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510(k) Data Aggregation
(72 days)
QUADRASPHERE 30 TO 60
QuadraSphere Microspheres are indicated for embolization of hypervascularized tumors and peripheral arteriovenous malformations.
The QuadraSphere Microspheres are sterile, biocompatible, hydrophilic, non-resorbable, expandable, acrylic copolymer microspheres. QuadraSphere Microspheres size is: 30 to 60µm in containers (vials) containing 25 mg of dry microspheres, which can absorb aqueous media up to 64 times their dry state volume. 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.
The QuadraSphere Microspheres have the following properties:
- Retains 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 absorbs contrast media and 0.9% saline solution. The spheres are positively charged, which allows them to bond ionically with negatively charged aqueous based solutions.
- Compresses in the vessel lumen, providing more surface contact with vessel intima.
- Expands 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 device. 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 BioSphere Medical QuadraSphere® Microspheres 30 to 60µm is a medical device for embolization and is substantially equivalent to the predicate device, QuadraSphere Microspheres (K052742). The main difference is the additional size offering of 30 to 60µm.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly list specific quantitative "acceptance criteria" with numerical targets for the new 30-60µm size. Instead, the acceptance is based on demonstrating that the new size performs similarly to the predicate device and meets established design and performance specifications. The table below summarizes the key evaluations and their outcomes.
| Acceptance Criteria Category | Specific Evaluation/Parameter | Predicate Device Performance (K052742) | Subject Device Performance (30-60µm) | Result/Comment |
|---|---|---|---|---|
| Material & Physical Properties | Shelf Life (single use) | Three years (36 months) | Three years (36 months) | Met: Same shelf life. |
| Material Composition | PVA Acrylic Copolymer (vinyl alcohol-sodium acrylate) | PVA Acrylic Copolymer (vinyl alcohol-sodium acrylate) | Met: Same material composition. | |
| Physical Characteristics (Biocompatible, hydrophilic, deformable, non-resorbable, expandable, conformable, swells upon exposure to aqueous solutions) | Described as having these characteristics. | Described as having these characteristics. | Met: Same physical characteristics. The document states the new size also retains spherical shape, rapidly absorbs contrast/saline, compresses in vessel lumen, and expands up to four times its dry diameter. | |
| Sterilization Method | Radiation Sterilized | Radiation Sterilized | Met: Same sterilization method. | |
| Volume of Microspheres in Vial (dry) | 25 mgs per vial | 25 mgs per vial | Met: Same quantity per vial. | |
| Performance - In-Vitro | Granulometry (size distribution) | Within expected size ranges for 50-100µm, 100-150µm, 150-200 µm. | Within expected size range. | Met: In vitro granulometry of the 30-60µm microspheres demonstrated they were within the expected size range. |
| Swelling in Contrast Agent | Expands approximately 4 times dry size. | Expands approximately 4 times dry size. | Met: The document states "All of the QuadraSphere Microspheres react the same and expand approximately 4 times their dry size when properly reconstituted in saline." Testing for this was successful for the new size. | |
| Optical Inspection | (Assumed to meet specifications) | Met requirements. | Met: Optical Inspection successfully met requirements. | |
| Water Content (Microsphere) | (Assumed to meet specifications) | Met requirements. | Met: Water Content (Microsphere) successfully met requirements. | |
| Performance - In-Vivo | Safetgy (animal behavior, blood tests, histopathology) | (Assumed acceptable for predicate) | No significant adverse events post procedure. Hepatic artery embolization was "feasible and tolerated well both clinically and biologically." | Met: Safety was assessed from animal behavior, blood tests, and histopathological examination. No significant adverse events reported. |
| Location of Occlusion / Product Performance | Designed for controlled, targeted embolization when vessel conformity is desired (completely block the arterial lumen). | Mean occluded vessel diameter: 146 ± 46µm (median 136µm). Mean number of microspheres in occluded vessel section: 1.4 ± 0.8 (median 1.0). "Embolization was successful for all animals." | Met: The animal study confirmed successful embolization and vessel occlusion with the 30-60µm size. The findings were consistent with similar studies of histological response to embolic particles. | |
| Biocompatibility | Met ISO 10993-1 for permanent implants in contact with blood. | Adopted from predicate. | Met: Based on identical materials and processes, biocompatibility from the predicate device was adopted, demonstrating satisfaction of the requirement. |
2. Sample size used for the test set and the data provenance:
- Test Set Description: The primary test set mentioned for the 30-60µm device is an animal study.
- Sample Size: The document refers to "healthy mini-pigs" and states that "Embolization was successful for all animals," implying a small, but sufficient, number of animals for this pre-clinical feasibility and safety study when coupled with the in-vitro data. The exact number of animals is not explicitly stated.
- Data Provenance: The data is from a prospective animal study conducted to evaluate the safety and product performance of the new 30-60µm QuadraSphere Microspheres. The origin is not specified by country, but it's a pre-clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given text. For an animal study, "ground truth" would typically come from veterinary pathologists or other trained animal researchers/clinicians.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the given text. Given it's an animal study focusing on objective measurements (histopathology, granulometry), a formal adjudication process as seen in multi-reader human image interpretation studies is unlikely or not explicitly detailed.
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:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a device modification for an embolization microsphere, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical embolization microsphere, not a software algorithm. Its performance is evaluated through its physical and biological effects, both in vitro and in vivo.
7. The type of ground truth used:
The ground truth for the animal study (in-vivo testing) was established using:
- Histopathology: Microscopic examination of tissue samples to evaluate vessel occlusion, tissue response (e.g., presence of macrophages), and confirms the location of the microspheres.
- Animal behavior and blood tests: To assess overall safety and well-being.
- In-vitro granulometry: Objective measurement of microsphere size distribution.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI algorithm, so there is no "training set" in the context of machine learning. The device's design and manufacturing processes are refined through engineering and material science, not data training.
9. How the ground truth for the training set was established:
Not applicable. As stated above, there is no "training set" for this type of device. The "ground truth" for its development would be based on established engineering principles, material science, and prior knowledge from the predicate device.
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