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Embozene Color-Advanced Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH). The device is not intended for neurovascular use.

Embozene Color-Advanced Microspheres (hereafter may be referenced as Embozene Microspheres or Embozene) are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer shell (Polyzene-F). The microspheres are suspended in liquid and then injected into the bloodstream to permanently occlude blood vessels. They are used to stop bleeding when the underlying lesion is not likely to heal or block arteries supplying a tumor to cause tumor necrosis and/or shrinkage. Embozene Color-Advanced Microspheres are sterile, single use devices and are supplied in pre-filled 20 ml syringes containing 2ml of microspheres in approximately 7 ml of transport solution. The Embozene Microspheres are available in 40-1300 µm sizes.

The provided text is a 510(k) Premarket Notification from the FDA regarding "Embozene Color-Advanced Microspheres". This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing efficacy study data with acceptance criteria for a new device.

Therefore, the document does not contain the requested information regarding specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The submission confirms that:

• The device is "substantially equivalent" to a legally marketed predicate device (K180102).
• The substantial equivalence is based on the devices having "the same indications for use and the same technological characteristics."
• The only change in the subject device is an "updated syringe due to end of life of the previously used syringe."
• Non-clinical testing (mechanical performance, biocompatibility, sterility, packaging, and shelf-life) was conducted to ensure the updated device meets the specifications of the predicate device.

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Embozene Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benien prostatic hyperplasia (BPH).

This device is not intended for neurovascular use.

Embozene™ Color-Advanced Microspheres (hereafter referenced as Embozene or Embozene Microspheres) are spherical, tightly calibrated, biocompatible, hydrogel microspheres coated with proprietary polymer (Polyzene®-F). The microspheres are compressible to enable smooth delivery through the indicated delivery catheter and color-coded by size to allow for easy identification.

Microspheres are supplied sterile and packaged in 20 ml syringes with an approximate 7ml fill volume across the range. Embozene microspheres syringes are available in 2 ml microsphere volume for 40 -1300 µm.

Acceptance Criteria and Device Performance for Embozene Color-Advanced Microspheres

This information is extracted from the provided 510(k) Summary for Embozene Color-Advanced Microspheres (K180102).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Embozene Color-Advanced Microspheres for the expanded indication of prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) are implicitly derived from the primary endpoints of the prospective clinical study, which focused on safety and symptomatic improvement. Specific quantitative acceptance criteria are not explicitly stated in the provided document, but the results demonstrate successful outcomes relative to baseline.

The document also refers to non-clinical tests for biocompatibility and performance for the Embozene Microspheres (which were previously cleared). The acceptance criteria for these tests were "All tests passed, indicating that the device materials are biocompatible for its intended use" and "All tests passed demonstrating the device meets the predetermined performance requirements." These include:

• Biocompatibility: Cytotoxicity, Sensitization, Sub-Acute and Sub-Chronic Systemic Toxicity, Systemic Toxicity- Material Mediated Pyrogenicity, Genotoxicity (Bacterial Mutagenicity, In-vitro Chromosome Aberration, In-Vivo Micronucleous Assay), Implantation, Hemocompatibility (hemolysis, partial thromboplastin time, platelet/leukocyte counts).
• Performance: Microsphere size distribution, visual inspection, pH of transport solution, Osmolality of transport solution, Microsphere suspension, Catheter compatibility, and Elution Test: Determination of leachable substances by UV-Vis, HPLC, and ICP-MS.

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

• Sample Size: 38 patients (male evaluable subjects).
• Data Provenance: Prospective clinical study at a single center. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a U.S.-based company (Boston Scientific Corporation).

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 the test set. The clinical study collected patient-reported outcomes (IPSS, QoL, IIEF) and objective clinical measurements (Qmax, PVR, PV, PSA) which serve as the primary evaluation metrics for efficacy and safety. These are standard clinical assessments rather than expert-adjudicated ground truth in a diagnostic sense.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. The data presented are reported clinical outcomes and adverse events collected directly from patients and clinical assessments.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a prospective single-arm study evaluating the device's performance directly in patients, not assessing human reader performance 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, Embozene Color-Advanced Microspheres, is a medical device (embolization microspheres) used in a medical procedure performed by a physician, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study's primary endpoints was based on:

• Patient-reported outcomes: International Prostate Symptom Score (IPSS), Quality of Life (QoL) questionnaires, and International Index of Erectile Function (IIEF).
• Objective clinical measurements: Peak flow rate (Qmax), Post Void Residual (PVR), Prostate Volume (PV), and Prostate Specific Antigen (PSA) levels.
• Safety assessment: Reported adverse events.
• Procedural success: Radiographic evidence.

8. The Sample Size for the Training Set

No training set is mentioned as this is a medical device and not an AI/ML algorithm.

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

Not applicable, as no training set was used for an AI/ML algorithm.

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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

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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