(41 days)
The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.
The TRUFILL® DCS Syringe II consists of a 14-cc barrel with a pressure gauge, a threaded plunger assembly with a locking mechanism, and a flexible high-pressure extension tube with a male luer connector. The gauge faceplate is calibrated for use with the TRUFILL DCS ORBIT™ Detachable Coil and the TRUFILL® DCS Detachable Coil; i.e., the TRUFILL® family of Detachable Coils. The TRUFILL® DCS Syringe II is used to generate controllable pressure for preparation and coil detachment of the TRUFILL™ family of Detachable Coils.
The provided document describes the TRUFILL® DCS Syringe II, an artificial embolization device, and its substantial equivalence to a predicate device. The information details the performance and safety testing, as well as design validation, conducted to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Performance and Safety Testing" and "Design Validation Testing" conducted. The reported device performance is that these tests were conducted and the device performed as intended and met specifications.
| Acceptance Criteria (Implied from Test Titles) | Reported Device Performance |
|---|---|
| Gauge Accuracy and Pressure Cycling Accuracy | Testing conducted; device performs as intended |
| Luer Lock Connector Dimensional Verification adherence | Testing conducted; device performs as intended |
| Chemical Compatibility | Testing conducted; device performs as intended |
| Joint Pull Strength | Testing conducted; device performs as intended |
| Device Integrity | Testing conducted; device performs as intended |
| Torque Functionality | Testing conducted; device performs as intended |
| Device Flush Particulate Levels | Testing conducted; device performs as intended |
| Biocompatibility | Testing conducted; device performs as intended |
| Syringe Packaging Integrity | Testing conducted; device specifications conform to user needs |
| Purge and Detachment of TRUFILL® DCS Detachable Coils Functionality | Testing conducted; device specifications conform to user needs |
| Purge and Detachment of TRUFILL DCS ORBIT™ Detachable Coils Functionality | Testing conducted; device specifications conform to user needs |
| Syringe Integrity | Testing conducted; device specifications conform to user needs |
| Ability to Pressurize Syringe | Testing conducted; device specifications conform to user needs |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each specific test or the data provenance (e.g., country of origin of the data, retrospective or prospective). It generally states that "in-vitro laboratory performance testing" and "in-vitro testing" were conducted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies described are in-vitro laboratory tests, which typically rely on measurement instruments and adherence to technical specifications rather than human expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and is not provided. Given the nature of in-vitro engineering and performance testing, there's no mention of human adjudication methods like 2+1 or 3+1.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The studies described are in-vitro performance and design validation tests of the device itself, not studies comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device is a physical medical instrument (a syringe) used to manipulate medical coils. It does not involve an "algorithm" or "AI" in the context of image analysis or diagnostic support. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The tests performed are standalone in the sense that they assess the device's technical specifications and functionality independent of a human operator, but it's not an AI or algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the in-vitro tests would have been established by engineering specifications, validated measurement techniques, and established industry standards for device performance, material compatibility, and sterile processing. For example, gauge accuracy would be compared against a known standard, and dimensional verification against engineering drawings.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument, not an AI or machine learning algorithm 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 medical device like the TRUFILL® DCS Syringe II.
§ 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).