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The Primi™ Support Catheter is intended to be used in conjunction with guidewires in order to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. The support catheter also may be used to selectively infuse/deliver physician specified diagnostic and/or therapeutic agents, such as sterile saline, contrast agents, vaso-dilators, anti-blastics, lytics, and anti-thrombotics, with or without a guidewire in position.

The ThermopeutiX Support Catheter that is the submission is a single lumen catheter with a radiopaque marker that aids in positioning the catheter and a tapered tip to facilitate entry. The catheter utilizes an integral spine wire. The catheter is available in several diameters and lengths which are 0.014", 0.018", or 0.035" guidewire compatible. The working lengths are 90 cm thru 170 cm. Reference Table 1 for model number availability. The distal portion of the catheter shaft has a hydrophilic coating to facilitate insertion. The device has a luer hub connector to allow infusion of diagnostic and/or therapeutic agents. The device is supplied sterile and is intended for single use only. Reference Table 2 below for physical and performance characteristics.

The provided text describes a 510(k) premarket notification for the ThermopeutiX Primi™ Support Catheter with an advanced hydrophilic coating. This submission aims to demonstrate substantial equivalence to a previously cleared version of the same catheter (K130850) by ThermopeutiX, Inc., with the primary difference being the advanced hydrophilic coating.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the physical and performance characteristics of the predicate device and the new device. The study demonstrates that the new device's performance is either identical or comparable, and meets internal protocol requirements and product specifications.

Study Proving Device Meets Acceptance Criteria:

The study conducted is a non-clinical performance and safety study comparing the new device with the advanced hydrophilic coating to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify an exact numerical sample size for each individual test. It states "The non-clinical tests performed on sample devices are listed below," and "All performance testing was repeated on samples with a minimum of 10 month aging." This indicates that multiple samples were used for testing, including aged samples, but the exact number isn't quantified.

• Sample Size for Test Set: Not explicitly stated as a number, but "sample devices" were used, including aged samples.
• Data Provenance: The data is from in-vitro (bench) testing performed by the manufacturer, ThermopeutiX, Inc., in the United States. This is prospective testing performed for the purpose of this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This type of submission (510(k) for a medical device with minor modification) typically relies on engineering and biological testing against established standards and product specifications, rather than expert interpretation of a test set in the way AI/ML algorithms use ground truth. Therefore, the concept of "experts establishing ground truth for the test set" is not applicable here. The "ground truth" is the objective physical and performance measurements determined by standardized testing protocols.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this study is based on objective physical and performance measurements via bench testing, not subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI, not for performance testing of a physical medical device like a catheter. The aim here is to show "substantial equivalence" of device characteristics and safety, not to measure human reader improvement with AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical device, not an algorithm or AI system. The "standalone" performance is the device's measured performance during bench testing without human intervention in the device's function.

7. The Type of Ground Truth Used

The ground truth used for this study is based on objective physical and performance measurements derived from standardized engineering and biocompatibility tests (e.g., flow rate, tensile strength, lubricity, cytotoxicity, etc.) and comparison to the known characteristics of the predicate device. It's essentially test results against predetermined specifications and accepted standards (e.g., ISO, ASTM).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The device itself is the product, and its performance is being evaluated, not an algorithm's learning capability.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical medical device.

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The ThermopeutiX TAPAS™ Catheter is intended for general intravascular use in the peripheral vasculature in arteries 1.8 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.

The TAPAS™ Catheter is contraindicated for use in the coronary and intracranial arteries.

The TAPAS™ Catheter is not intended for embolic protection or as an aspiration catheter.

Other than deletion of an optional extracorporeal circuit connection and the addition of a second balloon, the TAPAS™ catheter that is the subject of this submission is a substantially equivalent to the predicate ThermopeutiX DuoFlo catheter. The TAPAS™ catheter, as does the DuoFlo™ catheter, consists of two coaxial tubular shafts (inflow and outflow lumens) that can infuse diagnostic and/or therapeutic agents to selected regions, as well as direct arterial blood or other solutions to a specific region or organ. The lumens may be accessed using external devices connected to these lumens. There are three additional smaller lumen is used for inflation of the distal balloon on the inflow lumen. one is for optional pressure monitoring and the third lumen permits inflation of the balloon on the outflow lumen.

This document is a 510(k) summary for the ThermopeutiX TAPAS™ Catheter. It describes the device, its intended use, and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify numerical sample sizes for the mechanical and biocompatibility tests performed. It states "Physical testing was performed and results were in compliance with relevant standards and the product specification." and "The biological safety of the device has been demonstrated through biocompatibility studies of patient contact materials in accordance with the standards outlined in ISO 10993-1."

There is no information regarding data provenance (e.g., country of origin, retrospective or prospective) as these are non-clinical, in-vitro/bench tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The tests performed are mechanical and biological (biocompatibility) in nature, not involving expert interpretation of data like medical image analysis. The "ground truth" for these tests would be established by the physical and chemical properties of the materials and device components, measured against established standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or subjective assessments that would require an adjudication method. The outcomes of the tests are objective measurements against predefined specifications or standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is a medical catheter, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance and safety tests described (biocompatibility, dimensions, balloon characteristics, bond strengths, etc.) is based on established industry standards (e.g., ISO 10993-1) and ThermopeutiX's internal product specifications. These serve as objective benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device submission, which does not involve machine learning models or training sets.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device submission.

