(30 days)
QuadraSphere Microspheres are indicated for embolization of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.
QuadraSphere Microspheres are sterile, biocompatible, hydrophilic, nonresorbable, expandable, acrylic copolymer microspheres. QuadraSphere Microspheres are packaged in a vial 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.
This document describes the QuadraSphere Microspheres, a vascular embolization device. The main change in this submission is the extension of the product line to include a 20-40 µm size, in addition to existing sizes.
Here's the information regarding the acceptance criteria and study as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a precise "acceptance criteria" table with numerical targets, but it lists performance parameters tested and states that the device met the pre-determined acceptance criteria for each.
| Parameter Tested | Reported Device Performance |
|---|---|
| Macroscopic appearance of the powder | Met pre-determined acceptance criteria |
| Microscopic examination of the microspheres | Met pre-determined acceptance criteria |
| Swelling in Hexabrix of the microspheres | Met pre-determined acceptance criteria |
| Humidity of the microspheres | Met pre-determined acceptance criteria |
| Bacterial endotoxins | Met pre-determined acceptance criteria |
| Catheter compatibility | Met pre-determined acceptance criteria |
| Animal testing | Met pre-determined acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., number of microsphere batches for appearance, number of animals for in-vivo testing).
- Provenance: The studies were conducted by Biosphere Medical, S.A. No specific country of origin for the data is mentioned beyond the company's location in France. The document describes "design verification and validation testing," implying this was prospective testing directly supporting the device's clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is not a study requiring expert readers to establish ground truth for image interpretation or diagnosis. The tests are focused on physical and biological properties of the microspheres themselves.
4. Adjudication Method for the Test Set:
Not applicable. This is a technical performance study, not one requiring adjudication of diagnostic interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. This document does not describe an MRMC study. The device is a physical product (microspheres), not an AI algorithm for diagnostic assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This device is not an AI algorithm.
7. The Type of Ground Truth Used:
The ground truth for the performance tests was based on established engineering and biological specifications for medical device manufacturing and safety. For example:
- Physical properties (appearance, microscopic features, swelling) are typically compared against pre-defined specifications for the material and design.
- Biocompatibility is assessed against ISO 10993-1 standards.
- Bacterial endotoxin levels are measured against established safety limits.
- Catheter compatibility is tested against functional requirements for delivery.
- Animal testing would have pre-defined endpoints to evaluate safety and function in a biological system.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. This device is not an AI algorithm.
§ 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).