Who is the manufacturer of TULSA-PRO System?

Profound Medical, Inc. filed the 510(k) submission for TULSA-PRO System (K230692).

What is the FDA product code for TULSA-PRO System?

PLP. It is classified under 21 CFR 876.4340 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for TULSA-PRO System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like TULSA-PRO System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TULSA-PRO System

K230692 · Profound Medical, Inc. · PLP · Sep 20, 2023 · Gastroenterology, Urology

Device Facts

Record ID	K230692
Device Name	TULSA-PRO System
Applicant	Profound Medical, Inc.
Product Code	PLP · Gastroenterology, Urology
Decision Date	Sep 20, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4340
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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

Device Story

TULSA-PRO system performs transurethral ultrasound ablation of prostate tissue using real-time MR imaging and MR thermometry. System includes transurethral ultrasound applicator (UA) and transrectal endorectal cooling device (ECD). Physician uses console to plan ablation on MR images; software provides closed-loop process control, adjusting ultrasound frequency and power based on real-time thermometry. Thermal Boost feature allows user-enabled temperature increase (up to 65°C) for large prostates (>15mm radius). Procedure occurs in MRI suite; operated by physician. Output is precise thermal coagulation of prescribed tissue. Benefits include customized treatment planning to minimize impact on critical structures like rectum and neurovascular bundles.

Clinical Evidence

Clinical performance evaluated in 71 adult male patients using Thermal Boost. Primary safety endpoint: rate of serious adverse events compared to predicate. Adverse events (e.g., urinary retention, incontinence, erectile dysfunction) were consistent with historical pivotal trial data; no new complications observed. Technical performance endpoints (Dice Similarity Coefficient 0.90, controller overshoot 6.4%, undershoot 3.9%) met established criteria. Physician usability assessment confirmed effective training and no new use errors.

Technological Characteristics

System comprises main console, PC, LCD display, water cooling circuit, transurethral ultrasound applicator (UA), and endorectal cooling device (ECD). UA uses linear array of 10 planar rectangular ultrasound transducers (4-4.8 MHz low frequency; 13.4-14.4 MHz high frequency). Energy source: high-intensity directional ultrasound. Connectivity: MRI-integrated. Software: closed-loop process control algorithm. Sterilization: Ethylene oxide (no change).

Indications for Use

Indicated for transurethral ultrasound ablation (TULSA) of prostate tissue in adult male patients.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the high intensity ultrasound system for prostate tissue ablation is subject to the following special controls:

*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.

Predicate Devices

TULSA-PRO® System (K191200)

Reference Devices

TULSA-PRO® System (K202286)
TULSA-PRO® System (K211858)

Related Devices

K191200 — TULSA-PRO System · Profound Medical, Inc. · Aug 15, 2019
K211858 — TULSA-PRO System · Profound Medical, Inc. · Sep 6, 2022
K202286 — Tulsa-Pro System · Profound Medical, Inc. · Sep 16, 2020
K212150 — Exablate Prostate System · Insightec, Inc. · Nov 23, 2021
K172285 — Ablatherm Fusion · Edap Technomed, Inc. · Oct 3, 2017

Submission Summary (Full Text)

