HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece
Device Facts
| Record ID | K240200 |
|---|---|
| Device Name | HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece |
| Applicant | Procept Biorobotics |
| Product Code | PZP · General, Plastic Surgery |
| Decision Date | Aug 20, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4350 |
| Device Class | Class 2 |
| Attributes | AI/ML, Therapeutic |
AI Performance
| Output | Algorithm | Acceptance | Observed | Dev DS | Dev Readers | Test DS | Test Readers |
|---|---|---|---|---|---|---|---|
| Prostate tissue resection boundary | — | — | — | — | — | — | — |
| Prostate treatment landmarks | — | — | — | — | — | — | — |
Indications for Use
The HYDROS™ 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.
Device Story
HYDROS Robotic System is a fluid jet system for prostate tissue removal; used in OR by urologists. System components include tower, touchscreen monitors (surgeon/staff), motorpack, articulating arms, foot pedal, reusable TRUS probe, and single-use sterile handpiece with integrated CMOS scope. During procedure, surgeon uses TRUS imaging to visualize prostate; system performs automated resection via waterjet. Optional FirstAssist AI feature assists in planning by identifying prostate capsule boundary and suggesting treatment landmarks (start, bladder neck, mid-prostate, end). Output is visual feedback on monitors; system enables precise tissue removal. Benefits include minimally invasive treatment for BPH. Device supports optional cloud connectivity via Wi-Fi.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including system verification, usability (IEC 62366-1), electromagnetic compatibility (IEC 60601-1-2), basic safety (IEC 60601-1), sterilization validation (ISO 11135), biocompatibility (ISO 10993), and cybersecurity assessments. Simulated use and cadaver testing were performed to validate system performance.
Technological Characteristics
Fluid jet system for prostate tissue removal. Components: Tower, motorpack, articulating arms, foot pedal, reusable TRUS probe (ABS plastic/silicone), single-use handpiece (EtO sterilized, CMOS scope). Connectivity: Wi-Fi/network capable with optional cloud. Software: Embedded system with optional AI-based planning feature. Standards: IEC 60601-1, IEC 60601-2-37, ISO 10993, ISO 11135.
Indications for Use
Indicated for resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia.
Regulatory Classification
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.
Special Controls
In combination with the general controls of the FD&C Act, the fluid jet system for prostate tissue removal is subject to the following special controls:
*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.
Predicate Devices
- AQUABEAM ROBOTIC System (K231024)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
August 20, 2024
Procept BioRobotics Sara Muddell Sr. Director, Global Regulatory Affairs 150 Bavtech Drive San Jose, California 95134
Re: K240200
Trade/Device Name: HYDROS™ Robotic System: HYDROS™ Handpiece: HYDROS™ TRUS Probe Regulation Number: 21 CFR 876.4350 Regulation Name: Fluid jet system for prostate tissue removal Regulatory Class: II Product Code: PZP Received: July 19, 2024
Dear Sara Muddell:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
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Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Sharon M. Andrews -S
for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K240200
Device Name HYDROS™ Robotic System HYDROS™ Handpiece HYDROS™ TRUS Probe
#### Indications for Use (Describe)
The HYDROS™ 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.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in large, bold, blue letters. The "O" in "PROCEPT" is replaced by a blue water drop symbol. Below the word "PROCEPT" is the word "BioRobotics" in smaller, blue letters.
# 510(k) SUMMARY
Date Prepared: August 19, 2024
| Owner/Sponsor | PROCEPT BioRobotics Corporation<br>150 Baytech Drive,<br>San Jose, 95134<br>USA |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Contact Name: Sara Muddell<br>Title: Sr. Director of Global Regulatory Affairs<br>Address: 150 Baytech Drive, San Jose, CA 95134, USA<br>Telephone: (650) 232-7217<br>Cell: (669) 220-8583<br>Email: s.muddell@procept-biorobotics.com |
| Trade Name | 1. HYDROS™ Robotic System<br>2. HYDROS™ TRUS Probe<br>3. HYDROS™ Handpiece |
| Classification | Class II |
| Classification Name | Fluid jet system for prostate tissue removal |
| Product Code | PZP |
| Regulation Number | 21 CFR 876.4350 |
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Image /page/5/Picture/0 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is in large, bold, dark blue letters. The "O" in "PROCEPT" is replaced with a stylized image of a water droplet in shades of blue. Below the word "PROCEPT" is the word "BioRobotics" in smaller, dark blue letters.
