(7 days)
The KPS Rinspiration™ System is intended to infuse and aspirate in the peripheral vasculature.
The system consists of a Rinspiration™ Catheter and a KPS Rinspirator™ with accessories. The KPS Rinspiration™ Catheter is a multi-lumen catheter that has perforations located near the distal end of the catheter to dispense an infusible fluid. The Rinspiration™ Catheter will be placed in the peripheral vasculature of a patient over a quide wire. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The KPS Rinspirator™ with accessories is a hand activated mechanical device that connects to the hub of the catheter. It allows for simultaneous irrigation and aspiration of the treatment site. The device activates two syringes for infusion and aspiration. This action is known as "Rinspiration™ ,"
The provided text describes a 510(k) premarket notification for the KPS Rinspiration™ System and does not contain detailed information about specific acceptance criteria, a study that rigorously proves device performance against those criteria, or the methodology for establishing ground truth or training data. The document focuses on demonstrating substantial equivalence to a previously cleared device (K031485).
However, I can extract the information that is present and indicate what is not available.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | "safe for its intended use" |
| Effectiveness | "effective for its intended use" |
| Biocompatibility | "shown to be biocompatible when tested in accordance with ISO 10993-1" |
| Intended Use | "intended to infuse and aspirate in the peripheral vasculature" |
Missing Information:
- Specific numerical targets or thresholds for "safe" and "effective."
- Detailed metrics or quantitative results from the "bench testing" that demonstrated safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
Missing Information:
- There is no mention of a "test set" in the context of clinical data or a specific cohort of patients.
- The document states "Results of bench testing prove that the KPS Rinspiration™ System is safe and effective for its intended use." This implies the testing was done in a laboratory environment, not on human patients or a derived dataset from human patients. Therefore, information about data provenance (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Missing Information:
- No information is provided about experts used to establish a ground truth. Since the reported testing was "bench testing," it's unlikely that clinical expert review for ground truth was part of this submission's provided summary.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
Missing Information:
- No information is provided about an adjudication method, as there's no mention of a test set requiring expert review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improvement with AI vs. without AI assistance:
Missing Information:
- No MRMC comparative effectiveness study was mentioned. The device is a mechanical system, not an AI or imaging-based diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" is not applicable to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Missing Information:
- This device is not an algorithm or AI system. It is a physical catheter system for infusion and aspiration. Therefore, standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Missing Information:
- For the "bench testing," the "ground truth" would likely be engineering specifications, measurable physical properties, and established industry standards for material compatibility and performance. However, the specific type of "ground truth" used for each aspect of safety and effectiveness (e.g., flow rate measurements, pressure tolerance, material degradation assessment) is not detailed in the summary.
8. The sample size for the training set:
Missing Information:
- There is no mention of a "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Missing Information:
- Not applicable, as there is no "training set" for this device.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).