(165 days)
Bead Block microspheres are intended to be used for the embolization of hypervascular tumours, including uterine fibroids (UFE) and arteriovenous malformations (AVMs). Bead Block microspheres are also intended for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).
Bead Block, a permanent intravascular implant, is made up of preformed soft, compressible, biocompatible, hydrophilic, non-resorbable and precisely calibrated microspheres that occlude vessels for the purpose of blocking the blood flow to a target tissue. Bead Block compressible microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90-95% water and is compressible to approximately 30% by diameter. Bead Block microspheres are dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be suspended in contrast agents and delivered through microcatheters to the target location. Bead Block is available in bead sizes from 100 – 1200µm and supplied sterile in 20ml syringes which contain 1 or 2 ml of beads suspended in 6 or 5 ml of phosphate buffered saline, respectively. The different bead sizes of the product are differentiated by differently colored labels and syringe end caps. Bead Block is provided as a single use, non-pyrogenic, sterile (steam sterilized) device.
This document is a 510(k) Premarket Notification from the FDA regarding the "Bead Block" device. It attests to the device's substantial equivalence to previously marketed predicate devices for the specified indications for use.
Based on the provided text, the Acceptance Criteria and Device Performance for this medical device (Bead Block) are not defined in terms of typical AI/ML-based image analysis performance metrics (e.g., sensitivity, specificity, AUC). Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on safety and effectiveness for its intended use, which is embolization.
The "study" described is a retrospective data review of the clinical outcomes of patients treated with Bead Block for prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH). This is a clinical effectiveness study, not a study of an AI/ML device's diagnostic or analytical performance.
Therefore, many of the requested points related to AI/ML device study parameters (e.g., test set, ground truth experts, MRMC studies, standalone performance) are not applicable to this document.
Here's an attempt to answer the prompt based on the provided text, reinterpreting the "acceptance criteria" and "study" in the context of a medical device submission for substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for this 510(k) submission are not explicitly stated as quantitative thresholds for clinical performance but rather are implicitly tied to demonstrating safety and effectiveness comparable to predicate devices. The "reported device performance" refers to the clinical outcomes observed in the retrospective study.
| Acceptance Criteria (Implicit from 510(k) Process) | Reported Device Performance (from Retrospective Study) |
|---|---|
| Safety: Device is safe for intended use, with acceptable adverse event profile compared to predicate. | Observed AEs: 149/232 patients (64.2%) reported at least one AE. Most AEs were non-serious and transient. Most common were renal/urinary disorders (15.2%), dysuria (41.4%), pollakiuria (45.3%). Conclusion: "well tolerated treatment." |
| Effectiveness: Device effectively achieves intended clinical outcome, comparable to predicate. | Clinical Improvements at 12 Months: |
- 85% of patients: decrease in total IPSS by at least 3 points.
- 62% of patients: dropped at least 1 symptom category (severe to moderate to mild).
- Statistically significant and clinically relevant improvements in total IPSS, QoL, PSA, and prostate volume (p
§ 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.