(141 days)
The AQUABEAM® Robotic 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® Robotic System is intended for use in patients suffering from lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia (BPH). The AQUABEAM Robotic System is designed for resecting of prostate tissue during minimally invasive surgical procedures. The AQUABEAM Handpiece and AQUABEAM Scope are inserted via transurethral approach and advanced into the prostatic urethra. The AQUABEAM Robotic System is designed to utilize a high-velocity sterile saline waterjet as the cutting medium which is projected through a nozzle positioned within the prostatic urethra. The nozzle assembly motion is driven by a motor system, controlled by the user. The pressure is generated by a high-pressure pump system controlled by the AQUABEAM Console. The user is allowed to adjust the desired flow rates manually. All functions are displayed on the AQUABEAM Conformal Planning Unit. Pre-condition parameters are set on the AQUABEAM Conformal Planning Unit before operation. The AQUABEAM Robotic System, consists of the following nine components: AQUABEAM Console, AQUABEAM Motorpack, AQUABEAM Foot pedal, AQUABEAM Conformal Planning Unit, AQUABEAM Roll Stand, AQUABEAM Handpiece Articulating Arm, AQUABEAM TRUS Articulating Arm, AQUABEAM Handpiece, AQUABEAM Scope.
The provided text is a 510(k) summary for the AQUABEAM® Robotic System, which is intended for the resection and removal of prostate tissue. However, this document does not contain acceptance criteria or study data demonstrating the device meets specific performance criteria in the way that would typically be presented for an AI/ML medical device submission.
Instead, this 510(k) submission primarily focuses on:
- Device Description: What the AQUABEAM Robotic System is and how it works.
- Indications for Use: The medical conditions it is intended to treat.
- Technological Characteristics: Stating that these are unchanged from the predicate device.
- Device Comparison: Detailing changes only to the device labeling (specifically, to the contraindications section).
- Performance Data: Listing pre-existing non-clinical data (biocompatibility, sterilization, software/firmware verification, electrical safety, usability, system design validation, reliability testing) relied upon. This section does not outline new performance criteria or data related to the device's efficacy for tissue removal.
- Clinical Data Summary: Discussing a sub-group analysis from the WATER study (NCT02505919) and a study on circulating tumor cells (CTCs) in the context of the labeling change for contraindications, specifically regarding patients with diagnosed or suspected prostate cancer. This is to justify removing a contraindication, not to establish new performance metrics for the device's primary function of tissue removal.
Therefore, I cannot extract the requested information regarding acceptance criteria and study data proving the device meets those criteria, as it is not present in the provided text. The document states that "The device's technological characteristics are unchanged, therefore no further non-clinical performance test data is required to support the subject device." and relies on prior non-clinical data and clinical data to support a change in contraindications.
The provided text does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set proving performance for tissue removal.
- Number of experts or their qualifications for establishing ground truth for a test set.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results or effect size for AI assistance.
- Standalone performance results.
- Type of ground truth used for performance validation.
- Sample size for a training set.
- How ground truth for a training set was established.
§ 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.