AquaBeam Robotic System

K202961 · Procept Biorobotics, Corporation · PZP · Mar 11, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202961
• Device Name: AquaBeam Robotic System
• Applicant: Procept Biorobotics, Corporation
• Product Code: PZP · General, Plastic Surgery
• Decision Date: Mar 11, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

AQUABEAM Robotic System performs minimally invasive prostate tissue resection using a high-velocity sterile saline waterjet. System components include a console, motorpack, conformal planning unit (CPU), foot pedal, articulating arms, handpiece, and scope. The handpiece and scope are inserted transurethrally; the nozzle assembly, driven by DC motors in the motorpack, directs the waterjet to resect tissue based on a pre-operative plan set on the CPU. The system integrates TRUS imaging to monitor treatment progress. Used by urologists in clinical settings. The CPU provides the user interface for planning and control. New features include network connectivity for encrypted log uploads to the cloud and updated firmware/hardware for improved communication and reliability. The device benefits patients by providing a controlled, robotic-assisted method for BPH treatment.

Clinical Evidence

No new clinical trials were conducted for this 510(k). The manufacturer relied on existing clinical data from the predicate device, asserting that design changes do not alter the device's mode of operation or mechanism of action. Design validation was supported by a cadaver study.

Technological Characteristics

System utilizes a high-velocity sterile saline waterjet for tissue resection. Components include a console, motorpack, CPU, and articulating arms. Connectivity via WiFi chipset for cloud log uploads. Software/firmware updated for MCU/FPGA communication. Electrical safety per ANSI AAMI ES 60601-1; EMC per IEC 60601-1-2. Handpiece is terminally sterilized (EO, SAL 10^-6).

Indications for Use

Indicated for males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).

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 System (DEN170024)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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.

March 11, 2021

PROCEPT BioRobotics Corporation Sara Muddell Director, Global Regulatory Affairs 900 Island Drive, Suite 101 Redwood City, CA 94065

Re: K202961

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: February 1, 2021 Received: February 2, 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 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.

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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 801and Part 809); 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mark J. Antonino, M.S. Acting 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) K202961

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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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 symbol in place of 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 symbol suggests that the company is involved in water-related technologies.

Traditional 510(k) application

## 510(k) SUMMARY

### Date of submission:

November 04, 2020

### Owner/Sponsor

| Owner/Sponsor | PROCEPT BioRobotics Corporation |
|---------------|-----------------------------------------------------------|
| | 900 Island Drive, |
| | Suite 101 |
| | Redwood City, 94065 |
| | USA |
| Contact Name: | Sara Muddell |
| Title: | Director of Global Regulatory Affairs |
| Address: | 900 Island Drive, Suite 101, Redwood City, CA, 94065, USA |
| Telephone: | [phone] |
| Cell: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |

### Trade/Device Name

AQUABEAM® Robotic System

#### Device Common Name

- AQUABEAM
- AQUABEAM Robotic System
- Fluid jet system for prostate tissue removal ●

#### Device Classification Number and Classification Name

21 CFR 876.4350, Fluid jet system for prostate tissue removal

# Regulatory Class: II

# Product Code: PZP

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

Trade Name: AQUABEAM System 510(k) Number: DEN170024 on 21 December 2017. Product Code: PZP Regulation Number: 876. 4350 Class II

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Image /page/4/Picture/0 description: The image shows the logo for Procept BioRobotics. The word "PROCEPT" is in large, bold, gray letters. The "O" in "PROCEPT" is replaced with a blue water droplet. Below "PROCEPT" is the word "BioRobotics" in smaller, gray letters.

Submission Number: DEN170024

# Intended Use/Indications for Use

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.

# 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 wateriet 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 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.

