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

AI/ML Overview

The provided text describes the AQUABEAM® Robotic System and its substantial equivalence to a predicate device (DEN170024). It details various non-clinical tests performed to demonstrate this equivalence, but does not include information about acceptance criteria or a specific study proving the device meets those criteria in a quantitative manner (e.g., using specific metrics like sensitivity, specificity, accuracy with established thresholds).

The document focuses on verification testing to show that changes to the device (e.g., software, hardware) perform as intended and that the system remains substantially equivalent to the previously cleared predicate device.

Here's a breakdown of the information that is available, and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

The document provides a table of "Non-Clinical Testing" and "Conclusion" which states that "all acceptance criteria were met" for various categories. However, it does not explicitly define those acceptance criteria (e.g., "Software performed as intended" is a conclusion, not a measurable criterion with a numerical target). Therefore, a detailed table as requested cannot be constructed from the provided text.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text mentions "cadaver study" for design validation, but doesn't specify sample size, origin, or retrospective/prospective nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/not provided. The device is a robotic system for surgical resection, not an AI diagnostic or assistance tool for human readers in the context of image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable/not provided. The device is a physical robotic system, not an algorithm in the typical sense of standalone AI performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the system design validation, the document mentions a "cadaver study." While it doesn't explicitly state the "ground truth" for this cadaver study, it implies that the performance of the system in resecting prostate tissue on cadavers served as a proxy for validating its functionality. The nature of the ground truth (e.g., precise tissue removal confirmed by dissection or imaging) is not detailed.

8. The sample size for the training set

This information is not applicable/not provided. The device is a robotic system, not a machine learning model that undergoes a "training set."

9. How the ground truth for the training set was established

This information is not applicable/not provided for the same reason as point 8.

Summary of available information related to acceptance criteria and performance:

The document states that a variety of non-clinical tests were performed on the AQUABEAM Robotic System to demonstrate substantial equivalence to its predicate device. For each category of testing, the conclusion is that "all acceptance criteria were met." However, the specific metrics and thresholds for these "acceptance criteria" are not detailed.

Here's what the document indicates regarding testing and conclusions:

Table of Acceptance "Criteria" (Implicit) and Reported Device Performance:

Non-Clinical Testing Category	Implicit Acceptance Criterion (as per conclusion)	Reported Device Performance/Conclusion
Software and Firmware Verification	Performance as intended, meeting all acceptance criteria.	Verification testing performed on CPU software, operating system, MCU firmware, and updates to Console FPGA and Motorpack FPGA. "The software and firmware performed as intended and all acceptance criteria were met demonstrating substantial equivalence."
Hardware Verification	Performance as intended, meeting all acceptance criteria.	Verification testing conducted on Console, Motorpack, and System. "The Console, Motorpack and System performed as intended and all acceptance criteria were met demonstrating substantial equivalence."
Electrical Safety and Electromagnetic Compatibility	Compliance with relevant standards.	"All testing passed EMC per IEC 60601-1-2 4th edition requirements. All testing passed electrical safety per the standards listed."
System Design Verification	Functional and simulated use performance, meeting all acceptance criteria.	Verification testing performed on the AQUABEAM Robotic System to test functional and simulated use. "All acceptance criteria were met demonstrating substantial equivalence to the predicate device."
System Design Validation	Performance in a cadaver study, meeting all acceptance criteria.	A design validation was conducted via a cadaver study. "All acceptance criteria were met demonstrating substantial equivalence to the predicate device."
Packaging Validation	Compliance with ASTM standards for packaging and transportation.	Validation performed on components with design changes (Console, Motorpack). "The components with design change passed all testing conducted."
Reliability Testing	Reliability equivalent to predicate device, documented use life.	Evaluated the reliability of components with design changes. "The results are equivalent to the predicate device. The use life is documented in the table above and in the product labeling."