#### Predicate Device
- 1. Primary Predicate1
Trade Name - AQUABEAM ROBOTIC System 510(k) Number - K231024 cleared on August 30, 2023. Product Code - PZP Regulation Number: 876. 4350 Device Classification - Class II
## Device Description
The HYDROS™ Robotic System has three components - the HYDROS Robotic System, HYDROS TRUS Probe, and HYDROS Handpiece.
#### 1. HYDROS Robotic System
The HYDROS Robotic System, consists of the following nine components:
- HYDROS Tower ●
- Touchscreen Interfaces Monitor that supports the Tower Monitor (Tmon) and ● Surgeon Monitor (Smon)
- HYDROS Software ●
- HYDROS Operating System
- Embedded Software
- Motorpack
- Handpiece Arm
- TRUS Probe Arm
- Foot Pedal .
The HYDROS Robotic System is provided non-sterilization is required prior to each use. The Tower, Foot Pedal, Roll Stand, Articulating Arms, and Motorpack are reprocessed per instructions provided with the device after each use. The HYDROS Robotic System does not come in contact with the patients during the procedure.
## 2. HYDROS TRUS Probe
The HYDROS TRUS Probe is a biplane transrectal ultrasound probe that is used in the conjunction with the HYDROS Robotic System and HYDROS Handpiece to provide ultrasound imaging to deliver the AQUABLATION procedure. The HYDROS TRUS Probe is re-usable and provided non-sterile. It is reprocessed prior to each use as per the instructions provided in the IFU.
## 3. HYDROS Handpiece
The HYDROS Handpiece is the single-use sterile surgical device introduced to the surgical site within the prostate through the urethra to visualize, resect and remove prostatic tissue. The HYDROS Handpiece is integrated with a digital CMOS Scope and is terminally sterilized by EtO.
<sup>1</sup> The predicate device has not been subject to any design related recall.
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Image /page/6/Picture/0 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is in large, bold, dark blue letters. The "O" in Procept is a stylized water droplet. Below the word "PROCEPT" is the phrase "BioRobotics" in a smaller, dark blue font.
#### Intended Use/Indications for Use
The HYDROS Robotic System is indicated for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia.
## Intended Patient Population
The intended patient population is males suffering from LUTS resulting from benign prostatic hyperplasia (BPH).
#### Intended Users
The intended user shall be a urologist, supported by OR staff, trained and familiar with performing endoscopic surgical procedures for BPH, such as TURP, and in recognizing and managing their complications. The intended user shall also be trained and familiar with TRUS imaging.
## Technological Comparison as compared to the Predicate Device
| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| HYDROS ROBOTIC SYSTEM | | |
| Device Trade Name | HYDROS® Robotic<br>System | AQUABEAM® Robotic<br>System (P1G2) |
| Manufacturer | PROCEPT BioRobotics<br>Corporation | PROCEPT BioRobotics<br>Corporation |
| REF/Model Number | HY1000 | AB2000 |
| Pre-Market Notification Type | Traditional 510(k) | Traditional 510(k) |
| 510(k) number | K240200 | K231024 |
| Regulation Number | 21 CFR 876.4350 | 21 CFR 876.4350 |
| Regulation Name | Fluid jet system for<br>prostate tissue removal | Fluid jet system for prostate<br>tissue removal |
| Product Classification | Class II | Class II |
| Product Code | PZP | PZP |
| Intended Use/Indications for Use | The HYDROS Robotic<br>System is indicated for the<br>resection and removal of<br>prostate tissue in males<br>suffering from lower<br>urinary tract symptoms<br>(LUTS) due to benign<br>prostatic hyperplasia. | The AquaBeam Robotic<br>System is intended for the<br>resection and removal of<br>prostate tissue in males<br>suffering from lower urinary<br>tract symptoms (LUTS) due<br>to benign prostatic<br>hyperplasia. |
| Intended User | The intended user shall be<br>a urologist supported by | Urologists and support staff<br>who are trained and familiar |
| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| | HYDROS ROBOTIC SYSTEM | |
