(30 days)
Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Target Detachable 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 Target Detachable Coils are comprised of the following coil types: Target 360 Nano. 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 the Stryker Neurovascular 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 Coils in the 360-shape, 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.
The Stryker Neurovascular 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, K161429, concerns the 510(k) premarket notification for Stryker Neurovascular Target Detachable Coils, specifically the new Target XXL 360 Detachable Coils. The submission aims to demonstrate substantial equivalence to previously cleared Target Detachable Coils.
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes "Verification Testing" to demonstrate substantial equivalence. The acceptance criteria for the new Target XXL 360 Detachable Coils are explicitly stated as meeting the same criteria as the predicate device for each test. The reported device performance is that the new coils Met the same criteria as the predicate device.
| Test | Test Method Summary/Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensions | Coil Secondary Diameter and 2D Loop Secondary Diameter are measured. | Met the same criteria as the predicate device. | Met the same criteria as the predicate device. |
| Visual | Visual confirmation that the entire coil is contained within the introducer sheath. | Met the same criteria as the predicate device. | Met the same criteria as the predicate device. |
| Durability | The coil is visually inspected for damage and Main Junction Tensile Strength is tested after simulated deployment/retraction in a tortuous model. | Met the same criteria as the predicate device. | Met the same criteria as the predicate device. |
| Particulates | Particulate release due to delivery of the coil is measured. | Met the same criteria as the predicate device. | Met the same criteria as the predicate device. |
| Friction | Frictional force through an introducer sheath and a compatible microcatheter is measured. | Met the same criteria as the predicate device. | Met the same criteria as the predicate device. |
| Biocompatibility | • MEM Elution Cytotoxicity/Part 5 | ||
| • Hemolysis Direct/Extract Contact/Part 4 | |||
| • USP Physicochemical USP | |||
| • FTIR/Part 18 | |||
| • Natural Rubber Latex | Met the same criteria as the predicate device. | Met the same criteria as the predicate device. | |
| Packaging | Assess the ability of the packaging system to protect the finished device. | Met the same criteria as the predicate device. | Met the same criteria as the predicate device. |
| Simulated Use | • Coil conformability | ||
| • Coil durability during repositioning | |||
| • Microcatheter compatibility | |||
| • Coil friction during delivery through the microcatheter | |||
| • Introducer sheath friction acceptability | |||
| • Removal of coil from the packaging hoop without damaging the device | Met the same criteria as the predicate device. | Met the same criteria as the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set for any of the verification tests. It also does not provide information on the data provenance, such as country of origin or whether the data was retrospective or prospective. The tests described are laboratory-based engineering and material testing, not clinical studies involving human patients or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided in the document. The "ground truth" in this context refers to the defined engineering and material properties acceptable within the product specifications, not to clinical diagnoses or interpretations by medical experts. The tests are designed to measure physical and chemical properties against established internal specifications, which likely involve engineering standards and regulatory requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies involving observer variability in assessments (e.g., image interpretation). The verification tests performed are objective, measurable physical and chemical tests, not requiring human adjudication.
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
An MRMC comparative effectiveness study was not conducted. This document describes the clearance of a medical device (detachable coils) based on substantial equivalence through engineering and material testing, not an AI or imaging diagnostic device. Therefore, questions regarding human reader improvement with or without AI assistance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance study for an algorithm was not conducted. This document pertains to the clearance of a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the verification tests performed is based on defined engineering specifications, material properties, and regulatory standards for similar predicate devices. The acceptance criteria are "the same criteria as the predicate device," indicating that the "truth" is established by the performance and specifications of previously cleared, substantially equivalent devices. This is not derived from expert consensus, pathology, or outcomes data in the clinical sense, but from established physical and performance benchmarks for the device type.
8. The sample size for the training set
This information is not applicable and not provided. As this is not an AI/machine learning device, there is no "training set." The coils are physical devices validated through engineering tests.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As there is no "training set" in the context of this device clearance, the method of establishing its ground truth is irrelevant.
§ 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).