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The FlexCath Advance Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The FlexCath Advance Steerable Sheath and Dilator is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. The FlexCath Advance Steerable Sheath and Dilator can be deflected to provide additional maneuverability to catheters that are advanced through the sheath and into the right or left chamber of the heart. The sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath.

This premarket notification presents proposed design and material changes to the hemostasis valve component, located within the handle section. Product performance requirement changes related to the updated hemostasis valve are also being implemented for the subject device. All other aspects of the device (overall design/technology, labeling, etc.) remain unchanged and are identical as compared to the predicate device, the FlexCath Advance Steerable Sheath and Dilator cleared under K183174.

The provided text describes the FlexCath Advance Steerable Sheath and Dilator, which is a medical device for percutaneous catheter introduction. The submission is for design and material changes to the hemostasis valve component of the device.

Here's the information about the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance:

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

The document states that "All design verification testing was performed on final finished product incorporating the proposed design and material changes." However, the exact sample sizes for each specific test (e.g., number of devices tested for kink, pull force, etc.) are not provided in the given text.

The data provenance is from Medtronic CryoCath LP, Canada, as indicated by the applicant's address: 9000 Autoroute Transcanadienne, Point-Claire, Quebec H9R 5Z8, Canada. The studies appear to be prospective bench and laboratory testing performed to verify the changes.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable as the studies described are for design verification, biocompatibility, and sterilization qualification of a physical medical device, not for an AI/algorithm-based diagnostic or assistive system requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as point 3. The testing involves objective measurements to meet specified product requirements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which doesn't apply to this medical device submission focused on physical changes to a sheath and dilator.

6. Standalone (Algorithm Only) Performance:

Standalone performance was not done. This concept is specific to AI algorithms operating without human interaction. The FlexCath Advance is a physical medical device.

7. Type of Ground Truth Used:

The "ground truth" for this device, in essence, is the pre-defined product requirements and established regulatory standards (e.g., ISO 10993-1:2018 for biocompatibility). The tests confirm that the device performs according to these engineering and safety specifications.

8. Sample Size for the Training Set:

This information is not applicable as the submission is not for an AI/machine learning device that would require a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reason as point 8.

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The FlexCath Advance Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning.

The FlexCath Advance Steerable Sheath is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring.

The FlexCath can be deflected to provide additional maneuverability to catheters that are advanced through the sheath and into the right or left chamber of the heart. The FlexCath Advance Steerable Sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath.

This premarket notification presents proposed updates to the Instructions for Use (IFU) manual; changes resulting in the subject device are limited to these IFU updates only. All other aspects of the device (design/technology, performance specifications, etc.) remain unchanged and are identical as compared to the predicate device, the FlexCath Advance originally cleared under K123591.

The provided text is a 510(k) summary for the Medtronic CryoCath LP FlexCath Advance Steerable Sheath and Dilator. However, this submission (K183174) is specifically for updates to the Instructions for Use (IFU) manual only.

The document explicitly states:

• "This premarket notification presents proposed updates to the Instructions for Use (IFU) manual; changes resulting in the subject device are limited to these IFU updates only. All other aspects of the device (design/technology, performance specifications, etc.) remain unchanged and are identical as compared to the predicate device, the FlexCath Advance originally cleared under K123591."
• "No performance testing (bench, animal or clinical) was required to support the proposed IFU updates. The existing performance data previously submitted under K123591 remains valid and applicable for this subject device."

Therefore, this specific 510(k) (K183174) does not contain information on acceptance criteria or a study proving the device meets those criteria, as its purpose was not to establish device performance from scratch but rather to update labeling based on an already cleared device (K123591).

To answer your questions, one would need to refer to the original 510(k) submission (K123591) for the FlexCath Advance Steerable Sheath and Dilator. Since that document is not provided, I cannot fulfill your request for details about acceptance criteria and the study proving the device meets them from the given text.

In summary, based only on the provided document (K183174):

• 1. A table of acceptance criteria and the reported device performance: Not available in this document. This submission is for IFU updates, not performance data.
• 2. Sample sized used for the test set and the data provenance: Not applicable to this submission.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to this submission.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to this submission.
• 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 a medical device, not an AI software.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable to this submission.
• 8. The sample size for the training set: Not applicable to this submission.
• 9. How the ground truth for the training set was established: Not applicable to this submission.

