(249 days)
Penumbra Reperfusion Catheters and Separators: As part of the Penumbra System, the Reperfusion Catheters and Separators are 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 is a component to the currently available Penumbra System. The Reperfusion Catheter JET 7 component provides a larger lumen to assist in the efficient removal of thrombus from the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.
The Penumbra System Reperfusion Catheter JET 7 is a medical device for revascularization in acute ischemic stroke. It was compared to a predicate device, the Penumbra System ACE 68 Reperfusion Catheter, to demonstrate substantial equivalence through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
The device underwent various non-clinical tests (biocompatibility, bench-top, and animal studies) to confirm its safety and performance. The tables below summarize the acceptance criteria and results for key tests mentioned in the provided text.
Biocompatibility Testing
| Test | Acceptance Criteria | Results | Pass/Fail |
|---|---|---|---|
| In Vitro Cytotoxicity | Sample extracts must yield cell lysis grade 2 or lower | Grade 1: Slight | Pass |
| Sensitization | Test Group shall yield Grade 10% weight loss in ≥3 animals, ≥2 mortalities, ≥2 abnormal behaviors) | No evidence of systemic toxicity (no weight loss, no death, all animals appeared normal) | Pass |
| Rabbit Pyrogen Study | Sample extracts must not cause a total rise in body temperature of ≥0.5°C | Non-pyrogenic: No single animal had a total body temperature rise of ≥0.5°C | Pass |
| In Vitro Hemolysis | Sample extracts must be non-hemolytic (≤ 2% hemolytic index) | Non-hemolytic: Hemolytic Index = 0.70%, Corrected Hemolytic Index = 0.00% | Pass |
| Coagulation (Prothrombin Time) | Clotting times must be similar to negative control values | Test article coagulation times were statistically lower than negative control | Pass |
| Coagulation (Partial Thromboplastin Time) | Clotting times must be similar to predicate (negative control) values using analysis of variance | Test article coagulation times were statistically similar to the predicate | Pass |
| Complement Activation | Concentrations of C3a and SC5b-9 in test samples statistically similar to predicate and lower than positive control | Test sample concentrations of C3a and SC5b-9 were statistically similar or lower than predicate, and statistically lower than positive control | Pass |
| Dog Thrombogenicity | Device must be non-thrombogenic after 4 hours in vivo compared to a control device | No significant thrombosis with a Grade of 0 observed in 2 out of 2 test and 2 out of 2 control sites | Pass |
Bench-top Testing
| Attribute | Specification | Results |
|---|---|---|
| Dimensional / Visual Inspection | Units meet all product specifications. | Pass |
| Simulated Use (Intracranial Access, Vessel Access Entry Performance, Delivery/Retrieval Forces & Clot Removal) | Effectiveness of clot removal and catheter does not collapse under vacuum in an anatomical model. | Pass |
| Physician Evaluation (Deliverability & Clot Removal) | Performance evaluated in a simulated neurovascular tortuosity model with predicate as baseline. | Pass |
| Kink Resistance (Distal, Midshaft, Proximal) | No kinking when formed in 2.5 mm, 10 mm, and 25 mm radius. | Pass |
| Particulate testing | ≥ 10 μm ≤ 6000 particles; ≥ 25 μm ≤ 600 particles | Pass (for mandated sizes) |
| Coating Integrity | Coating has not delaminated, peeled, or flaked prior to or after simulated use particulate testing. | Pass |
| Markerband Visibility | The markerband is fluoroscopically visible. | Pass |
| Hub Air Aspiration | No leaks detected when vacuum is pulled on the injection lumen. | Pass |
| Pressure Test | 45 psi for 30 sec minimum. | Pass |
| JET 7 / Sheath or 8F Guide Catheter Friction Force | Maximum value per specification. | Pass |
| JET 7 / 0.014 in. Guidewire Friction Force | Maximum value per specification. | Pass |
| Joint sections bond strength | Minimum value per specification. | Pass |
| Markerband Section Bond Strength | Minimum value per specification. | Pass |
| Hub to Shaft Bond Strength | Minimum value per specification. | Pass |
| Hub to Hypotube Bond Strength | Minimum value per specification. | Pass |
| Elongation to failure | Elongation ≥ 5%. | Pass |
| Corrosion | No visible corrosion immediately after corrosion testing procedure. | Pass |
2. Sample Sizes Used for the Test Set and Data Provenance
- Biocompatibility: The specific number of samples for each biocompatibility test (e.g., number of extracts, animals) is not explicitly stated in the summary, but it implies standard practices for these types of tests conducted under GLP. The data provenance is from previously performed studies (leveraged from the predicate device ACE 68, K161640 cleared on July 12, 2016). These studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP). The location of these previous studies is not specified but is assumed to be within a regulated, GLP-compliant environment.
