(63 days)
The POD System is indicated for the embolization of:
Intracranial aneurysms
Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
Arterial and venous embolizations in the peripheral vasculature
The POD System functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of soft platinum coils to achieve occlusion in an equivalent fashion to existing bare-platinum embolization coils. The POD System consists of three components: a Coil Implant attached to a Detachment Pusher and a Detachment Handle.
The provided text describes the acceptance criteria and study results for the Penumbra POD™ System, a neurovascular embolization device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet EN ISO 10993 requirements for: In Vitro Cytotoxicity, Sensitization, Irritation, Systemic Toxicity (Acute, Sub-acute/Sub-chronic, IV Toxicity, Pyrogenicity), Genotoxicity (Mouse Lymphoma, Ames, Micronucleus), Implantation, Hemocompatibility (Hemolysis, Complement Activation, Thrombogenicity) | All tests Passed |
| Dimensional / Visual Inspection | Units meet all inspection criteria for release of finished goods (clinically acceptable) product. | 100% Pass |
| Fatigue Testing | Coil Implant retains its secondary shape after being cycled into/out of introducer sheath 5 times. | 100% Pass |
| Friction Testing | Push/pull friction acceptable through an 0.025in ID microcatheter. | 100% Pass |
| Stiffness Testing | Appropriate stiffness per coil specifications. | 100% Pass |
| Simulated Use Flow Model Testing | Units meet all inspection criteria for release of finished goods (clinically acceptable) product after simulated use. | 100% Pass |
| Coil Dimensional Inspection (after simulated use) | Units withstood the simulated use testing. | 100% Pass |
| Distal System Tensile Test | Coil Implant and Detachment Pusher joints have sufficient tensile strength. | 100% Pass |
| MRI Compatibility | Minor design changes will have no impact on RF heating; same MRI conditions as predicate device are safe. | Concluded as safe |
| GLP Animal Testing (Design Validation) | Characterize the POD System's interaction with the vasculature. | Fully characterized by predicate device study |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Bench-top Testing: The document states that testing was performed "using units which were 2x sterilized and met finished goods release requirements." It also mentions "statistical sampling methods as required by the Penumbra Design Control procedures." However, specific sample sizes for each bench-top test are not provided.
- Biocompatibility Testing: The document states "Studies, were selected in accordance with EN ISO 10993 -1 guidelines" and "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices." Specific sample sizes for each biological test are not provided. For the "Implantation GLP Study - Penumbra Coil System in Swine Venous Pouch Aneurysm Model" and "Intramuscular Implant Test 13 Week Duration," it mentions "Swine" and "13 Week Duration," implying animal models, but no specific animal count is given.
- Data Provenance: The studies are described as "Non-clinical testing" and conducted under "Good Laboratory Practices (GLP)," indicating they are laboratory-based studies rather than human clinical data. The "Implantation GLP Study" mentions a "Swine Venous Pouch Aneurysm Model," indicating animal data. The document does not specify the country of origin for the data, but Penumbra, Inc. is located in Alameda, CA, USA. The studies are prospective in nature as they are conducted for device verification and validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable to this device submission. This submission focuses on engineering, biocompatibility, and animal (GLP) testing for substantial equivalence to a predicate device, not on diagnostic accuracy requiring expert interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set:
- Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC comparative effectiveness study was not performed as this is a device submission for an embolization system, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation. The focus is on the device's physical, mechanical, and biological properties, and its substantial equivalence to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
- Not applicable. The POD System is a medical device (coil implant, detachment pusher, handle) for physical embolization, not a software algorithm.
7. The Type of Ground Truth Used:
- Bench-top Testing: Engineering specifications and objective measurements (e.g., dimensional measurements, force measurements for friction/tensile tests, visual inspection criteria, retention of shape).
- Biocompatibility Testing: Established international standards and guidelines (EN ISO 10993) and Good Laboratory Practices (GLP) for biological responses.
- Design Validation (GLP Animal Testing): Biological responses in animal models, evaluated against expected physiological interactions and safety profiles.
8. The Sample Size for the Training Set:
- Not applicable. This submission describes a medical device, not an AI/ML algorithm that requires a training set. The "training set" concept does not apply here.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).