(529 days)
The DSB is intended for artificial embolization of symptomatic carotid cavernous fistulae in patients for whom, in the judgment of the neurosurgical management team, other medical or neurosurgical means would not be indicated.
The DSB consists of a silicone balloon which is inflated with contrast agent and detached via catheter at the desired site of embolization.
The provided document describes the FDA 510(k) submission for the Detachable Silicone Balloon (DSB) Artificial Embolization Device. The submission focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for AI/software devices. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth for an AI-like device is not applicable to this 1998 medical device submission.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device testing mentioned in the document is primarily bench testing and biocompatibility testing, not performance metrics based on clinical outcomes relevant to AI. Acceptance criteria are implied by successful completion of these tests to demonstrate safety and functional validity for its intended use and substantial equivalence to predicate devices. Specific quantitative acceptance criteria or reported device performance in a clinical context were not provided in detail.
| Criteria Category | Details from Document | Performance Demonstrated |
|---|---|---|
| Biocompatibility | Performed | Safe for intended use |
| Functional Bench Testing (implied acceptance: successful operation) | Cycle testing | Safe for intended use |
| Rupture testing | Safe for intended use | |
| Pressure volume testing | Safe for intended use | |
| Detachment force testing | Safe for intended use | |
| Inflation-deflation cycle rate testing | Safe for intended use | |
| Catheter insertion valve testing | Safe for intended use |
2. Sample Size for the Test Set and Data Provenance
Not applicable. The submission describes bench testing and biocompatibility testing, not a clinical study with a "test set" of patient data in the context of an AI device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study involving expert review of images or data for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI device, and no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's safety and effectiveness relies on successful completion of biocompatibility and functional bench tests, and the demonstration of substantial equivalence to existing predicate devices. This is a regulatory pathway, not a data-driven ground truth for an AI algorithm.
8. Sample Size for the Training Set
Not applicable. There is no AI model or "training set" for this physical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Relevant Information from the Document:
- Device Name: Detachable Silicone Balloon (DSB) Artificial Embolization Device
- Intended Use: Artificial embolization of symptomatic carotid cavernous fistulae in patients for whom other medical or neurosurgical means would not be indicated.
- Testing Performed:
- Biocompatibility testing
- Functional bench testing: cycle testing, rupture testing, pressure volume testing, detachment force testing, inflation-deflation cycle rate testing, and catheter insertion valve testing.
- Outcome of Testing: Demonstrated the device to be safe for its intended use.
- Regulatory Pathway: 510(k) premarket notification, where the primary focus is demonstrating substantial equivalence to legally marketed predicate devices.
- Predicate Devices:
- Target Therapeutics Detachable Platinum Coil (GDC)
- Target Therapeutics (ITC) Radiopaque Spherical Emboli (RSE)
- Target Therapeutics (ITC) Contour Emboli (CE)
- Target Therapeutics (ITC) Occlusion Balloon Catheter (mentioned conceptually, but not in the detailed comparison)
- Substantial Equivalence: Claimed based on equivalence/identity in intended use, materials, manufacturing, design parameters, method of delivery, and method of deployment to the predicate devices. The comparison chart specifically details similarities in general description, indications, device function, material (though DSB is silicone, GDC is platinum/tungsten, RSE is silicone, CE is Polyvinyl Alcohol), delivery, and deployment methods.
This document clearly outlines a 510(k) submission for a physical medical device, not a software or AI-driven device. Therefore, the questions tailored for AI/software performance studies do not directly apply.
§ 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).