(29 days)
The Gel-Block 10x embolization pledgets is intended for use in the embolization of hypervascular tumors and arteriovenous malformations (AVMs).
The Gel-Block 10x embolization pledgets is an embolic device consisting of 10 radially compressed porcine derived gelatin pledgets packaged in one transparent glass vial. A delivery syringe is provided for introduction of the pledgets into the delivery catheter (not included). The pledgets are available in three sizes compatible with a delivery catheter having a minimum inner diameter of ≥ 0.038", ≥ 0.027", or ≥ 0.021". When unconstrained in a blood vessel, each pledget will occlude blood flow by swelling to a specified swell size. The finished product is sterilized by electron-beam irradiation and is intended for single use only.
This document is a 510(k) premarket notification for the "Gel-Block 10x embolization pledgets." The FDA found the device to be substantially equivalent to a predicate device (K113266 - Gel-Block embolization pledgets). The information provided focuses on demonstrating this substantial equivalence, primarily by showing that the new device has similar technological characteristics and performance to the predicate device, especially considering changes in packaging.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that a series of tests were performed and that the "results... met the specified acceptance criteria." However, the exact numerical acceptance criteria and the detailed reported device performance values are not explicitly provided in the text. The document only confirms that the criteria were met.
| Test Category | Acceptance Criteria (Not explicitly detailed) | Reported Device Performance (Summary) |
|---|---|---|
| Functional / Design | Not explicitly detailed | Deliverability: Met specified acceptance criteria |
| Biocompatibility | Not explicitly detailed | Cytotoxicity: Met specified acceptance criteria |
| Sensitization: Met specified acceptance criteria | ||
| Irritation/Intracutaneous Reactivity: Met specified acceptance criteria | ||
| Acute Systemic Toxicity: Met specified acceptance criteria | ||
| Hematology: Met specified acceptance criteria | ||
| Packaging Validation | Not explicitly detailed | Met specified acceptance criteria |
| Sterilization Validation | Not explicitly detailed | Met specified acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the tests (deliverability, biocompatibility, package validation, or sterilization validation). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. These details are typically found in the full study reports, which are not included in this summary document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the type of device and studies described. The studies conducted are primarily bench, biocompatibility, and sterilization tests, not clinical studies requiring expert interpretation of patient data or ground truth establishment in a medical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the studies are not clinical trials involving human interpretation or adjudication of medical findings.
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
This information is not applicable. The device is a vascular embolization pledget, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical device, not an algorithm or software. "Standalone performance" in the context of AI does not apply here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the types of tests described (deliverability, biocompatibility, package, and sterilization), the "ground truth" would be established by:
- Deliverability: Engineering specifications and performance metrics (e.g., successful passage through a catheter of a specified size, consistent deployment).
- Biocompatibility: Established ISO 10993 standards and guidelines for biological evaluation of medical devices, which define acceptable thresholds for cytotoxicity, sensitization, etc.
- Package and Sterilization Validation: Industry standards (e.g., ISO, ASTM) and internal quality control specifications for maintaining sterility and package integrity.
These are not "expert consensus, pathology, or outcomes data" in the typical clinical sense, but rather objective measurements against predefined technical standards.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above; there is no training set for this type of medical device.
§ 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).