(112 days)
The ClearLumen II Peripheral Thrombectomy System is intended to remove/aspirate fluid and thrombus from the peripheral vasculature.
The ClearLumen II Peripheral Thrombectomy System is a multi-lumen device that allows for simultaneous hydro-mechanical thrombus disruption and thrombus aspiration. It is designed to simultaneously deliver a stream of high pressure saline via a displacement pump to the distal tip of the catheter, while aspirating thrombotic material macerated by the saline stream.
The ClearLumen II Peripheral Thrombectomy System consists of one aspiration catheter, which connects to the ClearLumen II Pump Set and the ClearLumen Peripheral Saline Drive Unit (SDU). In use, thrombus enters the distal catheter tip via the suction force provided by a 60 ml VacLok syringe, which is connected to the vacuum sensor. The peripheral SDU and pump set deliver a stream of sterile saline through the secondary lumen to break up and dilute the thrombus within the catheter. The diluted thrombus and saline is drawn back through the primary lumen and deposited into the syringe. No saline is injected into the patient during normal operation.
The proximal end of the pump set consists of a spike and an in-line drip chamber that is used to pierce the saline bag and connect the pump set to the saline source. The cassette, which is centered in the pump set, contains a piston pump and is mounted onto the peripheral SDU. The cassette is powered by the motor contained in the peripheral SDU. The distal end of the pump set has a connector, which mounts to the proximal end of the Y-connector of the peripheral catheter and delivers the saline to the peripheral catheter.
The peripheral SDU is a reusable, IV pole mounted device. The fork drive of the peripheral SDU is designed to run the piston pump contained in the pump set to deliver the stream of saline to the peripheral catheter, when activated by the vacuum sensor. Vacuum is achieved by a vacuum syringe (not provided), which is connected to the vacuum sensor. The vacuum sensor is connected to the aspiration lumen on the Y-connector of the peripheral catheter. The peripheral SDU contains a microprocessor controlled circuit and firmware that monitors various functions of the motor and vacuum to assure that the device is functioning as expected. Various colored LED lights on the front panel indicate to the user the current status of the SDU. Energy is provided by a 24 volt external power supply, which is connected to mains power.
The provided document describes the ClearLumen II Peripheral Thrombectomy System (K163051). The acceptance criteria and the study proving the device meets these criteria are related to non-clinical performance and a pre-clinical study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, it does not explicitly list specific numerical or qualitative acceptance criteria for each test or the exact performance metrics achieved. Instead, it lists the types of tests performed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical integrity and strength of welded/glued joints (Pull test) | Met acceptance criteria, fell within pre-determined product specifications. |
| Resistance to fluid leakage (Leak) | Met acceptance criteria, fell within pre-determined product specifications. |
| Pressure and flow characteristics (Pressure Flow) | Met acceptance criteria, fell within pre-determined product specifications. |
| Resistance to kinking (Kink resistance) | Met acceptance criteria, fell within pre-determined product specifications. |
| Rotational force transmission and durability (Torque strength) | Met acceptance criteria, fell within pre-determined product specifications. |
| Compatibility with guidewires (Guidewire compatibility) | Met acceptance criteria, fell within pre-determined product specifications. |
| Ease and success of navigation through tortuous pathways (Deliverability in tortuous model) | Met acceptance criteria, fell within pre-determined product specifications. |
| Efficacy in removing simulated clots (Performance - simulated clot removal) | Met acceptance criteria, fell within pre-determined product specifications. |
| Biocompatibility in accordance with ISO 10993-1 | Met acceptance criteria, acceptable for patient contact. |
| Adequacy of sterilization cycle in accordance with AAMI TIR 28 | Met acceptance criteria, adequately sterilized. |
| Ability to withstand shipping and distribution (Transportation and Shelf Life Testing - ISTA 2A) | Met acceptance criteria. |
| Maintenance of device integrity and function over time (Shelf Life Testing) | Met acceptance criteria. |
| Safety of peripheral catheter in peripheral arteries (Pre-clinical study - histological evaluation) | Established safety. |
2. Sample Size Used for the Test Set and Data Provenance
- Non-Clinical (Design Verification, Biocompatibility, Sterilization, Transportation, Shelf Life): The document does not specify the sample sizes (e.g., number of catheters, pump sets, etc.) used for these in vitro tests. The provenance is internal company testing ("Walk Vascular's risk analysis"). These are laboratory/bench studies, not patient data.
- Pre-Clinical Study: The document states "A pre-clinical study was conducted to evaluate the safety of the peripheral catheter." It does not specify the sample size (e.g., number of animals) or the provenance (e.g., specific animal model, institution). This study is prospective in nature as it evaluates the device in an animal model before human use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Non-Clinical Tests: No explicit mention of external experts or their qualifications for establishing ground truth for these engineering or material science tests. These typically rely on defined industry standards, internal specifications, and trained technicians/engineers.
- Pre-Clinical Study: Ground truth was established through "Histological evaluation." While this implies expertise in pathology, the document does not specify the number of experts or their qualifications (e.g., board-certified pathologists with X years of experience).
4. Adjudication Method for the Test Set
Not applicable for the described non-clinical and pre-clinical studies. These types of studies typically involve direct measurement against defined criteria or single expert evaluation (e.g., a pathologist for histology), rather than an expert consensus/adjudication process commonly used in clinical image interpretation studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. The document explicitly states: "No clinical data were generated to establish substantial equivalence." This means there was no study involving human readers (e.g., physicians interpreting images) to assess the effectiveness of the device, with or without AI assistance. The device is a thrombectomy system, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance Study
Not applicable. The ClearLumen II Peripheral Thrombectomy System is a medical device for mechanical clot removal, not a diagnostic algorithm or AI system. Therefore, there is no "algorithm only" performance to evaluate.
7. Type of Ground Truth Used
- Non-Clinical (Design Verification): Ground truth was based on pre-determined product specifications and external standard requirements (e.g., for strength, flow, kink resistance). For "Performance (simulated clot removal)," the ground truth would be the extent of clot removal in a simulated environment, measured against a benchmark or expected outcome.
- Biocompatibility: Ground truth was established against ISO 10993-1 standards.
- Sterilization: Ground truth was established against AAMI TIR 28.
- Transportation and Shelf Life: Ground truth was based on ISTA 2A standards and the device maintaining its specified qualities over time.
- Pre-Clinical Study: "Histological evaluation" was used as the ground truth to assess the safety and tissue response in peripheral arteries. This represents a form of pathology ground truth.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training set" concept is relevant for machine learning models, not for mechanical medical devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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).