(94 days)
The Trevo XP ProVue Retriever (4x30mm) 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 XP ProVue Retriever (4x30mm) consists of a flexible, tapered core wire with a shaped section at the distal end. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Radiopaque platinum wires in the shaped section and radiopaque markers on the distal end allow fluoroscopic visualization. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device is provided with the Retriever to facilitate manipulation. The torque device is used to lock the core wire to the microcatheter during the procedure. Locking of the torque device to the wire allows the microcatheter and Retriever to be retracted as a system during clot retrieval. An insertion tool is provided to introduce the Retriever into a microcatheter. The proximal end of the device is compatible with the Abbott guide wire extension to facilitate removal or exchange of a catheter while maintaining the Retriever position in the vessel.
The provided text describes a 510(k) premarket notification for the Trevo XP ProVue Retriever (4x30mm). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new clinical outcome. Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not explicitly present in the provided text as they are typically associated with de novo approvals or significant device modifications requiring new clinical evidence.
However, I can extract information related to the acceptance criteria for bench and animal testing, and the study methodologies employed to demonstrate substantial equivalence.
Here's the information derived from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test were "meets acceptance criteria." The device performance is generally stated as having met these unspecified criteria. The document emphasizes substantial equivalence to the predicate device through bench and animal testing.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional Verification | Meets acceptance criteria | Dimensional verification meets acceptance criteria. |
| Retriever Mid Joint Tensile Strength | Meets acceptance criteria | Retriever Mid Joint Tensile Strength meets acceptance criteria. |
| Retriever Tip Tensile Strength | Meets acceptance criteria | Retriever Tip Tensile Strength meets acceptance criteria. |
| Retriever Shaped Section Radial Force | Meets acceptance criteria | Retriever Shaped Section Radial Force meets acceptance criteria. |
| Retriever / Vessel Interaction (Tip Flexibility) | Meets acceptance criteria | Retriever/Vessel Interaction (Tip Flexibility) meets acceptance criteria. |
| Retriever Torque Tensile Durability | Meets acceptance criteria | Retriever Torque Tensile Durability meets acceptance criteria. |
| Retriever Platinum Wire Joint Strength | Meets acceptance criteria | Retriever Platinum Wire Joint Strength meets acceptance criteria. |
| Retriever Platinum Wire and Joint Durability | Meets acceptance criteria | Retriever Platinum Wire and Joint Durability meet acceptance criteria. |
| Radiopacity | Meets acceptance criteria | Radiopacity meets acceptance criteria. (Due to same platinum weave wires and configuration as predicate). |
| Retriever / Microcatheter Deliverability | Meets acceptance criteria | Retriever/Microcatheter Deliverability meets acceptance criteria. |
| Particulate Evaluation | All samples meet acceptance criteria | All samples meet acceptance criteria. |
| Coating Integrity Evaluation | All samples meet acceptance criteria | All samples meet acceptance criteria. |
| Simulated Use | Meets acceptance criteria | Simulated Use meets acceptance criteria. |
| Animal Studies (Safety and Usability) | Met acceptance criteria | The safety and usability results from the animal studies met acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: The sample sizes for individual bench tests are not explicitly stated in the summary document. The phrasing "All samples meet acceptance criteria" suggests that a sufficient number of devices were tested per manufacturing and quality control standards, but the exact N is not provided.
- Animal Testing: The document mentions that a "larger diameter device (6x30mm) than the subject device (4x30mm)" was used for animal studies as a "worst case." The number of animals used is not specified.
- Data Provenance: The bench and animal studies were conducted by Concentric Medical, Inc. (the submitter). These are prospective studies performed specifically for this 510(k) submission. No country of origin for the data is explicitly mentioned beyond the submitter's location in Mountain View, California, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Bench Testing: No external experts are mentioned for establishing ground truth for the bench tests. These tests are industrial performance evaluations against internal specifications.
- Animal Testing: The animal studies were conducted in compliance with GLP regulation (21 CFR Part 58), which implies qualified personnel (e.g., veterinarians, pathologists, study directors) were involved in the conduct and evaluation, but their specific number or qualifications are not detailed.
- Clinical Data: No clinical study was performed for this 510(k) submission (stated in the document as "No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the subject device."). Therefore, no experts were used to establish ground truth from a clinical test set.
4. Adjudication Method for the Test Set
Not applicable, as no human-read test set or clinical study requiring adjudication is described. The evaluations were based on quantifiable bench tests and animal observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the subject device."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a medical device in the context of hardware, specifically a "thrombus retriever" catheter. The concept of "standalone algorithm performance" is not applicable here as it is not an AI/software device.
7. The Type of Ground Truth Used
- Bench Testing: Ground truth for bench tests is based on engineering specifications and physical measurements, which are inherently objective and quantitative (e.g., tensile strength, radial force, dimensions).
- Animal Testing: Ground truth in animal studies would typically involve pathological examination and observations for adverse events (e.g., "evidence of arterial transmural dissection or perforation"). This is based on direct biological and histological assessment.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument (thrombus retriever), not a machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device is a physical medical instrument (thrombus retriever), not a machine learning algorithm.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).