(29 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 Riptide™ Large Bore Aspiration Tubing is provided sterile and intended for single-use. The Riptide™ Large Bore Aspiration Tubing serves as a conduit to supply vacuum from the Riptide™ Aspiration Pump to the distal tip of the catheter. The Riptide™ Large Bore Aspiration Tubing provides a connection between the sterile and non-sterile environments. The proximal end of the Riptide™ Large Bore Aspiration Tubing is connected to the Riptide™ Canister (outside of the sterile environment) while the distal end of the Riptide™ Large Bore Aspiration Tubing is connected to the catheter (inside the sterile environment). The Riptide™ Canister is connected to the Riptide™ Aspiration Pump (also outside of the sterile environment) via the Intermediate Tubing. The Riptide™ Large Bore Aspiration Tubing is designed to allow the user to control the application via an in-line flow switch.
Here's an analysis of the provided text, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary for the FDA. These summaries typically focus on demonstrating substantial equivalence to a predicate device, often by leveraging data from the predicate or conducting limited bench testing. They are not necessarily full-fledged clinical trials for a new device's efficacy. This document describes a component of a system (Large Bore Aspiration Tubing) and mostly relies on prior testing of the overall system and predicate device. Therefore, many of the typical AI/medical device study questions (like effect size, reader improvements, ground truth establishment for a training set) aren't directly applicable or answered in this context.
1. A table of acceptance criteria and the reported device performance
The document lists several tests, and for most, the acceptance criterion is implied by the "met the acceptance criteria" statement. Specific numerical criteria are not detailed in this summary.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Compatibility | Compatible with specified catheters and collection canister | Met acceptance criteria |
| Ethylene Oxide (EO) Residual | Within acceptable limits for EO residual | Met acceptance criteria |
| Ethylene Chlorohydrin (ECH) Residual | Within acceptable limits for ECH residual | Met acceptance criteria |
| Bioburden Recovery | Met acceptance criteria | Met acceptance criteria |
| Bioburden | Met acceptance criteria | Met acceptance criteria |
| Bacterial Endotoxin | Within acceptable limits for bacterial endotoxin | Met acceptance criteria |
| Packaging Aseptic Presentation | Maintained aseptic presentation | Met acceptance criteria |
| Seal Width | Within specified seal width range | Met acceptance criteria |
| Dye Leak | No dye leakage detected | Met acceptance criteria |
| Visual Inspection | Passed visual inspection | Met acceptance criteria |
| Bubble Leak | No bubble leakage detected | Met acceptance criteria |
| Legibility | Labeling was legible | Met acceptance criteria |
| Foreign Material | No foreign material detected | Met acceptance criteria |
| Seal Strength | Within specified seal strength limits | Met acceptance criteria |
| Dimensional Inspection | Dimensions (length, inner/outer diameter) within specifications | Met acceptance criteria |
| Identification (ON/OFF Heat Shrink Bands) | Heat shrink bands correctly identified | Met acceptance criteria |
| Identification (Flow Switch) | Flow switch correctly identified | Met acceptance criteria |
| Joint Tensile Strength | Withstood specified tensile force without failure | Met acceptance criteria |
| Leak (Vacuum Decay) | Maintained specified vacuum pressure without significant decay | Met acceptance criteria |
| Degree of Collapse | Met requirements of ISO 10079-3 for degree of collapse | Met acceptance criteria |
| Recanalization (System) | Met acceptance criteria for recanalization (leveraged) | Met acceptance criteria |
| Vacuum Pressure (System) | Met acceptance criteria for vacuum pressure (leveraged) | Met acceptance criteria |
| Volumetric Flow Rate (System) | Met acceptance criteria for volumetric flow rate (leveraged) | Met acceptance criteria |
| Usability (System) | Met acceptance criteria for usability (leveraged) | Met acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for specific tests. The tests mentioned are primarily bench tests on the device itself or leveraged from a predicate device. So, it refers to the number of units tested.
- Data Provenance: The tests are non-clinical bench tests. It doesn't involve human patient data or geographic origin in the way clinical studies do. The data is generated in a lab setting. It is essentially prospective in the sense that these tests were performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/diagnostic device that establishes a "ground truth" based on expert interpretation. The tests are engineering and performance evaluations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/diagnostic device requiring expert adjudication of results.
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
Not applicable. This is a medical device (aspiration tubing), not an AI diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the bench tests would be the established engineering/performance specifications and standards (e.g., ISO, ASTM, internal specifications) against which the device's performance is measured. For example, a leak test's "ground truth" is that there should be no detectable leak under specified pressure/vacuum.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI model.
§ 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).