(155 days)
The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥ 50 years of age with a prostate volume ≥ 30cm³ and ≤ 80cm³. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
The reusable Rezūm Generator is provided with the following reusable components:
- Generator
- One Power Cord
The Rezūm Delivery Device Kit contains the following disposable components: - One sterile Delivery Device with cable and tubing
- One sterile Syringe
- One sterile Spike Adaptor
- One 50 ml Sterile Water Vial
Additional spike adaptor and syringe accessory is provided as an Accessory Pack.
The provided text describes the Rezūm System, a medical device for treating Benign Prostatic Hyperplasia (BPH), and its clinical studies to support substantial equivalence.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a set of predefined thresholds for clinical outcomes. Instead, it reports the "effectiveness" of the device, primarily measured by the International Prostate Symptom Score (IPSS), and its "safety." The approval for substantial equivalence suggests that the reported performance was deemed acceptable by the FDA.
| Metric (Implicit Acceptance Criteria) | Reported Device Performance | Study |
|---|---|---|
| Effectiveness (IPSS Improvement) | ||
| Significant IPSS improvement | Rapid IPSS improvement observed at 1 month, continuing to improve through 6 months and 12 months. | Rezūm FIM Optimization Study |
| Consistent IPSS improvement | IPSS improvement consistent with FIM study, persisting through 2-year follow-up. At month 3, 6, 12, and 24, >80% of subjects were responders. | Rezūm I Pilot Study |
| Superior effectiveness to control | At 3 months, effectiveness was superior to the control group (p |
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).