The TULSA-PRO system combines real-time Magnetic Resonance (MR) imaging and MR thermometry with transurethral directional ultrasound and closed-loop process control software to deliver precise thermal ablation of physician prescribed prostate tissue. The system consists of both hardware and software components. The transurethral ultrasound ablation (TULSA) treatment is delivered completely within the MR bore. A real-time MRI interface is used by closed-loop features of the TULSA-PRO system: real-time MRI prostate temperature measurements are processed by TULSA-PRO software which communicates with TULSA-PRO hardware, thereby controlling frequency, power and rotation rate of ultrasound to ablate physician prescribed prostate tissue with a high degree of precision. The physician inserts two catheters, one transurethral and another transrectal, into the patient before he is moved into the MR bore. The transurethral catheter consists of an Ultrasound Applicator (UA) which delivers energy from within the prostate tissue, heating it to thermal coagulation. The transrectal catheter is an Endorectal Cooling Device (ECD) which does not emit any energy and cools the rectal wall adjacent to the prostate. The modified ECD component provides users with a rectal bubble removing feature, and is manufactured using a 3-D printed technology. Both catheters have fluid flowing inside throughout the treatment to thermally protect the urethra and rectum, in order to minimize the potential of any thermal damage to either the urinary or rectal pathways. The physician uses the TULSA-PRO console that was cleared under K191200 to robotically position the Ultrasound Applicator in the prostate and plan the treatment by contouring the prescribed tissue on real-time high-resolution crosssectional MR images of the prostate. These cleared features provide the physician with the ability and the control to customize the treatment plan to minimize thermal impact to critical structures surrounding the prostate including the external urethral sphincter, rectum and neurovascular bundles. The treatment begins based upon the physician's instructions by enabling the software to initiate thermal ablation. The TULSA-PRO closed-loop process control software reads real-time MR thermometry measurements and adjusts automatically and dynamically the frequency, power and rotation rate of ultrasound provided by each UA transducer, to deliver precise ablation of the prescribed prostate tissue. The software controls automated. continuous and robotic rotation of the transurethral UA by 360 degrees in sync with the process-controlled delivery of thermal heating to all the required regions of the prostate. Following completion of the ablation process, the two catheters are removed from the natural orifices of the patients.

AI/ML Overview

The provided text is an FDA 510(k) summary for the TULSA-PRO® System, which is a medical device for prostate tissue ablation. The document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing the detailed acceptance criteria and study results typically found for a novel AI/ML-based medical device.

Therefore, many of the requested details regarding acceptance criteria, study design for proving performance (especially for AI/ML models), expert ground truth establishment, MRMC studies, and sample sizes for training/test sets are not present in the provided document, as this submission is for a modification to an existing device.

The submission states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This explicitly indicates that no clinical study (which would typically involve test sets, ground truth establishment, expert readers, etc.) was performed for this specific submission to prove device performance in a clinical setting. The "performance" being assessed here is the equivalence of the modified (and slightly different manufacturing process for the ECD component) to the previously cleared version.

However, based on the information available in the document, here's what can be inferred or stated:

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

Since no clinical study data is presented, acceptance criteria for performance metrics (like sensitivity, specificity, accuracy for an AI model) are not relevant or provided. The "performance" here is demonstrating that the modified device is as safe and effective as the predicate device through bench testing.

Acceptance Criteria (Implied for Substantial Equivalence of Modified ECD)	Reported Device Performance (as stated in the document)
The modified TULSA-PRO system meets the requirements of the product design specification.	"Bench Performance testing was conducted to demonstrate that the TULSA-PRO system meets the requirements of the product design specification and performs in accordance with its intended use."
The modified ECD component (with bubble removal feature and 3D printing) performs safely and effectively.	"Bench testing was performed to verify and validate the ECD performance and safety and effectiveness of the TULSA PRO system."
Biocompatibility requirements.	"Biocompatibility testing was conducted in accordance with the 2020 FDA guidance document, 'Use of International Standard ISO 10993-1 [...]'" and modified materials meet "Biocompatibility criteria for the intended use of ECD."
Device is as safe, as effective, and performs as well as or better than the predicate device.	"The verification and validation tests demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device."
No new concerns on safety and effectiveness compared to the predicate.	"The modified features of the TULSA-PRO Endorectal Cooling Device (ECD) do not raise any new concerns or different questions of safety and effectiveness."

