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Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord and spine.

The TRUFILL DCS ORBIT Detachable Coil System is indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL DCS ORBIT Detachable Coil is also intended for arterial and venous embolization in the peripheral vasculature.

The intent of endovascular treatment using embolic microcoils is to pack the lumen of the aneurysm with the microcoil mass, thereby eliminating the influx of blood into the aneurysm. As blood flow is disrupted within the aneurysm, intraluminal thrombosis leads to exclusion of blood flow from the parent artery into the aneurysm. Blood flow in the parent artery is then secluded from the aneurysm and the weakened wall of the aneurysm is isolated from arterial pressures. Coil embolization may also be used to treat arteriovenous malformations and fistulas by packing coils into the lumen of the parent vessel feeding into the unwanted arteriovenous structure, resulting in cessation of blood flow. Stagnated blood within the arteriovenous malformation or fistula then thromboses, leading to involution and absorption of the aberrant vessels.

The TRUFILL Vascular Occlusion System:
The Vascular Occlusion System consists of the TRUFILL Pushable Coils and TRUPUSH Coil Pusher. The TRUFILL Pushable Coil is loaded into the proximal end of a compatible microcatheter and advanced through the catheter to the desired vessel location. The coil is deployed using the TRUPUSH Coil Pusher which is sold separately. The TRUFILL Pushable Coils are made from platinum/tungsten and synthetic fibers, and are designed for use under fluoroscopy with the TRUPUSH Coil Pusher and microcatheters having a minimum ,021" I.D. (0.5 mm). The TRUFILL Pushable coils are available in straight and shaped configurations.

The TRUFILL DCS ORBIT Detachable Coil System:
The TRUFILL DCS ORBIT Detachable Coil System consists of a delivery system (delivery tube and coil introducer) and an embolic coil. The embolic coil is the implantable segment of the device, and is comprised of a vasoocclusion coil wound from a platinum alloy wire into a primary coil and then formed into a secondary helical or complex shape. The embolic coil is detached from the delivery tube via a proprietary hydraulic release mechanism using the TRUFILL DCS Syringe II which is sold separately. The TRUFILL DCS ORBIT Detachable Coil System is designed for use under fluoroscopy with compatible infusion catheters, and is available in Standard and Fill configurations.

The provided 510(k) summary (K123560) describes the TRUFILL® Pushable Coils and TRUFILL® DCS ORBIT™ Detachable Coil System.

Acceptance Criteria and Device Performance:

The submission aimed to demonstrate substantial equivalence to previously cleared predicate devices. Since no new technological characteristics were introduced, the primary acceptance criteria revolved around demonstrating that the packaging modifications did not negatively impact the device's design, safety, operation, or performance.

Study Details:

The study described in this 510(k) summary is non-clinical testing, specifically bench testing, to demonstrate substantial equivalence for packaging modifications.

• Sample size used for the test set and the data provenance: The document does not specify the exact sample sizes for each bench test conducted (e.g., number of packages tested for dye leak). It only states that "Codman performed non-clinical testing necessary to demonstrate substantial equivalence to the predicate devices." The data provenance is internal testing performed by Codman & Shurtleff, Inc., as stated in section G. "Summary of Nonclinical Testing" and H. "Summary of Clinical Testing". Given the nature of bench testing, it is prospective for the specific tests performed to evaluate the modified packaging components.

• 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): Not applicable. This was bench testing of physical properties and packaging, not clinical interpretation requiring expert consensus.

• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This was bench testing of physical properties and packaging, not clinical interpretation.

• 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: No. This submission is for physical medical devices (catheters and coils) and does not involve AI or human reader interpretation.

• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This submission is for physical medical devices and does not involve algorithms.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this non-clinical testing was defined by established engineering and material science standards for device performance, packaging integrity, biocompatibility, and sterilization, as confirmed through the various bench tests listed.

• The sample size for the training set: Not applicable. This was non-clinical testing of physical products, not an AI or machine learning model that requires a training set.

• How the ground truth for the training set was established: Not applicable.

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