(204 days)
Embosphere® and EmboGold™ Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including and uterine fibroids.
Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular turnors, and symptomatic uterine fibroids.
Embosphere® and EmboGold™ Microspheres are small, flexible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin. The microspheres are packaged in 0.9% saline and are provided sterile and nonpyrogenic. They are delivered to the target site by a catheter under fluoroscopic control.
Both products are provided in six size ranges in order to allow physicians to choose the calibration necessary for the vessel being embolized. The size ranges available are:
- 40-120 microns
- 100-300 microns
- 300-500 microns
- 500-700 microns
- 700-900 microns
- 900-1200 microns
Only microspheres of 500 microns or greater should be used for the embolization of uterine fibroids.
The only difference between Embosphere® and EmboGold™ Microspheres is the colorization of the EmboGold™ Microspheres. Embosphere® Microspheres are translucent, although they are visible to the naked eye when in suspension. EmboGold™ Microspheres are purple/red in color for improved visibility during preparation and handling by the physician.
The provided text describes the 510(k) submission for Embosphere® Microspheres and EmboGold™ Microspheres for use in Uterine Fibroid Embolization. Since this is an embolization device and not a diagnostic AI device, many of the requested criteria (e.g., acceptance criteria for diagnostic performance, sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from the provided text.
However, I can extract information related to the clinical study performed to support the device's safety and effectiveness for its intended use in uterine fibroid embolization.
Acceptance Criteria and Device Performance (Not directly applicable as this is not a diagnostic device with performance metrics like sensitivity/specificity):
The acceptance criteria for this type of device typically revolve around demonstrating safety and effectiveness for the intended use, often compared to an existing predicate device. The text states: "Clinical data was collected in a prospective clinical study to support the safety and effectiveness of Embosphere® Microspheres for uterine fibroid embolization." Specific quantitative acceptance criteria or detailed device performance metrics (e.g., success rates, complication rates, fibroid reduction) are not provided in this 510(k) summary.
Study Type and Design:
- Study Name: Not explicitly named, but referred to as a "prospective clinical study."
- Purpose: To support the safety and effectiveness of Embosphere® Microspheres for uterine fibroid embolization.
Missing Information (and why it's missing from this type of document):
Many of the questions are geared towards diagnostic AI models, which have different evaluation methodologies than medical devices like embolization microspheres. Therefore, much of the requested information cannot be found in this 510(k) summary for a medical device.
Here's a breakdown of the requested information based on the provided text, and an explanation for the missing parts:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (Not explicitly detailed in this summary) |
|---|---|
| Safety for Uterine Fibroid Embolization | Clinical data supported safety (specific metrics not provided) |
| Effectiveness for Uterine Fibroid Embolization | Clinical data supported effectiveness (specific metrics not provided) |
| Substantial Equivalence to Predicate Devices | Deemed substantially equivalent by FDA |
Detailed Study Information
-
Sample Size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: "Clinical data was collected in a prospective clinical study". The country of origin is not specified but is implicitly within the scope of FDA approval requirements, likely U.S. or international studies following regulatory guidelines.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a therapeutic device like embolization microspheres, "ground truth" as it applies to diagnostic image interpretation by experts is not a relevant concept. The "truth" would be clinical outcomes (e.g., fibroid reduction, symptom improvement), not interpretations of images.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 are used for resolving discrepancies in expert interpretations of images or data, which is not relevant for evaluating the performance of an embolization device in a clinical study.
-
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:
- No. This is not a diagnostic AI device, so MRMC studies involving human readers and AI assistance are not relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not a standalone algorithm. Its performance inherently involves human intervention (physician delivery).
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Outcomes Data. While not explicitly stated with detail, for a device used to treat uterine fibroids, the "ground truth" for effectiveness would be based on measured clinical outcomes such as reduction in fibroid volume, improvement in symptoms, and patient quality of life, alongside safety parameters.
-
The sample size for the training set:
- Not Applicable. As a medical device rather than a machine learning model, there is no "training set" in the AI sense. Performance is established through preclinical testing and clinical studies.
-
How the ground truth for the training set was established:
- Not Applicable. See point 7.
§ 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).