{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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 20, 2023 Profound Medical, Inc. Imen Ferchichi Regulatory Affairs Lead 2400 Skymark Avenue, Unit 6 Mississauga, ON L4W 5K5 Canada Re: K230692 > 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 11, 2023 Received: August 14, 2023 Dear Imen Ferchichi: 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, # Mark J. Antonino -S 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230692 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) X 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}------------------------------------------------ K230692 Page 1 of 10 Image /page/3/Picture/1 description: The image shows the word "PROFOUND" in blue font. A horizontal line goes through the middle of the word, intersecting the "O" in the middle. The "O" has a lighter blue circle in the middle. # TULSA-PRO System ## 510(k) Summary #### Submitter Information I. - Applicant Name: . Profound Medical Inc. 2400 Skymark Avenue, Unit 6, Mississauga, ON L4W 5K5, Canada T: 647.476.1350 F: 647.847.3739 - Regulatory Contact: Imen Ferchichi ● Regulatory Affairs Lead T: 647.476.1350 Ext.448 M: 416.788.2253 Email: iferchichi@profoundmedical.com - Date Prepared: August 07, 2023 . #### Device Identification II. | 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 The original TULSA-PRO® System was cleared under K191200. Subsequent changes to the original system were cleared under K202286 and K211858. | Predicate Device | TULSA-PRO® System | |------------------|-----------------------| | 510K Number | K191200 | | Decision Date | August 15, 2019 | | Manufacturer | Profound Medical Inc. | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "PROFOUND" in blue font. A horizontal line goes through the middle of the word, connecting to a circle in the middle of the "O". The font is sans-serif and the word is in all caps. The image is simple and clean, with a focus on the word itself. | Reference Device | TULSA-PRO® System | |------------------|-----------------------| | 510K Number | K202286 | | Decision Date | September 16, 2020 | | Manufacturer | Profound Medical Inc. | | Reference Device | TULSA-PRO® System | |------------------|-----------------------| | 510K Number | K211858 | | Decision Date | September 6, 2022 | | Manufacturer | Profound Medical Inc. | #### Device Description IV. 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 subject device includes a modification to the device software that is described below. The hardware components and treatment workflow description are identical to the predicate device. 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. Both catheters have fluid flowing inside throughout the treatment. The physician uses the TULSA-PRO console to robotically position the Ultrasound Applicator in the prostate and plan the treatment by contouring the prescribed tissue intended for ablation on real-time high-resolution cross-sectional MR images of the prostate. These 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 starting the thermal ablation in the software. The TULSA-PRO closed-loop process control software reads real-time MR thermometry measurements and adjusts automatically and dynamically the frequency and power of ultrasound provided by each ultrasound transducer, and rotation rate of the Ultrasound {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "PROFOUND" in blue font. A horizontal line goes through the middle of the word, intersecting the "O" in the middle. The "O" has a gradient, with the left side being a darker blue and the right side being a lighter blue. Applicator, to deliver precise ablation of the prescribed prostate tissue defined by the physician in the treatment plan. Software Modification: An optional feature called Thermal Boost is available in the software during the treatment delivery phase of the treatment workflow. The Thermal Boost feature is useful when the prostate is large and the treatment radius is >15mm for any active ultrasound element. In such cases, heat may not reach the prostate boundary due to prostate size or if tissue perfusion is preventing the heat from reaching the target boundary. The physician has a choice to use the Thermal Boost feature on the corresponding ultrasound transducer. When this feature is turned on, the treatment boundary temperature can reach ≤63 degrees or ≤65 degrees depending on the treatment radius. Thermal Boost does not change the ablation plan prescribed by the physician. Whether Thermal Boost is turned on or off, the tissue heating and monitoring principle of operation of the TDC software do not change. Following completion of the ablation process, the two catheters are removed from the natural orifices of the patient. #### V. Intended Use The TULSA-PRO® is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue. #### Substantial Equivalence VI. 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 software. The Thermal Boost feature offers an improvement to the cleared device. The conclusions from all verification and validation data suggest that the modifications do not adversely impact the safety and effectiveness of the predicate device. The substantial equivalence is demonstrated in Table 1. