(248 days)
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No
The summary describes an image-guided system for tissue removal using a water jet. While it uses imaging (TRUS) for planning, there is no mention of AI, ML, or advanced image processing techniques that would suggest the use of these technologies for tasks like automated tissue identification, treatment planning optimization based on complex patterns, or real-time adaptive control driven by learned models. The planning appears to be "predetermined" based on the image guidance, not necessarily involving AI/ML interpretation or decision-making.
Yes
The device is described as a system for the "resection and removal of prostate tissue" to treat lower urinary tract symptoms due to benign prostatic hyperplasia, indicating its direct therapeutic action on the body.
No
This device is described as a personalized image-guided prostate tissue removal system that uses a high-velocity water jet to resect and remove tissue. Its intended use is for the resection and removal of prostate tissue due to benign prostatic hyperplasia, not for diagnosis.
No
The device description explicitly lists multiple hardware components (Console, Motorpack, Handpiece, etc.) in addition to the planning unit.
Based on the provided information, the AQUABEAM System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the resection and removal of prostate tissue, which is a surgical procedure. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a system for physically removing tissue using a water jet, guided by imaging. This is a therapeutic device, not a diagnostic one.
- Input Imaging Modality: While it uses TRUS video for guidance, this is for surgical planning and execution, not for analyzing a biological specimen to make a diagnosis.
- Performance Studies: The performance studies focus on the safety and efficacy of the tissue removal procedure (e.g., IPSS scores, complication rates, resection time), not on the accuracy of a diagnostic test.
- Key Metrics: The absence of metrics like sensitivity, specificity, PPV, and NPV further indicates it's not an IVD, as these are standard metrics for evaluating diagnostic performance.
The AQUABEAM System is a surgical device used for the treatment of BPH.
N/A
Intended Use / Indications for Use
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.
Product codes
PZP
Device Description
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 (Figure 1) is comprised of nine main components along with accessories. The main components are as follows:
- AQUABEAM Conformal Planning Unit ●
- . AQUABEAM Console
- AQUABEAM Motorpack ●
- AQUABEAM Roll Stand
- AQUABEAM Foot Pedal ●
- AQUABEAM Handpiece Articulating Arm ●
- AQUABEAM TRUS Articulating Arm ●
- AQUABEAM Handpiece ●
- AQUABEAM Scope ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
transrectal ultrasound (TRUS) video
Anatomical Site
prostate / prostatic urethra
Indicated Patient Age Range
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Intended User / Care Setting
prescribed and administered under the direct supervision of a qualified and trained physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Study type: Animal testing
Sample size: 8 non-castrated male beagles
Key results: Demonstrated that the AQUABEAM system ablates targeted tissue in a controlled manner without damage to adjacent tissues. Animals sacrificed immediately (n=2) or up to 8 weeks (n=6) after treatment. The duration of the procedure ranged from 40 to 84 seconds (average 60.5 seconds). There was no active bleeding on any of the dogs during or after the procedure. Animals sacrificed immediately showed intact capsular architecture with a widely patent lumen between peripheral sphincter and bladder neck indicating the ablated (resected) zone. Beyond this zone, the glandular cells and interstitial stroma maintained normal cellular architecture. Survived animals showed a widely patent prostatic urethral lumen. The urethral channels were lined by several lavers of epithelium supported by a 0.4-0.5 thick layer of regenerative fibromuscular and elastic stroma underneath.
Study type: Clinical Trial (WATER study) - prospective, multicenter, international double-blinded randomized clinical trial
Sample size: 181 subjects enrolled, randomized and treated (116 with Aquablation, 65 with TURP).
Key results:
Primary Efficacy Endpoint: Change in International Prostate Symptom Score (IPSS) at 6 months. Aquablation was statistically and clinically non-inferior to TURP. Mean IPSS scores decreased from 22.9 at baseline to 5.9 at 6 months in the Aquablation group and from 22.2 at baseline to 6.8 in the TURP group.
