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 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

AI/ML Overview

Based on the provided text, the device in question is the PROCEPT BioRobotics AQUABEAM® Robotic System.

It's important to note that this document is a 510(k) summary for a Special 510(k), which means the device is being cleared as substantially equivalent to a previously cleared predicate device (AQUABEAM Robotic System 510(k) Number: K202961). The changes described are minor modifications related to sterility and the use life of a component. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily focused on demonstrating that these minor changes do not compromise the safety and effectiveness established in the predicate device's clearance.

The document does not provide details of acceptance criteria or a study that proves the device meets initial acceptance criteria in the way one might expect for a de novo device or a PMA application. Instead, it relies on substantial equivalence to a predicate device and non-clinical testing to confirm that the changes made do not negatively impact performance.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance data for this Special 510(k) relate specifically to the changes made to the predicate device, primarily the sterilization method for the AQUABEAM Scope and its updated use life. The document asserts that the fundamental performance characteristics (e.g., maximum angle rotation, maximum depth of penetration) remain the same as the predicate.

Acceptance Criteria (for the changes)	Reported Device Performance (as demonstrated by testing within this 510(k))
Scope Sterilization Efficacy: AQUABEAM Scope must be effectively sterilized by the new STERRAD 100NX Express cycle, meeting a Sterility Assurance Level (SAL) of 10^-6.	Sterilization Validation Testing (EN ISO 14937: 2009) was performed and found to conform to the standard, indicating effective sterilization.
Scope Biocompatibility: The scope, after reprocessing with the new cycle, must maintain biocompatibility.	Biological Evaluation (ISO 10993-5 and ISO 10993-12) was performed and found to conform for in vitro cytotoxicity, suggesting maintenance of biocompatibility.
Scope Use Life: The AQUABEAM Scope must maintain its functional integrity and sterility capabilities for "at least 10 use cycles."	AQUABEAM Scope Reliability testing was performed (though the specific results or methodology aren't detailed in this summary, the updated use life is stated as "at least 10 cycles," implying this was met).
Overall Safety and Effectiveness: The minor changes (IFU update and scope use life) must not compromise the overall safety and effectiveness of the device.	The conclusion states: "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." This is an overarching claim based on the non-clinical testing performed and the reliance on the predicate device's existing clearance.

Important Note: The original 510(k) for the predicate device (K202961) would contain the clinical trial data and design verification/validation testing that established the primary safety and effectiveness of the system for prostate tissue removal. This Special 510(k) is a supplement for minor changes.

2. Sample Size Used for the Test Set and Data Provenance

For the non-clinical testing described in this Special 510(k) (sterilization, biocompatibility, reliability of the scope): The document does not specify the sample sizes used for these specific tests (e.g., how many scopes were tested for sterility or reliability).
For any pre-existing "Clinical Trial data" referenced from the predicate device: The specific sample sizes and data provenance for the clinical studies supporting the predicate device's original clearance are not provided in this document. The document simply states "Clinical Trial data" was performed on the predicate device and is still applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This document pertains to a device (AQUABEAM Robotic System) for prostate tissue removal, not an AI/imaging diagnostic device. Ground truth, in the context of this device, would typically refer to the clinical outcomes and validation of its physical performance during surgery, rather than a diagnostic AI's performance against expert-labeled images.

Therefore, the concepts of "number of experts used to establish ground truth for the test set" and "qualifications of those experts" are not applicable in the context of this device's regulatory submission as described here. The "experts" involved would be the clinical investigators and surgeons who participated in the clinical trials supporting the predicate device's clearance.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

As this is not an AI/imaging diagnostic device requiring expert adjudication of image interpretations, an adjudication method for a test set is not applicable in the context of this device's regulatory review as described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

This is not applicable as the AQUABEAM Robotic System is a surgical device, not an AI or imaging diagnostic device where MRMC studies are typically performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable for the same reasons as above. The device is a robotic surgical system, not an AI algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the overall performance of the AQUABEAM Robotic System (as established by the predicate device's original clearance and affirmed by this Special 510(k)), the "ground truth" would be clinical outcomes data related to prostate tissue removal and improvement in LUTS due to BPH, potentially supported by pathology of removed tissue and confirmed through clinical follow-up.

