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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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