AquaBeam Robotic System

{0}------------------------------------------------ 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 6, 2021 PROCEPT BioRobotics Corporation Sara Muddell Director. Global Regulatory Affairs 900 Island Drive. Suite 101 Redwood City, CA 94065 Re: K212835 > Trade/Device Name: AQUABEAM® Robotic System Regulation Number: 21 CFR§ 876.4350 Regulation Name: Fluid Jet System For Prostate Tissue Removal Regulatory Class: II Product Code: PZP Dated: September 3, 2021 Received: September 7, 2021 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 (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 located 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. 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. {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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 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, 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K212835 Device Name AQUABEAM® Robotic System Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Procept BioRobotics. The logo consists of the word "PROCEPT" in a sans-serif font, with a stylized water droplet replacing the "O". Below the word "PROCEPT" is the word "BioRobotics" in a smaller sans-serif font. The logo is simple and modern, and the water droplet suggests that the company is involved in water-related technologies. # 510(k) SUMMARY ### Date Prepared September 30, 2021 #### Owner/Sponsor | Owner/Sponsor | PROCEPT BioRobotics Corporation<br>900 Island Drive,<br>Suite 101<br>Redwood City, 94065<br>USA | |---------------|-------------------------------------------------------------------------------------------------| | Contact Name: | Sara Muddell | | Title: | Director of Global Regulatory Affairs | | Address: | 900 Island Drive, Suite 101, Redwood City, CA, 94065, USA | | Telephone: | (650) 232-7217 | | Cell: | (669) 220-8583 | | Fax: | (650) 232-5782 | | Email: | s.muddell@procept-biorobotics.com | #### Device Trade Name AQUABEAM® Robotic System #### Common Name - AQUABEAM ● - AQUABEAM Robotic System ● - . Fluid jet system for prostate tissue removal #### Classification and Classification Name Class II Product Code: PZP 21 CFR 876. 4350. 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. #### Predicate Device AQUABEAM Robotic System 510(k) Number: K202961 on November 04, 2020. Product Code: PZP Regulation Number: 876. 4350 Class II {4}------------------------------------------------ #### Device Description 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 highpressure 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. Precondition 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 AQUABEAM Console, Motorpack, Conformal Planning Unit, Foot Pedal, Roll Stand, Handpiece Articulating Arm and TRUS Articulating Arm are provided non-sterilization is required prior to each use. The Console, Conformal Planning Unit, Foot Pedal, Roll Stand, Articulating Arms, and Motorpack are cleaned after each use. The Console, Conformal Planning Unit, Foot Pedal, Roll Stand, Articulating Arms, and Motorpack are not designed to come in contact with the patient during the Aquablation procedure. The Conformal Planning Unit is a reusable component of the AQUABEAM Robotic System, and it serves as the primary user interface of the System. The CPU is connected to the Console via a USB cable. The AQUABEAM Console is a reusable component of the AquaBeam Robotic System that controls the functionality of the high-velocity waterjet delivered by the Handpiece. The AQUABEAM Motorpack is a reusable component of the AQUABEAM Robotic System designed to dock, via a mechanical linkage, and connect with the disposable Handpiece. The Motorpack provides mechanical 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. {5}------------------------------------------------ The AQUABEAM Foot Pedal is a reusable, purchased component of the AQUABEAM Robotic System that contains three foot-activated momentary switches. It is connected to the Console with a flexible cable. The Aquablate Pedal is the large center switch which must be depressed to enable Aquablation. The AQUABEAM Roll Stand provides the main power source, via the isolation transformer, to the Console and serves as the chassis for the AQUABEAM Robotic System. The AQUABEAM Handpiece Articulating Arm fixes the Handpiece/Motorpack