(164 days)
Penumbra Reperfusion Catheters and Separators: As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) 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.
Penumbra 3D Revascularization Device: As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments) 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.
Penumbra Aspiration Tubing: As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
The Penumbra System Reperfusion Catheter JET 7 (modified) is a component to the currently available Penumbra System. The Reperfusion Catheter JET 7 (modified) delivers aspiration from the Aspiration Pump directly to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The devices are provided sterile, nonpyrogenic, and intended for single use only.
The provided document is a 510(k) Premarket Notification for the Penumbra System® (Reperfusion Catheter JETTM 7). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria for an AI/device performance.
Therefore, the requested information regarding acceptance criteria and a study proving a device meets acceptance criteria in a clinical or comparative effectiveness setting (especially for AI where human-in-the-loop performance is assessed) cannot be fully provided based on the given text.
The document does include acceptance criteria for biocompatibility testing and bench-top testing and reports whether the device passed these criteria. However, these are engineering and materials performance criteria, not clinical performance criteria with a test set of patient data, ground truth established by experts, or MRMC studies typically seen for AI-based diagnostic devices.
Here's what can be extracted and what cannot:
Information that CAN be extracted and presented:
- Table of acceptance criteria and reported device performance (for non-clinical tests): This is available for biocompatibility and bench-top testing.
- Sample size for non-clinical testing: This is generally implied by "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP)" for biocompatibility and for bench tests by "These evaluations confirm that the units used in this Design Verification testing meet all product specifications." but specific numbers are not given for each test.
- Data provenance for non-clinical testing: Performed internally by Penumbra, Inc. labs or contracted labs following GLP.
- Ground truth type for non-clinical testing: Based on established industry standards and regulatory guidelines (e.g., EN ISO 10993-1, specific assay results, physical measurements).
Information that CANNOT be extracted from the provided text:
- Sample sized used for the test set (clinical data): No specific clinical test set data is provided. The document states "No clinical study was conducted as bench and previously performed animal testing was determined sufficient for verification and validation purposes."
- Data provenance (e.g., country of origin of the data, retrospective or prospective) for clinical data: Not applicable, as no new clinical study was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no new clinical study was conducted involving expert ground truth for patient data. Physician evaluation was done for bench testing, but details on the number and qualifications of physicians are not given, nor is it a blind adjudication process.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device, but a physical medical device (catheter).
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical data: Not applicable.
- The sample size for the training set (for AI): Not applicable.
- How the ground truth for the training set was established (for AI): Not applicable.
Acceptance Criteria and Device Performance (Non-Clinical Data from provided text):
The device is a medical catheter, and the performance criteria discussed are related to its physical properties, material safety, and mechanical function, not an AI's diagnostic performance.
1. Table of acceptance criteria and the reported device performance (for Biocompatibility and Bench-Top Testing):
Biocompatibility Test Results
| Tests | Acceptance Criteria | Results | Conclusion |
|---|---|---|---|
| Cytotoxicity: MEM Elution (10993-5) | Sample extracts must have a cytotoxic reactivity score of grade 2 or lower. | Grade = 0 (Reactivity None) | Pass, Non-cytotoxic |
| Delayed-type hypersensitivity (Sensitization) (10993-10) | Test Group shall yield Grade 10% in 3 or more animals. | No evidence of systemic toxicity from sample extracts (both NaCl and CSO extracts). That is: No deaths; No signs consistent with toxicity; No weight loss > 10%. | Pass, Non-toxic |
| Systemic Toxicity: Material Mediated Pyrogen (10993-11, USP) | Sample extracts must not cause a total rise in body temperature of ≥ 0.5°C. | Non-pyrogenic: no single animal had an individual rise in body temperature ≥ 0.5°C. | Pass, Non-pyrogenic |
| Hemocompatibility: In vitro Thrombogenicity (10993-4) | The test article must have similar or less thrombus formation than predicate after 4 hours in vitro. | Test Article: 1, Thromboresistant; Control Article: 1, Thromboresistant | Pass, Thromboresistant |
| Hemocompatibility: Prothrombin Time (PT) (10993-4) | Clotting times of test article must be similar to predicate values using analysis of variance. | Test article coagulation times are statistically similar to predicate. | Pass, Hemocompatible |
