(175 days)
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The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are indicated for use to restore blood flow in the neurovasculature by removing thrombus for the ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received thrombolytic therapy. Endovascular therapy with the device should be started within 6 hours of symptom onset.
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The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for thrombolytic therapy or who fail thrombolytic therapy are candidates for treatment.
The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and middle cerebral artery (MCA). The device is supplied sterile and intended for single use only.
This document is a 510(k) Summary for a medical device (pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device) and focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable or not provided in this document because the submission relies on non-clinical performance data (bench testing) to demonstrate substantial equivalence, not clinical effectiveness or performance with human-in-the-loop.
Here's a breakdown of the available information based on your request, highlighting what is provided and what is absent:
Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing)
The document primarily discusses acceptance criteria in the context of bench testing. The general acceptance criterion for all non-clinical performance tests is that the device "met acceptance criteria" and "demonstrated compliance to all the design attributes and that the device performs as intended." Specific quantitative acceptance criteria for each test are not explicitly detailed beyond general descriptions.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Title | Acceptance Criteria (as described) | Reported Device Performance |
|---|---|---|
| Packaging Inspection | Corrugated shipper provides adequate protection to the carton, pouch, and device. Shelf carton provides adequate protection to the pouch and device. Sterile pouch provides adequate protection and sterile barrier to the device. | Pass |
| Relative Chronic Outward Force (RCOF) | The relative chronic outward force (RCOF) in the labeled vessel diameters must meet acceptance criteria. | Pass |
| Dimensional | The expanded outer diameter (OD) of the retriever device. The diameter of the body markers. The length of the body markers. (Implicitly, these measurements must be within specified tolerances). | Pass |
| Simulated Use | It shall be possible to safely and reliably prepare, deploy, and retract the device as described in the instructions for use without damage to the device. | Pass |
| Simulated Clot Retrieval | It shall be possible to retrieve synthetic clots from a 3D neurovascular model as described in the instructions for use. | Pass |
| Kink Resistance | The device system must have the ability to be delivered to the intended site without any kinking of the insertion wire. | Pass |
| Deployment | It shall be possible to safely and reliably deploy the device as described in the instructions for use without damage to the device. | Pass |
| Retraction into the Microcatheter | It shall be possible to advance a representative microcatheter over the deployed device, at the site of deployment, until it is fully contained within the inner lumen of the microcatheter without damage to the device. | Pass |
| Re-Sheathing | It shall be possible to re-sheath the device, as described in the instructions for use, after it has been prepared, deployed, and retracted as described in the instructions for use. | Pass |
| Ancillary Device Compatibility | The device shall be compatible with ancillary devices as listed in the Directions for Use (DFU). | Pass |
| Particulate Analysis | Number and size of particulates generated by device during simulated use shall be comparable to predicate device. (Implicitly, within acceptable limits and comparable to known safe predicate performance). | Pass |
| Radiopacity | Proximal end, distal end, and the body markers of the retrieval device must be radiopaque. (Implicitly, visible under fluoroscopy). | Pass |
| Biocompatibility (Cytotoxicity, Hemocompatibility) | Non-cytotoxic; No hemolysis indicated. | Non-cytotoxic; No hemolysis indicated |
| Sterilization | Sterility assurance level (SAL) of 10^-6 in accordance with EN ISO 11135:2014 & A1:2019 and AAMI TIR28:2016. | Validated |
| Shelf Life | Packaging remains functional and maintains sterility for up to 3 years; packaging integrity, seal strength, and device functionality met acceptance criteria. | Met acceptance criteria |
Information Not Applicable or Not Provided for a Substantial Equivalence (510k) Submission based solely on Non-Clinical Data:
This 510(k) submission states "No clinical testing was required to support substantial equivalence." Therefore, the following points regarding clinical studies, human readers, and ground truth for clinical data are not applicable in this context.
2. Sample sizes used for the test set and the data provenance: Not applicable given "No clinical testing was required." The "test set" here refers to non-clinical bench test samples (e.g., number of devices tested for kink resistance or clot retrieval). The document does not specify the exact number of devices tested for each bench test, but implies sufficient testing to support "Pass" conclusions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth typically refers to clinical diagnosis or outcome, which was not established in this non-clinical submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 medical device for mechanical thrombectomy, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" or standard for comparison is defined by engineering specifications, validated test methods (e.g., ASTM standards), and comparability to the predicate device's performance. For instance, in Simulated Clot Retrieval, the ground truth is successful retrieval of synthetic clots under defined conditions.
8. The sample size for the training set: Not applicable. This refers to training data for AI/ML models, which is not relevant for this mechanical device submission.
9. How the ground truth for the training set was established: Not applicable.
§ 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
(a)
Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including:
(i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces.
(ii) Mechanical testing to evaluate the radial forces exerted by the device.
(iii) Non-clinical testing to verify the dimensions of the device.
(iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions.
(v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized.
(vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions.
(vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions.
(3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device.
(4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life.
(5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure.
(6) The labeling must include:
(i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size.
(ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature.
(iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events.
(iv) A shelf life.