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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.

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.

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MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.

The GALAXY G3 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.

The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT Microcoil Delivery Systems consist of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. As shown in Figure 1, the Microcoil System consists of a microcoil attached to a Device Positioning Unit (DPU). The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the microcatheter catheter. The microcoil is the implantable segment of the device, and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable). The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which may contain either a polypropylene suture (SR) or an absorbable polymer suture and then formed into a secondary shape. The secondary shape may be spherical, complex, or helical. The DPU is a variable stiffness wire and has a radiopaque marker band located three (3) cm from its distal end. The Device Positioning Unit includes five (5) fluoro saver markers on the proximal section of the shaft. The markers are intended to indicate when the tip of the microcoil is approaching the tip of the microcatheter. When the distal-most marker reaches the proximal end of the Rotating Hemostatic Valve (RHV) on the microcatheter, the tip of the coil is approaching the tip of the microcatheter and fluoroscopy should be used to guide further coil insertion. The introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool. The EnPOWER Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU. The connecting cable delivers the energy necessary to detach the embolic coil from the Microcoil System's detachment zone. The connecting cable is connected between the Microcoil System's hub connector on the DPU and the output connector on the DCB. The connecting cables may be one of two types: one with a remote detach button (the EnPower Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00. The EnPower Detachment Control Box works with the EnPower Control Cable and with the standard connecting cable. The device in this submission includes design changes only to the Device Positioning Unit (DPU) element of the microcoil system. There are no modifications to the microcoil components or to the EnPOWER Detachment Control system.

This document describes the premarket notification (510(k)) for the MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT Microcoil Delivery Systems. The submission focuses on design changes to the Device Positioning Unit (DPU) element of the microcoil system, emphasizing that there are no modifications to the microcoil components or the detachment control system.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established as "PASS," indicating that the samples met the predetermined criteria for each test. Specific quantitative criteria are not explicitly detailed in this summary.

2. Sample Sizes Used for the Test Set and Data Provenance

The document states that testing was conducted using "statistical sampling methods as required by the Codman & Shurtleff, Inc. Design Control procedures." However, specific numerical sample sizes for each test are not provided.

The data provenance is not explicitly stated as retrospective or prospective, nor is a country of origin mentioned. However, being a premarket notification to the U.S. FDA, it can be inferred that the testing was conducted to meet U.S. regulatory standards, likely in a controlled laboratory environment. The testing is bench testing and biocompatibility testing, not human clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the studies described are bench tests and biocompatibility tests, not clinical studies involving human patients or expert interpretation of diagnostic images/data. The "ground truth" for these tests is defined by the technical specifications and performance requirements of the device, assessed through quantitative measurements and established protocols.

4. Adjudication Method for the Test Set

This information is not applicable for the bench and biocompatibility tests described. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "A clinical study was not required as appropriate verification and validation of the modified Device Positioning Unit (DPU) was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing." Therefore, there is no effect size for human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device described is a physical medical device (microcoil delivery system), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the performance verification testing, the ground truth is established by engineering specifications, direct physical measurements, and adherence to established industry standards and regulatory guidance documents (e.g., ISO, FDA Guidance Document: "Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices").
For biocompatibility testing, the ground truth is defined by established international standards (ISO 10993 series) and USP (United States Pharmacopeia) guidelines for biological response within acceptable limits.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above; there is no training set for a physical device.

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