(100 days)
- The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
- The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
- The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artely (ICA) or middle cerebral artely (MCA)-Ml segments with smaller core infarcts (0-50 cc for age
The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.
The provided document is a 510(k) summary for the Trevo NXT ProVue Retriever, a neurovascular mechanical thrombectomy device. It describes the device, its intended use, and a comparison to predicate devices, primarily focusing on non-clinical performance and biocompatibility data to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document provides a table of various performance tests, their methods, and conclusions. The acceptance criteria themselves are explicitly stated for biocompatibility tests, but for performance tests, the conclusion is generally "meets acceptance criteria," implying that specific thresholds were defined internally and met.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Testing | ||
| Dimensional Verification | (Implied specific measurements and tolerances) | Dimensional verification meets acceptance criteria. |
| Retriever Delivery Wire Kink Resistance | (Implied: no damage after three retrieval attempts in tortuous model per IFU) | Retriever Delivery Wire Kink Resistance meets acceptance criteria. |
| Tip Flexibility | (Implied: device withstands applied peak compression/flex force) | Tip Flexibility meets acceptance criteria. |
| Retriever Shaped Section Radial Force | (Implied: meets specified force at specified diameters) | Retriever Shaped Section Radial Force meets acceptance criteria. |
| Corrosion Resistance | No signs of corrosion after immersion in saline bath per EN ISO 10555-1. | Corrosion Resistance meets acceptance criteria. |
| Particulate Characterization | Acceptable number of particulates in specified size ranges (≥10µm, ≥25µm, ≥50µm, ≥100µm; and ≥200µm, ≥500µm, ≥1000µm if >100µm observed). | Particulate characterization was acceptable. |
| Coating Integrity Characterization | (Implied: no significant coating damage after simulated use in tortuous model) | Coating Integrity was acceptable. |
| ISO Fracture | No fractures after winding around a cylindrical former per EN ISO 11070, Annex F. | ISO Fracture meets acceptance criteria. |
| ISO Flexure | No damage or flaking of coating after 20 cycles of reverse bending and straightening per EN ISO 11070, Annex G. | ISO Flexure meets acceptance criteria. |
| Reloadability into Insertion Tool | (Implied: no damage after three retrieval attempts in tortuous model per IFU) | Reloadability into Insertion Tool meets acceptance criteria. |
| Coating Lubricity/Durability | (Implied: average frictional force at 6th cycle is within acceptable limits) | Coating Lubricity/Durability meets acceptance criteria. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Retriever / Microcatheter Deliverability (Track Test-First Push) | (Implied: maximum force from first 5cm push is within acceptable limits) | Retriever/Microcatheter Deliverability meets acceptance criteria. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Retriever In-Vivo Resheathability Into Microcatheter | (Implied: no damage after three retrieval attempts in tortuous model per IFU) | Retriever In-Vivo Resheathability into Microcatheter meets acceptance criteria. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Retractability of Retriever into BGC | (Implied: no damage after three retrieval attempts in tortuous model per IFU) | Retractability of Retriever into BGC meets acceptance criteria. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Retrievability of Retriever with Intermediate Catheter | (Implied: no damage after three retrieval attempts in tortuous model per IFU) | Retractability of Retriever with Intermediate Catheter meets acceptance criteria. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Product Integrity Post Removal | No kinks inspected on delivery wire or retriever after removal from packaging per IFU. | Product Integrity Post Removal meets acceptance criteria. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Stent Containment in Insertion Tool | Proper position of stent retriever within insertion tool after removal from packaging per IFU. | Stent Containment in Insertion Tool meets acceptance criteria. |
| Design Validation | (Implied: device performance successful in neurovascular model under simulated clinical conditions) | Design Validation testing met acceptance criteria. All Users observed that the Trevo NXT ProVue Retrievers successfully met all the design attribute evaluations defined in the design validation protocol. No additional risks identified. Adequately met customer needs. |
| Biocompatibility Testing | ||
| ISO 10993-4: Hemolysis | Hemolysis is ≤ 5%. | Acceptance criteria met. |
| ISO 10993-4: Thrombosis | Thrombosis is acceptable for clinical application. | Acceptance criteria met. |
| ISO 10993-5: Cytotoxicity | Not less than or equal to 50% cell viability. | Acceptance criteria met. |
| ISO 10993-10: Sensitization | Not a sensitizer. | Acceptance criteria met. |
| ISO 10993-10: Irritation | No significant irritation. | Acceptance criteria met. |
| ISO 10993-11: Material Mediated Pyrogenicity | No febrile reaction greater than 0.5°C. | Acceptance criteria met. -------------------------------------------------------------------------------------------------------------------------- |
| ISO 10993-11: Acute Systemic Toxicity | No mortality or evidence of systemic toxicity. | Acceptance criteria met. -------------------------------------------------------------------------------------------------------------------------- |
| ISO 10993-18: Physicochemical (USP ) | Non-volatile Residue ≤ 15 mg; Residue on Ignition ≤ 5 mg; Heavy Metals ≤ 1 ppm; Buffering Capacity ≤ 10.0 mL. | Acceptance criteria met. -------------------------------------------------------------------------------------------------------------------------- |
| FTIR | No unexpected readings. | Acceptance criteria met. -------------------------------------------------------------------------------------------------------------------------- |
| Latex (LEAP - ASTM D6400) | No detectable latex. | Acceptance criteria met. -------------------------------------------------------------------------------------------------------------------------- |
| Sterilization Assurance Level | SAL of 10⁻⁶. | Achieved. |
| EO Residuals | Met per EN ISO 10993-7 for limited contacting, externally communicated devices. | Achieved. |
| Shelf Life | Packaging remains functional and maintains sterility for 2 years. | Met all acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not explicitly mentioned for each specific performance test. The design validation states "All Users observed that the Trevo NXT ProVue Retrievers successfully met all the design attribute evaluations...". For biocompatibility, standard ISO tests were performed, which usually involve specific numbers of samples or animals as per the standard.
- Data Provenance: The studies are non-clinical (bench testing and in vitro simulated-use studies) and biocompatibility tests. They are not clinical studies involving human patient data, so concepts like country of origin or retrospective/prospective are not applicable in this context. The simulated-use studies were conducted internally for device verification and validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated. The design validation study mentions "Users evaluated the device in a simulated use tortuous anatomical model". It doesn't specify if these "Users" are experts in establishing ground truth, nor their number or qualifications as one would typically see in a clinical study where expert consensus might establish ground truth for a diagnostic device. In this context of a mechanical device, performance is evaluated against defined physical and functional criteria rather than expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is a device performance study focusing on physical and functional attributes, not a study requiring adjudication of clinical outcomes or interpretations.
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 non-clinical evaluation of a mechanical thrombectomy device, not an AI-assisted diagnostic or decision support system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For performance testing, the "ground truth" (or reference standard) is based on defined engineering specifications, industry standards (e.g., ISO, ASTM), and predetermined functional requirements. For example, a successful test means the device's dimension falls within a specified range, or it withstands a certain force, or it shows no damage after simulated use.
- For biocompatibility testing, the ground truth is established by the criteria outlined in recognized international standards (ISO 10993-x), which define acceptable biological responses (e.g., hemolysis ≤ 5%, not a sensitizer).
8. The sample size for the training set:
- Not applicable. This is a non-clinical evaluation of a mechanical thrombectomy device, not a machine learning model that requires a training set.
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.