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "PROFOUND" in blue font. The "O" in the word has a circle in the middle, and a horizontal line goes through the circle and connects the "O" to the "U". The font is sans-serif and appears to be bolded. ### Table 1. Substantial equivalence table | | Subject Device (TULSA-PRO System) | Predicate Device (TULSA-PRO System) | Comparison Results | |------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Profound Medical Inc. | Profound Medical Inc. | Same | | 510(k) No. | K230692 | 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 delivery software (TDC unit) Water cooling circuit (System Cart, Fluid Circuit) Transurethral Ultrasound Applicator (UA) Endorectal Cooling Device (ECD) Positioning System | Main console containing electronics and programmable hardware (System Electronics unit) PC computer, LCD display, custom ablation delivery software (TDC unit) Water cooling circuit (System Cart, Fluid Circuit) Transurethral Ultrasound Applicator (UA) Endorectal Cooling Device (ECD) Positioning System | Same | | | Subject Device (TULSA-PRO System) | Predicate Device (TULSA-PRO System) | Comparison Results | | | Disposable accessories | Disposable accessories | | | Patient position | Head-first supine | Head-first supine | Same | | Route of Energy Delivery | Trans-urethral | Trans-urethral | Same | | Prostate size limitation | Prostates up to 110cc | Prostates up to 110cc | Same | | Ablation modality | High Intensity Directional Ultrasound | High Intensity Directional Ultrasound | Same | | Imaging modality for localization, treatment and control | MRI | MRI | Same | | Ablation Frequency | Dual Ablation Frequency: Low Frequency range: 4 – 4.8 MHz High Frequency range: 13.4 – 14.4 MHz | Dual Ablation Frequency: Low Frequency range: 4 – 4.8 MHz High Frequency range: 13.4 – 14.4 MHz | 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 | | Ultrasound Transducer/Probe | Linear array of 10 planar rectangular ultrasound transducer elements with individually controlled frequency and power | Linear array of 10 planar rectangular ultrasound transducer elements with individually controlled frequency and power | Same | | Probe Placement | Manual transurethral device insertion with guidewire. Probe attached to custom Positioning | Manual transurethral device insertion with guidewire. Probe attached to custom Positioning | Same | | | Subject Device (TULSA-PRO System) | Predicate Device (TULSA-PRO System) | Comparison Results | | | System arm mounted to MRI base plate (3- axis manual adjustment). Automated linear probe adjustment within urethra based on MR image guidance. | System arm mounted to MRI base plate (3- axis manual adjustment). Automated linear probe adjustment within urethra based on MR image guidance. | | | Transducer Movement/Ablation volume | Automated device rotation using custom Positioning system. Transurethral probe rotates 360° to ablate prescribed prostate volume in one sweep. | Automated device rotation using custom Positioning system. Transurethral probe rotates 360° to ablate prescribed prostate volume in one sweep. | Same | | Fusion of ultrasound with other imaging modalities (DICOM) | No | No | Same | | Ultrasound Duty cycle | Continuous ultrasound delivery | Continuous ultrasound delivery | Same | | Lesion Shape | 5mm-wide directional beam (candle flame shape). Ten adjacent transducer elements produce overlapping heating pattern. Continuous volume of thermal ablation is delivered. | 5mm-wide directional beam (candle flame shape). Ten adjacent transducer elements produce overlapping heating pattern. Continuous volume of thermal ablation is delivered. | Same | | Ablation planning | Sagittal, Coronal and Axial planes | 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 | | | Subject Device (TULSA-PRO System) | Predicate Device (TULSA-PRO System) | Comparison Results | | Software Feature | | | | | Thermal Boost | User-enabled feature, per ultrasound element, to use variable control temperature from 57°C to 65°C (not intended for the whole gland). This feature is optional and can be turned on to achieve the intended ablation when prostate radius is >15 mm. | Fixed control temperature at 57°C around the whole gland | Modified: The method and control of prostate tissue ablation remains the same. When prostate radius is > 15 mm and ultrasound heating is not reaching the desired boundary, this feature can be enabled by the user during treatment delivery in a user- selected region. The software verification and validation activities provided under VOL_16 and VOL_20 do not indicate change to the TULSA-PRO safety and effectiveness. | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "PROFOUND" in blue letters. The letter "O" has a circle in the middle with a line going through it. The font is sans-serif and the letters are bold. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the word "PROFOUND" in all capital letters. The word is written in a blue sans-serif font. The letter "O" has a circle in the middle with a horizontal line going through it, which is a design element of the logo. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the word "PROFOUND" in blue, with a horizontal line going through the middle of the word. The "O" in "PROFOUND" has a circle in the middle of it, and the horizontal line goes through the center of the circle. The font is sans-serif and the letters are all capitalized. #### Summary of Non-clinical testing VII. The following non-clinical testing was provided in support of this submission: - Software verification and validation activities were performed in accordance ● with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11,2005) to assess that the performance of the modified software is equivalent to the predicate device. - Technical performance of the software with Thermal Boost enabled was compared to the predicate software during simulated prostate ablation in a tissuemimicking gel phantom. Tissue temperature profiles were measured using MR thermometry, which is representative of clinical use. There were no significant differences in the temperature profile with respect to location of peak temperature or rate of change of temperature at the prostate boundary. Although Thermal Boost