(118 days)
The HydroPearl® Microspheres are intended for the embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).
The HydroPearl TM Microspheres are a pre-formed, compressible, precisely calibrated, spherical embolic agent consisting of a biocompatible hydrogel. The HydroPearl TM Microspheres are offered in a variety of diameters ranging from 75-1100µm and are provided in a sterile syringe pre-filled with microspheres in phosphate buffered saline. The pre- filled syringe is packaged in a sealed sterile dispenser tray. The HydroPearl TM Microspheres are delivered to the treatment site through a delivery catheter.
The provided document describes the acceptance criteria and study for the HydroPearl Microspheres, specifically for the expanded indication of prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH).
Here's an organized breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds (e.g., "IPSS score reduction must be X%"). Instead, it reports the observed clinical outcomes and concludes that these results support safe and effective use. The "acceptance criteria" here are implied through the positive clinical outcomes and the comparison to established understanding of PAE effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance (HydroPearl Microspheres) |
|---|---|
| Primary Endpoint: Reduction in IPSS score during follow-up | Mean baseline IPSS: 20.7 (range; 4-30) |
| Mean IPSS at latest follow-up (8.6 months): 9.1 (range; 2-18) | |
| (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.