(122 days)
Target Detachable Coils are intended for use in the treatment of intracranial aneurysms and other neuro and peripheral vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Target Coils are indicated for endovascular embolization of:
• Intracranial aneurysms
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• Arterial and venous embolizations in the peripheral vasculature
Boston Scientific's InZone Detachment System is intended for use with all Boston Scientific Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.
Boston Scientific Corporation's Target Detachable Coils are comprised of four coil types: Target Coil 360 STANDARD, Target Coil 360 SOFT, Target Coil 360 ULTRA and Target Coil HELICAL ULTRA. All Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with Boston Scientific's InZone™ Detachment System (sold separately).
Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coil 360 STANDARD, Target Coil 360 SOFT and Target Coil 360 ULTRA coils the distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil to facilitate placement of the coil. The diameter of the distal loop is 75% that of the rest of the main coil loops.
Boston Scientific's InZone Detachment System is intended for use with all Boston Scientific Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.
The provided text describes Boston Scientific Corporation's Target Detachable Coils and InZone Detachment System. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, specific device performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods is not present in the provided document.
However, based on the available information, here's what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or detailed performance metrics. Instead, it states that "Verification testing has demonstrated Target Detachable Coils are substantially equivalent to the current legally marketed predicate devices" and similarly for the InZone Detachment System, electrical safety testing "has demonstrated the devices to be substantially equivalent to the current legally marketed predicate device."
The "performance" reported is that the devices are substantially equivalent to their respective predicate devices. This implies that their performance, in terms of safety and effectiveness for their intended use, is considered comparable to already approved devices.
2. Sample Sizes Used for the Test Set and Data Provenance:
The document states "Verification testing has demonstrated..." and "Verification testing of the InZone Detachment System, including electrical safety testing in accordance with applicable parts of the EN 60601-series of standards, has demonstrated..."
This indicates that pre-clinical verification testing was performed. However, specific sample sizes for these tests are not provided. The data provenance is also not specified, but given this is pre-clinical bench and electrical safety testing, it would largely be laboratory-generated data, not human patient data in the context of geographical origin or retrospective/prospective nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided and is generally not applicable to a 510(k) submission for this type of device, which relies heavily on bench testing and comparison to predicate devices, rather than human expert evaluation of clinical cases or images.
4. Adjudication Method for the Test Set:
This information is not provided and is not applicable in the context of the reported verification testing.
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:
This is not applicable. The device (embolization coils and their detachment system) is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device.
7. The Type of Ground Truth Used:
For the "verification testing," the ground truth implicitly used would be established engineering specifications, performance standards (like EN 60601 for electrical safety), and the known characteristics/performance of the predicate devices. For example, if testing tensile strength, the "ground truth" would be the specified strength range for safe performance.
8. The Sample Size for the Training Set:
This information is not provided and is not applicable as this is a physical medical device and not an AI/machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not provided and is not applicable for the same reason as point 8.
§ 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).