(403 days)
The BioSphere QuadraSphere™ Microspheres are intended for embolization of hypervascularized tumors and peripheral vascular arteriovenous malformations (AVMs).
QuadraSphere Microspheres are indicated for embolization of hypervascularized arteriovenous malformations.
BioSphere Medical, Inc., QuadraSphere™ Microspheres are sterile, biocompatible, hydrophilic (absorbent), non-resorbable, acrylic copolymer microspheres. They are provided in three (nominal) microsphere sizes: 50 to 100 um, 100 to 150 um, and 150 to 200 um in containers (vials) containing 50 mg of the dry spheres.
The provided text is a 510(k) summary for a medical device (QuadraSphere™ Microspheres), which focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as one might find in a clinical trial report.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and study designs are not present in this type of regulatory submission. The document states that "In-vitro and in-vivo design verification and validation testing demonstrates that the BioSphere Medical, Inc. QuadraSphere™ Microspheres fulfill design and performance specifications," but it does not elaborate on what those specifications or the detailed results were.
Here's a breakdown of what can be extracted and what cannot, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the 510(k) summary. A 510(k) summary typically focuses on demonstrating substantial equivalence to existing devices rather than detailing specific numerical acceptance criteria and performance outcomes from a statistically powered study. It states that "In-vitro and in-vivo design verification and validation testing demonstrates that the BioSphere Medical, Inc. QuadraSphere™ Microspheres fulfill design and performance specifications," but doesn't list the specifications or the results.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. The summary mentions "in-vitro and in-vivo" testing but does not specify the sample sizes or the origin of any data (e.g., country of origin, retrospective/prospective). This is common for 510(k) submissions, which often rely on bench testing and animal studies rather than large-scale human clinical trials.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided. As no clinical study is described with a ground truth establishment process, there is no mention of experts, their number, or qualifications.
4. Adjudication Method for the Test Set:
This information is not provided, as no clinical test set adjudication process is described.
5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study:
This information is not provided. The document makes no mention of an MRMC study or any comparison of human readers with and without AI assistance. The device is an embolization agent, not an AI-powered diagnostic tool.
6. Standalone Performance (Algorithm Only):
This information is not applicable/not provided. The device is a physical medical implant (microspheres) for embolization, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.
7. Type of Ground Truth Used:
This information is not provided. Since no specific human clinical study with a defined ground truth for efficacy or safety is outlined, the type of ground truth is not detailed. The "performance testing" likely refers to engineering, biocompatibility, and animal studies.
8. Sample Size for the Training Set:
This information is not provided. As the device is not an AI algorithm, there is no concept of a "training set" in the context of machine learning.
9. How Ground Truth for the Training Set Was Established:
This information is not applicable/not provided for the same reason as point 8.
Summary of Provided Information Relevant to Performance:
- Performance Testing: The summary states that "In-vitro and in-vivo design verification and validation testing demonstrates that the BioSphere Medical, Inc. QuadraSphere™ Microspheres fulfill design and performance specifications."
- Intended Use: Embolization of hypervascularized tumors and peripheral vascular arteriovenous malformations (AVMs).
- Technological Characteristics: Sterile, biocompatible, hydrophilic (absorbent), non-resorbable, acrylic copolymer microspheres, available in three nominal sizes (50 to 100 um, 100 to 150 um, and 150 to 200 um). Delivered via catheters, mixed with contrast media for visualization.
- Substantial Equivalence: The claim is based on intended use, indications for use, fundamental technological characteristics, and fundamental operational characteristics being similar to predicate devices (GelSpheres, BeadBlock Compressible Microspheres, Contour SE, Contour Emboli, Embospheres). This implies that the performance is considered acceptable because it is similar to already legally marketed devices.
This 510(k) summary serves to demonstrate that the new device is as safe and effective as a legally marketed predicate device, not to independently prove its efficacy and safety against a set of predefined, quantifiable acceptance criteria in a detailed clinical study.
§ 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).