Regarding points 2-9:

These points are primarily relevant for submissions involving new AI/ML device performance claims or significant changes requiring clinical validation/testing. As stated in the document, "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." Therefore, the following information is not applicable or not provided in this specific 510(k) summary:

Sample sized used for the test set and the data provenance: Not applicable, as no clinical test set for AI performance was used. The testing was bench-based.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for image interpretation by experts is not described, as there was no clinical study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic device submission requiring such a study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a standalone AI diagnostic algorithm. The TULSA-PRO system has software with closed-loop process control, but this submission pertains to mechanical/material modifications to a component (ECD) and expanded MR scanner compatibility, not a new or significantly altered AI component requiring standalone validation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as detailed clinical performance validation with ground truth is not the subject of this 510(k). The ground truth for their bench testing would be engineering measurements and material specifications.
The sample size for the training set: Not applicable. This document does not describe the development or training of a new AI model. The software exists and controls the ablation process, but no new AI training is discussed.
How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) submission for demonstrating substantial equivalence of a modified version of an already cleared device, primarily through non-clinical bench testing of hardware/material changes (specifically to the Endorectal Cooling Device and expanded MR compatibility). It does not contain the detailed clinical study data, AI model performance metrics, or ground truth establishment processes that would be typically found for a novel AI/ML device or a significant software upgrade requiring clinical validation. The "study" mentioned here refers to the bench testing conducted to ensure the modified device retains its safety and effectiveness compared to the predicate.

Summary

{0}------------------------------------------------

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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Profound Medical, Inc. Golddy Kaur VP Product Leader Sonalleve 2400 Skymark Avenue Unit #6 Mississauga. Ontario L4W 5K5 Canada

Re: K211858

Trade/Device Name: TULSA-PRO® System Regulation Number: 21 CFR§ 876.4340 Regulation Name: High Intensity Ultrasound System for Prostate Tissue Ablation Regulatory Class: II Product Code: PLP Dated: August 3, 2022 Received: August 4, 2022

Dear Golddy Kaur:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

{1}------------------------------------------------

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Reginald K. Avery, Ph.D. 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K211858

Device Name TULSA-PRO® System

Indications for Use (Describe) The TULSA-PRO® is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

I. Submitter Information

• Applicant Name:	Profound Medical Inc.2400 Skymark Avenue, Unit #6,Mississauga, ON L4W 5K5, CanadaT: 647.476.1350 F: 647.847.3739
-------------------	------------------------------------------------------------------------------------------------------------------------------

Regulatory Contact: Nicole Baker . Director Quality and Regulatory Affairs
T: 647.476.1350 Ext.414 M: 416.788.2253 Email: nbaker@profoundmedical.com
Date Prepared: September 1, 2022

II. Device Identification

Proprietary Name:	TULSA-PRO® System
Common Name:	High Intensity Ultrasound System for Prostate Tissue Ablation
Classification Name:	High Intensity Ultrasound System for Prostate Tissue Ablation
Regulatory Class:	Class II
Regulation:	21 CFR 876.4340
Product Code:	PLP

III. Predicate & Reference Device Information

Predicate Device	TULSA-PRO® System
510K Number	K191200
Decision Date	August 15, 2019
Manufacturer	Profound Medical Inc.

Reference Device	TULSA-PRO® System
510K Number	K202286
Decision Date	September 16, 2020
Manufacturer	Profound Medical Inc.