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The FlexCath Select Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left the heart through the interatrial septum. The sheath deflection facilitates catheter positioning.

The Medtronic FlexCath™ Select Steerable Sheath is a sterile, single-use, percutaneous catheter introducer fitted with a valve to allow for introduction, withdrawal, and exchange of catheters and wires while minimizing blood loss. A side port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. A dilator is packaged with the FlexCath Select. The handle incorporates a deflection mechanism and a deflection wire that is integrated into the catheter shaft. This allows the sheath to be deflected to provide additional maneuverability to catheters that are advanced through the sheath into the right or left chamber of the heart. The FlexCath Select sheath is comprised of two (2) main sections: the shaft and the handle.

The provided FDA 510(k) summary (K163268) for the Medtronic FlexCath™ Select Steerable Sheath and Dilator describes modifications to an existing predicate device (K142684). The assessment for this device focuses on demonstrating substantial equivalence through bench testing, rather than an AI/ML driven study with comprehensive acceptance criteria and ground truth evaluations typically found in software as a medical device (SaMD) clearances.

Therefore, the requested information regarding acceptance criteria, study details like sample sizes, data provenance, expert qualifications, and MRMC studies, and ground truth establishment is largely not applicable in the context of this specific medical device clearance, which is for a physical medical device with minor material and manufacturing process changes.

However, I can extract information related to the bench testing performed to ensure the modified device remains substantially equivalent to its predicate.

Here's a summary of the available information and an explanation of why some of the requested details are not present in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "Bench testing was completed to support the proposed modifications to the FlexCath Select. Performance testing verified that the subject device performs as designed and is suitable for the intended use." and "All results demonstrate that the properties and performance of the modified FlexCath Select are suitable for the intended use."

While specific numerical acceptance criteria (e.g., "leak rate must be less than X%") are not explicitly detailed in this summary, the criteria would typically be established based on the predicate device's performance, industry standards, and risk analysis for such devices. The "reported device performance" is that the device met these unstated acceptance criteria, thus remaining substantially equivalent.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided summary. For bench testing of physical devices, sample sizes are typically determined statistically to ensure sufficient power for the tests and often involve a certain number of units for each test (e.g., 3, 5, 10 units).
• Data Provenance: The testing was "Bench testing" performed by the manufacturer, Medtronic CryoCath LP, to support the modifications. This is internal testing. The country of origin of data is not explicitly stated but would be derived from the manufacturing/testing location of the applicant (Canada/USA). This is typically prospective testing, meaning the tests were designed and conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. For a physical device like a steerable sheath, "ground truth" in the AI/ML sense (e.g., consensus among radiologists for image interpretation) is not relevant. The "truth" is determined by objective physical and mechanical measurements according to established engineering and quality control standards. The "experts" involve engineers and technicians conducting the bench tests and evaluating the results against design specifications and predicate device performance.

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

• Not Applicable. Adjudication methods are relevant for subjective interpretations, especially in clinical or image-based studies. For bench testing of physical properties, the results are typically objective measurements, which do not require adjudication.

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 a physical medical device, not an AI/ML driven diagnostic or assistive software. Therefore, an MRMC study is not relevant to this submission.

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

• Not Applicable. This is a physical medical device. There is no algorithm or software component being evaluated in a "standalone" or "human-in-the-loop" manner.

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

• Not Applicable / Objective Measurements. The "ground truth" for this device's performance is based on objective physical and mechanical properties measured during bench testing, compared against predetermined engineering specifications, and the performance of the predicate device. For example, leak rates are measured quantitatively, bond pull forces are measured in Newtons, etc.

8. The sample size for the training set

• Not Applicable. This submission does not involve an AI/ML algorithm that requires a training set.

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

• Not Applicable. As there is no AI/ML training set, this question is not relevant.

In summary, this 510(k) submission for the FlexCath™ Select Steerable Sheath and Dilator is for a modified physical device, not a software or AI/ML product. The evaluation relies on demonstrating substantial equivalence through standard bench testing of physical characteristics and mechanical performance, rather than clinical or AI/ML-specific studies.

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The FlexCath Select Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum. The sheath deflection facilitates catheter positioning.