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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.

| | Subject Device<br>AQUABEAM Robotic<br>System | Predicate Device<br>AQUABEAM System | Change | |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------|
| Device Class | Class II | Class II | Same | |
| Product Code | PZP | PZP | Same | |
| Product Regulation<br>Number | 876.4350 | 876.4350 | Same | |
| Intended<br>Use/Indications for<br>Use | The AQUABEAM Robotic<br>System is intended 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<br>urinary tract symptoms<br>(LUTS) due to benign<br>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<br>(BPH). | The intended patient<br>population is males<br>suffering from LUTS<br>resulting from benign<br>prostatic hyperplasia<br>(BPH). | Same | |
| Intended Users | The intended users are<br>urologists and support<br>staff who are trained and<br>familiar with Transrectal<br>Ultrasound (TRUS) and<br>performing endoscopic<br>surgical benign prostatic<br>hyperplasia procedures | The intended users are<br>urologists and support<br>staff who are trained and<br>familiar with Transrectal<br>Ultrasound (TRUS) and<br>performing endoscopic<br>surgical benign prostatic<br>hyperplasia procedures | Same | |
| | Subject Device<br>AQUABEAM Robotic<br>System | Predicate Device<br>AQUABEAM System | Change | Traditional 510(k) app |
| | and in recognizing and<br>managing their<br>complications. | and in recognizing and<br>managing their<br>complications. | | |
| Patient Contact | The AQUABEAM Robotic<br>System shall be used<br>endoscopically accessing<br>the 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<br>the prostate via the urethra<br>(external communicating<br>device, tissue/bone/dentin,<br>with limited exposure (<24<br>hours). | Same | |
| Energy Source | 100/115/220/230/240<br>VAC<br>1000 W<br>50/60 Hz | 115-230 VAC<br>600 W<br>50/60 Hz | Equivalent | |
| Sterilization method | Ethylene Oxide<br>Sterilization (EO)<br>SAL 10-6 | Ethylene Oxide<br>Sterilization (EO)<br>SAL 10-6 | Same | |
| Operating<br>Environment | Temperature: 0° to 35° C<br>Humidity: 0% to 90%,<br>non-condensing<br>Atmospheric Pressure: 70<br>kPA to 107 kPA | Temperature: 0° to 35° C<br>Humidity: 0% to 90%,<br>non-condensing<br>Atmospheric Pressure: 70<br>kPA to 106 kPA | Same | |
| Transportation and<br>Storage 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°<br>C<br>Humidity: 15% to 90%,<br>non-condensing<br>Atmospheric Pressure: 70<br>kPA to 106 kPA | Same | |
| Use Life of the system | 185 cycles | 3 Years | Changed to<br>represent use life in<br>cycles instead of<br>time duration. | |
| Use Life of the<br>Articulating Arms | 200 cycles | 4 months (19 cycles) | No change to TRUS<br>articulating arms,<br>the changed use life<br>is due to results<br>from continued<br>testing. | |
| Use Life of the<br>AQUABEAM Scope<br>(reusable component<br>that requires<br>reprocessing prior to<br>each use) | 58 cycles | 8 months (58 cycles) | Removed the<br>number of months in<br>the subject device,<br>no change to the<br>testing or the<br>AQUABEAM Scope | |
| | Subject Device<br>AQUABEAM Robotic<br>System | Predicate Device<br>AQUABEAM System | Change | |
| | | | that resulted in the<br>change | |
| Shelf Life (Handpiece<br>is the single use<br>component provided<br>sterile) | 24 months (2 Years) | 24 months (2 Years) | Same | |
| Maximum angle<br>rotation | 225 degrees | 225 degrees | Same | |
| Maximum depth of<br>penetration | 24.3 mm | 24.3 mm | Same | |

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K202961 Page 4 of 8

Traditional 510(k) application

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K202961 Page 5 of 8

Traditional 510(k) application

# Subject Device Design Changes

The AQUABEAM Robotic System, subject of this traditional 510(k) includes the changes listed below. These changes do not impact the mode of operation and/or the mechanism of action of the subject device. The mode of operation and/or mechanism of action of the subject device is the same as that of the predicate device.

