(21 days)
The Nexus Detachable Coils are intended for the endovascular embolization of intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) be inoperable. The Nexus Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
The Nexus Helix Super Soft CSR arc platinum alloy coils, enlaced with absorbable polymer fibers, and attached to a stainless steel guiding system with a radiopaque positioning coil. Nexus Helix Super Soft CSR coils are designed for use with the NXT Detachment System specifically designed for coil detachment. The NXT Detachment System is sold separately.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Nexus Helix Super Soft CSR device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | Implicit criteria: Demonstrate equivalence to the predicate device and meet established safety/performance standards for neurovascular embolization devices. Specific quantitative criteria are not detailed in the provided document, but the device must demonstrate comparable performance to the predicate and established norms for safety and efficacy.** | Met established criteria for all listed categories: |
| Coil Deformation | (Implicit: Maintain intended shape and structural integrity under anticipated forces.) | Met established criteria |
| Dimensional & Visual Analysis | (Implicit: Conform to specified dimensions and be free from visual defects.) | Met established criteria |
| Coating Integrity | (Implicit: Maintain a robust and intact coating.) | Met established criteria |
| Force Transfer | (Implicit: Efficiently transfer force for deployment and withdrawal.) | Met established criteria |
| Ease of Delivery/Coil Frictional Characteristics | (Implicit: Demonstrate smooth and controlled delivery with acceptable frictional properties.) | Met established criteria |
| Fiber Endurance Testing | (Implicit: Fibers, if present, must withstand expected stresses over time.) | Met established criteria |
| Reliability After Fatigue & Premature Detachment | (Implicit: Maintain integrity and prevent premature detachment after simulated fatigue.) | Met established criteria |
| Fiber Pull-Out | (Implicit: Fibers must remain securely attached to the coil structure.) | Met established criteria |
| Tensile Strength | (Implicit: Possess adequate tensile strength for handling and deployment.) | Met established criteria |
| Particulate Generation – Adjusted Particles / 1 mL | (Implicit: Generate minimal and acceptable levels of particulates to prevent adverse events.) | Met established criteria |
| PGLA Tensile Testing | (Implicit: If PGLA is used, its tensile properties must meet standards.) | Met established criteria |
| Packaging Integrity | (Implicit: Packaging must maintain sterility and protect the device.) | Met established criteria |
| Overall Substantial Equivalence to Predicate Device | Same intended use, same operating principle, same basic design, similar construction and material, packaged and sterilized using same processes. | The data presented demonstrates technological similarity and is actively compared with the predicate device Nexus Detachable Coils, leading to an opinion of substantial equivalence. |
Study Details:
The provided document describes a Special 510(k) submission for the Nexus Helix Super Soft CSR device. This type of submission relies on the concept of substantial equivalence to a previously cleared predicate device (K050543, Nexus Detachable Coil System). Therefore, the "study" is primarily a bench testing and comparative analysis rather than a full-scale clinical trial.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the sample size used for each bench test. It merely states that the tests "Met established criteria."
- Data Provenance: The data provenance is from Micro Therapeutics, Inc., the manufacturer. It is retrospective in the sense that the testing was conducted by the manufacturer for the purpose of the 510(k) submission, likely in a controlled laboratory setting. No country of origin for the data is explicitly mentioned beyond the company's address in Irvine, California, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Experts and Qualifications: This information is not provided in the document. For bench testing, "ground truth" is typically established by engineering specifications, validated test methods, and industry standards, rather than expert consensus in the clinical sense. The "established criteria" would have been determined by the manufacturer based on these engineering and regulatory requirements.
4. Adjudication Method for the Test Set
- Adjudication Method: This information is not applicable/provided. Bench testing results are typically objectively measured against pre-defined engineering criteria, not adjudicated by a panel in the way clinical study outcomes might be.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This document describes the clearance of a physical medical device (neurovascular embolization coils) through a 510(k) pathway, which primarily relies on bench testing and comparison to an existing predicate device. It is not an AI-assisted diagnostic or imaging device, so MRMC studies involving human readers and AI assistance are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical embolization coil, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- Ground Truth Type: The "ground truth" for the bench tests is the pre-established engineering specifications, performance standards, and safety requirements for neurovascular embolization devices, as well as the performance characteristics of the predicate device. These are derived from a combination of scientific principles, regulatory guidelines, and industry best practices.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model that requires a "training set." The development of the device would involve engineering design and iterative testing, but not in the context of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable. As explained above, there is no "training set" in the context of this device and submission type.
§ 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).