Primary Safety Endpoint: Occurrence of Clavien-Dindo persistent grade 1 or 2 or higher perioperative complications at 3 months. Aquablation demonstrated statistical superiority over TURP (25.0% vs 40.0% occurrence). The rate difference (Aquablation - TURP) was -15.0%, with a 95% Cl of -29.2 to -1.0%. This was driven primarily by lower rates of retrograde ejaculation in the Aquablation group (11.3% vs. 36.4%).
Secondary Endpoints:
- Resection time: Statistically significant superiority for Aquablation (3.9 minutes vs 27.4 minutes for TURP).
- Reoperation/reintervention, hospital length of stay, and major adverse urologic events (MAUE): Non-inferiority demonstrated.
- Worsening of sexual function: 32.9% in Aquablation group vs 52.8% in TURP group.
Additional Endpoints: - IPSS QOL: Improved in both groups (1.3 for Aquablation, 1.5 for TURP at 6 months).
- Qmax: Increased in both groups (20.3 cc/sec for Aquablation, 18.0 cc/sec for TURP at 6 months).
- Post void residual (PVR): Improved in both groups (42 cc for Aquablation, 48 cc for TURP at 6 months).
- Incontinence: Improved in both groups.
- Quality and quantity of ejaculate (MSHQ-EjD): Increased slightly but not significantly in Aquablation group, decreased in TURP group.
- IIEF-5: No changes from baseline in either group.
- Dysuria: Decreased from baseline at month 3 in Aquablation group, not in TURP group.
- Pelvic pain: Low and similar throughout follow-up.
- Reoperation for BPH within 30 days: 0 Aquablation, 1 TURP subject.
- Postoperative blood transfusion rate: 1 Aquablation, 0 TURP subjects.
Key Metrics
Efficacy:
- IPSS change score at 6 months (Aquablation): -16.9 (SD 6.6)
- IPSS change score at 6 months (TURP): -15.1 (SD 7.9)
- Difference in IPSS change score (Aquablation - TURP): 1.8 points larger for Aquablation (95% CI -0.4 to 4.0).
- IPSS QOL at 6 months (Aquablation): 1.3 (SD 1.4)
- IPSS QOL at 6 months (TURP): 1.5 (SD 1.5)
- Qmax at 6 months (Aquablation): 20.3 cc/sec (SD 10.9)
- Qmax at 6 months (TURP): 18.0 cc/sec (SD 7.5)
- Post void residual at 6 months (Aquablation): 42 cc (SD 50)
- Post void residual at 6 months (TURP): 48 cc (SD 57)
Safety:
- Primary safety endpoint (Clavien-Dindo grade 1 persistent or grade 2 or higher event in the first 3 months):
- Aquablation: 29 subjects (25.0%)
- TURP: 26 subjects (40.0%)
- Rate difference (Aquablation - TURP): -15.0% (95% Cl -29.2 to -1.0%)
- Persistent retrograde ejaculation in the first 6 months (sexually active, baseline & study visit):
- Aquablation: 8 subjects (11.3%)
- TURP: 16 subjects (36.4%)
- Worsening of sexual function (6-month decrease in MSHO score of at least 2 points or decrease in IIEF-5 score of at least 6 points):
- Aquablation: 32.9%
- TURP: 52.8%
- Clavien-Dindo grade 1 persistent or grade 2 or higher event at 6 months:
- Aquablation: 30 subjects (25.9%)
- TURP: 28 subjects (43.1%)
- Point estimate for difference: -17% (95% CI -31.5 to -3.0%)
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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DE NOVO CLASSIFICATION REQUEST FOR AQUABEAM SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Fluid jet system for prostate tissue removal. 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 (BPH). 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.
