(84 days)
QuadraSphere Microspheres are indication of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.
QuadraSphere Microspheres are sterile, biocompatible, hydrophilic, nonresorbable, expandable, acrylic copolymer microspheres. QuadraSphere Microspheres are in vials containing 25 mg of dry microspheres. The expansion rate is dependent on ionic concentration. When in contact with blood, non-ionic contrast media, or normal saline (NaCl 0.9%), QuadraSphere Microspheres expand to approximately 4 times their dry state diameter; equal to 64x volume. They are available in a range of sizes: 30-60 um, 50-100 um, 100-150 um, and 150-200 um. QuadraSphere Microspheres have the following properties: Spherical shape with consistent cross sectional diameter after reconstitution with aqueous-based solutions such as contrast media and 0.9% saline solution for predictable flow directed level of occlusion in the vasculature. Rapidly absorb contrast media and 0.9% saline solution. Conform to vessel lumen, providing more surface contact with vessel intima. Expand up to four times the stated dry diameter when hydrated with non-ionic aqueous solutions, resulting in an increase in surface area contact for a more complete vessel occlusion. The principles of operation for the QuadraSphere Microspheres are the same as the predicate devices K052742 (50-100um, 100-150um and 150-200μm) and K113822 (30-60μm). QuadraSphere Microspheres are permanent implantable devices and are designed for controlled, targeted embolization. The device is provided dry (in a vial) and must be rehydrated before use. The microspheres are injected into the target vessel with an intravascular catheter(s) to selectively occlude blood vessels. Contrast enhancement using commercially available ionic or non-ionic contrast media allows the embolization procedure to be monitored using fluoroscopy. The embolization agents are intended for single use and are provided sterile.
This document is a 510(k) Premarket Notification from BioSphere Medical S.A. for their QuadraSphere Microspheres. It states that the subject device is substantially equivalent to previously cleared predicate devices, K052742 and K113822, with the only change being an update to the indications for use. Therefore, the information provided focuses on the substantial equivalence of the device's technical characteristics and performance to its predicates, rather than presenting a de novo study with acceptance criteria and device performance for a new, unproven device.
Given that this is a 510(k) submission for substantial equivalence based on identical technological characteristics to the predicate devices, a traditional AI/medical device study with specified acceptance criteria and detailed performance reporting (as might be found for a novel AI algorithm) is not present in this document. The document explicitly states: "No new testing was performed since both predicate devices... and the QuadraSphere Microspheres have identical technological subject characteristics, manufacturing, processing and sterilization."
However, I can extract the information related to the device's fundamental attributes and the studies performed on the predicate devices that establish the overall safety and performance.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for substantial equivalence with identical technological characteristics, no new acceptance criteria or reported device performance are provided for the subject device. Instead, the document refers to studies performed on the predicate devices to demonstrate substantial equivalence. The "acceptance criteria" are effectively that the new device is identical to the predicates.
| Attribute | Predicate Device Performance (Applicable to Subject Device) |
|---|---|
| Shelf Life | Three years (36 months) |
| Material | PVA Acrylic Copolymer (vinyl alcohol-sodium acrylate) |
| Physical Characteristics | Biocompatible, hydrophilic, non-resorbable, expandable, conformable, and swell upon exposure to aqueous solutions |
| Sterilization | Radiation Sterilized |
| Performance | Designed for controlled, targeted embolization when vessel conformity is desired |
| Volume of Microspheres in Vial (dry) | 25 mgs per vial |
| Biocompatibility | In accordance with ISO 10993-1:2009 for permanent implants in contact with blood |
| Other Non-Clinical Tests | Chemical analysis, Size range, Catheter compatibility, Density, Packaging performance, Shelf Life, Sterility Safety |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe specific "test sets" for a new study, but rather relies on the equivalency to previously cleared devices. Therefore, these details are not available in this filing. The previous studies on the predicate devices would have encompassed these aspects.
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)
This information is not provided in this 510(k) submission as it relies on substantial equivalence to predicate devices, not on a new, independent clinical study requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this document does not describe a new test set or clinical study requiring adjudication.
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 is a medical device (microspheres for embolization), not an AI-based diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the predicate devices, safety and performance would have been established through a combination of:
- Physical and Chemical Testing: Evaluating material composition, size, sterility, expansion characteristics.
- Biocompatibility Studies: In vitro and in vivo tests based on ISO 10993-1:2009 (as mentioned).
- Pre-clinical Animal Studies: To assess embolization effectiveness and safety in biological systems.
- Clinical Data (if available for predicates): Though not explicitly detailed here, general clinical outcomes for embolization procedures would inform the understanding of safe and effective use.
The document implicitly uses the "ground truth" established by the prior clearance of the predicate devices, meaning their safety and effectiveness were already demonstrated.
8. The sample size for the training set
Not applicable. This document is for a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This document is for a physical medical device, not an AI model.
§ 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).