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Embozene® Microspheres are indicated for the embolization of arteriovenous malformations and hypervascular tumors including uterine fibroids and hepatoma.

ONCOZENE™ Microspheres are indicated for the embolization of arteriovenous malformations and hypervascular tumors including hepatoma.

Embozene® Microspheres and ONCOZENE™ Microspheres are tightly calibrated, compressible microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue such as a hypervascular tumor (HVT) or arteriovenous malformation (AVM). The microspheres are manufactured from sodium polymethacrylate and coated with proprietary Polyzene®F. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter. Embozene® Microspheres are available opaque or color coded by size to allow easy identification of the different sizes; ONCOZENE™ Microspheres are available in opaque only.

Embozene® / ONCOZENE™ Microspheres are supplied sterile and packaged in 20ml polycycloolefin syringes with a standard 7ml fill volume across the range. Embozene® Microspheres syringes or vials are available in 1 ml or 2 ml microsphere volume; ONCOZENE™ Microspheres are available in 2 ml or 3 ml microsphere volume.

The provided document is a 510(k) Summary of Safety and Effectiveness for CeloNova BioSciences' Embozene® Microspheres and ONCOZENE™ Microspheres. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and proving new device performance against those criteria as would be typical for a novel device.

The core of this submission is an expanded indication for use to explicitly include "hepatoma" among the hypervascular tumors treated with these embolization devices. Therefore, the "acceptance criteria" here are implicitly related to the safety and effectiveness for this expanded indication, demonstrated by comparison to predicate devices and existing clinical data.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for an expanded indication and not a de novo submission, there are no explicit, quantifiable "acceptance criteria" presented in the document in the format of a novel device performance study. Instead, the "acceptance criteria" are implied to be demonstration of substantial equivalence to legally marketed predicate devices, particularly regarding the safety and effectiveness for the embolization of hypervascular tumors, specifically hepatoma.

The "device performance" is primarily the finding that the subject devices are substantially equivalent to the predicate devices and that existing clinical data supports their safety and effectiveness for the expanded indication.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated as a defined "test set" with a specific sample size. The clinical information reviewed included "published and unpublished data on the use of Embozene® for the treatment of hypervascular tumor including hepatoma (outside the United States) and postmarket experience with the cleared device." The exact number of patients or cases in this cumulative "test set" is not provided.
• Data Provenance: The data provenance mentioned is "outside the United States" for the use of Embozene® for hepatoma, and general "postmarket experience" with the cleared devices. This suggests a mix of retrospective (published studies, postmarket reports) and potentially some prospective data if "unpublished data" includes ongoing registries or smaller studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish a "ground truth" for a specific test set. The clinical information reviewed was "published and unpublished data" and "postmarket experience," implying that the assessment of safety and effectiveness relied on existing medical literature and real-world usage data, which inherently includes diagnoses and outcomes established by medical professionals in various clinical settings.

4. Adjudication Method for the Test Set

No explicit adjudication method is mentioned. The review seems to be a synthesis of existing literature and postmarket surveillance rather than a specific study with a defined adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission is for an expanded indication based on substantial equivalence and a review of existing data, not for a comparative effectiveness study of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a medical product (microspheres for embolization), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating safety and effectiveness for hepatoma embolization was based on the outcomes data and findings reported in published and unpublished clinical studies, as well as postmarket surveillance data. This includes diagnoses by clinicians, treatment effectiveness, and adverse events.

8. The Sample Size for the Training Set

This question is not applicable. The device is a medical product, not an AI or algorithm that requires a "training set." The submission relies on existing clinical evidence, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the reasons mentioned above.

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Embozene® Microspheres are intended for embolization of arteriovenous malformations, and hypervascular tumors, including uterine fibroids.

Embozene® Microspheres are tightly calibrated, compressible microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue such as a hypervascular tumor (HVT) or arteriovenous malformation (AVM). Embozene® Microspheres are manufactured from sodium polymethacrylate and coated with proprietary Polyzene®-F. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter. Embozene® Microspheres are color coded by size to allow easy identification of the different sizes. Embozene® Microspheres are supplied sterile and packaged in 20ml polycycloolefin syringes with a standard 7ml fill volume across the range. Embozene® Microspheres syringes or vials are available in 1 ml or 2 ml microsphere volume.