| Hemocompatibility: Partial Thromboplastin Time (PTT) (10993-4) | Clotting times of test article must be similar to predicate values using analysis of variance. | Test article coagulation times are statistically similar to predicate. | Pass, Hemocompatible |
| Hemocompatibility: Complement Activation (10993-4) | The concentrations of C3a and SC5b-9 of test article must be similar to predicate values using analysis of variance. | C3a: Test article concentrations are statistically similar to predicate at all exposure time points (30 min, 60 min, 90 min); SC5b-9: Test article concentrations are statistically similar to predicate at all exposure time points (30 min, 60 min, 90 min). | Pass, Hemocompatible |
| Hemocompatibility: Hemolysis, indirect contact (10993-4) | Sample extracts must be non-hemolytic (≤ 2% hemolytic index). | Hemolytic Index = 0.00% | Pass, Non-hemolytic |
| Hemocompatibility: Hemolysis, direct contact (10993-4) | Sample must be non-hemolytic (≤ 2% hemolytic index). | Hemolytic Index = 0.00% | Pass, Non-hemolytic |
Design Verification - Bench Top Testing
| Attribute | Specification | Results |
|---|---|---|
| Dimensional/Visual Inspection | These evaluations confirm that the units used in this Design Verification testing meet all product specifications. | Pass |
| Simulated Use | Simulated use testing of the Penumbra System Reperfusion Catheter was performed with accessory devices in an anatomical model which simulated the tortuosity of the neurovasculature. Devices were delivered through the tortuous anatomical model to evaluate the effectiveness of the devices to remove clots and that the Reperfusion Catheter does not collapse under vacuum. | Pass |
| Physician Evaluation | Multiple Physician performance evaluation of the Penumbra System Reperfusion Catheter JET 7 in a simulated neurovascular tortuosity model with the predicate Penumbra System Reperfusion Catheter JET 7 and ACE 68 used as a baseline. | Pass |
| Reperfusion Catheter / Sheath or 8F Guide compatibility (Friction Force) | Maximum value per specification. | Pass |
| Reperfusion Catheter / 0.014" Guidewire compatibility (Friction Force) | Maximum value per specification. | Pass |
| Markerband Visibility | The markerband is fluoroscopically visible. | Pass |
| Torsion | Number of turns will be recorded for informational purposes only (FIPO). | FIPO |
| Corrosion | No visible corrosion on Reperfusion Catheter immediately after corrosion testing procedure. | Pass |
| Particulate Testing | ≥ 10 µm will be ≤ 6000 particles; ≥ 25 µm will be ≤ 600 particles; ≥ 75 µm particles will be recorded for informational purposes only; ≥ 125 µm particles will be recorded for informational purposes only. | Pass |
| Coating Integrity | Coating has not delaminated, peeled, or flaked after simulated use particulate testing. | Pass |
| Hub/Air Aspiration | When negative pressure is pulled, no air may leak into hub. | Pass |
| Pressure Test | Minimum value per specification. | Pass |
| Markerband Section Bond Strength | Minimum value per specification. | Pass |
| Bond Strength Distal Joint 1 | Minimum value per specification. | Pass |
| Bond Strength Distal Joint 2 | Minimum value per specification. | Pass |
| Bond Strength Midjoint | Minimum value per specification. | Pass |
| Proximal Joints: Hub to Shaft Bond Strength / Hub to Hypotube Bond Strength | Minimum value per specification. | Pass |
| Elongation to Failure - Reperfusion Catheter | Elongation ≥ 5%. | Pass |
2. Sample sized used for the test set and the data provenance:
- Biocompatibility: "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP)." Specific sample sizes for each test are not detailed but are implied by GLP standards. Data provenance is implied to be laboratory testing within the US (due to FDA submission) or by a GLP-compliant lab.
- Bench-Top Testing: No specific sample sizes mentioned for each attribute, but the results indicate performance of "the units used in this Design Verification testing." Data provenance is laboratory testing.
- Clinical/AI study: No clinical study was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Biocompatibility/Bench-Top Testing: For "Physician Evaluation" in bench testing, "Multiple Physician performance evaluation" was conducted. The specific number or qualifications are not provided beyond "Physician." This is not establishing "ground truth" in the sense of clinical disease states.
- Clinical/AI study: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set for diagnosis/AI performance was used.
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. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Biocompatibility: Ground truth is based on established, quantitative laboratory standards and biological responses as defined by ISO and USP guidelines.
- Bench-Top Testing: Ground truth is based on engineering specifications, physical measurements, and functional performance in simulated environments.
- Clinical/AI study: Not applicable.
8. The sample size for the training set:
- Not applicable. This is not an AI device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI device.
In summary, the provided document details the non-clinical (biocompatibility and bench) testing and acceptance criteria for a physical medical device (catheter) to demonstrate substantial equivalence, rather than a clinical study for an AI-based diagnostic device.
§ 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).