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The DuoFlo™ Catheter is intended for general intravascular use in the peripheral vasculature in arteries 3.5 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region when connected to an extracorporeal circuit. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer. The DuoFlo™ Catheter is contraindicated for use in the coronary and intracranial arteries. The DuoFlo™ Catheter is not intended for embolic protection or as an aspiration catheter.

The DuoFlo™ Catheter is a sterile single use device that consists of concentric shafts with four lumens with access via Luer connectors as follows, one for balloon inflation, one for pressure monitoring and two concentric lumens for infusate injection or extracorporeal circuit connections. The central through lumen accepts up to a 0.038" guidewire.

The provided text is a 510(k) summary for the ThermopeutiX DuoFlo Catheter (Heparin Coated). This document is primarily focused on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves a device meets specific acceptance criteria in the way a diagnostic software or AI model might.

Here's an analysis based on the available information, addressing your specific points where possible, and noting where information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present specific quantitative acceptance criteria or detailed performance results in the format typically used for a diagnostic device's clinical study. The device is a "Temporary Intravascular Occluding Catheter" and the focus is on its safety and equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text. The document refers to "biocompatibility studies" but does not detail their methodology, sample sizes, or data provenance. This is a medical device clearance, not typically a clinical trial for a diagnostic algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The ground truth establishment by experts is relevant for diagnostic AI/software evaluations, not for the clearance of a mechanical catheter based on substantial equivalence and biocompatibility.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided for the same reasons as point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study is not applicable/provided. This device is a catheter, not an AI or imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study is not applicable/provided. This device is a physical medical instrument, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context revolves around:

• Biocompatibility: Adherence to ISO standards, likely demonstrated through in vitro and in vivo testing (e.g., cytotoxicity, sensitization, irritation, genotoxicity, hemocompatibility studies).
• Sterility: Verification of the sterilization process to achieve the specified SAL.
• Physical/Mechanical Properties: Verification that the design and construction are identical to the predicate (except for the coating), which implies similar mechanical performance.
• Heparin Coating Efficacy (implied): The claim that the heparin helps minimize thrombus formation would ideally be supported by in vitro or in vivo studies demonstrating reduced thrombus compared to the uncoated predicate. However, detailed data for this is not presented in the summary, only the claim is made.

8. The sample size for the training set

This information is not applicable/provided. A "training set" is relevant for machine learning algorithms, not for the type of device being described.

9. How the ground truth for the training set was established

This information is not applicable/provided. (See point 8).

Summary of the Study Mentioned (as much as can be gleaned):

The primary "study" mentioned for the ThermopeutiX DuoFlo™ Catheter (Heparin Coated)'s performance and safety is:

• Biocompatibility Studies: These were conducted on the patient contact materials in accordance with ISO 10993-1 standards. The exact details (e.g., specific tests, sample sizes, animal models if any) are not provided in this summary, but the claim is that biological safety has been "demonstrated."
• Sterility Validation: The device's sterility "conforms to a Sterility Assurance Level (SAL) of 10⁻⁶." This indicates that sterilization processes were validated to meet this standard.

The overall approach for this 510(k) is demonstrating substantial equivalence to a predicate device (K080700). The "study" largely consists of showing that the device is identical in design and construction, with the only change being the addition of a bound heparin coating. The safety of this change hinges on the biocompatibility studies of the new material and the claim that the heparin helps minimize thrombus, implying it's a beneficial addition without new safety concerns. No comparative clinical effectiveness study against the predicate is described in this document to quantify improvement due to the heparin coating.

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The DuoFlo™ Catheter is intended for general intravascular use in the perioheral vasculature in arteries 3.5 mm and larger. Once placed in the selected region, the catheter can be used for infusion of diagnostic and/or therapeutic agents, and for controlling blood flow to the selected region when connected to an extracorporeal circuit. The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the manufacturer.

The Duo-Flo Catheter is contraindicated for use in the coronary and intracranial arteries.

The Duo-Flo Catheter is not intended for embolic protection or as an aspiration catheter.

The DuoFlo™ Catheter is a sterile single use device that consists of concentric shafts with four lumens with access via Luer connectors as follows, one for balloon inflation, one for pressure monitoring and two concentric lumens for infusate injection or extracorporeal circuit connections. The central through lumen accepts up to a 0.038" guidewire.

The provided text is a 510(k) summary for the ThermopeutiX DuoFlo™ Catheter, and it does not contain the level of detail typically found in a study report for an AI/ML-based medical device. Therefore, I cannot extract all the requested information. This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and basic performance/safety validation for a physical medical device (a catheter), not a software algorithm.

