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 FDA 510(k) summary does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and the study proving the device meets them. This document primarily focuses on demonstrating substantial equivalence to a predicate device, particularly regarding a software change. It indicates that most performance data relies on previous testing of the predicate device.

However, based on the information available, here's what can be extracted:

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

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance for the new software version. Instead, it discusses the purpose of the software change and states that testing was performed to ensure it works as intended and does not impact safety and effectiveness.

The key change described in the software is:

Previous Software (SW0021-281): User had the option to exceed the depth for bladder neck, mid-prostate, and median lobe. Purple lines on the GUI blinked when depth was exceeded. Maximum depth constraint could not let the user place markers beyond 24.3 mm.
New Software (SW0021-282): Limits the user from planning a cut in profile path beyond the depth of the cut defined in the angle step for mid prostate and bladder neck. The purple line indicator flashing is removed as the user is now limited. The median lobe depth of cut is not limited. The maximum depth constraint is removed from the Profile Landmark step, allowing the user to place 4 landmark points beyond 24.3 mm depth, though the maximum planned depth remains 24.3 mm.

Implied Acceptance Criteria (based on the software change description):

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from software change)	Reported Device Performance (as stated in the document)
Software Functionality	1. Limit user from planning beyond defined depth for mid prostate and bladder neck.	Testing performed to ensure "software and OS works as intended" and "changes do not impact the safety and effectiveness."
	2. Remove purple line indicator flashing for mid prostate and bladder neck when depth is exceeded (since it's now limited).	Implied: The flashing (if applicable under old conditions) is now absent as the planning limitation prevents exceeding depth in these areas.
	3. Allow flexible planning for median lobe depth of cut (no limitation).	Testing performed to ensure "software and OS works as intended."
	4. Enable user to place 4 landmark points beyond 24.3 mm depth in the Profile Landmark step, while keeping maximum planned depth at 24.3 mm.	Testing performed to ensure "software and OS works as intended."
Safety and Effectiveness	No adverse impact on safety and effectiveness compared to the predicate device.	"The new software and operating system verification and validation testing to ensure that the software and the operating system changes do not impact the safety and effectiveness of the subject device..."

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

The document states "The new software and operating system verification and validation testing to ensure that the software and the operating system changes do not impact the safety and effectiveness of the subject device and the subject device software and OS works as intended."

However, no specific sample size or details about data provenance (e.g., country of origin, retrospective/prospective) are provided for this software verification and validation testing. The document largely relies on the past performance data of the predicate device.

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. The document refers to "verification and validation testing" for the software without detailing who performed or reviewed these tests, or how ground truth was established within this context.

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 provided in the document. The device in question is a robotic system for prostate tissue removal, not an AI-assisted diagnostic imaging system that would typically involve human readers.

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

This information is not directly applicable or provided for this type of robotic surgical device. The software changes described are related to planning and constraints within the user interface of the robotic system, which inherently involves a human operator (surgeon). The verification and validation testing would assess the software's behavior in this human-in-the-loop context.

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

For the software changes, the "ground truth" would likely be the expected and specified behavior of the software as defined by the developers and engineers, validated through testing scenarios. It is not equivalent to clinical 'ground truth' from pathology or outcomes data in the usual sense for diagnostic devices. However, the document does mention "Clinical Trial Data" as pre-existing non-clinical data relied upon, implying that the overall safety and effectiveness of the system (of which the software is a component) has been supported by clinical outcomes in the past. Details of this clinical trial ground truth are not provided for this specific submission.

8. The sample size for the training set

This information is not provided in the document. While the software was verified and validated, there is no indication that it employs machine learning or AI that would require a "training set" in the typical sense. It appears to be a rule-based or algorithmic software update.

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

As there is no mention of a "training set" in the context of machine learning, this information is not provided and likely not applicable.

