(118 days)
The Kerberos Proximal Solutions Rinspiration System is intended to infuse and aspirate physician specified fluid in the coronary and peripheral vasculature.
The system consists of a Rinspiration™ Catheter, and a Rinspirator™ with accessories, The Rinspiration Catheter is a multi-lumen, rail configuration 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 vasculature of a patient over a quide wire. The Rinspiration Catheter is offered with a standard tip and a short tip. 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 Rinspirator and accessories is a sterile, single-use mechanical device. This hand activated device allows for simultaneous infusion and aspiration of fluids at the treatment site. The device activates two syringes, one for infusion and one for aspiration. This simultaneous infusion and aspiration action is known as "Rinspiration."
The KPS Rinspiration System is a medical device intended to infuse and aspirate physician-specified fluid in the coronary and peripheral vasculature. The provided text describes the regulatory submission for this device but does not contain acceptance criteria or a study proving that the device meets specific performance criteria in terms of clinical effectiveness or accuracy.
Instead, the document focuses on functional testing, biocompatibility, and sterility to demonstrate substantial equivalence to predicate devices, which is a regulatory pathway for approval.
Here's a breakdown of the information that can be extracted, and what cannot be found based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text.
The document states: "Functional testing was conducted on the KPS Rinspiration System to ensure that the product will function according to its Instructions for Use. This functional testing was performed per KPS protocol and referenced International Standard ISO 10555, Sterile, Single Use Intravascular Catheters - Part 1. All testing conducted confirmed the acceptability of the KPS Rinspiration System to perform as intended."
This indicates that internal protocols and an international standard were used, and the device met these, but the specific quantifiable acceptance criteria (e.g., flow rate, aspiration volume, catheter strength, etc.) and the exact performance results are not reported.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for clinical effectiveness/accuracy study as one was not described.
For the functional tests, the sample size is not mentioned. The data provenance is internal to KPS (Kerberos Proximal Solutions).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable as no clinical effectiveness/accuracy study with ground truth establishment was described.
4. Adjudication Method
Not applicable as no clinical effectiveness/accuracy study with ground truth establishment was described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was described. The provided text does not mention any study comparing human readers with and without AI assistance, nor does it mention AI.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study for an algorithm was described. The device is a physical catheter system, not an AI algorithm.
7. Type of Ground Truth Used
Not applicable as no clinical effectiveness/accuracy study requiring ground truth was described. The testing mentioned was functional, biocompatibility, and sterility testing, not clinical performance against a true clinical outcome.
8. Sample Size for the Training Set
Not applicable as this refers to a training set for an AI algorithm, and no AI algorithm or training was described.
9. How the Ground Truth for the Training Set Was Established
Not applicable as this refers to a training set for an AI algorithm, and no AI algorithm or training was described.
Summary of what was reported:
The provided document describes the regulatory submission for a medical device (KPS Rinspiration System). The "study" mentioned refers to:
- Functional Testing: This was performed according to KPS's internal protocols and referenced ISO 10555 (Sterile, Single Use Intravascular Catheters - Part 1). The document states, "All testing conducted confirmed the acceptability of the KPS Rinspiration System to perform as intended." However, no specific quantitative acceptance criteria or detailed results are provided.
- Biocompatibility Testing: Conducted according to ISO 10993-1. The device materials "passed the necessary biocompatibility tests."
- Sterilization Validation: Conducted according to ISO 11135 to assure a sterility assurance level (SAL) of 10⁻⁶.
These tests are standard for demonstrating the safety and fundamental functionality of a device for regulatory clearance through substantial equivalence, rather than proving performance against specific clinical efficacy metrics.
§ 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).