| Change | Subject device | Predicate device | Reason for change |
|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Network Connectivity | CPU board includes a<br>WIFi chipset allowing<br>network connectivity | Network connectivity<br>is not available. | Allows upload of the<br>encrypted treatment<br>logs to PROCEPT<br>Cloud for future device<br>improvements. |
| Hardware architecture<br>changes:<br>MCU firmware<br>Updates to console<br>FPGA and Motorpack<br>FPGA | A new firmware was<br>added to the Console,<br>Microcontroller Unit<br>(MCU) Firmware.<br>The Console FPGA<br>and the Motorpack<br>FPGA.<br>Updates to Console<br>FPGA and Motorpack<br>FPGA to accommodate<br>the new MCU<br>firmware. | MCU firmware is not<br>included in the<br>predicate device<br>Console. | Enhance<br>communication with<br>the CPU and the<br>Motorpack FPGA |
| Hardware changes | Motorpack - New R<br>motor with 24 V<br>capability<br><br>Console<br>- added SPI cable | Motorpack – R motor<br>without the 24V<br>capability<br><br>Console:<br>No SPI cable (no<br>MCU)<br>HPP cable exists<br>Tubing exist | Motorpack - new R<br>motor added for<br>improved reliability<br><br>Console:<br>- SPI cable is<br>needed for<br>communication<br>with the MCU<br>firmware<br>- Enhanced signal<br>integrity of HPP |

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Image /page/8/Picture/1 description: The image shows the logo for Procept BioRobotics. The logo consists of the word "PROCEPT" in a bold, sans-serif font, with a stylized water droplet symbol incorporated into the "O". Below the word "PROCEPT" is the word "BioRobotics" in a smaller, sans-serif font. The overall design is clean and modern.

Traditional 510(k) application

| | | Traditional 510(k) | |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| | - HPP cable<br>- Flexible expandable tubing | cable<br>- Ease of assembly | |
| Software changes | An optional icon was added on the AQUABEAM Conformal Planning Unit (CPU) Software, Graphical User Interface (GUI) that allows the adjusting of the gain, depth and frequency of the third party TRUS. | Third party TRUS is used for adjusting the gain, depth and frequency. | Thew optional feature is added for ease of use. |
| Labeling change | Removed contraindication “known allergy to device materials” | Includes contraindication “Known allergy to device materials” | This change is not relevant to the subject or the predicate device and has no impact on the safety and effectiveness of the device. |

# Performance Data

A list of the non-clinical testing performed on the subject device, AQUABEAM Robotic System to demonstrate substantial equivalence includes verification and other testing is listed below. The non-clinical testing conducted are the same as those completed for the predicate device.