| | OR staff, trained and<br>familiar with performing<br>endoscopic surgical<br>procedures for BPH, such<br>as TURP, and in<br>recognizing and managing<br>their complications. The<br>intended user shall also be<br>trained and familiar with<br>TRUS imaging. | with performing endoscopic<br>surgical benign prostatic<br>hyperplasia procedures and<br>in recognizing and<br>managing their<br>complications. Users must<br>possess a thorough<br>understanding of the<br>technical principles, clinical<br>application, and risks<br>associated with the<br>AQUABEAM Robotic<br>System and complete the<br>PROCEPT BioRobotics<br>Corporation training<br>program prior to use. |
| Patient Population | Males suffering from<br>LUTS resulting from<br>benign prostatic<br>hyperplasia (BPH). | Males suffering from LUTS<br>resulting from benign<br>prostatic hyperplasia (BPH). |
| Intended Body/Tissue Interaction | The HYDROS Robotic<br>System is not patient<br>contacting. | The AquaBeam Robotic<br>System is not patient<br>contacting. |
| Operating Environment | Temperature: 10° to 30° C<br>Humidity: 20% to 80%,<br>non-condensing<br>Atmospheric Pressure: 70<br>kPA to 101 kPA | Temperature: 0° to 35° C<br>Humidity: 0% to 90%, non-<br>condensing<br>Atmospheric Pressure: 70<br>kPA to 107 kPA |
| Storage Environment | Temperature: 10° to 30°<br>Humidity: 20% to 80%,<br>non-condensing<br>Atmospheric Pressure: 70<br>kPA to 101 kPA | Temperature: 0° to 35° C<br>Humidity: 0% to 90%, non-<br>condensing<br>Atmospheric Pressure: 70<br>kPA to 107 kPA |
| Transportation Environment | Temperature: -18° to 60°<br>C<br>Humidity: 15% to 90%,<br>non-condensing<br>Atmospheric Pressure: 60<br>kPA to 106 kPA | Temperature: -18° to 60° C<br>Humidity: 15% to 90%,<br>non-condensing<br>Atmospheric Pressure: 60<br>kPA to 106 kPA |
| Cleaning and Disinfection Method | Clean using quaternary<br>ammonium -based cleaner<br>and disinfect using | Clean using quaternary<br>ammonium -based cleaner<br>and disinfect using |
| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| | HYDROS ROBOTIC SYSTEM | |
| Use Life | intermediate level<br>disinfectant.<br>1 year | intermediate level<br>disinfectant.<br>3 Years |
| Surgeon Interface | Two monitors for display – one surgeon<br>monitor (Smon) for use in the sterile<br>environment and the tower monitor (Tmon)<br>which can be used by support staff.<br>- Portrait view<br>- Interaction is through<br>touchscreen.<br>- Physician authorization<br>is enabled only on the<br>surgeon monitor. | Single monitor for display for use by both<br>the surgeon and the support staff<br>- landscape view<br>- Interaction is through<br>the keyboard and the<br>trackball on the<br>keyboard.<br>- Physician authorization<br>is enabled by pressing<br>the “+” button on the<br>motorpack. |
| Ultrasound | Integrated ultrasound and a<br>compatible TRUS probe is<br>provided with the<br>HYDROS Robotic<br>System. | A third-party ultrasound<br>system and a third-party<br>compatible ultrasound probe<br>is used with the AquaBeam<br>Robotic System per its<br>indications for use. |
| Cystoscope Imaging | The CMOS scope connects<br>to the HYDROS Robotic<br>System and specifically<br>the camera control unit<br>(CCU) located within the<br>tower infrastructure of the<br>device for cystoscope<br>image processing. | The AquaBeam Scope<br>which is part of the<br>AquaBeam Robotic System<br>was connected to a third-<br>party cystoscopy unit for<br>providing the live<br>cystoscope imaging during<br>the Aquablation therapy. |
| Maximum angle rotation | 225 degrees | 225 degrees |
| Maximum depth of penetration | 24.3 mm | 24.3 mm |
| Network Connection Capability | The HYDROS Robotic<br>System component (PC)<br>includes a Wi-Fi card that<br>creates network connection<br>capability. | The AquaBeam Robotic<br>System and its components<br>do not include a Wi-Fi card<br>and there is no network<br>connection capability. |
| Cloud Connection + Wi-Fi<br>connection | The software allows<br>enabling and disabling the | AquaBeam Robotic<br>Systems do not provide any<br>options for connected |
| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| | HYDROS ROBOTIC SYSTEM | |
| | cloud connection on the<br>Wi-Fi connected systems.<br>Users have the option to<br>choose a disconnected<br>system. | systems and/or options for<br>connection to Cloud servers. |
