Search Results

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.

Ask a specific question about this device

The intended use of the TRUFILL® Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) is as follows:

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 TRUPUSH® Coil Pusher is used in coil embolization procedures in both the neuro and peripheral vascular systems. An embolic coil is loaded into the proximal end of a compatible microcatheter and the Coil Pusher is used to advance the device through the catheter lumen until it has exited the distal tip of the catheter.

This document describes the 510(k) premarket notification for the TRUPUSH® Coil Pusher, a component of the TRUFILL® Vascular Occlusion System. The submission aims to demonstrate substantial equivalence to a predicate device, focusing on process changes, packaging changes, and manufacturing site transfer.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly detailed with quantitative targets in the provided document. Instead, the "Design Verification Testing" and "Design Validation Testing" sections list the types of tests performed. The implication is that the device met the inherent acceptance criteria for each test to support substantial equivalence. Without specific numerical thresholds, we can only infer that the performance was deemed acceptable for regulatory clearance.

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

The document does not explicitly state the sample sizes used for each of the "Design Verification Testing" or "Design Validation Testing" items. It also does not specify the provenance of the data (e.g., country of origin).

The document mentions "in-vitro and in-vivo testing." In-vitro testing typically refers to tests conducted in a controlled environment, such as a lab bench, using bench models or simulators. In-vivo testing often involves animal models or human subjects. Given the context of a 510(k) for a device like a coil pusher, in-vivo testing likely refers to animal studies to simulate real-world use conditions, as human clinical trials are typically not required for 510(k) unless there are significant performance or safety questions not addressed by bench testing or animal studies. The text does not specify sample sizes or details of these studies.

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

This information is not applicable and not provided in the document. The studies conducted are engineering and performance tests (e.g., dimensional measurements, mechanical strength, pushability, retractability, package integrity), not diagnostic or interpretative tasks requiring human expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. The tests described are objective engineering and performance measurements, not subjective evaluations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or algorithms where human readers interpret medical images, and the AI's impact on their performance is assessed. The TRUPUSH® Coil Pusher is a physical medical device, not an AI or diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone study (in the context of an algorithm's performance) was not done. The device is a physical medical instrument, not an algorithm. The "standalone" performance here refers to the physical device's function as designed, which is what the design verification and validation tests aim to assess.

7. Type of Ground Truth Used

The "ground truth" for the tests described are engineering specifications, measurement standards, and functional performance requirements for mechanical and material properties, as well as operational characteristics like pushability and retractability. For example, the ground truth for "Total Product Length" would be the engineering drawing's specified length with its permissible tolerance range. The ground truth for "Seal Integrity Test (Dye Penetration)" would be the absence of dye penetration under specified conditions.

8. Sample Size for the Training Set

This information is not applicable. The TRUPUSH® Coil Pusher is a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable, as there is no training set for a machine learning model.

Ask a specific question about this device

The Cordis Endovascular Systems, Inc. Vascular Occlusion System may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.

The Vascular Occlusion System consists of straight and shaped TRUFILL Pushable Coils (made from platinum allow and synthetic fibers) and the TRUPUSH Coil Pusher (with 1 or 2 radiopaque markers). The pushable coils are designed for use under fluoroscopy with microcatheters having a minimum 0.21" inner diameter.

This document, K983483, is a 510(k) premarket notification for the Cordis Endovascular Systems, Inc. Vascular Occlusion System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not applicable or not provided in this type of regulatory document. 510(k) submissions primarily rely on comparison to previously cleared devices.

Here's a breakdown of what is and is not present based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Not applicable / Not provided. This document does not describe a clinical or performance study with a "test set" in the context of an algorithm or device performance study. The "testing" referred to is biocompatibility, which typically involves laboratory assays, not human subject data sets in the way implied by the question. The substantial equivalence argument relies on comparison to existing devices, not a new performance study.

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

• Not applicable / Not provided. As no "test set" for performance evaluation is described, there's no mention of experts establishing ground truth for such a set.
  • The "experts" involved are the FDA reviewers and the manufacturer's regulatory affairs personnel.

4. Adjudication Method for the Test Set:

• Not applicable / Not provided. No test set requiring adjudication in the context of performance metrics is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC study was not done or described in this 510(k) premarket notification. These studies are typically for evaluating the impact of AI on human reader performance, which is not the focus of this device (a physical embolization coil system).

6. Standalone (Algorithm Only) Performance Study:

• No. This is a physical medical device (embolization coils), not an algorithm or software device. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

• Not applicable / Not provided directly. For biocompatibility, the "ground truth" would be the established safety profiles and recognized standards for biological compatibility. For substantial equivalence, the "ground truth" is the established regulatory clearance and safety/effectiveness of the predicate devices. There's no clinical "ground truth" (e.g., pathology, outcomes data) presented from a de novo study.

8. Sample Size for the Training Set:

• Not applicable / Not provided. This is not an AI/ML device where a "training set" would be used.

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

• Not applicable / Not provided. As this is not an AI/ML device, there's no training set or ground truth establishment for such a set.

In summary: This 510(k) submission primarily focuses on demonstrating that the "Vascular Occlusion System" is "substantially equivalent" to predicate devices already on the market, as opposed to presenting novel clinical study data against defined acceptance criteria. The only performance detail provided is the successful completion of biocompatibility testing.

Ask a specific question about this device