Summary

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September 30, 2024

Procept BioRobotics Sara Muddell Sr. Director, Global Regulatory Affairs 150 Bavtech Drive San Jose, California 95134

Re: K241952 Trade/Device Name: AQUABEAM Robotic System (AB2000) Regulation Number: 21 CFR 876.4350 Regulation Name: Fluid Jet System For Prostate Tissue Removal Regulatory Class: II Product Code: PZP Received: September 3, 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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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,

Mark R. Kreitz -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

Submission Number (if known)

K241952

Device Name

AQUABEAM Robotic System (AB2000)

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)

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K241952 Page 1 of 3

510(k) SUMMARY

Date Prepared

July 2, 2024

Owner/Sponsor	PROCEPT BioRobotics Corporation150 Baytech Dr.,San Jose, 95134USA
Submitter	Contact Name: Sara MuddellTitle: Sr. Director of Global Regulatory AffairsAddress: 150 Baytech Dr., San Jose, CA 95134, USATelephone: (650) 232-7217Cell: (669) 220-8583Email: s.muddell@procept-biorobotics.com
Trade Name	AquaBeam Robotic System
Classification	Class II
Classification Name	Fluid jet system for prostate tissue removal
Common Name	Fluid jet system for prostate tissue removal
Product Code	PZP: A fluid jet system for prostate tissue removal is a prescriptiondevice intended for the resection and removal of prostatic tissue forthe treatment of benign prostatic hyperplasia (BPH). The devicecuts tissue by using a pressurized jet of fluid delivered to theprostatic urethra. The device is able to image the treatment area, orpairs with an imaging modality, to monitor treatment progress.
Regulation Number	21 CFR 876. 4350

Predicate Device

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

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Image /page/5/Picture/0 description: The image shows the logo for Procept BioRobotics. The logo is in blue and features the word "PROCEPT" in large, bold letters. The "O" in "PROCEPT" is replaced with a stylized water droplet design. Below the word "PROCEPT" is the text "BioRobotics" in a smaller font.

AQUABEAM Handpiece and AQUABEAM Scope are inserted via transurethral approach and advanced into the prostatic urethra.

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

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.

The intended use of the subject device is identical to the intended use of the predicate device.

Intended Patient Population

The intended patient population is males suffering from benign prostatic hyperplasia (BPH).

Technological Comparison as compared to the Predicate Device

This 510K is submitted for introduction of the new software and version for AQUABEAM Robotic System. All the other technological characteristics of the device are identical to the predicate device. The table below compares the predicate device and the subject device for the comparison -

Device Characteristic	Subject Device	Predicate Device
Software	SW0021-282The software shall limit the user fromplanning a cut in profile path beyond thedepth of the cut defined in the angle stepfor mid prostate and bladder neck. Sincethe user is now limited to exceed thedepth defined, the purple line indicatorflashing is removed. The median lobedepth of cut is not limited.The maximum depth constraint isremoved from the Profile Landmark	SW0021-281The user has the option toexceed the depth for bladderneck, mid-prostate, and medianlobe. The purple lines on theGUI blink when the depth isexceeded.The maximum depthconstraint could not let the

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Image /page/6/Picture/0 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 clean and modern, and the water droplet suggests that the company is involved in water-related technologies.

step. The user is able to place the 4landmark points beyond the 24.3 mmdepth. The maximum depth the usercan plan still is in 24.3mm	user place the markersbeyond the 24.3mm.
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Performance Data

The new software and operating system verification and validation testing to ensure that the software and the operating system changes do not impact the safety and effectiveness of the subject device and the subject device software and OS works as intended. Apart from the software and the operating system changes, device's technological characteristics are unchanged, therefore no further non-clinical performance test data is required to support the subject device. The following pre-existing non-clinical data continues to be relied upon to support the safety and effectiveness of the subject device:

Biocompatibility Sterilization ●
Electrical Safety and EMC Compatibility
. Usability
. System Design Verification and Validation Reliability Testing, AQUABEAM Robotic System
. Clinical Trial Data

Conclusion:

The overall performance together with the prior non-clinical performance testing performed on the predicate device, supports that the AQUABEAM Robotic System with the new software and operating system version is as safe, as effective, and performs as well as the legally marketed predicate device. The materials provided in this special 510(k) premarket notification demonstrate compliance to the special controls prescribed in 21 CFR 876.4350.

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.