(136 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™ and its 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 guide wire. The Rinspiration™ Catheter is available in over the wire and rail configurations. The catheter includes a radiopaque marker band at the distal tip and two radiopaque marker bands designating the infusion portion of the catheter. The catheter has a hub on the proximal end that allows access to the infusion and aspiration lumens. The KPS Rinspirator™ and its accessories is a sterile, single-use mechanical device. This hand-activated device 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™."
Here's an analysis of the provided text regarding the acceptance criteria and study for the KPS Rinspiration™ System:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness for Intended Use (implied, not explicitly stated as a quantitative criterion) | "Results of bench testing demonstrate that the KPS Rinspiration™ System is safe and effective for its intended use." (Functional Test Results). The device is found "substantially equivalent" to predicate devices. |
| Biocompatibility (implied, not explicitly stated as a quantitative criterion) | "The materials used in the KPS Rinspiration™ System have been shown to be biocompatible when tested in accordance with ISO 10993-1 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing requirements." |
Critique: The provided document does not explicitly state quantitative acceptance criteria for the device's performance. Instead, it makes general statements about safety, effectiveness, and biocompatibility, and concludes substantial equivalence based on these.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document mentions "bench testing," but doesn't provide details on the number of units tested or the specific conditions.
- Data Provenance: Not specified. It's implied to be internal testing by the applicant ("Results of bench testing demonstrate..."), but no country of origin or whether it's retrospective/prospective is mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. This study appears to be a bench test of a physical device, not related to interpretation of images or clinical data by experts.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This study appears to be a bench test, not requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission describes bench testing, not a study involving human readers or clinical cases.
- Effect Size of AI assistance: Not applicable, as no AI component or human-in-the-loop study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Standalone Study: Yes, in a sense, the "Functional Test Results" which state "Results of bench testing demonstrate that the KPS Rinspiration™ System is safe and effective for its intended use" represent the standalone performance of the device itself. However, this is for a physical medical device, not a software algorithm.
7. Type of Ground Truth Used:
- Ground Truth Type: For the functional test results, the ground truth is likely based on engineering specifications and performance metrics defined by the manufacturer and accepted industry standards for infusion/aspiration systems in the peripheral vasculature. For biocompatibility, the ground truth is established by the ISO 10993-1 standard and its specific testing requirements.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. The device is a physical catheter system, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
- Ground Truth Establishment: Not applicable, as there is no training set for an AI model.
Summary of deficiencies in the provided information relative to AI/software device submission expectations:
The provided document is a 510(k) summary for a physical medical device (catheter system) from 2003. It predates the widespread regulatory focus on AI/ML-driven medical devices and therefore does not contain the type of information typically required for an AI/ML device submission, particularly concerning:
- Quantitative performance metrics (e.g., sensitivity, specificity, AUC)
- Detailed test set characteristics (sample size, data provenance, expert labels)
- Specific ground truth establishment methods for algorithms
- Any mention of training sets, validation sets, or AI model development
- Studies involving human readers or comparative effectiveness with or without AI assistance
The "acceptance criteria" discussed are primarily about general safety, effectiveness, and biocompatibility, demonstrating substantial equivalence to predicate devices through bench testing, rather than the rigorous statistical evaluation of algorithm performance against a defined ground truth that would be expected for an AI-powered device today.
§ 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).