(18 days)
The ClotTriever Thrombectomy System is indicated for:
• The non-surgical removal of thrombi and emboli from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
The ClotTriever Sheaths are indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.
The ClotTriever Thrombectomy System ("ClotTriever System") is a single-use over-the-wire catheter-based system used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system consists of ClotTriever Catheters, ClotTriever Sheaths and Protrieve Sheath, each packaged separately. The ClotTriever Sheath consist of a polymeric shaft with a distal self-expanding nitinol mesh funnel, a proximal hub with a hemostasis valve and a sideport tubing. The mesh funnel is deployed by retracting the slide actuator back until it snaps into place. The mesh funnel self-expands to the diameter of the vessel and serves as a backstop as clot is removed through the lumen of the sheath. A hemostasis valve is integrated into the proximal hub of the sheath to prevent blood loss from devices passing through it. The sideport tubing has a large-bore stopcock and a terminal quick-disconnect coupling for connection to the Large Bore 60 cc Syringe for the aspiration of clot. A pre-dilator is provided with the ClotTriever Sheaths, to expand the target vessel prior to sheath insertion. A dilator is provided to aid insertion and positioning of the sheath, while the loading tool facilitates insertion of the mesh funnel into the dilator.
Here's an analysis of the provided FDA 510(k) summary regarding the ClotTriever Sheath, focusing on "acceptance criteria" and "study that proves the device meets the acceptance criteria."
Important Note: The provided document is a 510(k) clearance letter and summary for a medical device (ClotTriever Sheath). It is not a typical AI/Software as a Medical Device (SaMD) submission that would involve performance metrics like sensitivity, specificity, AUC, or a comparative effectiveness study with human readers assisting AI. Therefore, most of the requested information (sample size for test set, expert qualifications, MRMC study, standalone performance, training set details) will either be explicitly stated as "not applicable" or inferred from the nature of the device submission.
The "device" in this context is a physical medical device (catheter sheath), not an AI algorithm. The "acceptance criteria" and "performance" relate to its physical and functional characteristics, and its "study" refers to non-clinical (bench) testing, not clinical trials with human readers or AI algorithms.
Acceptance Criteria and Device Performance for ClotTriever Sheath
The acceptance criteria for the ClotTriever Sheath, as described in this 510(k) submission, are primarily centered around demonstrating substantial equivalence to a predicate device (Protrieve Sheath) through non-clinical performance characteristics, and the safety and effectiveness of the device for its indicated uses.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a physical device and not an AI algorithm, the "acceptance criteria" are typically defined by engineering specifications, material properties, and functional performance benchmarks to ensure safety and effectiveness for its intended use. The "reported device performance" is demonstrated through verification testing.
| Acceptance Criterion (Implicit from comparison & non-clinical testing) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Intended Use & Indications for Use Equivalence | The modified Indications for Use for the ClotTriever Sheath are stated to be substantially equivalent to the predicate Protrieve Sheath: "use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions." The broader ClotTriever Thrombectomy System (which the sheath is part of) also maintains indications for non-surgical removal of thrombi/emboli and injection/aspiration of fluids in peripheral vasculature. The submission states the indications for use are the same as the predicate except for the additional "ClotTriever Sheaths" wording. |
| Technological Characteristics Equivalence | The ClotTriever Sheath has similar principles of operation and technological characteristics compared to the predicate Protrieve Sheath (e.g., guidewire compatibility of 0.035", sterilization method of SAL 10-6 and EtO, 2-year shelf-life). While dimensions differ (ClotTriever Sheath: 13 Fr ID - 0.180", 16 Fr ID - 0.215"; Protrieve Sheath: ID - 0.270"), these differences are implicitly acceptable as they satisfy the defined purpose and do not raise new safety or effectiveness concerns according to the FDA. |
| Functional Performance (e.g., conduit function, blood loss minimization) | The submission explicitly states: "Verification testing provided in K180329 and K192036 remains applicable to support use of the ClotTriever Sheaths as conduits for the insertion of endovascular devices into the peripheral vasculature." This implies that the prior non-clinical testing for the ClotTriever System (which includes the sheath) already demonstrated its ability to function as a conduit and minimize blood loss, and these results are considered valid for the current modification. The summary states that "the change to the Indications for Use does not raise new or different questions of safety and effectiveness." This is the primary "acceptance criterion" for this type of submission. |
| Biocompatibility | Not explicitly detailed in the provided snippet but implied. All medical devices coming into contact with the body must undergo biocompatibility testing (e.g., cytotoxicity, irritation, sensitization). Given previous clearances (K180329 and K192036), these tests would have been performed and the materials found to be biocompatible. |
| Sterility | Achieved by SAL 10-6, EtO sterilization method, as stated for both subject and predicate devices. This indicates that the sterility acceptance criteria (e.g., no microbial contamination) are met. |
| Shelf-Life / Stability | 2 years, as stated for both subject and predicate devices. This implies that the device maintained its functional integrity and sterility for this duration during stability testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. For a physical device like a sheath, the "test set" would typically refer to the number of devices or components tested during non-clinical verification. This number is not specified in the provided summary, as it's typically found in detailed test reports, not the 510(k) summary itself. The summary only refers to "Verification testing provided in K180329 and K192036."
- Data Provenance: Not applicable in the context of human data. The testing mentioned in the previous 510(k)s (K180329 and K192036) would be non-clinical (bench and potentially animal) testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This submission is for a physical medical device, not an AI/SaMD. "Ground truth" in this context refers to engineering specifications and performance benchmarks, not expert annotations of medical images or data.
4. Adjudication Method for the Test Set
- Not applicable. This relates to expert review for AI/SaMD and is not relevant for this physical device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size (e.g., human readers improve with AI vs without AI assistance)
- No, not applicable. This is a physical device, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, not applicable. This is a physical device, not a standalone algorithm.
7. The Type of Ground Truth Used
- Engineering specifications and documented performance characteristics. For medical devices, the "ground truth" for non-clinical testing refers to established engineering standards, material properties, functional requirements, and safety benchmarks (e.g., burst pressure, tensile strength, flow rates, biocompatibility results), along with performance observed in simulated-use environments (e.g., flow models). The comparison to the predicate device also establishes a "ground truth" of already cleared and accepted performance.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/Machine Learning device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no "training set" as this is not an AI/Machine Learning device.
In summary, this 510(k) pertains to a non-active, physical medical device (catheter sheath). The "acceptance criteria" and "proof" primarily stem from demonstrating substantial equivalence to a legally marketed predicate device (Protrieve Sheath) based on shared intended use, similar technological characteristics, and prior non-clinical verification testing, without raising new questions of safety or effectiveness. The questions about AI-specific validation metrics are not applicable here.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).