The FlexCath Select Steerable Sheath is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while preventing air ingress and minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. The FlexCath Select Steerable Sheath can be deflected to provide additional maneuverability to catheters that are advance through the sheath and into the right or left chamber of the heart. The FlexCath Select Steerable Sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath. This application introduces FlexCath Select 10 French (10Fr) FlexCath Select Steerable Sheath (990065), which is a modification of the 12 French (12Fr) FlexCath Advance Sheath (4FC12). Modifications were made to the shaft, cap and strain relief components, hemostasis valve assembly (stopcock, valve, and hub), dilator, new adhesive material and packaging tray cavity.

This document describes a 510(k) premarket notification for the "FlexCath Select Steerable Sheath and Dilator (Model 990065)". The submission aims to establish substantial equivalence to predicate devices, namely the "FlexCath Advance Steerable Sheath & Dilator (Model 4FC12)" and the "HeartSpan Steerable Introducer (Models FST-085-00, FST-085-01, and FST-085-02)". The primary modification and expansion of indications for use revolve around the ability to introduce the catheter into the left side of the heart through the interatrial septum (transseptal puncture).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria and the reported device performance" in a quantitative format with specific values for acceptance and performance. Instead, it describes a substantial equivalence comparison with predicate devices and states that "all testing demonstrated that acceptance criteria were met" and "all testing passed by meeting the established requirements".

However, we can infer some performance characteristics and implicit "acceptance criteria" from the comparative tables and descriptions:

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

The document states: "In-vitro testing was performed to demonstrate substantial equivalence with the predicate devices and also to comply with user needs and safety and effectiveness requirements." It further mentions "Non-clinical performance testing (bench testing) was performed to support substantial equivalence".

• Sample Size for Test Set: The document does not specify the sample sizes used for the various in-vitro or bench tests. It broadly refers to "all relevant key performance attributes were tested".
• Data Provenance: The data is described as "in-vitro testing" and "non-clinical performance testing (bench testing)". This inherently means the data is retrospective in the sense that it evaluates the manufactured device against pre-defined specifications. There is no mention of human subject data or clinical studies for this 510(k) submission, as it focuses on substantial equivalence through bench testing. The testing was presumably conducted by Medtronic CryoCath LP, which is based in Canada.

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

This section is not applicable as the ground truth for this device's performance was established through bench testing and engineering specifications against predicate devices, not through expert consensus on medical images or clinical outcomes. The "ground truth" here is the performance of the predicate devices and the established engineering requirements for safe and effective function.

4. Adjudication Method for the Test Set

This is not applicable as the evaluations were based on objective engineering and performance testing rather than subjective human interpretation requiring adjudication.

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

This is not applicable. The device (FlexCath Select Steerable Sheath and Dilator) is a physical medical device, not an AI or imaging-related product. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is entirely outside the scope of this submission.

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

This is not applicable as the device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for demonstrating substantial equivalence was primarily based on:

• Performance of Predicate Devices: The established performance characteristics, safety, and effectiveness of the FlexCath Advance Steerable Sheath & Dilator (K123591) and the HeartSpan Steerable Introducer (K132164).
• Engineering Specifications and Bench Testing: The device's ability to meet pre-defined engineering and functional requirements through mechanical and performance verification.
• Risk Assessment: Evaluation of new failure modes, particularly those related to transseptal puncture, against acceptable risk levels, often informed by clinical knowledge of procedures.

8. The Sample Size for the Training Set

This is not applicable. As a physical medical device, there is no "training set" in the context of an AI/machine learning model. The device design and materials were developed based on engineering principles and knowledge gained from previous device designs (e.g., FlexCath Advance and HeartSpan).

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

This is not applicable for the same reasons as point 8. The "ground truth" for the device's design and functionality was established through engineering design processes, material science, and prior experience with similar devices, rather than a data-driven "training set" in the computational sense.

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The FlexCath Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning.

The FlexCath Advance Steerable Sheath is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while preventing air ingress and minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. The FlexCath can be deflected to provide additional maneuverability to catheters that are advance through the sheath and into the right or left chamber of the heart. The FlexCath Advance Steerable Sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath. This application addresses modifications to the 12 French (12F) FlexCath Steerable Sheath which resulted in the creation of the 12F FlexCath Advance Steerable Sheath (4FC12). Modifications were made to the stopcock, shaft (pullwire and ring assembly), deflection stopper, and barrel and slider assembly. In addition, an updated Technical Manual (Instructions for Use) and updated packaging labeling was developed for the FlexCath Advance Steerable Sheath.

