(48 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 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:
| Characteristic/Performance Aspect | Acceptance Criteria (Implied from Predicate/Requirements) | Reported Device Performance (FlexCath Select Steerable Sheath) |
|---|---|---|
| Intended Use | Facilitates introducing various cardiovascular catheters into the heart. | Same as predicate FlexCath Advance and HeartSpan: Facilitates introducing various cardiovascular catheters into the heart. |
| Indications for Use | Similar to predicate FlexCath Advance; for transseptal puncture, similar to predicate HeartSpan. | 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. (Expanded from FlexCath Advance, equivalent to HeartSpan). |
| Contraindications | Similar to predicates, particularly regarding atrial septal issues, thrombus, and myxoma. | FlexCath Select contraindications align with predicates: intra-atrial septal patch/occluder, surgical intervention in/adjacent to septum, left atrial thrombus, known/suspected atrial myxoma. |
| Steerable Catheter Introducer | Yes | Yes |
| Unidirectional/Deflectable | Yes | Yes |
| Hemostasis valve | Yes | Yes (New Stopcock design, but functional equivalence implied) |
| Braided Shaft | Yes | Yes |
| Sheath ID (10F) | Adequate for intended catheters (implied from predicate 12F and new 10F design). | 0.131" (10F) |
| Deflection | ≥ 135° when loaded with specific balloon catheters (for FlexCath Advance, Arctic Front/Advance). | ≥ 135° when loaded with Freezor MAX CryoAblation Catheters and phased RF PVAC (different specific catheters, but same deflection performance cited). |
| Dilator OD (10F) | Adequate for transseptal puncture and sheath introduction (implied from predicate HeartSpan 8.5F and new 10F design). | 0.128" (10F) |
| Dilator Material (Stiffness) | Resistant to skiving and damage from transseptal needles (HeartSpan predicate characteristic). | Copolyester TPE (Hytrel 7246 with 40% BaSO4) - identical to predicate HeartSpan for increased stiffness, resistant to skiving/damage. |
| Dilator Guide Wire Compatibility | Up to 0.038" (HeartSpan predicate). | 0.032" to 0.035" |
| Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) |
| Usage | Single use and disposable. | Single use and disposable. |
| Shelf Life | 2 years (FlexCath Advance); 3 years (HeartSpan). (Note: FlexCath Select has a 1-year shelf life, which is a difference but deemed acceptable) | 1 year (A difference from predicates, but not explicitly stated as failing acceptance criteria; implies it was justified and accepted by FDA for market clearance). |
| Safety and Effectiveness | No new questions of safety or effectiveness when compared to predicates. | All testing demonstrated acceptance criteria were met and device does not raise new questions of safety or effectiveness. |
| Compatibility with transseptal needles | Resistant to skiving and damage (HeartSpan predicate). | Modified dilator material identical to HeartSpan, chosen for resistance to skiving and damage. |
| Risk Assessment | Residual risks associated with transseptal procedures are acceptable. | Residual risks classified as level 2 (Medium Risk/As Reasonably Practical) based on HeartSpan predicate and internal testing, deemed acceptable. Air embolism added as potential adverse event (inherent risk of transseptal puncture). |
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.
§ 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).