Additional relevant points from the text:

Clinical Trial Data: "Existing clinical trial data is sufficient to establish the safety and effectiveness of 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." This indicates that previous clinical data for the predicate device, which shares the same indications for use and mechanism of action, is being leveraged, eliminating the need for new clinical trials for this specific 510(k) submission.
The 510(k) submission is for changes to an existing, already cleared device, demonstrating substantial equivalence to its predicate (DEN170024). The focus is on showing that the changes do not negatively impact safety or effectiveness.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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:	(650) 232-7217
Cell:	(669) 220-8583
Fax:	(650) 232-5782
Email:	s.muddell@procept-biorobotics.com

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, 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 DeviceAQUABEAM RoboticSystem	Predicate DeviceAQUABEAM System	Change
Device Class	Class II	Class II	Same
Product Code	PZP	PZP	Same
Product RegulationNumber	876.4350	876.4350	Same
IntendedUse/Indications forUse	The AQUABEAM RoboticSystem is intended for theresection and removal ofprostate tissue in malessuffering from lowerurinary tract symptoms(LUTS) due to benignprostatic hyperplasia.	The AQUABEAM RoboticSystem is intended for theresection and removal ofprostate tissue in malessuffering from lowerurinary tract symptoms(LUTS) due to benignprostatic hyperplasia.	Same
Intended PatientPopulation	The intended patientpopulation is malessuffering from LUTSresulting from benignprostatic hyperplasia(BPH).	The intended patientpopulation is malessuffering from LUTSresulting from benignprostatic hyperplasia(BPH).	Same
Intended Users	The intended users areurologists and supportstaff who are trained andfamiliar with TransrectalUltrasound (TRUS) andperforming endoscopicsurgical benign prostatichyperplasia procedures	The intended users areurologists and supportstaff who are trained andfamiliar with TransrectalUltrasound (TRUS) andperforming endoscopicsurgical benign prostatichyperplasia procedures	Same
	Subject DeviceAQUABEAM RoboticSystem	Predicate DeviceAQUABEAM System	Change	Traditional 510(k) app
	and in recognizing andmanaging theircomplications.	and in recognizing andmanaging theircomplications.
Patient Contact	The AQUABEAM RoboticSystem shall be usedendoscopically accessingthe prostate via the urethra(external communicatingdevice, tissue/bone/dentin,with limited exposure (<24hours).	The AQUABEAM RoboticSystem shall be usedendoscopically accessingthe prostate via the urethra(external communicatingdevice, tissue/bone/dentin,with limited exposure (<24hours).	Same
Energy Source	100/115/220/230/240VAC1000 W50/60 Hz	115-230 VAC600 W50/60 Hz	Equivalent
Sterilization method	Ethylene OxideSterilization (EO)SAL 10-6	Ethylene OxideSterilization (EO)SAL 10-6	Same
OperatingEnvironment	Temperature: 0° to 35° CHumidity: 0% to 90%,non-condensingAtmospheric Pressure: 70kPA to 107 kPA	Temperature: 0° to 35° CHumidity: 0% to 90%,non-condensingAtmospheric Pressure: 70kPA to 106 kPA	Same
Transportation andStorage Environment	Temperature: -18° to 60°CHumidity: 15% to 90%,non-condensingAtmospheric Pressure: 60kPA to 106 kPA	Temperature: -18° to 60°CHumidity: 15% to 90%,non-condensingAtmospheric Pressure: 70kPA to 106 kPA	Same
Use Life of the system	185 cycles	3 Years	Changed torepresent use life incycles instead oftime duration.
Use Life of theArticulating Arms	200 cycles	4 months (19 cycles)	No change to TRUSarticulating arms,the changed use lifeis due to resultsfrom continuedtesting.
Use Life of theAQUABEAM Scope(reusable componentthat requiresreprocessing prior toeach use)	58 cycles	8 months (58 cycles)	Removed thenumber of months inthe subject device,no change to thetesting or theAQUABEAM Scope
	Subject DeviceAQUABEAM RoboticSystem	Predicate DeviceAQUABEAM System	Change
			that resulted in thechange
Shelf Life (Handpieceis the single usecomponent providedsterile)	24 months (2 Years)	24 months (2 Years)	Same
Maximum anglerotation	225 degrees	225 degrees	Same
Maximum depth ofpenetration	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 aWIFi chipset allowingnetwork connectivity	Network connectivityis not available.	Allows upload of theencrypted treatmentlogs to PROCEPTCloud for future deviceimprovements.
