(73 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Leak/air ingress performance (Hemostasis valve) meets pre-defined limits | Performance verified |
| Valve performance following insertion/removal cycling (sheath/valve) maintained | Performance verified |
| Dilator insertion/removal force within acceptable range | Performance verified |
| Bond pull force (sheath/hub) meets strength requirements | Performance verified |
| Compatibility with existing systems/catheters | Performance verified |
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.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).