However, I can provide information based on what is available in the document regarding the performance and safety aspects of the physical device.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document mentions Performance and Safety validation but does not provide specific quantitative acceptance criteria or detailed reported performance in a tabular format as would be expected for an AI/ML study. It generally states that the device meets safety and integrity requirements.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as the document describes validation for a physical catheter through biocompatibility and physical integrity testing, not a clinical study on a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The validation described does not involve establishing ground truth by human experts for a test set, as it's not a diagnostic or AI/ML device requiring such evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided for the same reasons as item 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/provided. The device is a physical catheter, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable/provided. There is no algorithm for this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/provided. The "ground truth" for a physical device like a catheter would be its physical properties, material safety, and functional performance metrics, not clinical outcomes derived from expert assessment or pathology.

8. The sample size for the training set

This information is not applicable/provided. There is no training set for a physical catheter.

9. How the ground truth for the training set was established

This information is not applicable/provided. There is no training set for a physical catheter.

Summary of Study (Based on available information):

The "study" described in the 510(k) summary is primarily comprised of:

• Biocompatibility studies: Conducted on the raw materials in accordance with ISO 10993-1 to demonstrate the safety of materials in contact with the body.
• Physical testing: Performed to assure the integrity of the catheter, including verification of catheter body and balloon burst pressure. The document states that these tests were done to "assure catheter integrity."
• Sterility validation: The device is supplied with a Sterility Assurance Level (SAL) of 10⁻⁶.

The overall approach for this device relies on demonstrating substantial equivalence to already legally marketed predicate devices in terms of general indications, design, features, construction materials, and safety profile. The validation tests (biocompatibility, physical integrity, sterility) confirm that the DuoFlo™ Catheter meets established safety and performance standards for its type.

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The VascuTraK™ II PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the iliac, femoral, popliteal, ilio-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The VascuTraK™ II Catheter is a sterile single use device that consists of a flexible shaft with a single through lumen terminating in a semi-compliant balloon. The catheter has a 24 cm lumen proximal to the balloon that accepts a 0.014" guidewire and an 18 mm lumen distal to the balloon that accepts a 0.014" guidewire. The distal balloon is inflated via a central lumen terminated in a luer fitting at the proximal end. The balloon is available in various diameters and lengths,

The provided text is a 510(k) summary for the VascuTraK™ II PTA Dilatation Catheter. It describes a medical device, its intended use, and the comparison to a predicate device. However, it does not include a study that proves the device meets specific acceptance criteria in the manner requested by the prompt (e.g., performance metrics like sensitivity, specificity, accuracy, or human reader improvement for an AI/CAD system).

This document is a regulatory submission for a physical medical device (a catheter), not a software or AI-based diagnostic device. Therefore, many of the requested categories like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "number of experts used to establish ground truth," "adjudication method," "sample size for training set," and "how ground truth for training set was established" are not applicable to this type of device.

The "acceptance criteria" and "device performance" in this context refer to engineering and biocompatibility testing for the catheter itself.

Here's an attempt to extract and reframe the information based on the provided text, acknowledging the limitations for a physical device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in a quantifiable manner for the specific tests mentioned. The text states "Testing of the modified catheter was performed," but does not detail the sample sizes for balloon performance or tip tensile testing. Data provenance is not applicable in the context of clinical data for AI/CAD, as this is a physical device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. "Ground truth" in this context would refer to established engineering standards and material science, not expert interpretation of diagnostic images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in diagnostic studies.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/CAD device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/CAD device.

7. The Type of Ground Truth Used

For biocompatibility, the ground truth is established by ISO 10993-1 standards.
For sterilization, the ground truth is established by regulatory requirements for Sterility Assurance Level (SAL).
For balloon and tip performance, the ground truth is established by engineering specifications and performance data of the original (predicate) device.

8. The Sample Size for the Training Set

Not applicable. This refers to a training set for an algorithm, which is not relevant for this physical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This refers to ground truth for an algorithm's training data.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The document details a Special 510(k) Device Modification for the VascuTraK™ II PTA Dilatation Catheter, which is a modification of the previously cleared VascuTraK™ PTA Dilatation Catheter (cleared under K063657).

The primary modification is to the distal tip configuration, changing from a short lumen tip to permit the use of an external guidewire for easier catheter exchange.

The study that proves the device meets acceptance criteria consists of:

• Reliance on prior demonstrations:
  • Biocompatibility of patient contact materials was previously demonstrated in accordance with ISO 10993-1, and no new materials were used in the modification.
  • The modification does not affect the ability to sterilize the device, so prior sterilization testing establishing a Sterility Assurance Level (SAL) of 10⁻⁶ is considered valid.
• Specific testing of the modified catheter:
  • Balloon performance testing was conducted.
  • Tip tensile testing was conducted.
  • The "results for the modified device were consistent with those of the original device," indicating that the modification did not negatively impact these critical performance characteristics and that the device still met the established performance benchmarks set by its predicate.

The document concludes that there are "no new safety or effectiveness issues related to this device" based on these tests and comparisons. This type of submission relies heavily on the equivalence to a legally marketed predicate device, especially when the changes are minor and do not introduce new technology or materials.

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