(87 days)
TRUFILL PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations and neoplastic lesions when presurgical devascularization is desirable.
TRUFILL PVA particles
Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study details.
Based solely on the provided text, the device is not an AI/ML medical device and therefore the requested information regarding acceptance criteria and studies to prove device performance is not present in the format you're looking for. This document describes a traditional medical device (particulate embolization) submission.
Therefore, many of your requested fields related to AI/ML device validation will be "N/A" or indicate that the information is not provided because it's not relevant to this type of submission.
Analysis of K965174: Cordis Endovascular Systems, Inc. Trufill PVA Particles Modification
This 510(k) submission is for a "modification" to an existing device, TruFill™ PVA Particles, and refers to predicate devices. The focus of the submission is on substantial equivalence, biocompatibility, and intended use for vascular occlusion. It does not involve any AI/ML components.
- A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated for this type of device) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet established standards for medical devices (implied by "All appropriate biocompatibility tests were successfully performed"). | "All appropriate biocompatibility tests were successfully performed on the TruFill PVA Particles." |
| Design/Construction/Indications/Performance: Similar to predicate devices to establish substantial equivalence. | "The TruFill PVA are similar in their basic design, construction, indication for use and performance characteristics to other commercially available poly vinyl alcohol particles." |
| Material: Polyvinyl Alcohol (PVA) | Implied (Device name is "TruFill™ PVA Particles") |
| Intended Use: Vascular occlusion within the neurovascular systems for AVMs and neoplastic lesions. | Stated "TRUFILL PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations and neoplastic lesions when presurgical devascularization is desirable." |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This 510(k) summary does not describe a clinical study in the sense of patient data or algorithm performance. The primary "testing" mentioned is biocompatibility. For biocompatibility, testing is typically performed on device materials or extracted components rather than human clinical samples, and therefore "sample size for the test set" is not relevant in the context of diagnostic accuracy.
- Data provenance for biocompatibility testing is usually laboratory-based, not patient-based.
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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)
- N/A. Not applicable as this is not an AI/ML diagnostic or prognostic device requiring expert ground truth for image interpretation or similar tasks.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable.
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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
- N/A. Not applicable. This device is not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. Not applicable. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility tests, "ground truth" would be established by validated analytical methods and adherence to ISO standards (e.g., ISO 10993 series).
- For substantial equivalence, the "ground truth" is the performance and safety profile of the predicate devices.
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The sample size for the training set
- N/A. Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established
- N/A. Not applicable.
§ 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).