(146 days)
Penumbra Coil 400:
- Intracranial aneurysms.
- Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
- Arterial and venous embolizations in the peripheral vasculature.
Ruby Coil System:
- Arterial and venous embolizations in the peripheral vasculature.
POD System (For POD Coils with nominal sizes ≤ 6 mm):
- Intracranial aneurysms.
- Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
- Arterial and venous embolizations in the peripheral vasculature.
POD System (For POD Coils with nominal sizes > 6 mm):
- Arterial and venous embolizations in the peripheral vasculature.
The subject devices (Penumbra Coil System and POD System) are designed for embolization in the neuro and/or peripheral vasculature. This is achieved by using coils to exclude the intended treatment area from blood flow, thus creating stasis and allowing thrombosis to occur. The subject devices consist of a bare platinum embolization coil for the treatment of aneurysms or other vascular abnormalities. The devices should only be used by physicians who have received appropriate training in interventional techniques.
The subject devices consist of the following components:
- Coil: The Coil is attached to a Delivery Pusher both contained within an Introducer Sheath. The Coil is an implantable medical device intended to exclude the treatment area from blood flow, thus creating stasis and allowing thrombosis to occur.
- Delivery Pusher: The Delivery Pusher is composed of a shaft with a radiopaque positioning marker, a Distal Detachment Tip (DDT) and a pull wire. The Delivery Pusher may also be referred to as the Detachment Pusher.
- Introducer Sheath: The Introducer Sheath is intended to cover the entire length of the Coil and the distal flexible segment of the Delivery Pusher. The Introducer Sheath is secured onto the Delivery Pusher with a friction lock to prevent unsheathing until use.
- Detachment Handle: The Detachment Handle is packaged separately. It is intended for use in multiple coil detachments performed during a single procedure.
This document, a 510(k) Premarket Notification for the Penumbra Coil System and POD System, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for performance, especially concerning Artificial Intelligence (AI) or software-based diagnostics.
Therefore, many of the requested details about acceptance criteria, clinical study design (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), and training set information are not applicable to this type of submission. This document describes a medical device (embolization coils) that is a physical product, not an AI/software device.
Here's an attempt to extract relevant information and note where the requested information is not present:
Device: Penumbra Coil System (Penumbra Coil 400 and Ruby Coil System); POD System
Device Type: Neurovascular Embolization Device
Acceptance Criteria and Reported Device Performance (Non-AI/Software Context)
For this physical device, "acceptance criteria" are typically defined by engineering specifications and performance benchmarks, proven through bench-top (laboratory) and biocompatibility testing. The "performance" is the passing of these tests, demonstrating that the device functions as intended and is safe.
Here's a table based on the provided "Bench-Top Testing" and "Biocompatibility Testing" sections:
| Feature/Test Category | Acceptance Criteria (Specification) | Reported Device Performance (Results) |
|---|---|---|
| Bench-Top Testing | ||
| Dimensional/Visual Inspection | Meet all product specifications | Pass |
| Fatigue Resistance | Coil retains secondary shape after cycling into/out of 0.025 in. ID microcatheter | Pass |
| Torsional Resistance | Minimum value per specification | Pass |
| Friction (Pull & Push) | Maximum value per specification | Pass |
| Simulated Use Flow Model Testing | Effectiveness to embolize targeted vasculature in anatomical model | Pass |
| Distal System Tensile Test | Minimum per specification | Pass |
| Stiffness Testing | Maximum value per specification | Pass |
| Biocompatibility Testing | ||
| In Vitro Cytotoxicity | Non-Toxic | Non-Toxic |
| Sensitization | Non-Sensitizing | Non-Sensitizing |
| Irritation (Intracutaneous Reactivity) | Non-Irritant | Non-Irritant |
| Implant study | Non-Irritant | Non-Irritant |
| Systemic Toxicity (Acute) | Non-Toxic | Non-Toxic |
| Material Mediated Pyrogen | Non-Pyrogenic | Non-Pyrogenic |
| Sub-Chronic Toxicity (Sub-Acute Toxicity) | Non-Toxic | Non-Toxic |
| In Vitro Hemolysis | Non-Hemolytic | Non-Hemolytic |
| Dog Thrombogenicity Coagulation | Non-Thrombogenic | Non-Thrombogenic |
| Complement Activation | No greater biological response than corresponding control | No greater biological response than corresponding control |
| Genotoxicity (Mouse Lymphoma) | Non-Mutagenic | Non-Mutagenic |
| Genotoxicity (Ames Mutagenicity) | Non-Mutagenic | Non-Mutagenic |
| Genotoxicity (In Vivo Mouse Micronucleus) | Non-Mutagenic | Non-Mutagenic |
| MR Compatibility Testing | Compliant with ASTM F2182-11, F2052-15, F2213-06 (R-11), F2119-07 (R-13) for 1.5T & 3T MR environments | Testing performed; advises MR conditional statement in IFU |
| MRA Testing | Maximum artifact distance beyond implant of 2 mm using clinical MRA sequence | Maximum artifact distance was 2 mm |
Information Not Applicable or Not Provided for This Type of Submission (AI/Software-Specific Questions)
-
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- N/A. This is a physical device, and the "test set" here refers to the number of units or biological samples used in bench-top and biocompatibility testing, not a clinical data set for an AI model. The document does not specify the number of units tested for each bench-top criterion. Biocompatibility tests followed ISO and CFR guidelines.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- N/A. Ground truth establishment by experts is relevant for AI/diagnostic software. For a physical device, ground truth is established by objective measurements against engineering specifications and biological material reactions.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Adjudication is for resolving discrepancies in expert interpretations, not for physical device testing.
-
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:
- N/A. This applies to AI-assisted diagnostic tools, not physical embolization coils.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This applies to AI/software.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, "ground truth" related to performance is based on engineering specifications, direct physical measurements, and well-established biological response criteria (e.g., cell viability, immune response markers) in a laboratory setting, as well as adherence to recognized standards like ASTM and ISO. There is no "expert consensus" on ground truth for the physical and biological properties being tested here in the way there would be for a diagnostic image.
-
The sample size for the training set:
- N/A. There is no "training set" as this is not an AI/machine learning device.
-
How the ground truth for the training set was established:
- N/A. There is no "training set" or AI model.
§ 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).