(72 days)
The intended use of the TRUFILL® Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) is as follows:
Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.
The TRUPUSH® Coil Pusher is used in coil embolization procedures in both the neuro and peripheral vascular systems. An embolic coil is loaded into the proximal end of a compatible microcatheter and the Coil Pusher is used to advance the device through the catheter lumen until it has exited the distal tip of the catheter.
This document describes the 510(k) premarket notification for the TRUPUSH® Coil Pusher, a component of the TRUFILL® Vascular Occlusion System. The submission aims to demonstrate substantial equivalence to a predicate device, focusing on process changes, packaging changes, and manufacturing site transfer.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly detailed with quantitative targets in the provided document. Instead, the "Design Verification Testing" and "Design Validation Testing" sections list the types of tests performed. The implication is that the device met the inherent acceptance criteria for each test to support substantial equivalence. Without specific numerical thresholds, we can only infer that the performance was deemed acceptable for regulatory clearance.
| Test Category | Specific Test (Acceptance Criteria Implicitly Met) | Reported Device Performance/Outcome |
|---|---|---|
| Design Verification | Total Product Length | Implied to meet specified dimensional requirements. |
| Taper Length | Implied to meet specified dimensional requirements. | |
| OD of the Proximal Joint | Implied to meet specified dimensional requirements. | |
| OD of the Distal Joint | Implied to meet specified dimensional requirements. | |
| OD of the Proximal End of the PTFE Sleeve | Implied to meet specified dimensional requirements. | |
| Proximal Marker Position | Implied to meet specified positional requirements. | |
| Distal Placement of the PTFE Sleeve | Implied to meet specified positional requirements. | |
| PTFE Sleeve Visual Inspection | Implied to pass visual inspection for defects. | |
| Distal End of PTFE Sleeve Visual Inspection | Implied to pass visual inspection for defects. | |
| Overall Visual Inspection | Implied to pass overall visual inspection for defects. | |
| Distance from the Proximal End of the PTFE Sleeve to the Corewire Taper | Implied to meet specified dimensional requirements. | |
| Distal Solder Joint Length | Implied to meet specified dimensional requirements. | |
| Distal Solder Joint Visuals | Implied to pass visual inspection for defects and proper formation. | |
| Turns to Failure | Implied to demonstrate sufficient torsional strength/durability for intended use. | |
| Distal Joint Strength | Implied to demonstrate sufficient strength at the distal joint for intended use. | |
| Package Integrity | Implied to pass tests ensuring package integrity (e.g., preventing microbial ingress). | |
| Package Challenge | Implied to pass tests challenging package robustness or performance. | |
| Seal Integrity Test (Dye Penetration) | Implied to pass, indicating no dye penetration and thus a sterile barrier. | |
| Packaging-Seal Strength (Pull Test) | Implied to meet specified pull strength requirements for package seals. | |
| Product Migration | Implied to demonstrate that the product does not migrate within the package unexpectedly or detrimentally. | |
| Design Validation | 3-cavity torque device clip | Implied to perform as intended with a 3-cavity torque device clip, likely related to securement or deployment. |
| Pushability | Implied to demonstrate acceptable ease of advancement through a microcatheter. | |
| Retractability | Implied to demonstrate acceptable ease of withdrawal from a microcatheter. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for each of the "Design Verification Testing" or "Design Validation Testing" items. It also does not specify the provenance of the data (e.g., country of origin).
The document mentions "in-vitro and in-vivo testing." In-vitro testing typically refers to tests conducted in a controlled environment, such as a lab bench, using bench models or simulators. In-vivo testing often involves animal models or human subjects. Given the context of a 510(k) for a device like a coil pusher, in-vivo testing likely refers to animal studies to simulate real-world use conditions, as human clinical trials are typically not required for 510(k) unless there are significant performance or safety questions not addressed by bench testing or animal studies. The text does not specify sample sizes or details of these studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided in the document. The studies conducted are engineering and performance tests (e.g., dimensional measurements, mechanical strength, pushability, retractability, package integrity), not diagnostic or interpretative tasks requiring human expert ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. The tests described are objective engineering and performance measurements, not subjective evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or algorithms where human readers interpret medical images, and the AI's impact on their performance is assessed. The TRUPUSH® Coil Pusher is a physical medical device, not an AI or diagnostic tool.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No, a standalone study (in the context of an algorithm's performance) was not done. The device is a physical medical instrument, not an algorithm. The "standalone" performance here refers to the physical device's function as designed, which is what the design verification and validation tests aim to assess.
7. Type of Ground Truth Used
The "ground truth" for the tests described are engineering specifications, measurement standards, and functional performance requirements for mechanical and material properties, as well as operational characteristics like pushability and retractability. For example, the ground truth for "Total Product Length" would be the engineering drawing's specified length with its permissible tolerance range. The ground truth for "Seal Integrity Test (Dye Penetration)" would be the absence of dye penetration under specified conditions.
8. Sample Size for the Training Set
This information is not applicable. The TRUPUSH® Coil Pusher is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a machine learning 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).