{4}------------------------------------------------

IV. Device Description

The transurethral ultrasound ablation (TULSA) treatment is delivered completely within the MR bore. A real-time MRI interface is used by closed-loop features of the TULSA-PRO system: real-time MRI prostate temperature measurements are processed by TULSA-PRO software which communicates with TULSA-PRO hardware, thereby controlling frequency, power and rotation rate of ultrasound to ablate physician prescribed prostate tissue with a high degree of precision.

The physician inserts two catheters, one transurethral and another transrectal, into the patient before he is moved into the MR bore. The transurethral catheter consists of an Ultrasound Applicator (UA) which delivers energy from within the prostate tissue, heating it to thermal coagulation. The transrectal catheter is an Endorectal Cooling Device (ECD) which does not emit any energy and cools the rectal wall adjacent to the prostate. The modified ECD component provides users with a rectal bubble removing feature, and is manufactured using a 3-D printed technology. Both catheters have fluid flowing inside throughout the treatment to thermally protect the urethra and rectum, in order to minimize the potential of any thermal damage to either the urinary or rectal pathways.

The physician uses the TULSA-PRO console that was cleared under K191200 to robotically position the Ultrasound Applicator in the prostate and plan the treatment by contouring the prescribed tissue on real-time high-resolution crosssectional MR images of the prostate. These cleared features provide the physician with the ability and the control to customize the treatment plan to minimize thermal impact to critical structures surrounding the prostate including the external urethral sphincter, rectum and neurovascular bundles. The treatment begins based upon the physician's instructions by enabling the software to initiate thermal ablation. The TULSA-PRO closed-loop process control software reads real-time MR thermometry measurements and adjusts automatically and dynamically the frequency, power and rotation rate of ultrasound provided by each UA transducer, to deliver precise ablation of the prescribed prostate tissue. The software controls automated. continuous and robotic rotation of the transurethral UA by 360 degrees in sync with the process-controlled delivery of thermal heating to all the required regions of the prostate. Following completion

{5}------------------------------------------------

of the ablation process, the two catheters are removed from the natural orifices of the patients.

V. Intended Use:

The TULSA-PRO® is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.

VI. Summary of Non-clinical testing

The following non-clinical testing was provided in support of this submission:

. Bench Performance testing was conducted to demonstrate that the TULSA-PRO system meets the requirements of the product design specification and performs in accordance with its intended use.
Biocompatibility testing was conducted in accordance with the 2020 FDA guidance document, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".

The following non-clinical testing provided in the original 510(k) remains applicable to the subject TULSA-PRO system, and is not included in this submission:

Sterilization validation activities were performed in accordance with "ISO ● 11135 Second edition - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices."
- This standard is not applicable for this submission. There was no change o to the sterilization specification.
Electrical Safety and Electromagnetic Compatibility had been confirmed by . Nationally Recognized Testing Laboratory. This standard is not applicable for this submission.
- There was no change to the device specification that impact O Electromagnetic disturbances.
Animal Studies Animal testing is not provided in support of this 510k ● submission, as bench testing and clinical testing addresses all concerns of substantial equivalence of the subject device.

{6}------------------------------------------------

Conformance to Recognized Standards

The changes to the TULSA-PRO System in this submission comply with applicable sections of the following recognized consensus standards:

IEC 60601-1:2005/A1:2012 Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance.
ISO 14971:2019 Medical devices Application of risk management to medical ● devices
ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical devices Part ● 1: Evaluation and testing within a risk management process
. ISO 10993-5 Third edition 2009-06-01 - Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity.
ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices -. Part 10: Tests for irritation and skin sensitization.
ISO 11737-1 Third edition 2018-01 Sterilization of health care products -● Microbiological methods - Part 1: Determination of a population of microorganisms on product.
ISO 15223-1 Third Edition 2016-11-01 Medical devices Symbols to be used with . medical device labels, labelling, and information to be supplied
ASTM F2052-15 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2182-11a Standard Test Method for Measurement of Radio Frequency ● Induced Heating on a Near Passive Implants during Magnetic Resonance Imaging
ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced . Torque on Medical Devices in the Magnetic Resonance Environment

