(139 days)
The Solitaire™ 2 Revascularization Device is intended 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 intravenous tissue plasminogen activator (IVt-PA) or fail IVt-PA therapy are candidates for treatment.
The Solitaire™ 2 device is designed to restore blood flow in subjects experiencing ischemic stroke due to large intracranial vessel occlusion within 8 hours of symptom onset. It is indicated for subjects who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy. The distal nitinol portion of the device facilitates clot retrieval and has Pt-Ir radiopaque markers on the proximal and distal ends.
This purpose of this application is to add one (1) new model number (SFR2-4-40) to the Solitaire™ 2 Revascularization Device family. The additional model will be identical to the currently cleared Solitaire™ 2 4x20 (SFR2-4-20) model, with the exception of a longer retriever length.
The provided document is a 510(k) summary for the Solitaire™ 2 Revascularization Device, specifically for the addition of a new 4x40mm model (SFR2-4-40). The application aims to demonstrate substantial equivalence to previously cleared Solitaire™ devices. As such, it relies on bench and animal testing rather than a new clinical study. The concept of "acceptance criteria" and "device performance" in the context of this document refers to the results of these non-clinical tests meeting specific thresholds, often in comparison to the predicate device.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
For this device, "acceptance criteria" are implied by the conclusions that "All devices met acceptance criteria" and that performance was "same as the predicate device" or that findings were "comparable." Specific numerical acceptance criteria are not explicitly detailed in this summary, but the successful conclusions for each test imply they were met.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Total System Length | Met specified dimensions | All devices met acceptance criteria. |
| Distal Tip to Fluoro Safe Marker Length | Met specified dimensions | All devices met acceptance criteria. |
| Delivery Force | Comparable to predicate device; within acceptable thresholds | All devices met acceptance criteria. Delivery force same as the predicate device. |
| Retrieval Force | Comparable to predicate device; within acceptable thresholds | All devices met acceptance criteria. Retrieval force same as the predicate device. |
| Radial Force | Within acceptable range (measured 100% in-process) | Radial force was measured 100% in-process on DVT builds. |
| Durability | No irregularities, breaks, kinks, marker coil migration, glue separations, or other defects after extended use | All devices showed no irregularities, breaks, kinks, marker coil migration, glue separations, or other observed defects after all attempts. Durability same as the predicate device. |
| Performance (Clot Retrieval) | Successful retrieval of soft and firm clots from specified vessels | All devices successfully retrieved the soft and firm clots from the respective vessels. Performance is the same as the predicate device. |
| Biocompatibility | No new materials, comparable to predicate | Biocompatibility data for the Solitaire™ FR device adopted; no new materials introduced. |
| Sterilization & Shelf Life | Identical to predicate device validation | Adopted from the predicate device; identical materials, design, manufacturing, and packaging. |
| Tissue Damage (Animal Study) | Minimal or comparable tissue damage to predicate | No histological remarkable difference in the vessel in regards to tissue injury. |
| Hemorrhage (Animal Study) | Minimal or comparable hemorrhage to predicate | No histological remarkable difference in the vessel in regards to hemorrhagic evaluation. |
| Thrombogenicity (Animal Study) | Minimal or comparable thrombogenicity to predicate | No histological remarkable difference in the vessel in regards to thrombogenic evaluation. |
| Usability (Animal Study) | Equivalent to predicate device in delivery, positioning, deployment, repositioning, retrieval, and condition | Safe, usable, and equivalent to the predicate device based on interventionalist assessment. |
2. Sample sizes used for the test set and the data provenance
- Bench Testing: The document does not specify the exact sample sizes for each bench test (e.g., number of devices tested for delivery force). It generally states "Samples were measured" or "Samples were evaluated."
- Animal Study Test Set:
- Sample Size: 12 swine. (6 for acute study, 6 for chronic 30-day study).
- Provenance: Not explicitly stated (e.g., country of origin for the animals), but it's an animal study conducted by the manufacturer/sponsor (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular) to support the device. It is a prospective study in the sense it was designed and executed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Bench Testing: Not applicable. Bench tests rely on direct measurement and established engineering principles, not expert interpretation of data as ground truth for a test set in the same way clinical data would.
- Animal Study: "Usability for the acute and chronic study were assessed by an interventionalist." The number of interventionalists is not specified, nor are their specific qualifications provided beyond the title "interventionalist."
4. Adjudication method for the test set
- Bench Testing: Not applicable. These are objective measurements against internal specifications or predicate device performance.
- Animal Study: No explicit adjudication method (e.g., 2+1, 3+1 consensus) is described for the animal study. The "interventionalist" assessed usability, and histological findings were compared.
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 submission is for a medical device (thrombus retriever) that directly treats a condition, not an AI/imaging diagnostic tool that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device (thrombus retriever), not an algorithm or AI system. Its performance is evaluated through its mechanical capabilities and biological interaction, not as a standalone algorithm.
7. The type of ground truth used
- Bench Testing: The "ground truth" for bench tests is the objective, physical measurement of device characteristics against pre-defined engineering specifications or direct comparison to the predicate device's measured performance.
- Animal Study: The "ground truth" was established through:
- Angiographic images: Visual assessment of vessel status.
- Histopathological evaluation: Microscopic examination of tissue for damage, hemorrhage, and thrombi.
- Interventionalist assessment: Subjective (but expert-driven) assessment of usability attributes (delivery, positioning, deployment, etc.).
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this device's evaluation, as it is not an AI/machine learning device. The 510(k) process for this type of device relies on demonstrating equivalence through non-clinical (bench and animal) testing to a predicate device, not through training a model on data.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML model, this question is not relevant to this device submission.
§ 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).