(144 days)
Boston Scientific's 0.018 and 0.035 Fibered Platinum Coils are intended for arterial and venous embolizations in the peripheral vasculature.
Boston Scientific's 0.018 Fibered Platinum Coils consist of platinum-tungsten alloy coils with synthetic fibers and are available in six different shapes; Vortx, Vortx Diamond, Complex Helical, Figure-8, Multi-Loop and Straight. The coil is provided with an introducer that is secured at both ends by a retaining clip during shipping and storage. The coil plunger, supplied with the coil, is used to push the coil out of the introducer and into the microcatheter.
Boston Scientific VortX-35 and 2D Helical-35 Fibered Platinum Coils are helically-shaped platinum-tungstent alloy coils with synthetic fibers. The coils are provided with an introducer that is secured at both ends by a retaining clip during shipping and storage. A coil plunger, supplied with the coil, is used to push the coil out of the introducer and into the catheter.
The provided text is a 510(k) summary for Boston Scientific's Fibered Platinum Coils, specifically related to modifications for MRI compatibility. It details regulatory information, device descriptions, and non-clinical testing for MRI safety. However, the document does NOT contain information about acceptance criteria or a study proving that the device meets specific performance criteria for its primary function (embolization effectiveness).
The "Non-Clinical and Clinical Test Summary" section exclusively discusses MRI compatibility testing.
Therefore, based on the provided text, I cannot complete the requested information regarding acceptance criteria and a study proving the device meets those criteria for its primary function.
Here's a breakdown of what can be extracted concerning the MRI compatibility testing, and what cannot be derived from the document for the other requested points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (MRI Compatibility) | Reported Device Performance (MRI Compatibility) |
|---|---|
| No additional risk during MRI procedure compared to gravitational, normal daily activities, or feverish conditions. | Non-clinical testing demonstrates that coils will not present additional risk during an MRI procedure in comparison to risks imposed by gravitational, and other normal daily activities, or a temperature rise that is experienced during a feverish condition. |
| MR Conditional for 1.5 Tesla or 3.0 Tesla static magnetic fields in normal operating mode. | Coils are MR Conditional and can be scanned safely under a static magnetic field of 1.5 Tesla or 3.0 Tesla in normal operating mode. |
| MR Conditional for a static magnetic field gradient less than 25 T/m. | Coils are MR Conditional and can be scanned safely in a static magnetic field gradient less than 25 T/m. |
| (Implicit) Compliance with ASTM standards for MRI safety. | Testing conducted under methods described by ASTM F2182-09, ASTM F2052-06e1, ASTM F2213-06, and ASTM F2119-07. |
Missing Information/Cannot Answer based on the provided text for the following points as they relate to the primary function of the embolization device:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No information on test set sample sizes or provenance for the embolization function. The MRI testing is non-clinical (in-vitro).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for the non-clinical MRI testing. No information for the embolization function.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the non-clinical MRI testing. No information for the embolization function.
- 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: This is a physical medical device (embolization coils), not an AI/imaging diagnostic device. Therefore, an MRMC study is not relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For MRI compatibility, the "ground truth" is defined by the physical properties measured according to the ASTM standards. For the embolization function, this information is not provided.
- The sample size for the training set: Not applicable as this is a physical medical device. There is no "training set" in the context of an algorithmic device.
- How the ground truth for the training set was established: Not applicable.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).