The following recognized consensus standards are applicable to the TULSA-PRO System, but these standards were not applied for the changes in this submission and there has been no change in conformance to these standards:

{7}------------------------------------------------

IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment Part 1-2: . General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests -
- This standard is not applicable for this submission. There was no change to O the device specification that impact Electromagnetic disturbances.
IEC 60601-1-6 Edition 3.1 2013-10 General requirements for basic safety and ● essential performance - Collateral standard: Usability.
- This standard is not applicable for this submission. There was no new risk o introduced that related to usability.
ANSI/AAMI 62366-1 Edition 1.0 2015-02 Medical devices Part 1: Application of ● usability engineering to medical devices.
- This standard is not applicable for this submission. There was no new risk o introduced that related to usability.
. IEC 60601-1-8 Edition 2.1 2012-11 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
- о This standard is not applicable for this submission. No alarm was changed under this submission.
IEC 60601-1-10 Edition 1.1 2013-11 Medical electrical equipment Part 1-10: . General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers.
- o This standard is not applicable for this submission. There was no change to physiologic closed-loop under this submission.
IEC 60601-2-62 Edition 1.0 2013-07- Medical Electrical Equipment Part 2-62: ● Particular Requirements for The Basic Safety And Essential Performance Of High Intensity Therapeutic Ultrasound (HITU) Equipment.
- O This standard is not applicable for this submission. There was no change to the device ultrasound specification.
ANSI/AAMI/IEC 62304 Edition 1.1 2015-06 Medical device software Software ● life cycle processes
- This standard is not applicable for this submission. There was no change to O the medical device software.
ISO 10993-4 Third edition 2017-04 Biological evaluation of medical devices Part . 4: Selection of tests for interactions with blood.

{8}------------------------------------------------

This standard is not applicable for this submission. There was no change to o the device specification related to parts interact with blood.
ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices -. Part 7: Ethylene oxide sterilization residuals.
- This standard is not applicable for this submission. There was no change to o the sterilization specification.
. ISO 10993-11 Third edition 2017-09 - Biological evaluation of medical devices -Part 11: Tests for systemic toxicity.
- This standard is not applicable for this submission. There was no change to о the device specification which impact toxicity.
ISO 11135 Second edition 2014-07-15 Sterilization of health-care products -● Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
- This standard is not applicable for this submission. There was no change to O the sterilization specification.
ANSI/AAMI/ISO 11607-1:2006/(R) 2010 Packaging for terminally sterilized . medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging.
- This standard is not applicable for this submission. There was no change to o the sterile barrier specification.
ANSI/AAMI/ISO 11607-2:2006/(R) 2010 Packaging for terminally sterilized ● medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
- O This standard is not applicable for this submission. There was no change to the sterile barrier specification.
ANSI/AAMI/ISO 11737-2:2009/(R) 2014 Sterilization of medical devices ● Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
- O This standard is not applicable for this submission. There was no change to the sterile barrier specification.
EN ISO 14155 Second edition 2011-02-01 Clinical investigation of medical devices ● for human subjects - Good clinical practice.
- This standard is not applicable for this submission. There was no clinical о study required for this notification submission.

{9}------------------------------------------------

Clinical Data VII.

Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications.

VIII. Substantial Equivalence

The modified TULSA-PRO system is substantially equivalent to the TULSA PRO that was submitted under K191200. The modified TULSA-PRO system has the same intended use and basic characteristics compared to the predicate device with respect to the functionality of the ECD bubble removal feature.

The substantial equivalence is demonstrated in Table 1.

