(10 days)
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.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).