is not intended to be enabled for an entire prostate ablation {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the word "PROFOUND" in blue letters. A horizontal line goes through the middle of the word, intersecting the letters O, U, N, and D. There is a blue circle in the middle of the first "O" that is intersected by the horizontal line. procedure, this scenario was evaluated as a worst case and specifications related to rectal cooling and treatment controller targeting statistics were met. The following non-clinical testing that was 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 to O the sterilization specification. - 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"". - There is no change to the device materials or biocompatibility specification O for the device with this submission. - Electrical Safety and Electromagnetic Compatibility had been confirmed by ● Nationally Recognized Testing Laboratory. - There was no change to the device specification that impacts electrical safety O or electromagnetic compatibility. There is no change to ultrasound power levels or frequency of device operation. - Animal Studies The animal testing that was provided in the original 510(k) ● remains applicable to support this 510(k) submission, as the principle of operation for heating tissue and monitoring the extent of ablation remains the same. The software verification and clinical data validation addresses all concerns of safety and effectiveness of the subject device. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the word "PROFOUND" in blue font. A horizontal line goes through the middle of the word, intersecting the "O" in the middle. The font is sans-serif and the letters are all capitalized. ### VIII. Clinical Data The predicate TULSA-PRO system (K191200) has previously been evaluated in prospective clinical studies, Phase I safety study (NCT01686958) and the Phase 2 pivotal study (herein referred to as the 'TACT' trial) (NCT02766543). ### Clinical testing of the Subject Device: Clinical performance of the Thermal Boost feature was evaluated to demonstrate that this feature does not raise further questions for safety and efficacy of the subject TULSA-PRO system when compared with the predicate device. Clinical performance data were collected from 71 adult male patients treated with the commercially available TULSA-PRO system with Thermal Boost applied during the prostate ablation treatment, where needed. The area of prostate requiring Thermal Boost was determined by the treating physician. The device performance was documented and evaluated through adverse events assessed by the treating physician for a six-month period post-treatment, technical treatment performance statistics, and physician usability assessment of the feature. The primary endpoint for determination of safety was rate of serious adverse events and adverse events with Thermal Boost compared to the predicate device. Patient follow-up of at least 6-month duration post-treatment was used to identify adverse events, using MedDRA for terminology and the Clavien-Dindo classification for grading. All events were captured regardless of causality. Adverse events reported with Thermal Boost are similar to those that were previously reported in the pivotal clinical data set for TULSA-PRO (epididymitis, urinary retention, pain/discomfort, urinary urgency, nocturia, urinary incontinence, ejaculation disorder, erectile dysfunction, urinary tract infection, and hematuria). There were no new complications observed in the Thermal Boost population. The technical treatment performance was evaluated by comparing the physician-defined ablation plan to the temperature maps measured during ablation delivery by the software. These performance endpoints are used to assess the accuracy of the treatment controller and are the same as were evaluated for the predicate device clearance (K191200). With Thermal Boost enabled during treatment, the median (IQR) Dice Similarity Coefficient was 0.90 (0.88-0.92), Controller overshoot percentage was 6.4% (3.6%-10%), and controller undershoot percentage was 3.9% (1.7%-7.1%). All technical endpoints met the established performance criteria. A usability questionnaire was administered to physicians who used the TUSLA-PRO System with the Thermal Boost feature. The purpose of this assessment was to evaluate that information provided to the users about the Thermal Boost feature was perceived, {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the text "K230692" on the first line. The second line of the image says "Page 10 of 10". The text is in a simple, sans-serif font and is centered on the page. The image appears to be a page number or document identifier. Image /page/12/Picture/1 description: The image shows the word "PROFOUND" in blue font. A horizontal line goes through the middle of the word, intersecting the letters O, U, and N. There is a blue dot on the line, in the middle of the letter O. understood, and supports correct use of the software feature. Responses from the usability questionnaire indicated that identification of the feature and training material was effective and there were no new use errors identified. The results of the clinical study do not indicate any new risks or any concerns about safety or performance of the Thermal Boost feature of the TULSA-PRO software when compared to the predicate software. #### Conclusion IX. The modified TULSA-PRO software with the Thermal Boost feature does not raise any new concerns regarding device risk or different questions of safety and effectiveness. Software verification testing in a tissue mimicking phantom along with clinical data demonstrate that the device is as safe, as effective, and performs as well as the predicate device.