NEW REGULATION NUMBER: 21 CFR 876.4350
CLASSIFICATION: II
PRODUCT CODE: PZP
BACKGROUND
DEVICE NAME: AQUABEAM System
SUBMISSION NUMBER: DEN170024
DATE DE NOVO RECEIVED: April 17, 2017
SPONSOR INFORMATION:
PROCEPT BioRobotics Corporation 900 Island Drive Suite 101 Redwood Shores, California 94065
INDICATIONS FOR USE
The AQUABEAM System is indicated as follows:
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.
LIMITATIONS
The sale, distribution, and use of the AQUABEAM System is restricted to prescription use in accordance with 21 CFR 801.109.
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Use of the AOUABEAM System must be prescribed and administered under the direct supervision of a qualified and trained physician, after appropriate urologic patient evaluation. Limitations on device use are also achieved through the following statements included in the Instructions for Use:
Contraindications:
Do not use the AQUABEAM System in patients with:
- . Active urinary tract or systemic infection
- Known allergy to device materials
- Inability to safely stop anticoagulants or antiplatelet agents perioperatively ●
- Diagnosed or suspected cancer of the prostate ●
Warnings:
- A thorough understanding of the technical principles, clinical application and risks . associated with the AQUABEAM System is necessary before using this product. Read the entire User Manual and Instruction for Use prior to using the AOUABEAM System. Completion of PROCEPT's training program is required prior to use of the AQUABEAM System
- . The AQUABEAM Handpiece is designed for use ONLY with the AQUABEAM Console, Motorpack, and Conformal Planning Unit
- . Do not place assembled Roll Stand on a plane inclined at an angle greater than 5° from the horizontal plane during normal use or while unattended
- . To avoid injury, do not transport assembled Roll Stand on ramps greater than 9° incline. Do not leave unattended on ramps with greater than 9° incline
- . This device is not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen
- Each AOUABEAM Handpiece is designed for Single Use Only, DO NOT attempt to re-. sterilize or reuse the Handpiece. Discard each AQUABEAM Handpiece after use. Neither the sterility nor the functionality of a reused Handpiece can be guaranteed and injury to the subject may occur
- The AQUABEAM Scope must be cleaned and sterilized prior to each procedure. To minimize the risk of transmitting disease from one patient to another, after each procedure the Scope must be cleaned and sterilized as described in Scope Reprocessing instructions
- . To minimize the risk of transmitting disease from one patient to another, the AQUABEAM Console, Conformal Planning Unit, Foot Pedal, Power Cord, Handpiece Articulating Arm, TRUS Articulating Arm, Motorpack and Roll Stand must be properly cleaned after each procedure. Failure to properly clean after each procedure may compromise patient safety
- . To avoid potential contamination of the AQUABEAM Handpiece Articulting Arm, Motorpack and TRUS Articulating Arm, they must be draped with new sterile drapes for each procedure
- . Failure to drape the AQUABEAM Console on all sides may result in fluid ingress from Aquablation saline supply into the Console
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
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DEVICE DESCRIPTION
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 (Figure 1) is comprised of nine main components along with accessories. The main components are as follows:
- AQUABEAM Conformal Planning Unit ●
- . AQUABEAM Console
- AQUABEAM Motorpack ●
- AQUABEAM Roll Stand
- AQUABEAM Foot Pedal ●
- AQUABEAM Handpiece Articulating Arm ●
- AQUABEAM TRUS Articulating Arm ●
- AQUABEAM Handpiece ●
- AQUABEAM Scope ●
Image /page/2/Picture/12 description: The image shows an AquaBeam Conformal Planning Unit (CPU) with various components labeled. The components include the AquaBeam Console, AquaBeam Scope, AquaBeam Motorpack, and AquaBeam Handpiece. Additionally, the image identifies the Articulating Arm, Tissue Collection Container, Roll Stand, and Foot Pedal.
