(112 days)
The Kerberos Proximal Solutions Rinspiration System is intended to infuse physician specified fluid and remove/aspirate fluid, fresh, soft emboli and thrombi from 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 guide 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."
Here's an analysis of the provided FDA 510(k) summary, specifically addressing the acceptance criteria and study information for the Kerberos Proximal Solutions Rinspiration System:
It's important to note that the provided documents are a 510(k) summary for a medical device submitted in 2005, and an administrative correction letter from 2021. This type of submission focuses on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices, rather than establishing de novo clinical effectiveness through a new clinical trial with specific performance acceptance criteria and a detailed study report. For Substantial Equivalence (SE), the primary goal is to show that the new device is as safe and effective as a predicate device, or that any differences do not raise new questions of safety or effectiveness.
Therefore, the information you're asking for, particularly around "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of clinical performance metrics, is generally not directly present or required in the same detailed manner for a 510(k) submission as it would be for a PMA (Premarket Approval) application or a de novo classification.
However, I can extract the relevant information presented in the 510(k) summary related to testing and "acceptance" in the context of functional and safety equivalence.
Acceptance Criteria and Device Performance (Context: 510(k) Substantial Equivalence)
Given the nature of a 510(k) submission, the "acceptance criteria" are primarily established against industry standards and the performance of predicate devices, focusing on demonstrating equivalence in safety and functional attributes.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion (Implied/Stated) | Reported Device Performance |
|---|---|---|
| Functional Performance | Device functions according to its Instructions for Use. | "All testing conducted confirmed the acceptability of the KPS Rinspiration System to perform as intended." |
| Material Biocompatibility | Materials are biocompatible when used as directed. | "The KPS Rinspiration System materials passed the necessary biocompatibility tests, complying with ISO 10993-1..." |
| Sterility Assurance | Achieves a sterility assurance level (SAL) of 10⁻⁶. | "Sterilization Validation was conducted according to ISO 11135... to assure a sterility assurance level (SAL) of 10⁻⁶." |
| Mechanical System Integrity | Catheter integrity, aspiration/infusion performance. (Implied by ISO 10555) | "Functional testing was performed per KPS protocol and referenced International Standard ISO 10555, Sterile, Single Use Intravascular Catheters - Part 1..." |
| Substantial Equivalence | Equivalent to predicate devices in intended use, function, materials, and sterilization. | Stated that the device "is substantially equivalent to the predicate devices with regard to intended use, function, materials, and sterilization method." |
| No New Safety/Effectiveness Concerns | No differences that have a significant effect on safety or effectiveness. | Stated that the device "does not have any differences that have a significant effect on safety or effectiveness." |
Study Details (Based on available 510(k) information)
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Sample Size Used for the Test Set and Data Provenance:
- Test Set (Functional/Biocompatibility/Sterility): The summary does not specify the exact sample sizes (e.g., number of catheters, material samples tested) for the functional, biocompatibility, or sterility testing. This level of detail is typically found in the full test reports referenced in the 510(k), not in the summary.
- Data Provenance: The testing was conducted internally by Kerberos Proximal Solutions ("KPS protocol"). It's in vitro and in-house testing, not clinical data from patients. No country of origin for clinical data is applicable as this is not a clinical study report. It is prospective testing performed for the submission.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This question is not applicable in the context of this 510(k) submission. The "ground truth" for functional, biocompatibility, and sterility testing is typically defined by established engineering specifications, published standards (ISO 10555, ISO 10993-1, ISO 11135), and the performance of predicate devices, not by expert human consensus on clinical cases.
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Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 refer to clinical endpoint adjudication by multiple experts, typically in a clinical trial. The testing described here is laboratory-based (functional, material, sterility).
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is a type of clinical comparative effectiveness study, often used for diagnostic imaging devices to assess human reader performance with and without AI assistance. This device is an embolectomy catheter, a therapeutic device, and the submission is a 510(k) focused on substantial equivalence based on in vitro testing and comparison to predicates, not a clinical effectiveness trial for human reader improvement.
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical catheter system for mechanical intervention, not an algorithm, AI, or software-only device. Performance inherently involves human operation.
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The Type of Ground Truth Used:
- For Functional Testing: The "ground truth" or reference standard for functional testing is adherence to predefined engineering specifications and the ability to perform the intended mechanical actions (infuse and aspirate) as described in the Instructions for Use, validated against relevant ISO standards.
- For Biocompatibility: The ground truth is compliance with the toxicological and biological safety requirements outlined in ISO 10993-1.
- For Sterility: The ground truth is achieving a specified Sterility Assurance Level (SAL) of 10⁻⁶, validated against ISO 11135.
- For Substantial Equivalence: The ultimate "ground truth" for the 510(k) process is demonstrating that the device is as safe and effective as a legally marketed predicate device(s).
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The Sample Size for the Training Set:
- Not applicable. "Training set" refers to data used to train a machine learning algorithm. This device is not an AI/ML product. The term might broadly apply to the design and development cycle (e.g., initial prototypes or manufacturing runs used for internal testing and refinement), but it's not a formal "training set" in the context of AI.
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How the Ground Truth for the Training Set Was Established:
- Not applicable for the reasons stated above (not an AI/ML device).
Summary of Device and 510(k) Context:
The Kerberos Proximal Solutions Rinspiration System is an embolectomy catheter. The 510(k) submission (K050130) demonstrates Substantial Equivalence (SE) to predicate devices by focusing on:
- Identical Intended Use.
- Similar technological characteristics (multi-lumen, rail configuration, infusion/aspiration mechanism).
- Compliance with recognized international standards for functional performance (ISO 10555), biocompatibility (ISO 10993-1), and sterilization (ISO 11135).
- No new safety or effectiveness concerns identified.
The FDA's decision to clear the device is based on this demonstration of SE, rather than a de novo clinical trial demonstrating quantitative performance against specific clinical acceptance criteria for a novel technology. The "limitations" noted in the 2005 letter are important, clarifying that while secondary thrombus removal may occur, the system's safety and effectiveness have not been established for the exclusive use of thrombectomy or embolic protection. This further emphasizes that the clearance was for the primary stated intended use, not for broader claims requiring more extensive clinical evidence.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).