Hardware architecturechanges:MCU firmwareUpdates to consoleFPGA and MotorpackFPGA	A new firmware wasadded to the Console,Microcontroller Unit(MCU) Firmware.The Console FPGAand the MotorpackFPGA.Updates to ConsoleFPGA and MotorpackFPGA to accommodatethe new MCUfirmware.	MCU firmware is notincluded in thepredicate deviceConsole.	Enhancecommunication withthe CPU and theMotorpack FPGA
Hardware changes	Motorpack - New Rmotor with 24 VcapabilityConsole- added SPI cable	Motorpack – R motorwithout the 24VcapabilityConsole:No SPI cable (noMCU)HPP cable existsTubing exist	Motorpack - new Rmotor added forimproved reliabilityConsole:- SPI cable isneeded forcommunicationwith the MCUfirmware- Enhanced signalintegrity 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- Flexible expandable tubing	cable- 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 Firmwareverification	IEC 62304 Edition 1.1 2015-06CONSOLIDATED VERSION Medicaldevice software - Software life cycleprocessesNIST FIPS 140-2, Security Requirements forCryptographic ModulesNIST FIPS 140-2 Suite B CryptographicModuleNon-Proprietary Security Policy	Verification testing was performedon the:- CPU software,- Operating system- MCU firmware- Updates to Console FPGA- Updates to Motorpack FPGAThe software and firmwareperformed as intended and allacceptance criteria were metdemonstrating substantialequivalence.
Hardware Verification	None	Verification testing was conductedon the:- Console- Motorpack- SystemThe Console, Motorpack andSystem performed as intended and
	Traditional 510(k) application
		all acceptance criteria were metdemonstrating substantialequivalence.
Electrical Safety andElectromagneticCompatibility	EMC - IEC 60601-1-2 Edition 4.0 2014-02Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance – Collateral standard:electromagnetic disturbances – Requirementsand testsElectrical Safety:ANSI AAMI ES 60601-1:2005/(R)2012Medical electrical equipment - Part 1:General requirements for basic safety andessential performanceIEC 60601-1-6 Edition 3.1 2013-10 Medicalelectrical equipment - Part 1-6: Generalrequirements for safety - CollateralStandard: UsabilityANSI AAMI IEC 62366-1:2015 Medicaldevices - Part 1: Application of usabilityengineering to medical devicesIEC 80601-2-77 Edition 1.0 2019-07Medical electrical equipment - Part 2-77:Particular requirements for the BASICSAFETY and essential performance ofrobotically assisted surgical equipment.IEC 60601-2-18: Edition 3.0 2009-08Medical electrical equipment - Part 2-18:Particular requirements for the basic safetyand essential performance of endoscopicequipment.	All testing passed EMC per IEC60601-1-2 4th editionrequirements.All testing passed electrical safetyper the standards listed.
System DesignVerification	None	Verification testing was performedon the AQUABEAM Robotic systemto test the functional and simulateduse and all acceptance criteriawere met demonstratingsubstantial equivalence to thepredicate device.
System DesignValidation	None	A design validation of theAQUABEAM Robotic System wasconducted by performing acadaver study and all acceptancecriteria were met demonstratingsubstantial equivalence to the
		Traditional 510(k) applicapredicate device.
Packaging Validation	ASTM D4169-16 2016-04-01 StandardPractice for Performance Testing of ShippingContainers and Systems	Packaging and transportationvalidation was performed on thefollowing components with designchange:- Console- MotorpackThere are no changes to packagingthat are subject of this traditional510(k). The components withdesign change passed all testingconducted.
	ASTM D4332-14 Standard Practice forConditioning Containers, Packages, orPackaging Components for Testing
	ASTMD5276 – Test Method for Drop Testof Loaded Containers by Free Fall
	ASTM D999 – Test Method for Vibrationtesting of Shipping Containers
	ASTM D4728 – Test Method for RandomVibration Testing of Shipping Containers
	ASTM D6653 – Low pressure (altitude)
	ASTM D642 – Vehicle Stacking
	ASTM D6344 - Concentrated Impact
Reliability Testing	None	The reliability of the componentswith design changes wereevaluated and the results areequivalent to the predicate device.The use life is documented in thetable above and in the productlabeling.

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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.
1. 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.

Regulation Number and Section

§ 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.