(118 days)
Gel-Bead embolization spheres are intended for use in embolization of hypervascular tumors.
The Gel-Bead embolization spheres (Gel-Bead) consists of biodegradable gelatin spheres prefilled in a 20 ml syringe. The syringe contains 2 ml of spheres suspended in 4 ml of saline. Gel-Bead is offered in four nominal size ranges: 100-300 um, 300-500 um, 500-700 um and 700-1000 um. 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Gel-Bead device, based on the requested information:
This device is a medical device (embolization spheres), not an AI/ML device. Therefore, many of the requested fields pertinent to AI/ML device studies (like those related to AI effectiveness, ground truth for training sets, etc.) are not applicable in this context and will be marked as such.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Characteristic | Reported Device Performance (Met/Not Met) |
|---|---|
| Sphere suspension in contrast | Met acceptance criteria |
| Pepsin digestion | Met acceptance criteria |
| Supplied volume | Met acceptance criteria |
| Deliverability | Met acceptance criteria |
| Glutaraldehyde residuals | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each of the bench tests (sphere suspension, pepsin digestion, supplied volume, deliverability, glutaraldehyde residuals). It also does not explicitly mention the data provenance in terms of country of origin or whether it was retrospective or prospective, as these are bench tests rather than clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. These are bench tests measuring physical and chemical properties of the device, not diagnostic interpretations requiring expert ground truth in the context of AI/ML.
4. Adjudication Method for the Test Set
Not applicable, as ground truth establishment by experts is not relevant for these bench tests. The acceptance criteria were likely objective measurements defined by the manufacturer based on regulatory guidelines and validated methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for these bench tests would be the established scientific and engineering principles, regulatory standards, and internal specifications for the physical and chemical properties of the embolization spheres. For example, for "supplied volume," the ground truth would be the expected nominal volume (2 ml) and acceptable deviation from that volume. For "glutaraldehyde residuals," the ground truth would be the acceptable safe limit for residuals.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The device, "Gel-Bead" embolization spheres (2 ml fill), underwent a series of bench tests to demonstrate substantial equivalence to its predicate device (Gel-Bead, K133237). The studies focused on evaluating the device's functionality and technological characteristics.
The specific tests conducted were:
- Sphere suspension in contrast: This likely assesses how well the spheres remain suspended in a contrast agent, which is crucial for their navigability and visualization during clinical use.
- Pepsin digestion: This test evaluates the biodegradability of the gelatin spheres, confirming they break down as intended over time after embolization.
- Supplied volume: This verifies that the actual volume of spheres provided in the syringe meets the specified amount (2 ml).
- Deliverability: This assesses the ability of the spheres to be successfully delivered through compatible catheters without clumping or clogging, which is critical for clinical efficacy.
- Glutaraldehyde residuals: This measures any residual glutaraldehyde (a cross-linking agent sometimes used in gelatin products), ensuring it is below safe limits.
The document states that "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." This indicates that for each of these measured characteristics, the device performed within the predefined acceptable ranges or thresholds. The exact numerical acceptance criteria are not provided in this document, but the overall conclusion is that they were successfully met.
§ 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).