Search Results

The Kerberos Proximal Solutions Rinspiration Catheter System is intended to infuse physician specified fluid and remove/aspirate 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 quide wire. The catheter includes a radiopaque marker band at the distal tip and two radiopague marker bands designating the infusion 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 only difference between the cleared Rinspiration System and the Rinspiration Catheter System with Fluid Infusion Stopcock Port is the addition of a 4-way stopcock and a co-extruded paratube that replaces the infusion and aspiration lines.

The fluid infusion stopcock port consists of a 4-way stopcock which attaches directly to the infusion check valve. This addition provides the user another means to infuse physician specified fluids.

In order to streamline the appearance of the Rinspiration Catheter System, a coextruded paratube replaces the infusion and aspiration lines.

I am sorry, but the provided text does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device. The documents are FDA 510(k) letters and summaries for a device called the "Rinspiration System," which focus on its substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

Ask a specific question about this device

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

Study Details (Based on available 510(k) information)

1. 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.

2. 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.

3. 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).

4. 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.

5. 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.

6. 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).

7. 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.

8. 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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Kerberos Proximal Solutions Occluding Guide Catheter (OCG) and Accessories are intended to facilitate the use and guidance of intravascular catheters into selected blood vessels in the peripheral, cardiovascular and neurovascular systems. The balloon provides temporary vascular occlusion during these percutaneous procedures.

The Kerberos Proximal Solutions Occluding Guide Catheter (OGC) is a sterile single-use percutaneous catheter consisting of a dual lumen variable stiffness braided shaft catheter incorporating a flush mounted balloon at the distal tip. Guidance and tracking of the catheter through the coronary, neuro or peripheral vasculature is accomplished by torquing of the catheter and/or the use of a guide wire.

The provided text describes a medical device, the Kerberos Occluding Guide Catheter and Accessories, and its pre-market notification (510(k)) to the FDA. This specific document outlines the device's substantial equivalence to existing predicate devices based on design and performance testing. However, it does not contain the specific acceptance criteria or a detailed study report proving the device meets those criteria in the way you've requested for AI/diagnostic devices.

This document is typical for a Class II medical device where substantial equivalence is demonstrated through comparative testing with predicate devices, rather than establishing de novo performance metrics against specific acceptance thresholds like AI/diagnostic tools.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information. These elements are not typically part of a 510(k) submission for this type of device.

Instead, the document states:

Acceptance Criteria and Device Performance (Implicit):
The acceptance criteria are implicitly met by demonstrating "substantial equivalence to currently marketed predicate devices" and that "All data fell well within internal specification requirements, as well as external standard requirements and predicate performance expectations."

Study Information:
The study was conducted through "Design analysis, in vitro and in vivo data." The specific types of tests mentioned are:

• In vitro dimensional analysis
• Balloon performance
• Torque and kink resistance
• Leakage
• Bond strengths
• Biocompatibility tests

Missing Information (Not provided in the document):

1. A table of acceptance criteria and the reported device performance: Not explicitly provided in this summary. The summary states "All data fell well within internal specification requirements, as well as external standard requirements and predicate performance expectations."
2. Sample size used for the test set and the data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical device, not an AI/diagnostic tool requiring expert ground truth for interpretation.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is not relevant for a physical catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable in the context of diagnostic performance. For a physical device, "ground truth" would relate to engineering specifications and performance in various physical tests.
8. The sample size for the training set: Not applicable, as this is not an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

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:

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.

Ask a specific question about this device