kink diameter | Met the acceptance criteria for kink resistance. |
| Particulate | Met acceptance criteria per USP | Met the acceptance criteria for particulate evaluation. |
| Coating Lubricity | Met acceptance criteria for average friction forces | Met the acceptance criteria for coating lubricity. |
| Tensile Strength | Met acceptance criteria per ISO 10555-1. Annex B | Met the acceptance criteria for tensile strength at the hub and shaft. |
| Liquid Leak | Met acceptance criteria per ISO 10555-1. Annex C | Met the acceptance criteria for liquid leak. |
| Corrosion Resistance | Met acceptance criteria per ISO 10555-1. Annex A | Met the acceptance criteria for corrosion resistance. |
| Hub Aspiration Resistance | Met acceptance criteria per ISO 10555-1. Annex D | Met the acceptance criteria for hub air aspiration. |
| Radiopacity | Met acceptance criteria for markerband length, wall thickness, and fluoroscopy confirmation | Met the acceptance criteria for radiopacity. |
| Luer Standards | Met acceptance criteria per ISO 594-1 and ISO 80369-7 | Met the acceptance criteria for luer standards. |
| Torque Strength | Able to withstand torsional forces typical of clinical use | Was able to withstand torsional forces that are typical of clinical use. |
| Dynamic Pressure | Able to withstand pressures typical of clinical use | Was able to withstand pressures that are typical of clinical use. |
| Coating Integrity | Coating coverage and lubricity maintained | Remained coated and lubricous. |
| Recanalization | Met acceptance criteria for recanalization | Met the acceptance criteria for recanalization. |
| Vacuum Pressure | Met acceptance criteria for vacuum pressure | Met the acceptance criteria for vacuum pressure. |
| Suction Flow Rate | Met acceptance criteria for suction flow rate | Met the acceptance criteria for suction flow rate. |
| Usability | Met acceptance criteria for maneuverability, flexibility, aspiration, and clot retrieval | Met the acceptance criteria for usability. |
| Animal Testing | ||
| Safety, Efficacy, Usability | Demonstrated comparable safety, efficacy, and usability to predicate device | Evaluated in a porcine model at acute and chronic time points, in presence/absence of simulated clot. This testing supports substantial equivalence. |
2. Sample Sizes and Data Provenance (Not applicable for AI/software test set, but for testing performed)
- Biocompatibility and Bench Testing: The sample sizes are not explicitly stated for individual tests but are implied to be sufficient for standard regulatory testing (e.g., "The test article extract showed no evidence...", "Not a single animal showed..."). These are laboratory tests on physical devices/extracts.
- Animal Testing: Conducted in a porcine model. Data provenance is from non-clinical laboratory studies performed in accordance with 21 CFR Part 58 for Good Laboratory Practice (GLP). This is prospective animal testing.
3. Number of Experts and Qualifications (Not applicable to this type of device submission for establishing ground truth)
This information is typically relevant for AI/software devices where human experts establish ground truth for image or data interpretation. For a physical catheter, ground truth is established through physical measurements, chemical analysis, and physiological responses as per standardized test methods. The document does not mention experts for ground truth establishment in this context.
4. Adjudication Method (Not applicable)
Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human labelers/experts when establishing ground truth for AI/software performance evaluation. Not relevant for this physical device submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Not done/applicable)
MRMC studies are typically performed for AI/software devices to assess the impact of AI assistance on human reader performance. This device is a physical catheter, not an AI/software system, so such a study was not performed. The submission is based on demonstrating substantial equivalence to a predicate device through bench and animal testing.
6. Standalone Performance (Algorithm only without human-in-the-loop performance) (Not applicable)
This concept applies to AI/software algorithms. The Riptide Aspiration System is a physical catheter intended for use by a clinician. Its "performance" is inherently linked to its physical properties and interaction within a biological system, not a standalone algorithmic output.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily established by:
- Standardized Test Methods and Criteria: For biocompatibility, microbial, and performance bench tests, "ground truth" is defined by adherence to specific ISO standards (e.g., ISO 10993, ISO 10555, ISO 11737), USP standards, and ANSI/AAMI standards. These standards define the acceptable range or qualitative outcome.
- Physiological Observations and Measurements: In animal studies, ground truth for safety, efficacy, and usability comes from direct observation of animal health, physiological responses, and procedural outcomes.
8. Sample Size for the Training Set (Not applicable)
This concept is for AI/machine learning models. The Riptide Aspiration System is a physical medical device. It does not have a "training set" in the context of AI. Design and manufacturing improvements would be based on engineering principles and iterative testing.
9. How the Ground Truth for the Training Set was Established (Not applicable)
Again, this is an AI/ML concept. The "ground truth" for the development of catheter designs comes from engineering specifications, material science, and prior knowledge of predicate devices and clinical needs, rather than a labeled training set.
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