(93 days)
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.
| Acceptance Criteria (Implied from Study Endpoints) | Reported Device Performance (Embozene Prospective Data) |
|---|---|
| Safety: No serious adverse events or device-related events. | - No serious adverse events reported. |
- No device-related events reported.
- No post-prostatic artery embolization syndrome events reported.
- Total adverse events in 39.5% of subjects, none of which were serious or device-related. |
| Symptomatic Improvement of BPH (at 6 and 12 months) as measured by IPSS: - Improvement in average IPSS score over baseline.
- Proportion of subjects with at least 3 IPSS points improvement. | IPSS:
- Average 6-month IPSS score demonstrated 46% improvement over baseline.
- Average 12-month IPSS score demonstrated 47% improvement over baseline.
- 81.8% of subjects improved at least 3 IPSS points at 12 months. |
| Improvement in Quality of Life (QoL): - Improvement in average QoL score over baseline. | QoL:
- Baseline QoL score of 4.4 (mostly dissatisfied) improved to 2.3 (mostly satisfied) at 3 months, maintained through 12 months. |
| Physiological Improvements: - Prostate volume reduction.
- Increase in peak flow rates (Qmax). | Physiological Parameters:
- Prostate volume reduction maintained through follow-up.
- Increase of peak flow rates (Qmax) maintained through follow-up. |
| Procedural Success: - High success rate of embolization procedures.
- No non-targeted embolization. | Procedural Success:
- 100% (38/38) successful embolization procedures.
- No cases of non-targeted embolization. |
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.
§ 876.5550 Prostatic artery embolization device.
(a)
Identification. A prostatic artery embolization device is an intravascular implant intended to occlude the prostatic arteries to prevent blood flow to the targeted area of the prostate, resulting in a reduction of lower urinary tract symptoms related to benign prostatic hyperplasia. This does not include cyanoacrylates and other embolic agents which act by in situ polymerization or precipitation, or embolization devices used in neurovascular applications (see 21 CFR 882.5950).(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Evaluation of suitability for injection through catheters intended for use in embolization; and
(ii) Evaluation of the size distribution of the device.
(3) Performance data must support the sterility and pyrogenicity of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(5) Clinical data must evaluate post-embolization damage due to non-target embolization under anticipated use conditions.
(6) The labeling must include:
(i) Specific instructions on safe device preparation and use;
(ii) The device shelf life;
(iii) Data regarding urinary retention; and
(iv) Data regarding post-prostatic artery embolization syndrome.