The acceptance criteria for the Embozene® Microspheres and the study demonstrating its performance are detailed below.
It's important to note that this submission relies heavily on substantial equivalence to previously cleared predicate devices, rather than establishing entirely new performance criteria through a de novo study.

Acceptance Criteria and Reported Device Performance

• Same method of delivery, Rx status.
• Same mechanism of action (mechanical occlusion).
• Same material class, design, and composition (Crosslinked polyacrylate hydrogel with Polyzene-F).
• Same size ranges, biocompatibility, microsphere volume, sterility assurance level ($10^{-6}$), pyrogen-free status, packaging, and shelf-life (3 years). | All technological characteristics are identical to the primary predicate device (Embozene® Microspheres, K073417 and K132675). The only difference is the broadened indication for use to explicitly include uterine fibroids, which is supported by clinical data. | Non-Clinical Performance Testing (bench testing) and comparison to predicate device. |
  | Safety | No unique safety concerns regarding use for uterine fibroid embolization. | Review of published and unpublished data regarding adverse events did not identify any unique safety concerns. Adverse events observed in the Smeets et al. study (hysterectomy due to incomplete fibroid expulsion or persistent pain) are documented, but not deemed "unique safety concerns" for the device itself. | Clinical Experience (Smeets et al.) |
  | Clinical Effectiveness (for Uterine Fibroids) | Improvement in fibroid symptoms and/or reduction in fibroid/uterine volume, successful infarction. (Implicitly comparable to predicate device performance) | - UFS-QOL Symptom Severity Scores: Mean score dropped from 64 at baseline to 23 at 3 months (n=85), and to 16 at 12.8 months (n=81).
• Fibroid/Uterine Volume Reduction: Mean dominant fibroid volume reduction of 45% at 3 months. Mean total uterine volume reduction of 42% at 3 months.
• Fibroid Infarction: 94% rate of >90% infarction of dominant fibroid at 3 months. 91% rate of >90% infarction of total fibroid load at 3 months. | Clinical Experience (Smeets et al.) |

Study Details

The submission's primary evidence for meeting acceptance criteria for the expanded indication (uterine fibroids) comes from a review of clinical information, specifically a published study by Smeets et al., and a comparison to predicate devices. No new, prospective, de novo clinical trial was conducted for this 510(k) submission.

1. A table of acceptance criteria and the reported device performance:
See table above.

2. Sample size used for the test set and the data provenance:

• Sample Size for Clinical Data:
  • Smeets et al. study: n=85 patients for initial 3-month follow-up on UFS-QOL scores. n=81 patients for extended 12.8-month follow-up on UFS-QOL scores.
• Data Provenance:
  • Smeets et al. study: Published data, conducted outside the United States. The document states "published and unpublished data on the use of use of Embozene® for the treatment of uterine fibroids (outside the United States)". This indicates a retrospective or prospective observational study conducted previously.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the summary. The clinical study (Smeets et al.) relied on patient-reported outcomes (UFS-QOL) and objective measurements from MRI (uterine and fibroid volume, fibroid infarction). The interpretation of MRI results would have been by medical professionals (radiologists), but their number and specific qualifications are not specified in this 510(k) summary.

4. Adjudication method for the test set:

• This information is not provided in the summary. For the Smeets et al. study, it doesn't mention any specific adjudication method for patient-reported outcomes or MRI interpretations.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a vascular embolization device, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI assistance" is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No, this is not an algorithm or AI-based device. It is a physical device (microspheres) for embolization. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used:

• For the clinical effectiveness concerning uterine fibroids, the ground truth was established through:
  • Patient-reported outcomes: Uterine Fibroid Symptom Quality of Life (UFS-QOL) instrument.
  • Imaging-based objective measures: Uterine and fibroid volume reduction and percent fibroid infarction as determined by MRI.

8. The sample size for the training set:

• Not applicable / Not explicitly stated. This is not an AI/machine learning device that involves a training set in the conventional sense. The "training" for the device's effectiveness is based on the general understanding of embolization therapy and the established performance of predicate devices. The clinical data from Smeets et al. serves as evidence for effectiveness, not as a training set for an algorithm.

9. How the ground truth for the training set was established:

• Not applicable. As mentioned, there isn't a "training set" in the context of an algorithm. The evidence base relies on existing medical knowledge, predicate device performance, and clinical study outcomes.

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