assembly in position relative to the patient. The AQUABEAM TRUS Articulating Arm fixes the TRUS probe and stepper in position relative to the patient. The AQUABEAM Handpiece is a terminally sterilized, single-use disposable component of the AQUABEAM Robotic System. The AquaBeam Scope, a re-usable component of the AquaBeam Robotic System, needs to be reprocessed prior to each use per the AquaBeam Scope Reprocessing Instructions. The Scope is inserted into the central lumen of the Handpiece enabling direct visualization within the prostatic urethra during treatment. #### Intended Use/Indications for Use The intended use of the subject device is identical to the intended use of the predicate device. 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. #### Intended Patient Population The intended patient population of the subject device is identical to the intended use of the predicate device. The intended patient population is males suffering from benign prostatic hyperplasia (BPH). #### Intended Users The intended users of the subject device is identical to the intended use of the predicate device. The intended users are urologists and support staff who are trained and familiar with Transrectal Ultrasound (TRUS) and performing endoscopic surgical benign prostatic hyperplasia procedures and in recognizing and managing their complications. #### Technological Characteristics as Compared to the Predicate Device The technological characteristics of the AQUABEAM Robotic System such as design, material and chemical composition of patient contacting components and energy source remain equivalent to the predicate device, AQUABEAM System. The table below summarizes the comparison between the subject device and the predicate device - | COMPARISON<br>ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE | CHANGE | |--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | Device Class | Class II | Class II | Same | | Product Code | PZP | PZP | Same | | Product Regulation<br>Number | 21 CFR 876.4350 | 21 CFR 876.4350 | Same | | | | | | | Intended<br>Use/Indications for<br>Use | The AQUABEAM System is<br>intended for the resection and<br>removal of prostate tissue in<br>males suffering from lower<br>urinary tract symptoms<br>(LUTS) due to benign prostatic<br>hyperplasia. | The AQUABEAM System<br>is intended for the resection<br>and removal of prostate<br>tissue in males suffering<br>from lower urinary tract<br>symptoms (LUTS) due to<br>benign prostatic hyperplasia. | Same | | Intended Patient<br>Population | The intended patient<br>population is males<br>suffering from LUTS<br>resulting from benign<br>prostatic hyperplasia (BPH). | The intended patient<br>population is males<br>suffering from LUTS<br>resulting from benign<br>prostatic hyperplasia<br>(BPH). | Same | | Intended User | Urologists and support staff<br>who are trained and familiar<br>with performing endoscopic<br>surgical benign prostatic<br>hyperplasia procedures and in<br>recognizing and managing<br>their complications. Users<br>must possess a thorough<br>understanding of the technical<br>principles, clinical application,<br>and risks associated with the<br>AQUABEAM Robotic System<br>and complete the PROCEPT<br>BioRobotics Corporation<br>training program prior to use | Urologists and support staff<br>who are trained and familiar<br>with performing endoscopic<br>surgical benign prostatic<br>hyperplasia procedures and<br>in recognizing and managing<br>their complications. Users<br>must 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 | Same | | Patient Contact | The AQUABEAM Robotic<br>System shall be used<br>endoscopically accessing the<br>prostate via the urethra<br>(external communicating<br>device, tissue/bone/dentin,<br>with limited exposure (<24<br>hours). | The AQUABEAM Robotic<br>System shall be used<br>endoscopically accessing the<br>prostate via the urethra<br>(external communicating<br>device, tissue/bone/dentin,<br>with limited exposure (<24<br>hours). | Same | | Sterilization<br>method | Ethylene Oxide Sterilization<br>(ETO)<br>SAL 10-6 | Ethylene Oxide Sterilization<br>(ETO)<br>SAL 10-6 | Same | | Operating<br>Environment | Temperature: 0° to 35° C<br>Humidity: 0% to 90%, non-<br>condensing<br>Atmospheric Pressure: 70 kPA<br>to 107 kPA | Temperature: 0° to 35° C<br>Humidity: 0% to 90%, non-<br>condensing<br>Atmospheric Pressure: 70<br>kPA to 107 