Figure 1 AQUABEAM System
AQUABEAM Conformal Planning Unit (CPU)
The Conformal Planning Unit serves as the primary user interface of the AQUABEAM System. The CPU performs the following functions:
- Displays live transrectal ultrasound (TRUS) video ●
- Allows the user to visualize and identify kev anatomical markers (e.g. the prostatic ● capsule, verumontanum and bladder/bladder neck). These key markers optimize the
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placement and positioning of the AQUABEAM Handpiece and select target area for treatment
- Allows the user to plan the procedure by selecting the resection angles and calibrating the ● width and resection depth
- Records planned resection angles and treatment profile and transmit to the Console in ● order to initiate the procedure
- Provides the user with real time progress of the prostatic tissue resection
- Provides hazard and advisory notifications ●
- . Records and stores procedure data
AQUABEAM Console
The AQUABEAM Console performs the following functions:
- controls the functionality of the high-velocity waterjet delivered by the Handpiece
- accepts planned resection angles and treatment profile from the CPU to allow the . initiation of the procedure
- displays the status of the procedure modes ●
- displays pump level during the procedure
- provides an interface with the Motorpack, Foot Pedal and CPU ●
AQUABEAM Handpiece
The AQUABEAM Handpiece, a sterile single use component of the system, emits saline at high velocity to resect target prostate tissues. The Handpiece integrates with the Scope to provide live cystoscopic visualization of the prostatic urethra and bladder during insertion and treatment.
AQUABEAM Motorpack
The Motorpack docks with the Handpiece and provides power to the Handpiece by means of DC motors, which enable both rotational and longitudinal movement of the Handpiece probe providing controlled and precise resection of the prostatic tissue in accordance with the CPU treatment plan. The Motorpack additionally has user controls that signal the system to increment or decrement the High-Pressure Pump power when pressed. The Motorpack/Handpiece assembly is secured to the Handpiece Articulating Arm.
AQUABEAM Scope
The AQUABEAM Scope, a re-usable component of the AQUABEAM System, consists of a semi-flexible stainless steel hypotube at the distal end and a flexible Pebax sheath connected to a proximal eye piece. The Scope is inserted into the central lumen of the AQUABEAM Handpiece enabling direct visualization within the prostatic urethra during treatment.
AQUABEAM Foot Pedal
The AQUABEAM Foot Pedal contains three foot-activated buttons and is connected to the Console with a flexible cable. The surgeon depresses the buttons to begin the waterjet resection. Additional buttons control Handpiece priming and aspiration of fluid.
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AQUABEAM Roll Stand
The AQUABEAM Roll Stand serves as the chassis for various AQUABEAM System components and is the main power source for the system.
AQUABEAM Handpiece Articulating Arm
The AQUABEAM Handpiece Articulating Arm connects to standard bedrails and rigidly fixes the Handpiece and Motorpack in position relative to the patient. The Handpiece Articulating Arm has a release trigger that enables freedom of movement and locking of the arm. The arm allows ±20° of Handpiece rotation with 2° discrete locking points.
AQUABEAM TRUS Articulating Arm
The AQUABEAM TRUS Articulating Arm (Figure 2) connects to standard bedrails and fixes the TRUS probe and stepper in position relative to the patient. The TRUS Articulating Arm has a release trigger that enables freedom of movement and locking of the arm.
Image /page/4/Picture/6 description: The image shows a 3D rendering of an articulating arm with a bedrail clamp and stepper motor. The arm is labeled with numbers 1-5, which correspond to the articulating arm, bedrail clamp, articulation release, stepper lock, and stepper motor, respectively. The arm is gray and has multiple joints that allow it to be positioned in different ways. The bedrail clamp is black and is used to attach the arm to a bedrail. The stepper motor is located at the end of the arm and is used to control the movement of the arm.
Figure 2 TRUS Articulating Arm
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The AQUABEAM Handpiece and AQUABEAM Scope are the only components of the AQUABEAM System that have direct or indirect patient contact. These components were tested as per "external communicating device, tissue/bone/dentin with limited exposure (300. Eligible subjects were randomized 2:1 to Aquablation with AQUABEAM System or standard TURP. Randomization was stratified by study center and baseline IPSS ≥ or