| FirstAssist AI™ (previously Assisted<br>Planning) Feature | Optional FirstAssist AI<br>feature available during<br>the PLAN step.<br>FirstAssist AI ,<br>Transverse: When the<br>FirstAssist AI toggle<br>button is enabled in the<br>transverse view at the<br>angle and depth step, the<br>software provides the<br>handpiece nozzle position<br>and the prostate capsule<br>boundary.<br>FirstAssist AI , Sagittal:<br>When the FirstAssist AI<br>toggle button is enabled at<br>the profile landmark step<br>the software will place the<br>4 landmarks - treatment<br>start (TS), bladder neck<br>(BN), mid-prostate (MP)<br>and treatment end (TE).<br>The surgeon has the option<br>to adjust the landmarks as<br>needed. | No Optional FirstAssist AI<br>feature present in the PLAN<br>step |
| Workflow Enhancement | GUI Steps:<br>• Setup – includes<br>TRUS, Handpiece and<br>Align<br>• Plan -includes Manual<br>and optional<br>FirstAssist AI<br>Transverse Angle and<br>Depth planning | GUI Steps:<br>• Setup - includes TRUS,<br>Handpiece and Align<br>• Plan -includes Manual<br>Transverse Angle and<br>Depth planning,<br>registration, Manual<br>profile for Sagittal Plane |
| COMPARISON ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| HYDROS ROBOTIC SYSTEM | | |
| | Manual and Optional<br>FirstAssist AI profile<br>options for Sagittal<br>Plane and Contour.<br>Treat – includes treatment with the options for starting an additional pass or completing the procedure. | Treat - includes treatment with the options for starting an additional pass or completing the procedure. |
| Manual Aspiration Flow Rate | During Resection:<br>Nominal Waterjet Flow +<br>10ml/min<br>Manual: $360\pm75$ ml/min =<br>[285, 435] | During Resection: Nominal<br>Waterjet Flow + 10ml/min<br>Manual: 317ml/min +/- 10%<br>= [285,349] |
| Verumontanum protection<br>orientation | Transverse Plane - The user cannot modify the default orientation of the verumontanum protection zone. Sagittal Plane - The user has the ability to modify the length of the verumontanum protection zone. | Transverse Plane - The user has the ability to modify the default orientation of the verumontanum protection zone. Sagittal Plane - The user has the ability to modify the length of the verumontanum protection zone. |
| COMPARISON<br>ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE |
| Device Trade Name | HYDROS TRUS Probe | AQUABEAM ROBOTIC SYSTEM |
| Manufacturer | PROCEPT BioRobotics<br>Corporation | PROCEPT BioRobotics<br>Corporation |
| REF/Model Number | HU1000 | AB2000 |
| Pre-Market<br>Notification<br>Information | Traditional 510(k) | Traditional 510(k) |
| 510(k) number | K240200 | K231024 |
| Regulation Number | 21 CFR 876.4350 | 21 CFR 876.4350 |
| Regulation Name | Fluid jet system for prostate<br>tissue removal | Fluid jet system for prostate tissue<br>removal |
| Product Classification | Class II | Class II |
| Product Code | PZP | PZP |
| Intended<br>Use/Indications for Use | The HYDROS Robotic System is<br>indicated for the resection and<br>removal of prostate tissue in<br>males suffering from lower<br>urinary tract symptoms (LUTS)<br>due to benign prostatic<br>hyperplasia. | The AquaBeam Robotic System is<br>indicated for the resection and<br>removal of prostate tissue in males<br>suffering from lower urinary tract<br>symptoms (LUTS) due to benign<br>prostatic hyperplasia. |
| Intended User | The intended user shall be a<br>urologist, supported by OR staff,<br>trained and familiar with<br>performing endoscopic surgical<br>procedures for BPH, such as<br>TURP, and in recognizing and<br>managing their complications.<br>The intended user shall also be<br>trained and familiar with TRUS<br>imaging. | Urologists and support staff who<br>are trained and familiar with<br>performing endoscopic surgical<br>benign prostatic hyperplasia<br>procedures and in recognizing and<br>managing their complications.<br>Users must possess a thorough<br>understanding of the technical<br>principles, clinical application, and<br>risks associated with the<br>AQUABEAM Robotic System and<br>complete the PROCEPT<br>BioRobotics Corporation training<br>program prior to use |
| Patient Population | Males suffering from LUTS<br>resulting from benign prostatic<br>hyperplasia (BPH). | Males suffering from LUTS<br>resulting from benign prostatic<br>hyperplasia (BPH). |
| COMPARISON<br>ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE…
