(265 days)
The Penumbra LP Coil 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 Penumbra LP Coil System is comprised of the Penumbra LP Coil, a platinum embolization coil attached to a composite delivery pusher with a radiopaque positioning marker and the Penumbra LP Coil Detachment Handle.
The coil/delivery pusher is packaged separately from the Penumbra LP Coil Detachment Handle. Penumbra LP Coil includes the following coil configurations:
- Ruby Coil LP ●
- Packing Coil LP ●
- PTC Coil LP ●
- Helical Coil LP ●
- Hybrid Coil LP ●
The provided text is a 510(k) summary for the Penumbra LP Coil System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through an independent study with a defined ground truth, a test set, or expert adjudication.
Therefore, many of the requested data points (sample size of test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable to this type of submission.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes bench-top testing performed to evaluate the physical and mechanical properties of the subject device and demonstrate substantial equivalence to the predicate device. For each attribute, the "Specification" acts as the acceptance criteria, and the "Results" indicate the device met these criteria.
| Attribute | Acceptance Criteria (Specification) | Reported Device Performance (Results) |
|---|---|---|
| Dimensional/Visual Inspection | Confirm the dimensions of the test units meet all product specifications. | Pass |
| Friction Testing | Confirm that the friction within a microcatheter is acceptable. | Pass |
| Fatigue Resistance Testing | Confirm that the coil implant retains its shape after being cycled into/out of the microcatheter. | Pass |
| Simulated Use Testing | Simulated use testing in an anatomical model and post-detachment dimensional inspection. | Pass |
| Radiopacity Testing | Confirm fluoroscopic visibility of test units. | Pass |
| Torsional Resistance Testing | Confirm torsional resistance of test units. | Pass |
| Corrosion Testing | Confirm that there is no visible corrosion after testing. | Pass |
| Coil Stiffness Testing | Confirm that test units meet product specifications related to coil stiffness. | Pass |
| Tensile Testing | Confirm tensile strength of coil implant and Detachment Pusher joints. | Pass |
Additionally, the document states:
- Biocompatibility Testing: The Penumbra LP Coil System was determined to be biocompatible according to the requirements of ISO 10993-1. Specific tests for the Detachment Pusher (Cytotoxicity, Hemocompatibility) and Introducer Sheath (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility, Material-Mediated Pyrogenicity) were performed.
- Sterilization Testing: The device was tested to be sterile using identical acceptance criteria and testing methods as the predicate device in accordance with ISO 11135 and ISO 10993-7. The Sterilization Assurance Level (SAL) requirement is ≥10-6.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or images for an AI/CAD/software device. The tests performed are bench-top mechanical, chemical, and biological evaluations. The sample size for each bench-top test is not explicitly mentioned.
Data Provenance: Not applicable in the context of clinical data for this type of submission. The data is from laboratory testing (bench-top, biocompatibility, sterilization).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission is for a physical medical device (embolization coil system), not a diagnostic device relying on expert interpretation of images or clinical data. Ground truth, in this context, refers to established engineering specifications and international standards (e.g., ISO 10993-1, ISO 11135, ISO 10993-7).
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the sense of clinical cases requiring expert adjudication. The "Pass" results for bench-top tests indicate compliance with predefined engineering specifications.
5. 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
Not applicable. This is a physical medical device; it is not an AI/CAD/software device intended to assist human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device; it is not a standalone algorithm.
7. The Type of Ground Truth Used
For the bench-top testing, the "ground truth" or reference for evaluating performance was engineering specifications, product specifications, and relevant international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135 and ISO 10993-7 for sterilization).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set.
§ 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).