(126 days)
Bearing ™ nsPVA Embolization Particles are used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs). Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.
The Bearing™ nsPVA Embolization Particles are particles of They are noncross-linked polyvinyl alcohol (PVA). resorbable (permanent), hydrophilic and deformable particles that can be injected through a variety of catheters, depending on the size range, and are generally mixed with radiopaque contrast agent prior to their injection.
The provided text describes Merit Medical Systems, Inc.'s Bearing™ nsPVA Embolization Particles and their substantial equivalence to a predicate device, Boston Scientific's Contour™ Embolization Particles. The submission centers around demonstrating that the new device has characteristics that are substantially equivalent to a device already on the market, rather than proving performance against specific acceptance criteria through a full-scale clinical study with a detailed test set, ground truth, and statistical analysis as would be done for novel devices or AI systems.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or explicitly stated in the context of this 510(k) summary, which relies on the concept of "substantial equivalence."
Here's an attempt to extract and interpret the information based on the provided document, addressing each point as much as possible:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of "acceptance criteria" for clinical performance with specific metrics like sensitivity, specificity, or accuracy that would be typical for an AI/diagnostic device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to an existing predicate device based on various non-clinical tests and a literature review.
The "reported device performance" is essentially that the Bearing™ nsPVA Embolization Particles perform equivalently to the predicate device, Contour™ Embolization Particles, in achieving vascular occlusion for the indicated uses.
Here's a summary of the types of performance aspects assessed:
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Material Composition (Same chemical formula, structure, process materials, cross-linking) | Chemical Analysis: Subject and predicate devices are characterized as having the same chemical formula (polyvinyl alcohol), chemical structure, residual process materials, and degree of cross-linking. |
| Mechanical & Physical Properties (Ability to allow embolization to desired location via catheters, occlusion mechanism) | Demonstrated through various tests: |
- Polyvinyl Alcohol (PVA) Particle Testing
- Particle Size Ranges (granulometry)
- Assessment of Particle Size Compatibility with Recommended Delivery Catheter(s)
- Evaluation of the Uniform Dispersion and Suspension of Particles within a Catheter.
The principle of operation is stated as the same. |
| Intended Use (Embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral AVMs) | Same indications for use as the predicate device. |
| Safety & Biocompatibility (Non-toxic, non-pyrogenic, sterile, no adverse biological reactions) | Biocompatibility: Conforms to ISO 10993 standards (e.g., cytotoxicity, irritation, sensitization, systemic toxicity, implantation effects).
Sterilization: Conforms to ISO and NF EN standards for sterility assurance (SAL 10-6).
Endotoxins: Tested on each batch, limit per device 20 EU, labeled nonpyrogenic. |
| Shelf Life & Packaging (Maintains integrity and sterility over time) | Packaging Performance: Visual inspection, bubble emission, peel strength, sterile barrier maintenance after simulated transportation/storage.
Accelerated Aging: Product (visual inspection, granulometric, residual formaldehyde, IR analysis) and Primary Packaging (visual inspection, seal width, label inspection, burst test, seal strength test). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the traditional sense of a clinical trial test set. The validation was primarily based on non-clinical bench testing and a literature review.
- Data Provenance: The literature review analyzed existing clinical data on PVA particles. The document does not specify the country of origin of this data but refers to "medical/scientific databases, PubMed, and Cochrane Database of Systematic Reviews (CDSR)." This implies a broad, international scope of retrospective clinical evidence.
3. 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. There was no specific "test set" requiring expert ground truth establishment for this 510(k) submission, as it relied on non-clinical testing and a review of existing clinical literature for similar devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was performed.
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
Not applicable. This device is an embolization particle, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an embolization particle, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the literature review, the "ground truth" would be the clinical outcomes and safety profiles reported in previously conducted clinical trials and applications of similar PVA embolic devices. The document states that "the absence of materovigilance reports concerning similar PVA embolic devices are sufficient to establish the efficacy and safety." This points towards real-world outcomes data and safety surveillance as the basis.
For the non-clinical tests, the "ground truth" was established by standard laboratory testing methods (e.g., chemical analysis, granulometry, biocompatibility assays) comparing the subject device's properties to established norms or the predicate device's characteristics.
8. The sample size for the training set
Not applicable. This device is an embolization particle, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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).