(60 days)
The Penumbra Coil System is intended 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 Penumbra Coil System consists of the following components, which are sold separately:
- Standard Complex Coils attached to detachment pusher
- Soft Complex Coils attached to detachment pusher
- Soft Coils attached to detachment pusher
- Curve Extra Soft Coils attached to detachment pusher
- Curve Complex Extra Soft Coils attached to detachment pusher
- Detachment Handle
The coils are primarily manufactured from platinum wire and Nitinol wire. The coils are attached to a stainless steel / polymer detachment pusher. The coils are available in varying secondary diameters and shapes based on coil type.
The Penumbra Coils are sterile, non-pyrogenic and intended for single use only. The Penumbra Detachment Handle is sterile, non-pyrogenic and may be used to detach multiple coils within a single patient procedure.
The provided text is a 510(k) Summary for the Penumbra Coil System/Penumbra Coil 400. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific clinical acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested in the prompt regarding a study that proves the device meets acceptance criteria, an effects size for MRMC studies, or detailed information about ground truth establishment for a test set. This type of information is typically found in clinical trial reports or performance study reports, which are not part of a 510(k) summary focused on substantial equivalence.
However, based on the non-clinical data presented, I can extract and present the acceptance criteria for those tests and their reported performance.
Non-Clinical Acceptance Criteria and Reported Device Performance
For the non-clinical tests, the "acceptance criteria" are implied by the expected outcome for a safe and effective medical device, and the "reported device performance" are the results obtained.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | Non-Toxic | Non-Toxic |
| Sensitization | Non-Sensitizing | Non-Sensitizing |
| Intracutaneous Reactivity (Irritation) | Non-Irritant | Non-Irritant |
| Systemic Toxicity (Acute) | Non-Toxic | Non-Toxic |
| Subacute / Subchronic Toxicity | Non-Toxic | Non-Toxic |
| Genotoxicity | Non-Mutagenic | Non-Mutagenic |
| Implantation | Non-Irritant | Non-Irritant |
| Haemocompatibility (Complement Activation) | No greater biological response than corresponding control | No greater biological response than corresponding control |
| Haemocompatibility (Hemolysis) | Non-Hemolytic | Non-Hemolytic |
| Haemocompatibility (Thrombogenicity) | Non-Thrombogenic | Non-Thrombogenic |
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic |
| Design Verification Tests (General) | All tests passed successfully | All tests passed successfully |
| Dimensional / Visual Inspection | Met finished goods release requirements | Passed |
| Joint Tensile Strength | Met finished goods release requirements | Passed |
| Fatigue | Met finished goods release requirements | Passed |
| Friction | Met finished goods release requirements | Passed |
| Torsion | Met finished goods release requirements | Passed |
| Stiffness | Met finished goods release requirements | Passed |
| Corrosion | Met finished goods release requirements | Passed |
| Handle Function | Met finished goods release requirements | Passed |
| MRI Compatibility | Met finished goods release requirements | Passed |
| GLP Simulated Use | Met finished goods release requirements | Passed |
Information Not Available in the Provided Text:
- Sample size used for the test set and the data provenance: The document is a 510(k) summary demonstrating substantial equivalence for a labeling change. It does not contain information about a test set for clinical performance. The non-clinical tests were conducted using statistical sampling methods as required by Penumbra Design Control procedures, but specific sample sizes are not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set for performance is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical implant, not an AI-assisted diagnostic tool.
- 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 the biocompatibility and design verification tests, the "ground truth" is established by the validated methods themselves and the specified acceptance criteria for each test (e.g., "non-toxic," "non-irritant," "passed successfully").
- The sample size for the training set: Not applicable as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
§ 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).