The provided text describes a 510(k) submission (K123591) for the "FlexCath Advance™ Steerable Sheath & Dilator." This submission focuses on design modifications to an already cleared predicate device (FlexCath® Steerable Sheath & Dilator, Model 3FC12, K102176). The core of the submission is to demonstrate that the modified device is substantially equivalent to the predicate, meaning it performs as intended and does not raise new questions of safety or effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list specific quantitative acceptance criteria with pass/fail values. Instead, it states that "All testing passed" and that the device "meet the established specifications." The reported performance is summarized as successful completion of various tests, demonstrating that the modified device's characteristics were not compromised and that it met design specifications.

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

The document does not explicitly state the sample sizes (number of devices) used for each specific test (e.g., how many sheaths were tested for leak, how many for deflection). It mentions "accelerated aging study" for shelf life, implying a sample size was used for that, but the exact number is not provided.

The data provenance is from Medtronic CryoCath LP, Kirkland, Quebec, Canada, and Mounds View, MN, USA. The studies described are retrospective in the sense that they are bench tests conducted on manufactured devices to verify design modifications, rather than prospective clinical trials.

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

This information is not applicable here. The studies described are bench tests (mechanical, shelf-life, biocompatibility) rather than clinical studies where expert evaluation of, for example, medical images or patient outcomes would establish a "ground truth." The ground truth for these tests is based on objective measurements against engineering specifications and industry standards.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the tests are objective bench tests against defined specifications, there is no need for expert adjudication. The results are quantitative (e.g., pass/fail for leak, measurement of tensile strength, visual inspection for kink) rather than subjective.

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

This information is not applicable. The device is a "Steerable Sheath & Dilator," which is a medical instrument used for catheter introduction and positioning. It is not an AI-powered diagnostic or assistive tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.

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

This information is not applicable. As explained above, this device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The ground truth for the performance tests described is based on:

• Engineering Specifications: Defined parameters for mechanical performance (e.g., deflection range, tensile strength, leak limits).
• Industry Standards: Compliance with relevant ISO standards (e.g., ISO 10993 for biocompatibility) and FDA guidance.
• Predicate Device Performance: Although not explicitly an "acceptance criterion," the modified device's performance was compared against the known performance of the predicate device to demonstrate substantial equivalence.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The "design verification testing" is for a physical medical device.

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

This information is not applicable as there is no training set.

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The FlexCath Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning.

The FlexCath Steerable Sheath is a deflectable catheter introducer used to facilitate placement of a catheter through the skin into the artery or vein. It is comprised of the following two (2) main sections: the shaft and the handle. A dilator is included with each sheath. This application addresses changes to the 12F FlexCath sheath tip and valve assembly.

The FlexCath Steerable Sheath & Dilator (K102176) is intended for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath's deflection facilitates catheter positioning. The predicate devices are K081049 - FlexCath Steerable Sheath & Dilator, Models 3FC10, 3FC12.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state specific sample sizes for each test in the test set. However, it mentions "representative finished sterilized samples" were used for in vivo, ex vivo animal testing, biocompatibility, and mechanical testing. The data provenance is primarily through a series of standardized tests (ISO, USP, AAMI TIR). The source of the animal models for in vivo testing is not specified, but the human cells for hemolysis testing and canine for thrombogenicity testing are mentioned. It is implicitly a prospective study since testing was performed on the modified device to demonstrate performance.

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

Not applicable. This is a medical device, and the "ground truth" for performance is established through adherence to engineering standards and physical/biological test results, not expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. This is a medical device, and the "adjudication" is based on meeting predefined technical and biological specifications outlined in the referenced standards.

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

No, an MRMC comparative effectiveness study was not done as this is a medical device and not an AI-assisted diagnostic tool.

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

Yes, the device performance was evaluated in a standalone manner through various functional, mechanical, and biocompatibility tests. There is no "human-in-the-loop" aspect to these performance assessments, as they measure the intrinsic properties and behavior of the device itself.

7. The Type of Ground Truth Used

The ground truth used for this device's acceptance is based on an objective assessment of physical and biological properties against established industry standards and regulatory guidance. This includes:

• Engineering standards compliance: ISO 11070 for mechanical tests.
• Biocompatibility standards compliance: ISO 10993 series and USP 33 .
• Effectiveness of sterilization: AAMI TIR28:2001.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/algorithm-based system requiring a training set.

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

Not applicable. As there is no training set, there is no ground truth established for one.

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