(113 days)
The ClearLumen II Peripheral Thrombectomy System is intended to:
- remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature, and
- subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.
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 ClearLumen II Peripheral catheter has the ability to infuse fluid through the aspiration lumen and saline lumen.
For infusion through the aspiration lumen, an appropriate sized syringe filled with fluid is infused to the treatment area by passing through the side arm of the rotating hemostasis valve (RHV) that is attached to the catheter.
For infusion through the saline lumen, a non-vented Luer cap is placed between the rotating hemostasis valve (RHV) side arm and the pressure monitor tubing.
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.
This document, K172000, is a 510(k) premarket notification for the ClearLumen II Peripheral Thrombectomy System. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a study where the device meets specific acceptance criteria in a clinical or standalone setting with performance metrics.
Therefore, the requested information elements such as device performance, sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth, training set size, and how ground truth for training data was established are not present in this document. This submission primarily relies on non-clinical (in vitro) testing and a comparison of design features and intended use with a predicate device.
However, based on the provided text, I can infer the "acceptance criteria" and "reported device performance" in the context of this 510(k) submission, which focuses on design verification and substantial equivalence.
Here's the breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from tests performed) | Reported Device Performance (Summary) |
|---|---|
| Saline flow rate through aspiration lumen | Met acceptance criteria and fell within pre-determined product specifications and external standard requirements. |
| 60% ionic contrast media flow rate through aspiration lumen | Met acceptance criteria and fell within pre-determined product specifications and external standard requirements. |
| Infusion pressure of aspiration lumen | Met acceptance criteria and fell within pre-determined product specifications and external standard requirements. |
| Saline lumen pressure | Met acceptance criteria and fell within pre-determined product specifications and external standard requirements. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the in vitro tests.
- Data Provenance: The tests are described as "in vitro testing performed pursuant to Walk Vascular's risk analysis." This indicates the data was generated internally by the manufacturer, Walk Vascular, LLC. It is therefore de-facto prospective for the purposes of this submission, as it was conducted specifically to support this application. The country of origin is implicitly the United States, given the company's address and FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for these in vitro tests would typically be defined by engineering specifications and physical measurements, not expert clinician consensus.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods are typically for clinical studies involving human interpretation or subjective assessments. These were in vitro engineering tests.
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:
- No MRMC study was done. This document describes a medical device (thrombectomy system), not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The tests described are for the physical properties and functionality of a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the in vitro tests, the "ground truth" would be the established engineering specifications and physical measurement standards relevant to flow rates, pressure, etc. It's based on engineering measurement and pre-determined product specifications.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that would require a "training set."
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied for this device.
§ 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).