(25 days)
Target Detachable Coils are intended for use in the treatment of intracranial aneurysms and other neuro and peripheral vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Target Coils are indicated for endovascular embolization of:
- Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- Arterial and venous embolizations in the peripheral vasculature
Stryker Neurovascular's Target Detachable Coils are comprised of four coil types: Target Coil 360 STANDARD, Target Coil 360 SOFT, Target Coil 360 ULTRA and Target Coil HELICAL ULTRA. All Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with Stryker Neurovascular's InZone™ Detachment System (sold separately).
Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coil 360 STANDARD, Target Coil 360 SOFT and Target Coil 360 ULTRA coils the distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil to facilitate placement of the coil. The diameter of the distal loop is 75% that of the rest of the main coil loops.
Stryker Neurovascular's InZone Detachment System is intended for use with all Stryker Neurovascular Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.
The modifications described within this Special 510(k) have resulted in 12 new smaller coil sizes to be added to the currently approved Target Helical ULTRA and Target 360 ULTRA coil subtypes. These 12 new UPNs use the same processes as the current Target Detachable Coil products with the only difference being the use of a smaller Platinum (Pt) coil wire diameter of 0.00125in.
Here's a breakdown of the acceptance criteria and study information for the Target Detachable Coils, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes modifications to existing Target Detachable Coils, specifically the addition of 12 new smaller coil sizes using a thinner platinum wire. The acceptance criteria are framed around demonstrating that these modified devices are "substantially equivalent" to predicate devices and do not raise new questions of safety or effectiveness.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Mechanical Properties | Functional Testing to assess properties impacted by smaller Pt coil wire diameter (0.00125in), including: | Verification testing has demonstrated the modified Target Detachable Coils are substantially equivalent to the predicate Target Detachable Coils. |
| (Implicitly, all tests below met acceptance for substantial equivalence.) | ||
| - Main Junction Tensile Test | (Specific quantitative results not provided, but implicitly met for substantial equivalence) | |
| - Durability Challenge Test | (Specific quantitative results not provided, but implicitly met for substantial equivalence) | |
| - Coil/Catheter Compatibility | (Specific quantitative results not provided, but implicitly met for substantial equivalence) | |
| Safety - Migration Risk | Assessment of coil migration for smaller coil sizes via Use and Design Failure Modes and Effects Analyses (FMEAs). | Risk assessment of the modifications in the form of design and use FMEAs has been conducted in accordance with EN ISO 14971 +A1:2003. |
| Neurovascular has determined the modifications to the predicate devices raise no new questions of safety or effectiveness. | ||
| Intended Use/Indications | No alteration to the intended use or indications for use compared to predicate devices. | The modifications do not alter the intended use, indications for use, or the fundamental scientific technology of the predicate devices. |
| Fundamental Technology | No alteration to the fundamental scientific technology of the predicate devices. | The modifications do not alter the intended use, indications for use, or the fundamental scientific technology of the predicate devices. |
| Overall Equivalence | Demonstrate substantial equivalence to predicate devices, raising no new questions of safety or effectiveness. | Verification testing has demonstrated the modified Target Detachable Coils are substantially equivalent to the predicate Target Detachable Coils. |
| Risk assessment of the modifications and successful verification testing raise no new questions of safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each mechanical test (Main Junction Tensile Test, Durability Challenge Test, Coil/Catheter Compatibility). It refers to "Verification testing" without providing numerical details for the number of units tested.
- Data Provenance: Not explicitly stated. These appear to be laboratory in vitro or bench tests conducted by Stryker Neurovascular to evaluate the physical and functional properties of the modified coils. No patient or geographical data is mentioned. The tests are focused on the device itself.
- Retrospective/Prospective: These are laboratory/bench tests, not clinical studies, so the terms retrospective/prospective do not directly apply in the usual clinical sense. The tests were performed prospectively on newly manufactured modified devices to demonstrate their performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This information is not applicable. The "ground truth" for the verification testing is based on engineering specifications, material properties, and established test methods for medical devices, not on expert clinical interpretation or consensus.
4. Adjudication Method for the Test Set
- This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of data (e.g., imaging) by multiple human experts, whereas this document describes technical verification testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes a 510(k) submission for device modifications based on bench testing to demonstrate substantial equivalence, not a clinical effectiveness study involving human readers or AI.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- No, a standalone study was not done. This device is a physical medical implant (coils), not an algorithm or AI software. Therefore, performance without human intervention is not applicable in this context.
7. Type of Ground Truth Used
- The "ground truth" for the verification testing described is based on pre-defined engineering specifications, standard test methods, and performance benchmarks derived from the predicate devices. For example, the Main Junction Tensile Test would have a specific force tolerance, and Coil/Catheter Compatibility would have defined passage and deployment success criteria. Comparison to these established physical and functional parameters serves as the "ground truth."
8. Sample Size for the Training Set
- This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training" for such a device would be the manufacturing processes and quality control to ensure consistency.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable, as there is no "training set" in the context of an AI device. For a physical device, ground truth for manufacturing and quality (analogous to "training") is established through documented design specifications, validated manufacturing processes, and established quality control inspections, which would ensure that manufactured units meet the approved specifications.
§ 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).