	Subject Device(TULSA-PROSystem)	Predicate Device(TULSA-PROSystem)	Comparison Results
Manufacturer	Profound Medical Inc.	Profound Medical Inc.	Same
510(k) No.	K211858	K191200	N/A
Regulation Number	21 CFR 876.4340	21 CFR 876.4340	Same
Product Code	PLP	PLP	Same
Indications for Use	The TULSA-PRO® is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.	The TULSA-PRO® is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.	Same
Prescription Use	Yes	Yes	Same
Non-surgical, minimally invasive	Yes	Yes	Same
Outpatient procedures	Yes	Yes	Same
Anesthesia required	Yes	Yes	Same
Physician training required	Yes	Yes	Same
System Components	Main console containing electronics and programmable hardware (System Electronics unit) PC computer, LCD display, custom ablation	Main console containing electronics and programmable hardware (System Electronics unit) PC computer, LCD display, custom ablation	Same
	Subject Device(TULSA-PROSystem)	Predicate Device(TULSA-PROSystem)	Comparison Results
	delivery software(TDC unit)Water coolingcircuit (SystemCart, FluidCircuit)TransurethralUltrasoundApplicator (UA)Endorectal CoolingDevice (ECD)Positioning SystemDisposableaccessories	delivery software(TDC unit)Water coolingcircuit (SystemCart, FluidCircuit)TransurethralUltrasoundApplicator (UA)Endorectal CoolingDevice (ECD)Positioning SystemDisposableaccessories
Patient position	Head-first supine	Head-first supine	Same
Route of EnergyDelivery	Trans-urethral	Trans-urethral	Same
Prostate size limitation	Prostates up to110cc	Prostates up to110cc	Same
Ablation modality	High IntensityDirectionalUltrasound	High IntensityDirectionalUltrasound	Same
Imaging modality forlocalization, treatmentand control	MRI	MRI	Same
Ablation Frequency	Dual AblationFrequency:Low Frequencyrange: 4 - 4.8 MHzHigh Frequencyrange: 13.4 - 14.4MHz	Dual AblationFrequency:Low Frequencyrange: 4 - 4.8 MHzHigh Frequencyrange: 13.4 - 14.4MHz	Same
Total acoustic power	4 W per element(low frequency)2W per element(high frequency)Max (10 elements):40W / 20W	4 W per element(low frequency)2W per element(high frequency)Max (10 elements):40W / 20W	Same
Probe type	Linear array	Linear array	Same
UltrasoundTransducer/Probe	Linear array of 10planar rectangular	Linear array of 10planar rectangularultrasound	Same
	Subject Device(TULSA-PROSystem)	Predicate Device(TULSA-PROSystem)	Comparison Results
	transducer elementswith individuallycontrolledfrequency andpower	transducer elementswith individuallycontrolledfrequency andpower
Probe Placement	Manualtransurethral deviceinsertion withguidewire.Probe attached tocustom PositioningSystem armmounted to MRIbase plate (3-axismanual adjustment).Automated linearprobe adjustmentwithin urethra basedon MR imageguidance.	Manualtransurethral deviceinsertion withguidewire.Probe attached tocustom PositioningSystem armmounted to MRIbase plate (3-axismanual adjustment).Automated linearprobe adjustmentwithin urethra basedon MR imageguidance.	Same
TransducerMovement/Ablationvolume	Automated devicerotation usingcustom Positioningsystem.Transurethral proberotates 360º toablate prescribedprostate volume inone sweep.	Automated devicerotation usingcustom Positioningsystem.Transurethral proberotates 360º toablate prescribedprostate volume inone sweep.	Same
Fusion of ultrasoundwith other imagingmodalities (DICOM)	No	No	Same
Ultrasound Duty cycle	Continuousultrasound delivery	Continuousultrasound delivery	Same
Lesion Shape	5mm-widedirectional beam(candle flame shape).Ten adjacenttransducer elementsproduce overlappingheating pattern.Continuous volume	5mm-widedirectional beam(candle flameshape). Ten adjacenttransducer elementsproduce overlappingheating pattern.Continuous volume	Same
	Subject Device(TULSA-PROSystem)	Predicate Device(TULSA-PROSystem)	Comparison Results
Ablation planning	of thermal ablation is delivered.Sagittal, Coronal and Axial planes	of thermal ablation is delivered.Sagittal, Coronal and Axial planes	Same
Longitudinal motion	6.4 cm	6.4 cm	Same
Management of protocols	Close-loop control algorithm	Close-loop control algorithm	Same
MR Scanner Compatibility	Added Siemens Vida 3T, Siemens Sola 1.5T, Philips Ingenia 1.5T, and Philips Ingenia Evolution 1.5T	Siemens: Skyra 3T, Prisma 3T, Aera 1.5TPhilips: Achieva 3T, Ingenia 3T, Ingenia Elition 3T, Ingenuity PET-MR 3T	Modified: increase the number of MR scanners that can be used with the TULSA-PRO system.
Feature	Endorectal Cooling Device (ECD)
Bubble Removal	Additional two gel lubricant channels intended for the user to manually remove bubbles by suction.	Fluid lines for circulation of cooling fluid to cool the rectal tissue adjacent to the prostate.	Modified: provide the user with a means of bubble removal that is more deterministic than previous methods.Bench testing was performed to verify and validate the ECD performance and safety and effectiveness of the TULSA PRO system
Manufacturing Process of ECD Body	3D-printing technology	Injection molding technology	Modified: provide holes on the ECD body surface to inject and extract lubricant gel to remove trapped bubbles on the ECD surface by negative pressure.Bench testing was performed to verify and validate the ECD performance and safety and effectiveness of the TULSA PRO system
Material	BioMed Clear Resin	ABS LUSTRAN 348 Polyester (PET)	Modified: Both materials meet the
Subject Device(TULSA-PROSystem)	Predicate Device(TULSA-PROSystem)	Comparison Results
		Biocompatibilitycriteria for the intendeduse of ECD.

