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510(k) Data Aggregation
(350 days)
The ERIC Retrieval Device is indicated 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 ERIC™ (Embolus Retriever with Interlinked Cage) Retrieval Device is a mechanical thrombectomy device designed to restore blood flow by removing clots from vasculature in patients suffering from acute ischemic stroke. The device consists of retrieval spheres secured on a pusher wire that are designed to capture and remove blood clots from the neurovasculature. The device is inserted into a microcatheter to navigate to the target location and retrieve the thrombus while the device is withdrawn from the vessel.
Here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the ERIC Retrieval Device:
I. Acceptance Criteria and Reported Device Performance
| Test Description / Outcome | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bench/Verification Testing | ||
| Dimensional Testing (Expanded Diameter & Device Overall Length) | Device attributes (overall device length and expanded outer diameter (OD) of the shaped section) must meet specified criteria and not raise new questions regarding safety and efficacy compared to predicate. | Pass. The longer overall length and smaller OD of the subject device offerings do not affect the performance of the device. |
| Fluoroscopic Guidance Marker Testing (Radiopacity) | Markers must be sufficiently visible under fluoroscopy. | Pass. Both subject and predicate devices are sufficiently visible under fluoroscopy. |
| Advance/Retraction Force Testing | Advance and retract forces in a tortuous model must be comparable to predicate devices. | Pass. The advance and retract forces of the subject device were comparable with the forces measured for the predicate device. |
| Re-Sheathing Testing | Ability to re-sheath the device must be comparable to predicate devices. | Pass. The ability to re-sheath the subject device is comparable to that of the predicate device tested. |
| Radial Force Testing | Radial force must be comparable to predicate devices. | Pass. The radial force of the subject device is comparable to that of the predicate device tested. |
| Tensile Strength Testing | Peak tensile strength to failure in different sections must be comparable to predicate devices. | Pass. The system tensile strength of the subject device is comparable to that of the predicate device tested. |
| Kink Resistance Testing | Kink resistance must be equivalent to predicate devices. | Pass. Kink resistance of the subject device is equivalent to that of the predicate device tested. |
| Austenite Finish (Af) Testing | Af temperature must be less than product use temperature (body temperature) to satisfy clinical application requirements. | Pass. The Af temperature of the subject device is less than the product use temperature (body temperature) and, thus, satisfies requirements for clinical applications. |
| Simulated Use/Performance Testing | Ability to reliably deploy and use the device in a tortuous benchtop model must be comparable to predicate devices. | Pass. Simulated use testing was comparable with that of the predicate device. |
| Corrosion Resistance Testing | Metallic components intended for fluid path contact must show no signs of corrosion. | Pass. Corrosion resistance testing of the subject device showed no signs of corrosion. |
| Particulate Evaluation Testing | Particulate generation in a tortuous benchtop model must be comparable to predicate devices. | Pass. Particulate evaluation was comparable with that of the predicate device. |
| Torque Response Testing | Core wire of the subject device must rotate freely with the proximal sphere and have equivalent torqueability compared to the predicate device. | Pass. Torque response testing indicated that the core wire of the subject device rotates freely with the proximal sphere and, thus, has equivalent torqueability compared to the predicate device. |
| Biocompatibility Evaluation | Device must be non-cytotoxic, non-irritating, non-sensitizing, systemically non-toxic, non-pyrogenic, non-hemolytic, non-activating (complement activation), non-thrombogenic, and have no effect on coagulation of human plasma and hematological parameters. (Compliance with ISO 10993-1 and FDA Biocompatibility Guidance) | Pass. Demonstrated non-cytotoxic, non-sensitizer, non-irritating, systemically non-toxic, non-pyrogenic, non-hemolytic, no effect on coagulation of human plasma, non-activating, no effect on hematological parameters, and non-thrombogenic. |
| Sterilization, Shelf-Life, and Packaging Integrity | Achieve a minimum sterility assurance level (SAL) of 10^-6 for electron beam sterilization (specified as 10^-9) and bacterial endotoxin |
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(59 days)
- The Solitaire™ 2 Revascularization Device 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 plasogen activator (IV t-PA). Endovascular therapy with the device should be started within 6 hours of symptom onset.
- The Solitaire™ Revascularization Device is 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 IV t-PA or who fail IV t-PA therapy are candidates for treatment.
The Solitaire™ 2 Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ 2 Revascularization Device is designed for use in the neurovasculature such as the Internal Carotid Artery (ICA). M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the Solitaire™ 2 Revascularization Device facilitates clot retrieval and has Iridium radiopaque markers on the proximal and distal ends. The devices are supplied sterile and are intended for single-use only.
The provided text describes the acceptance criteria and the study that proves the Solitaire™ 2 Revascularization Device meets those criteria. Here's a structured breakdown of the requested information:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents two main categories of performance data: biocompatibility and bench testing. Clinical data is used for comparative effectiveness rather than direct acceptance criteria for the device itself in this specific section.
Biocompatibility Testing:
| Test Category | Test Description | Method | Acceptance Criteria | Conclusion |
|---|---|---|---|---|
| Cytotoxicity | L929 MTT Cytotoxicity | ISO 10993-5 | Viability is ≥70%. | Acceptance criteria met |
| Sensitization | Guinea Pig Maximization Sensitization | ISO 10993-10 | Test article does not elicit a sensitization response. | Acceptance criteria met |
| Irritation | Intracutaneous Irritation Test | ISO 10993-10 | Differences in the mean test and control scores of the extract dermal observations are . | Device was evaluated for particulate generation under simulated use in a representative tortuous anatomical model per USP (Same as method, implying conforming to USP limits). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Clinical Study (SWIFT PRIME):
- Total Randomized Subjects: 196 (98 in each group: IV t-PA alone vs. IV t-PA + Solitaire)
- Analysis Cohort (after exclusions): 161 subjects (84 in the IV t-PA + Solitaire™ group and 77 with IV t-PA only). Further refined to 144 subjects for primary and secondary efficacy endpoints after additional exclusions.