kPA | Same | | Transportation and<br>Storage<br>Environment | Temperature: 0° to 35° C<br>Humidity: 0% to 90%, non-<br>condensing<br>Atmospheric Pressure: 70 kPA<br>to 107 kPA | Temperature: 0° to 35° C<br>Humidity: 0% to 90%, non-<br>condensing<br>Atmospheric Pressure: 70<br>kPA to 107 kPA | Same | | | | | | | Use Life of the<br>system | 185 cycles | 185 cycles | Same | | Use Life of the<br>Articulating Arms | 200 cycles | 200 cycles | Same | | Reprocessing<br>Sterilization<br>methods for<br>AQUABEAM<br>Scope | STERIS System 1E Standard Cycle STERRAD 100NX Express Cycle STERRAD NX Standard or Advanced cycle STERRAD 100S STERIS V-Pro® 1 Plus - Non Lumen cycle STERIS V-Pro® maX – Non Lumen cycle STERIS V-Pro® mAX 2 – Non Lumen cycle Matachana 130HPO® and 50HPO® - Standard cycle Getinge GSS67F Low Temperature Steam and Formaldehyde - 55°C Cycle Ethylene Oxide (EtO) | STERIS System 1E Standard Cycle STERRAD 100NX Standard Cycle STERRAD NX Standard or Advanced cycle STERRAD 100S STERIS V-Pro® 1 Plus – Non Lumen cycle STERIS V-Pro® maX – Non Lumen cycle STERIS V-Pro® mAX 2 – Non Lumen cycle Matachana 130HPO® and 50HPO® - Standard cycle Getinge GSS67F Low Temperature Steam and Formaldehyde - 55°C Cycle Ethylene Oxide (EtO) | Updated the sterilization<br>methods for AQUABEAM<br>Scope to replace STERRAD<br>100NX Standard cycle with<br>STERRAD 100NX Express<br>cycle. | | Use Life of the<br>AQUABEAM<br>Scope (reusable<br>component that<br>requires<br>reprocessing prior<br>to each use) | At least 10 cycles | 58 cycles | Updated the use life cycles<br>after adding the STERRAD<br>100NX Express cycles. | | Shelf Life<br>(Handpiece is the<br>single use<br>component<br>provided sterile) | 24 months (2 Years) | 24 months (2 Years) | Same | | Mechanism of Action | | | | | COMPARISON<br>ELEMENT | SUBJECT DEVICE | PREDICATE DEVICE | COMMENTS | | Maximum angle<br>rotation | 225 degrees | 225 degrees | Same | | Maximum depth of<br>penetration | 24.3 mm | 24.3 mm | Same | {6}------------------------------------------------ # BIOROBOTICS {7}------------------------------------------------ ## Subject Device Design Changes The AQUABEAM Robotic System, subject of this 510(k) includes the following changes: - 1. IFU Change Replacing the scope sterilization cycle STERRAD 100NX Standard with STERRAD 100NX Express cycle. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is written in a bold, sans-serif font, with a stylized water droplet replacing the "O". Below the word "PROCEPT" is the word "BioRobotics" in a smaller, sans-serif font. The logo is simple and modern, and the water droplet suggests that the company is involved in water-related technologies. - 2. Update to the use life of AQUABEAM Scope - The scope life specification of the AQUABEAM Scopes is updated to at least 10 use cycles. #### Summary of Non-Clinical Performance Testing A list of the verification, validation and other testing that have been performed on the AQUABEAM Scope with the sterilization change is included below. | Non-clinical Testing | Conforming Standard and Guidance | |-----------------------------------------------|---------------------------------------------------| | Sterilization Validation testing for AQUABEAM | 1. EN ISO 14937: 2009 Sterilization of health | | Scope | care products - general requirements | | | for characterization of sterilizing agent and the | | | development, validation, and routine control of a | | | sterilization process for medical devices | | | 2. ISO 10993-5 Biological evaluation of medical | | | devices - Part 5: Tests for invitro cytotoxicity. | | | 3. ISO 10993-12 Biological evaluation of medical | | | devices - Part 5: Sample Preparation and | | | reference materials | | | 4. ISO 17664:2017 Processing of health care | | | products – Information to be provided | | | by the medical device manufacturer for the | | | processing of medical | | | devices. | | AQUABEAM scope Reliability testing | None | The following testing performed on the predicate device is still applicable to the subject device of this Special 510(k): - 1. Biocompatibility - 2. Clinical Trial data - 3. Design Verification and Design Validation testing #### Conclusion: The overall performance data in this submission supports that the AQUABEAM Robotic System is safe, effective, and substantially equivalent to the predicate device when utilized for its intended use.