(248 days)
The AOUABEAM System is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia.
The AQUABEAM System is a personalized image-guided prostate tissue removal system that uses a high-velocity water jet to resect and remove a predetermined volume of tissue. The AQUABEAM System is comprised of nine main components along with accessories: AQUABEAM Conformal Planning Unit, AQUABEAM Console, AQUABEAM Motorpack, AQUABEAM Roll Stand, AQUABEAM Foot Pedal, AQUABEAM Handpiece Articulating Arm, AQUABEAM TRUS Articulating Arm, AQUABEAM Handpiece, and AQUABEAM Scope.
The AQUABEAM System is a fluid jet system for prostate tissue removal intended for the resection and removal of prostatic tissue for the treatment of benign prostatic hyperplasia (BPH). The device cuts tissue using a pressurized fluid jet and can image the treatment area or pairs with an imaging modality to monitor treatment progress.
The provided text details the acceptance criteria and the study that proves the device meets these criteria. The study, named WATER, was a prospective, multicenter, international double-blinded randomized clinical trial comparing the AQUABEAM System (Aquablation) to transurethral resection of the prostate (TURP).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the "Special Controls" section, which outlines the performance data required to establish safety and effectiveness. The reported device performance is extracted from the "Safety Results" and "Efficacy Results" sections of the WATER clinical study.
| Acceptance Criteria (Special Controls) | Reported Device Performance and How It Meets the Criteria |
|---|---|
| 1. Clinical performance testing must evaluate: | WATER Clinical Study Results: |
| a. All adverse events associated with the device; | - Primary Safety Endpoint: Occurrence of Clavien-Dindo persistent grade 1 or grade 2 or higher perioperative complications at 3 months. |
- Aquablation (25.0%) vs. TURP (40.0%).
- Rate difference: -15.0% (95% CI: -29.2 to -1.0%).
- UCL (-1.0%)
§ 876.4350 Fluid jet system for prostate tissue removal.
(a)
Identification. A fluid jet system for prostate tissue removal is a prescription device intended for the resection and removal of prostatic tissue for the treatment of benign prostatic hyperplasia. The device cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra. The device is able to image the treatment area, or pairs with an imaging modality, to monitor treatment progress.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must evaluate the following:
(i) All adverse events associated with the device, and
(ii) Improvement in lower urinary tract symptoms (LUTS).
(2) Physician training must be provided that includes:
(i) Information on key aspects and use of the device, and
(ii) Information on how to override or stop resection.
(3) Animal testing must demonstrate that the device resects targeted tissue in a controlled manner without injury to adjacent non-target tissues.
(4) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Measurement of targeting accuracy and reproducibility of high velocity fluid jet, and
(ii) High pressure fluid jet verification testing at target and non-target tissues.
(5) Software verification, validation, and hazard analysis must be performed.
(6) The patient-contacting elements of the device must be demonstrated to be biocompatible.
(7) Performance data must demonstrate the electrical safety and electromagnetic compatibility of the device.
(8) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(9) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(10) Performance data must validate the instructions for reprocessing and reliability of reusable components.
(11) Labeling must include the following:
(i) A section that summarizes the clinical testing results, including the adverse event profile and improvement in LUTS;
(ii) A shelf life for single use components;
(iii) A use life for reusable components; and
(iv) Reprocessing instructions for reusable components.