- Data Provenance: Global, multicenter. The study was a prospective, randomized, open, blinded endpoint (PROBE) clinical study (IDE G120142).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not explicitly state the exact number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the clinical study's endpoints. However, it does mention:
- Blinded evaluation of modified Rankin Scale (mRS) for neurological disability outcomes. This implies that the mRS scores, which serve as a critical component of the ground truth for effectiveness, were assessed by experts who were blinded to the treatment arm.
- Clinical Events Committee adjudication for adverse events. This indicates a panel of experts reviewed and categorized adverse events.
- Core Laboratory assessed data for symptomatic ICH, infarct volume, and reperfusion ratio. This suggests specialized facilities with expert staff were responsible for these assessments.
While the specific count and detailed qualifications are not provided, the involvement of blinded evaluators, a Clinical Events Committee, and a Core Laboratory indicates that ground truth was established through expert assessment according to established protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document mentions "Clinical Events Committee adjudication" for adverse events. While it doesn't specify a 2+1 or 3+1 method, "adjudication" implies a process where a committee of experts reviews and resolves discrepancies in event classification or assessment. It suggests a structured review by multiple parties, but the exact number of reviewers per case or tie-breaking mechanism is not detailed.
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
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any mention of AI assistance. This study compared a medical device (Solitaire™ 2 Revascularization Device) with or without IV t-PA, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done, as this document is about a mechanical thrombectomy device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical study was established using a combination of:
- Clinical Outcomes Data: Primarily, the 90-day global disability assessed via the blinded evaluation of Modified Rankin Scale (mRS). This is a widely accepted functional outcome scale often based on trained interviewer assessment.
- Imaging-based Assessments: Volume of cerebral infarction, reperfusion ratio, and arterial revascularization (TICI 2b or 3) assessed by a Core Laboratory. This implies expert interpretation of medical images.
- Adjudicated Adverse Events: Reviewed and categorized by a Clinical Events Committee.
8. The sample size for the training set
The document does not describe the development or training of an algorithm or AI. Therefore, there is no training set sample size mentioned. The clinical study (SWIFT PRIME) is a comparative effectiveness study for a medical device in patients.
9. How the ground truth for the training set was established
As there is no training set for an algorithm or AI described in the document, this question is not applicable.
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(29 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 (IV t-PA) or who fail IV t-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.
The following modifications have been made to the device in support of this application:
• The attachment zone has been redesigned for greater tensile strength.
• The marker band has been redesigned to aid the crimping process.
• The pushwire now contains a fluorosafe marker.
• The Solitaire™ 2 Device uses one piece of PTFE tubing.
This K123378 submission for the Solitaire™ 2 Revascularization Device is a medical device submission for a thrombus retriever, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for an AI/ML device (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable.
The submission focuses on demonstrating substantial equivalence to a predicate device (Solitaire™ FR Revascularization Device) based on modifications to the device design and subsequent non-clinical bench testing:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a non-clinical bench testing submission for a medical device modification, the "acceptance criteria" are implied by successful completion of the specified tests, demonstrating that the device modifications do not adversely affect its performance compared to the predicate. No specific numerical thresholds (e.g., sensitivity, specificity) for performance are provided as would be expected for an AI/ML diagnostic or prognostic tool.
| Acceptance Criteria (Implied by Successful Testing) | Reported Device Performance (Summary) |
|---|---|
| Delivery Force within acceptable limits | Test performed to support changes |
| Withdrawal Force within acceptable limits | Test performed to support changes |
| Total System Length within specifications | Test performed to support changes |
| Fluoro Safe Marker Length within specifications | Test performed to support changes |
| Distal Tip to Fluoro Marker Length within specs | Test performed to support changes |
| Durability maintained | Test performed to support changes |
| Radiopacity maintained | Test performed to support changes |
| Torque Response maintained | Test performed to support changes |
| Torque Strength maintained | Test performed to support changes |
| System Tensile Strength maintained | Test performed to support changes |
| Performance after 1-Year Accelerated Aging Study | Delivery Force, Withdrawal Force, Durability, Torque Response, Torque Strength, System Tensile Strength maintained |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable. These were non-clinical bench tests on the device itself, not clinical data sets. The "sample" would refer to the number of devices or components tested for each parameter. This information is not detailed in the summary provided.
- Data provenance: Not applicable in the context of clinical data. The tests were performed in a lab setting by the manufacturer (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context typically refers to clinical diagnosis or outcome. For bench testing, the "ground truth" is defined by the engineering specifications and established test methods for device performance parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a clinical study involving reader adjudication.
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 not an AI/ML device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this device, the "ground truth" for non-clinical testing is defined by the engineering specifications and performance standards for medical devices of this type, which are assessed through a series of defined bench tests. There is no biological or clinical "ground truth" in the AI/ML sense in this submission.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
In summary, the K123378 submission demonstrates substantial equivalence for the Solitaire™ 2 Revascularization Device primarily through extensive non-clinical bench testing, focusing on the mechanical and physical performance characteristics of the modified device components. It does not involve any AI/ML components or clinical data analyses as would be relevant for the questions posed.
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