(90 days)
The TRUFILL® DCS Detachable Coil System is intended for embolizing certain 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: very high risk for management by traditional operative techniques, or, a) b) inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL® DCS Detachable Coil System is also intended for arterial and venous embolizations in the peripheral vasculature. The TRUFILL® DCS Detachable Syringe is indicated for use with the TRUFILL® DCS TRUFILL® DCS Syringe Intended Detachable Coil. Use
The TRUFILL® DCS Detachable Coil System is comprised of the TRUFILL® DCS Detachable Coil and TRUFILL® DCS Syringe.
- The TRUFILL® DCS Detachable Coil consists of a delivery system (delivery tube and . coil introducer) and an embolic coil. The delivery tube is comprised of a hub, a strain relief, a stiff proximal section, and a floppy distal section. The coil introducer is a tube designed to protect the detachable embolic coil in the packaging dispenser and provide support for introducing the embolic coil into the microcatheter. The embolic coil is the implantable segment of the device. It is comprised of a vasocclusion coil wound from a platinum alloy wire (92% Platinum / 8% Tungsten) into a primary coil and then formed into a secondary helical or complex shape.
- The TRUFILL®DCS Syringe consists of a 25-cc barrel with a pressure gauge, a threaded . plunger assembly with a locking wing mechanism, and a flexible high-pressure extension tube with a male luer connector.
The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device (TRUFILL® DCS Detachable Coil System). It focuses on demonstrating substantial equivalence to a predicate device rather than establishing novel acceptance criteria or presenting a standalone study for the device's performance against specific metrics.
Therefore, many of the requested sections about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment are not present in this document.
Here's a breakdown of what can be extracted and what is not available based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in terms of numerical acceptance criteria or performance metrics. The document instead focuses on comparative characteristics and "comparable safety and effectiveness" to a 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)
This information is not provided. The document broadly mentions "clinical testing" but does not detail the size or nature of the test set, nor its provenance or study design (retrospective/prospective).
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 provided. The concept of "ground truth" establishment by experts for a test set is not discussed in the context of this 510(k) summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are not discussed.
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 study is not mentioned and is not relevant for this type of device (an embolization coil, not an AI diagnostic tool).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not explicitly stated as the framework of "ground truth" against specific criteria is not detailed. The study's "clinical testing" likely refers to patient outcomes or clinical observations, but specifics are missing.
8. The sample size for the training set
This information is not provided. A "training set" in the context of machine learning is not applicable here. While there were "animal studies" and "in-vitro" testing, their sample sizes are not specified.
9. How the ground truth for the training set was established
This information is not applicable/provided. The concept of "ground truth for a training set" is for AI models, not for a physical medical device's testing directly.
Summary of Study and Device Performance (Based on provided text):
The study described is a comparative study aiming to demonstrate "substantial equivalence" of the TRUFILL® DCS Detachable Coil System to a predicate device, Target's Guglielmi Detachable Coil (GDC).
Acceptance Criteria (Implied by Substantial Equivalence):
The acceptance criteria are implicitly that the TRUFILL® DCS Detachable Coil System performs as safely and effectively as the predicate device (Target's GDC) across various characteristics and biological interactions. This is assessed through:
- Comparative Characteristics: Matching or being comparable in design, materials, and functional aspects to the predicate device.
- Non-Clinical Performance Data: Showing acceptable performance in in-vitro and animal tests.
- Clinical Data: Demonstrating comparable safety and effectiveness in human use.
Table of Performance (Based on Comparative Characteristics):
| Characteristics | Cordis Neurovascular, Inc. TRUFILL® DCS Detachable Coil and TRUFILL® DCS Syringe | Target's Guglielmi Detachable Coil GDC | Notes |
|---|---|---|---|
| Anatomical Sites | Peripheral and Neurovasculature | Peripheral and Neurovasculature | Performance/Equivalence: Identical |
| Intended Use | Aneurysms, AVMs, AVFs, Long-Term Use | Aneurysms, AVMs, AVFs, Long-Term Use | Performance/Equivalence: Identical |
| Method of Coil Attachment | Mechanical Elastomeric Press Fit | Gold/Tin Solder Joint | Performance/Equivalence: Different method, but implicitly considered equivalent in function. |
| Method of Coil Detachment | Hydraulically expandable gripper material | Electrolytically dissolvable solder joint | Performance/Equivalence: Different method, but implicitly considered equivalent in function. |
| Detachment Feedback | Pressure Gauge with detachment indicator | Voltmeter and ammeter with LED detachment indicator | Performance/Equivalence: Different feedback mechanisms, but implicitly considered equivalent in providing necessary feedback for detachment. |
| Coil Shape Configurations | Helical and Complex | Helical | Performance/Equivalence: TRUFILL® offers "Complex" in addition to "Helical," which is broadening the options but is not presented as a performance inferiority. |
| Coil Wire Outer Diameter (in) | 0.0015-0.004 | 0.00175-0.004 | Performance/Equivalence: Very similar range, with TRUFILL® covering a slightly smaller minimum. |
| Primary Coil Diameter (in) | 0.010-0.016 | 0.0095-0.015 | Performance/Equivalence: Very similar range, with TRUFILL® covering a slightly larger maximum and GDC a slightly smaller minimum. |
| Secondary Coil Diameter (mm) | 2 - 20 | 2 - 20 | Performance/Equivalence: Identical range. |
| Coil Length (cm) | 2 - 30 | 2 - 30 | Performance/Equivalence: Identical range. |
| Coil Material | Platinum/Tungsten | Platinum/Tungsten | Performance/Equivalence: Identical. |
| Delivery System Usable Length (cm) | 155-210 | 175 - 195 | Performance/Equivalence: TRUFILL® offers a broader range of usable lengths. |
| Delivery System Body Design | Microcatheter design | Guidewire design | Performance/Equivalence: Different designs, but implicitly considered equivalent in delivering the coil. |
| Radiopaque Marker Bands | Platinum/Tungsten coils, Window design | Platinum/Tungsten coil with Gold/Tin solder attachment joints. T design | Performance/Equivalence: Different designs and materials for attachment, but implicitly considered equivalent in providing radiopacity for visualization. |
The Study:
The study proving the device meets the acceptance criteria (of substantial equivalence) consisted of:
- In-vitro testing:
- Embolic coil radiopacity
- Markerband radiopacity
- Embolic coil softness
- Force exerted on the wall of a simulated aneurysm
- Force required to push the device through a microcatheter
- Migration in a simulated worst-case fistula model
- Distal tip softness
- Distal tip angular displacement
- Animal studies
- Biocompatibility tests
- Clinical testing: Demonstrated "comparable safety and effectiveness to the predicate device."
Conclusion: Results of in-vitro, animal, and clinical testing demonstrated that the TRUFILL® DCS Detachable Coil System is substantially equivalent to the predicate device, Target's GDC.
§ 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).