(171 days)
The Surgica Corporation MicroStat™ PVA Foam Embolization Particles are intended for the following indication: 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 (AVMs) and neoplastic lesions when presurgical devascularization is desirable.
Surgica Corporation MicroStat™ Polyvinyl Alcohol (PVA) foam cmbolization particles are artificial embolization devices used to obstruct or reduce the blood flow to hypervascular or neoplastic lesions via superselective catheter delivery. The embolization particles are supplied in various size ranges to enable appropriate size selection for the lesion to be treated. Polyviny) Alcohol (PVA) foam embolization particles are designed to be delivered under fluoroscopic guidance through compatible infusion catheters. The product is delivered sterilized with radiation, is nonpyrogenic, and is for single use only.
The provided document is a 510(k) summary for the Surgica Corporation MicroStat™ Polyvinyl Alcohol (PVA) Foam Embolization Particles. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies with specific acceptance criteria or performance metrics in the way AI/ML devices might.
Therefore, the document explicitly states: "Clinical Tests: None". This means there was no study conducted in the typical sense for this submission to "prove the device meets acceptance criteria." Instead, the acceptance is based on demonstrating similarity to an already approved device.
Given this, a direct answer to your request regarding acceptance criteria and a study to prove they are met cannot be fully provided from the given document as it would for a performance-based medical device claim. However, I can infer and frame the information within the constructs you've provided, addressing the aspects that are relevant and noting where information is not available due to the nature of the submission.
Here's a breakdown based on your requested information, making clear what is present and what is absent:
Acceptance Criteria and Device Performance (Derived from Equivalence):
As no clinical tests were performed, there are no specific quantitative "acceptance criteria" and "reported device performance" in terms of clinical outcomes or diagnostic accuracy from a study described in this document. The "acceptance" for this 510(k) relies on demonstrating substantial equivalence to the predicate device.
| Acceptance Criterion (Inferent from Equivalence to Predicate) | Reported Device Performance (Inherited/Assumed from Predicate) |
|---|---|
| Safety: Device is non-pyrogenic, sterilized, and for single use. | Similar safety profile to the predicate EMB™ PVA Foam Embolization Particle devices (K001678). No adverse events reported for the new device. |
| Basic Design & Construction: Similar material (PVA foam), form (embolization particles), and delivery mechanism (superselective catheter delivery with fluoroscopic guidance). | Basic design and construction are similar to the predicate. |
| Intended Use: Vascular occlusion of blood vessels in neurovascular systems for AVMs and neoplastic lesions, for presurgical devascularization. | Performs similarly to the predicate for the stated vascular occlusion and embolization purposes. |
| Performance Characteristics: Obstructs or reduces blood flow to hypervascular or neoplastic lesions. Provided in various size ranges for selection. | Similar performance characteristics to the predicate device in terms of embolization efficacy. |
Study Information (Based on the provided document):
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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):
- Not Applicable. No clinical test set or study was conducted for this 510(k) submission. Therefore, there's no data provenance information.
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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):
- Not Applicable. No ground truth establishment was described as no clinical study was performed. The ground truth for the predicate device's approval would have been established at that time, but not for this specific 510(k).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or study, hence no adjudication method.
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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:
- Not Applicable. This device is a physical medical implant (PVA foam embolization particles), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or AI assistance is relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or software device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable (for this submission). For the approval of this device, the "ground truth" was essentially the established safety and effectiveness of the predicate device (EMB™ PVA Foam Embolization Particle devices, K001678) demonstrated through its previous approval.
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The sample size for the training set:
- Not Applicable. No AI/ML model or training set is involved.
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How the ground truth for the training set was established:
- Not Applicable. No AI/ML model or training set is involved.
Summary of the K032619 Submission:
The approval of the Surgica Corporation MicroStat™ Polyvinyl Alcohol Fourn Embolizaion Particles (K032619) was based on demonstrating substantial equivalence to an existing predicate device (EMB™ PVA Foam Embolization Particle devices, K001678). This means the new device shares similar basic design, construction, intended use, and performance characteristics with the predicate. Because of this, no new clinical studies or tests were required or performed to establish "acceptance criteria" or "device performance" for this specific submission. The safety and effectiveness are inferred from the predicate's prior approval.
§ 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).