For the specific non-clinical tests in this Special 510(k) (sterilization, biocompatibility, scope reliability), the "ground truth" is adherence to established engineering and biological standards (e.g., SAL of 10^-6 for sterility, passing cytotoxicity tests, meeting internal design specifications for cycles).

8. The Sample Size for the Training Set

This is not applicable. The AQUABEAM Robotic System is a hardware-based medical device for surgery. It is not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as #8.

Summary

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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.

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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 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

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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)

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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 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 Corporation900 Island Drive,Suite 101Redwood City, 94065USA
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

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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.

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 -

COMPARISONELEMENT	SUBJECT DEVICE	PREDICATE DEVICE	CHANGE
Device Class	Class II	Class II	Same
Product Code	PZP	PZP	Same
Product RegulationNumber	21 CFR 876.4350	21 CFR 876.4350	Same

IntendedUse/Indications forUse	The AQUABEAM System isintended for the resection andremoval of prostate tissue inmales suffering from lowerurinary tract symptoms(LUTS) due to benign prostatichyperplasia.	The AQUABEAM Systemis intended for the resectionand removal of prostatetissue in males sufferingfrom lower urinary tractsymptoms (LUTS) due tobenign prostatic 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 User	Urologists and support staffwho are trained and familiarwith performing endoscopicsurgical benign prostatichyperplasia procedures and inrecognizing and managingtheir complications. Usersmust possess a thoroughunderstanding of the technicalprinciples, clinical application,and risks associated with theAQUABEAM Robotic Systemand complete the PROCEPTBioRobotics Corporationtraining program prior to use	Urologists and support staffwho are trained and familiarwith performing endoscopicsurgical benign prostatichyperplasia procedures andin recognizing and managingtheir complications. Usersmust possess a thoroughunderstanding of thetechnical principles, clinicalapplication, and risksassociated with theAQUABEAM RoboticSystem and complete thePROCEPT BioRoboticsCorporation trainingprogram prior to use	Same
Patient Contact	The AQUABEAM RoboticSystem shall be usedendoscopically accessing theprostate via the urethra(external communicatingdevice, tissue/bone/dentin,with limited exposure (<24hours).	The AQUABEAM RoboticSystem shall be usedendoscopically accessing theprostate via the urethra(external communicatingdevice, tissue/bone/dentin,with limited exposure (<24hours).	Same
Sterilizationmethod	Ethylene Oxide Sterilization(ETO)SAL 10-6	Ethylene Oxide Sterilization(ETO)SAL 10-6	Same
OperatingEnvironment	Temperature: 0° to 35° CHumidity: 0% to 90%, non-condensingAtmospheric Pressure: 70 kPAto 107 kPA	Temperature: 0° to 35° CHumidity: 0% to 90%, non-condensingAtmospheric Pressure: 70kPA to 107 kPA	Same
Transportation andStorageEnvironment	Temperature: 0° to 35° CHumidity: 0% to 90%, non-condensingAtmospheric Pressure: 70 kPAto 107 kPA	Temperature: 0° to 35° CHumidity: 0% to 90%, non-condensingAtmospheric Pressure: 70kPA to 107 kPA	Same

Use Life of thesystem	185 cycles	185 cycles	Same
Use Life of theArticulating Arms	200 cycles	200 cycles	Same
ReprocessingSterilizationmethods forAQUABEAMScope	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 sterilizationmethods for AQUABEAMScope to replace STERRAD100NX Standard cycle withSTERRAD 100NX Expresscycle.
Use Life of theAQUABEAMScope (reusablecomponent thatrequiresreprocessing priorto each use)	At least 10 cycles	58 cycles	Updated the use life cyclesafter adding the STERRAD100NX Express cycles.
Shelf Life(Handpiece is thesingle usecomponentprovided sterile)	24 months (2 Years)	24 months (2 Years)	Same
Mechanism of Action
COMPARISONELEMENT	SUBJECT DEVICE	PREDICATE DEVICE	COMMENTS
Maximum anglerotation	225 degrees	225 degrees	Same
Maximum depth ofpenetration	24.3 mm	24.3 mm	Same

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BIOROBOTICS

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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.

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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.

1. 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
1. Clinical Trial data
1. 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.

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.