(64 days)
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
The Penumbra System Separator Flex (026, 032, 041, and 054) is an alternative to the current Penumbra System Separators. The Separator Flex utilizes a Nitinol core wire in place of the current stainless steel corewire. The Flex utilizes a Nitinol core wire in all four current sizes (026, 032, 041, and 054). Both the existing Separators and the subject Separator Flex models will be available to address Physician preference of stainless steel and nitinol. The device is provided sterile, nonpyrogenic, and intended for single use only.
The Penumbra System® Separator™ Flex (K100769) is a medical device intended for the revascularization of patients with acute ischemic stroke. The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| In Vitro Cytotoxicity | No evidence of cell lysis or toxicity | No evidence of cell lysis or toxicity |
| Acute Intracutaneous Reactivity (Irritation) | No evidence of irritation | No evidence of irritation |
| Acute Systemic Toxicity | No evidence of systemic toxicity | No evidence of systemic toxicity |
| Rabbit Pyrogen Study | No evidence of material-mediated pyrogenicity | No evidence of material-mediated pyrogenicity |
| Sensitization | Non-sensitizing | Non-sensitizing |
| In Vitro Hemolysis | Non-hemolytic | Non-hemolytic |
| In Vitro Coagulation (PT, PTT) | Coagulation times within normal range, non-thrombogenic | Coagulation times within normal range, non-thrombogenic |
| Complement Activation | No greater biological response than corresponding control | No greater biological response than corresponding control |
| Design Verification (Bench-Top Testing) | ||
| Dimensional / Visual Inspection | Met established requirements | All sizes passed successfully |
| Simulated Use (Reperfusion Catheter / Separator Flex / Aspiration Tubing Assembly Performance) | Met established requirements | All sizes passed successfully |
| Separator Flexibility Test | Met established requirements | All sizes passed successfully |
| Separator Flex Bond Joint Test | Met established requirements | Passed successfully |
2. Sample Size and Data Provenance
The provided document does not specify the exact sample sizes for each non-clinical test (biocompatibility and bench-top testing). However, it states that "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices" for biocompatibility, and for design verification, "All testing was performed using units which met applicable Design Control processed goods release requirements." This indicates that standard laboratory testing practices were followed to ensure sufficient sample sizes for statistically valid results, even if the explicit numbers are not given.
The data provenance is from non-clinical studies conducted by Penumbra, Inc. in the USA (Alameda, CA), as indicated by the sponsor's address and the regulatory context of a 510(k) submission to the FDA. The testing can be considered prospective in the sense that it was specifically designed and executed to support the regulatory submission for this new device.
3. Number of Experts and Qualifications for Ground Truth
This submission pertains to a medical device (catheter/separator) and relies on non-clinical data (biocompatibility and bench-top testing) rather than clinical data requiring expert review of medical images or patient outcomes. Therefore, the concept of "ground truth" derived from experts, as typically understood in studies involving diagnostic devices or AI algorithms, does not apply in this context. The "ground truth" for these tests is based on established scientific methods and pass/fail criteria.
4. Adjudication Method for the Test Set
As the studies are non-clinical (biocompatibility and bench-top testing), an adjudication method in the context of expert review (e.g., 2+1, 3+1) is not applicable. The results are determined by objective measurements and analyses performed according to established scientific protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is a medical device (catheter) and not a diagnostic imaging AI algorithm, so such a study design is generally not relevant. The effectiveness is demonstrated through pre-clinical performance testing.
6. Standalone Performance Study
Yes, a standalone performance study was done in the form of the "Design Verification (Bench-Top Testing)". This section evaluates the physical, mechanical, and performance characteristics of the Penumbra System Separator Flex on its own, without human intervention during the actual tests (after the device is assembled and prepared for testing). The tests included:
- Dimensional / Visual Inspection
- Simulated Use (Reperfusion Catheter / Separator Flex / Aspiration Tubing Assembly Performance)
- Separator Flexibility Test
- Separator Flex Bond Joint Test
These tests demonstrate the intrinsic performance of the device against predefined specifications.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical studies is based on established scientific and engineering standards and methods.
- For biocompatibility, the ground truth is defined by the accepted criteria outlined in ISO-10993 - I (Biological Evaluation of Medical Devices) for various biological responses (cytotoxicity, irritation, systemic toxicity, pyrogenicity, sensitization, hemolysis, coagulation, complement activation).
- For design verification (bench-top testing), the ground truth is based on engineering specifications, physical measurements, and functional performance criteria defined by the manufacturer to ensure the device operates as intended and meets safety and performance requirements.
8. Sample Size for the Training Set
Not applicable. This submission describes a physical medical device (catheter/separator), not an AI algorithm that requires a training set. The performance is assessed through bench-top testing and biocompatibility studies.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning. The ground truth for its performance is established through adherence to engineering design specifications, international standards (like ISO-10993), and good laboratory practices.
§ 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).