- Bench-Top Testing: The text does not specify exact sample sizes for each bench-top test, but it states that "the units used in this Design Verification testing meet all product specifications," suggesting multiple samples were tested for each attribute.
- Animal Study: The study used porcine subjects. "One side of each swine was treated with the Reperfusion Catheter JET 7 and the contralateral side was treated with predicate device." The exact number of swine is not stated, but the Dog Thrombogenicity test (part of biocompatibility) mentions "2 out of 2 test site and 2 out of 2 control sites," suggesting a small number of animals for that specific test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Biocompatibility: Not directly applicable in the sense of expert consensus for ground truth on performance. Biocompatibility results are based on objective laboratory measurements against established standards (EN ISO 10993-1:2009/AC:2010). The animal study involved a "Sponsor Pathologist" to assess vascular response by gross necropsy and histopathology. No specific number or additional qualifications beyond "Sponsor Pathologist" are provided.
- Bench-Top Testing: A "Physician Evaluation" was performed for deliverability and clot removal. The number of physicians and their specific qualifications are not detailed beyond "Multiple Physician."
4. Adjudication Method for the Test Set
- Biocompatibility: For tests like Systemic Toxicity, the results were assessed based on objective criteria (e.g., weight loss, mortality, abnormal behavior). For the Dog Thrombogenicity study, assessment of thrombosis was made by the Sponsor Pathologist. No formal adjudication (e.g., 2+1, 3+1) is mentioned as it's typically not explicitly used for these types of non-clinical tests unless there are subjective interpretations needing consensus, which isn't detailed here.
- Bench-Top Testing (Physician Evaluation): The method of physician evaluation for deliverability and clot removal is not described as having an adjudication process beyond "multiple physician performance evaluation."
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done. The submission states, "No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes." The comparison was primarily against the predicate device based on non-clinical data and leveraging clinical outcomes from existing literature on similar devices.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This device (Penumbra System Reperfusion Catheter JET 7) is a physical medical device, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply. The device's performance is inherently "standalone" in vitro and in vivo animal testing, with human involvement primarily in operating the device and evaluating the results.
7. The Type of Ground Truth Used
- Biocompatibility: Ground truth was established by adherence to recognized international standards (EN ISO 10993-1:2009/AC:2010) and objective measurements defined within these standards. For the animal study, pathology (gross necropsy and histopathology by a Sponsor Pathologist) served as the ground truth for vascular response.
- Bench-Top Testing: Ground truth was established by engineering specifications, physical measurements, and qualitative assessments (e.g., "no kinking," "no leaks," "fluoroscopically visible") based on predefined acceptance criteria. For the "Physician Evaluation," the ground truth was expert opinion/observation on deliverability and clot removal compared to a baseline (predicate device).
8. The Sample Size for the Training Set
This product is a physical medical device and not an AI/machine learning algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable. The device's design and manufacturing processes are developed based on engineering principles and prior knowledge from predicate devices.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" does not apply to this physical medical 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).