| Non-Clinical Testing | Conforming standard | Conclusion |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software and Firmware<br>verification | IEC 62304 Edition 1.1 2015-06<br>CONSOLIDATED VERSION Medical<br>device software - Software life cycle<br>processes<br>NIST FIPS 140-2, Security Requirements for<br>Cryptographic Modules<br>NIST FIPS 140-2 Suite B Cryptographic<br>Module<br>Non-Proprietary Security Policy | Verification testing was performed<br>on the:<br>- CPU software,<br>- Operating system<br>- MCU firmware<br>- Updates to Console FPGA<br>- Updates to Motorpack FPGA<br>The software and firmware<br>performed as intended and all<br>acceptance criteria were met<br>demonstrating substantial<br>equivalence. |
| Hardware Verification | None | Verification testing was conducted<br>on the:<br>- Console<br>- Motorpack<br>- System<br>The Console, Motorpack and<br>System performed as intended and |
| | Traditional 510(k) application | |
| | | all acceptance criteria were met<br>demonstrating substantial<br>equivalence. |
| Electrical Safety and<br>Electromagnetic<br>Compatibility | EMC - IEC 60601-1-2 Edition 4.0 2014-02<br>Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and<br>essential performance – Collateral standard:<br>electromagnetic disturbances – Requirements<br>and tests<br>Electrical Safety:<br>ANSI AAMI ES 60601-1:2005/(R)2012<br>Medical electrical equipment - Part 1:<br>General requirements for basic safety and<br>essential performance<br>IEC 60601-1-6 Edition 3.1 2013-10 Medical<br>electrical equipment - Part 1-6: General<br>requirements for safety - Collateral<br>Standard: Usability<br>ANSI AAMI IEC 62366-1:2015 Medical<br>devices - Part 1: Application of usability<br>engineering to medical devices<br>IEC 80601-2-77 Edition 1.0 2019-07<br>Medical electrical equipment - Part 2-77:<br>Particular requirements for the BASIC<br>SAFETY and essential performance of<br>robotically assisted surgical equipment.<br>IEC 60601-2-18: Edition 3.0 2009-08<br>Medical electrical equipment - Part 2-18:<br>Particular requirements for the basic safety<br>and essential performance of endoscopic<br>equipment. | All testing passed EMC per IEC<br>60601-1-2 4th edition<br>requirements.<br>All testing passed electrical safety<br>per the standards listed. |
| System Design<br>Verification | None | Verification testing was performed<br>on the AQUABEAM Robotic system<br>to test the functional and simulated<br>use and all acceptance criteria<br>were met demonstrating<br>substantial equivalence to the<br>predicate device. |
| System Design<br>Validation | None | A design validation of the<br>AQUABEAM Robotic System was<br>conducted by performing a<br>cadaver study and all acceptance<br>criteria were met demonstrating<br>substantial equivalence to the |
| | | Traditional 510(k) applica<br>predicate device. |
| Packaging Validation | ASTM D4169-16 2016-04-01 Standard<br>Practice for Performance Testing of Shipping<br>Containers and Systems | Packaging and transportation<br>validation was performed on the<br>following components with design<br>change:<br>- Console<br>- Motorpack<br><br>There are no changes to packaging<br>that are subject of this traditional<br>510(k). The components with<br>design change passed all testing<br>conducted. |
| | ASTM D4332-14 Standard Practice for<br>Conditioning Containers, Packages, or<br>Packaging Components for Testing | |
| | ASTMD5276 – Test Method for Drop Test<br>of Loaded Containers by Free Fall | |
| | ASTM D999 – Test Method for Vibration<br>testing of Shipping Containers | |
| | ASTM D4728 – Test Method for Random<br>Vibration Testing of Shipping Containers | |
| | ASTM D6653 – Low pressure (altitude) | |
| | ASTM D642 – Vehicle Stacking | |
| | ASTM D6344 - Concentrated Impact | |
| Reliability Testing | None | The reliability of the components<br>with design changes were<br>evaluated and the results are<br>equivalent to the predicate device.<br>The use life is documented in the<br>table above and in the product<br>labeling. |

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Image /page/9/Picture/1 description: The image shows the logo for Procept BioRobotics. The logo consists of the word "PROCEPT" 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.

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Traditional 510(k) application

The following testing performed on the predicate device are still applicable to the subject device of this traditional 510(k):

- 1. Biocompatibility There are no changes to the AQUABEAM handpiece and AQUABEAM Scope subject of this traditional 510(k) that require a reassessment of biocompatibility.
- 2. Sterilization: There are no changes to the AQUABEAM Handpiece subject of this traditional 510(k) that require a new sterilization validation.
- Clinical Trial data: Existing clinical trial data is sufficient to establish the safety and effectiveness of 3. the subject device, AQUABEAM Robotic System with the changes in design subject of this traditional 510(k) do not change the mode of operation/mechanism of action of the device.

# Conclusion:

The changes subject of this traditional 510(k) do not change the indications for use, intended user, intended use, patient population, treatment access site, device classification regulation and mode of operation (mechanism of action) which remain identical to the predicate device. The overall performance data evaluated through non-clinical testing 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.