(28 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.
This document is a 510(k) summary for modifications made to the Target® Detachable Coils by Stryker Neurovascular. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of diagnostic accuracy or a new clinical claim. Therefore, many of the requested categories (such as diagnostic performance metrics, expert qualifications, adjudication methods, or MRMC studies) are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Not explicitly stated as numeric targets, but implied to be "acceptable") | Reported Device Performance (Implied "meets acceptance criteria") |
|---|---|---|
| Functional Testing | Coil / Catheter Compatibility: Acceptable | Successfully demonstrated acceptable Coil / Catheter Compatibility. |
| Product Removal from Flushing Dispenser Coil: Acceptable | Successfully demonstrated acceptable Product Removal from the Flushing Dispenser Coil. | |
| Packaging Verification | Ability of new introducer sheath to protect finished device: Acceptable | Successfully demonstrated the ability of the new introducer sheath to protect the finished device. |
| Shelf Life Testing | Ability of new introducer sheath to protect finished device (after climatic conditioning/distribution simulation): Acceptable | Successfully demonstrated the ability of the new introducer sheath to protect the finished device after simulated conditions. |
| Confirmatory Biocompatibility | Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Injection, Rabbit Pyrogen, Hemolysis, Partial Thromboplastin Time, In Vitro Hemocompatibility, Complement Activation, USP Physico-Chemical, Latex Testing: All within acceptable limits. | All specified biocompatibility tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Injection, Rabbit Pyrogen, Hemolysis, Partial Thromboplastin Time, In Vitro Hemocompatibility, Complement Activation, USP Physico-Chemical, Latex Testing) were successfully met. |
| Design Validation (Physician Assessment) | New introducer sheath & retention clip ability to: a) protect finished device; b) provide acceptable introducer sheath friction; c) provide proper hydration; d) enable easy removal: All acceptable. | Physician assessed and found the new configuration acceptable for all specified points (protection, friction, hydration, easy removal). |
| Revised DFU: Clear, legible, easy to read: Acceptable. | Physician assessed and found the revised DFU clear, legible, and easy to read. | |
| Risk Assessment (FMEA) | Modifications raise no new questions of safety or effectiveness. | Risk assessment conducted (EN ISO 14971 +A1:2003) determined no new questions of safety or effectiveness were raised. |
| Substantial Equivalence | Modified device is substantially equivalent to predicate devices. | Verification testing demonstrated the modified Target Detachable Coils are substantially equivalent to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of diagnostic performance involving patient data. This is a pre-market notification for device modifications, focusing on engineering verification and validation. Therefore, the "samples" refer to the medical devices themselves used in various engineering and biocompatibility tests.
- Sample Sizes: Not explicitly stated for each individual test. Typically, these are engineering sample sizes (e.g., n=3, n=5, n=10, n=30) determined by statistical power for the specific test.
- Data Provenance: Not applicable as it's not patient data. The tests were performed internally or by contracted labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of submission. "Ground truth" in a clinical/diagnostic sense is not relevant here as the study is about material and functional changes to a medical device.
For the Design Validation testing, it mentions "a physician assessed the new introducer sheath and new retention clip."
- Number of Experts: One physician is explicitly mentioned ("a physician").
- Qualifications: Not explicitly stated beyond "physician."
4. Adjudication Method for the Test Set
Not applicable. The assessments were either direct measurements (functional, packaging, shelf life), lab results (biocompatibility), or a physician's direct assessment, not a consensus process for diagnostic interpretation.
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 not a diagnostic imaging or AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used
- For functional, packaging, and shelf-life tests: Engineering specifications and measurement standards served as the "ground truth" (e.g., tensile strength, detachment time, protection capability).
- For biocompatibility tests: ISO/ASTM standards and established toxicological limits served as the "ground truth" (e.g., acceptable cytotoxicity levels, absence of sensitization).
- For design validation by the physician: Expert clinical judgment of the device's handling and functionality.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. 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).