Table 1. Substantial equivalence table

{10}------------------------------------------------

PROF UNIF

{11}------------------------------------------------

PROFC AME

{12}------------------------------------------------

PROF

{13}------------------------------------------------

Image /page/13/Picture/1 description: The image shows the word "PROFOUND" in blue font. The "O" in the word has a circle in the middle with a line going through it. The font is bold and sans-serif.

IX. Conclusion

The modified features of the TULSA-PRO Endorectal Cooling Device (ECD) do not raise any new concerns or different questions of safety and effectiveness. The verification and validation tests demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device.

Regulation Number and Section

§ 876.4340 High intensity ultrasound system for prostate tissue ablation.

(a)
Identification. A high intensity ultrasound system for prostate tissue ablation is a prescription device that transmits high intensity therapeutic ultrasound energy into the prostate to thermally ablate a defined, targeted volume of tissue, performed under imaging guidance. This classification does not include devices that are intended for the treatment of any specific prostate disease and does not include devices that are intended to ablate non-prostatic tissues/organs.(b)
Classification. Class II (special controls). The special controls for this device are:(1) 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) Characterization of acoustic pressure and power output at clinically relevant levels;
(ii) Measurement of targeting accuracy and reproducibility of high intensity ultrasound output;
(iii) Ultrasound-induced heating verification testing at target and non-target tissues;
(iv) Electrical safety testing; and
(v) Electromagnetic compatibility testing.
(2) Software verification, validation, and hazard analysis must be performed.
(3) The elements of the device that may contact the patient's mucosal tissue must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device components that contact the patient's mucosal tissue.
(5) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the identified shelf life.
(6) Performance data must support the instructions for reprocessing all reusable components.
(7)
In vivo testing must demonstrate that the device thermally ablates targeted tissue in a controlled manner without thermal injury to adjacent, non-target tissues.(8) Clinical testing must document the adverse event profile, provide evidence of prostatic ablation, and demonstrate that the device performs as intended under anticipated conditions of use.
(9) Training must be provided so that upon completion of the training program, the physician can:
(i) Use all safety features of the device;
(ii) Accurately target the high intensity ultrasound energy within the desired region of the prostate; and
(iii) Perform the ablation procedure in a manner that minimizes damage to non-target tissues.
(10) Labeling must include:
(i) A section that summarizes the clinical testing results, including the adverse event profile and evidence of prostate ablation achieved; and
(ii) An expiration date or shelf life for single use components.