(186 days)
Gel-Bead embolization spheres is intended for use in embolization of hypervascular tumors.
The Gel-Bead embolization spheres (Gel-Bead) consists of biodegradable gelatin spheres pre-filled in a 20 ml syringe. The syringe contains 1 ml of spheres suspended in 5 ml of saline. Gel-Bead is offered in four size ranges: 100-300 µm, 300-500 µm, 500-700 µm and 700-1000 µm. The spheres are intended to be used with a delivery catheter with an inner diameter that is adequate for sphere delivery (not included). The finished product is sterilized by Gamma irradiation and is intended for single use only.
The provided text describes a 510(k) submission for the Gel-Bead embolization spheres device. This is a medical device submission, and the focus of the "study" and "acceptance criteria" is on demonstrating substantial equivalence to existing predicate devices, rather than a clinical trial-style study with direct performance metrics in humans.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet ISO 10993-1 recommendations for cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, hematology, and genotoxicity. | All listed biocompatibility tests (Cytotoxicity: L929 MEM Elution, Agar Diffusion; Sensitization: Kligman Maximization Sensitization Test (Direct); Irritation/Intracutaneous Reactivity: Intracutaneous Injection (Direct); Acute Systemic Toxicity: Acute Systemic Injection Test, Material Mediated Rabbit Pyrogen (Direct Exposure); Hematology: Hemolysis (Direct), Hemolysis (Indirect), Complement Activation (Direct); Genotoxicity: Bacterial Mutagenicity Test Ames Assay, Mouse Lymphoma Forward Mutation Assay, Rodent Bone Marrow Micronucleus Assay) were performed and their results met the specified acceptance criteria. |
| Device Functionality | Consistent and reliable implantation in selected target arteries; successful arterial occlusion. | GLP Animal Study: Gel-Bead spheres were consistently and reliably implanted in the selected target arteries of appropriate size and not in additional non-target tissues or regions. All instances of Gel-Bead delivery resulted in successful arterial occlusion at the time of implant, as confirmed by angiography. |
| Safety (Clinical Pathology) | No clinically significant abnormalities in clinical pathology blood results that negatively reflect on the device. | GLP Animal Study: There were no clinically significant abnormalities identified in the clinical pathology blood results that negatively reflected on either the test (Gel-Bead) or control (Embosphere) devices. |
| Safety (Systemic) | No systemic abnormalities identified in tissues distant to implantation sites. | GLP Animal Study: Examination of the tissues distant to the implantation sites did not identify any systemic abnormalities. |
| Clinical Efficacy | Creation of mechanical obstruction to blood flow in the target vessel, as evidenced by disruption in contrast flow rate. | GLP Animal Study: Similar well-demarcated foci of infarction, indicative of successful embolization, were observed in the target organs of both test article animals (Gel-Bead and Embosphere). |
| Overall Substantial Equivalence | Device design, technological characteristics, and indications for use are substantially equivalent to predicate devices, with no new safety or performance issues raised. | The verification, animal study, and biocompatibility test results met the specified acceptance criteria and did not raise new safety or performance issues. The device is considered substantially equivalent to the predicate devices based on comparisons of device functionality, technological characteristics, and indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Animal Study): 12 mature miniature swine.
- 8 animals implanted with Gel-Bead.
- 4 animals implanted with a control (Embosphere Microspheres).
- Data Provenance: Prospective animal study (GLP animal study), conducted with animals survived up to 12 weeks following implantation. The country of origin of the data is not specified, but it's typically conducted in a controlled lab environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or qualifications of experts used to establish ground truth. However, given the nature of a GLP animal study, it would typically involve:
- Veterinary Pathologists: To interpret tissue examinations and identify foci of infarction.
- Veterinarians/Surgeons: For implantation procedures, clinical observation, and interpretation of clinical pathology results.
- Radiologists/Interventionalists: To interpret angiographic confirmation of arterial occlusion.
The document states "similar well-demarcated foci of infarction, indicative of successful embolization, observed in the target organs of both test article animals," which implies expert pathological assessment.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method for the animal study (e.g., 2+1 review). The findings related to successful occlusion, infarction, and clinical pathology are presented as observed outcomes of the study. GLP studies inherently have rigorous protocols for data collection and interpretation, but specific adjudication of disagreements is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (embolization spheres), not an AI/imaging diagnostic device that would typically involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm-only) performance study was not done. This device is not an algorithm; it is a physical medical device. The "study" here refers to the animal study demonstrating the physical device's function and safety.
7. The Type of Ground Truth Used
The ground truth for the animal study was established through a combination of:
- Direct Observation/Angiography: Confirmation of successful arterial occlusion at the time of implant.
- Pathology: Histopathological examination of target organs to observe "well-demarcated foci of infarction, indicative of successful embolization."
- Clinical Pathology: Blood results to assess for systemic toxicity.
- Gross Examination: Of tissues distant to implantation sites.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here because this is a physical medical device submission, not an AI/machine learning algorithm that requires training data. The animal study described is a verification and validation study for the device's performance and safety.
9. How the Ground Truth for the Training Set Was Established
As there is no training set in the context of this device submission, this question is not applicable.
§ 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).