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 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.

AI/ML Overview

The provided text describes modifications to the TULSA-PRO System, specifically a software update introducing an optional feature called "Thermal Boost." The document is a 510(k) summary, aimed at demonstrating substantial equivalence to a previously cleared predicate device rather than presenting a novel device that requires a full, de-novo clinical trial with extensive acceptance criteria.

Therefore, the acceptance criteria and study detailed here are focused on demonstrating that the modification (Thermal Boost feature) does not adversely impact the safety and effectiveness of the existing, cleared TULSA-PRO system. It's not a study to establish the device's efficacy from scratch, but rather to show that the new feature maintains the established safety and performance profile.

Here's an analysis based on the provided text:

Key Takeaway: The "acceptance criteria" for this 510(k) submission are implicitly about demonstrating that the software modification (Thermal Boost) does not introduce new safety or effectiveness concerns compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, the "acceptance criteria" are not explicitly defined as pass/fail thresholds for specific metrics in a table format for the Thermal Boost feature itself in a clinical comparative study. Instead, the focus is on showing that the modified device's performance, particularly in terms of safety and technical metrics, is consistent with or better than the predicate device.

The document highlights the following evaluation points for the Thermal Boost feature:

Criteria Category	Specific Metric/Approach	Reported Device Performance (Thermal Boost)	Comparison to Predicate/Acceptance
Safety	Rate of serious adverse events and adverse events	Adverse events reported with Thermal Boost were similar to those previously reported in the pivotal clinical dataset for TULSA-PRO (K191200). (e.g., epididymitis, urinary retention, pain/discomfort, urinary urgency, nocturia, urinary incontinence, ejaculation disorder, erectile dysfunction, urinary tract infection, and hematuria). No new complications were observed.	This implicitly meets the acceptance criteria of not increasing adverse event rates or introducing novel complications compared to the predicate device. The "similarity" indicates acceptance.
Technical Performance	Dice Similarity Coefficient (DSC) (Physician-defined ablation plan vs. temperature maps)	Median (IQR) DSC: 0.90 (0.88-0.92)	All technical endpoints met the established performance criteria. (The specific numerical criteria for the predicate are not detailed in this document for direct comparison, but the statement indicates meeting pre-defined thresholds).
Technical Performance	Controller overshoot percentage (Physician-defined ablation plan vs. temperature maps)	Median (IQR) Controller overshoot: 6.4% (3.6%-10%)	All technical endpoints met the established performance criteria. (Same as above)
Technical Performance	Controller undershoot percentage (Physician-defined ablation plan vs. temperature maps)	Median (IQR) Controller undershoot: 3.9% (1.7%-7.1%)	All technical endpoints met the established performance criteria. (Same as above)
Usability	User perception and understanding of Thermal Boost feature; identification of new use errors via questionnaire	Responses indicated that identification of the feature and training material was effective. No new use errors identified.	This meets the criterion of demonstrating that the feature is usable and does not introduce new risks due to user error.
Non-clinical (Software V&V)	Performance of modified software compared to predicate software (in tissue-mimicking phantom)	No significant differences in temperature profile with respect to location of peak temperature or rate of change of temperature at the prostate boundary. Rectal cooling and treatment controller targeting statistics were met even in worst-case scenario.	This non-clinical testing directly serves as an "acceptance criterion" that the software modification functions as intended without adverse changes in a controlled environment, validating its equivalence to the predicate.

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

Sample Size for Clinical Performance (Test Set): 71 adult male patients.
Data Provenance: Clinical performance data were collected from patients presumably treated with the commercially available TULSA-PRO system with Thermal Boost applied. The location of the clinical study is not explicitly stated, but the company is based in Canada. Given it's a 510(k) for a known device, it's likely a prospective collection of data on patients treated with the modified system in a clinical setting. It is not explicitly stated if it was retrospective or prospective, but the phrasing "Clinical performance data were collected from 71 adult male patients treated..." implies prospective data collection tailored to assess the new feature's impact.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts or their qualifications involved in establishing "ground truth" for the clinical test set concerning the Thermal Boost feature. The assessment appears to rely on:

Treating Physician's Determination: The area of prostate requiring Thermal Boost was determined by the treating physician.
Adverse Event Assessment: Adverse events were assessed by the treating physician for a six-month period post-treatment.
Technical Performance: Evaluation was via comparison of physician-defined ablation plan to temperature maps measured during ablation delivery by the software. This implies the software's ability to monitor and report accurate temperature data serves as a form of "ground truth" for real-time ablation monitoring, validated by physical phantom testing.
Usability Questionnaire: Administered to physicians who used the system.

Given the nature of the submission (510(k) for a software modification to an already cleared device), the "ground truth" is primarily whether the software controls maintained their accuracy and if clinical outcomes (adverse events, usability) remained comparable to the cleared predicate, as reported by the treating physicians and the device's own monitoring systems.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1 consensus) for the clinical data. Adverse events were assessed by the treating physician. Technical performance was automatically evaluated by the system comparing its plan to measured temperature maps. Usability was through a questionnaire. This implies no external, multi-expert adjudication process beyond the primary treating physicians' reports and the device's internal technical metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not explicitly stated or implied for this submission.
- This type of study is more common for AI-driven diagnostic or interpretative tools where human reader performance (with vs. without AI) is a direct measure of the AI's clinical utility.
- The TULSA-PRO System is an ablation device with a software control modification. Its "effectiveness" is primarily a measure of its ability to ablate tissue safely and accurately, not an interpretative aid. The efficacy of the TULSA-PRO system itself was established in previous clearances (K191200 onward). This 510(k) focuses on the safety and performance impact of a new control feature.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

Yes, in a non-clinical context.
- "Technical performance of the software with Thermal Boost enabled was compared to the predicate software during simulated prostate ablation in a tissue-mimicking gel phantom."
- This phantom study effectively tested the algorithm's performance in a standalone, controlled environment, measuring temperature profiles and confirming its targeting statistics. This demonstrates the algorithm's behavior independent of human intervention, although the "Thermal Boost" is a user-enabled feature.

7. The Type of Ground Truth Used

The "ground truth" depends on the evaluation aspect:

Safety: The ground truth for safety was based on clinically reported adverse events identified by the treating physicians and classified using MedDRA and Clavien-Dindo.
Technical Performance: The ground truth was the real-time MR thermometry measurements during ablation delivery, compared against the physician-defined ablation plan. This implies the MR thermometry is considered the benchmark for actual temperature distribution, while the physician's plan is the target.
Usability: The ground truth for usability was the direct subjective feedback from physicians via a questionnaire.
Non-clinical (Software V&V): For the phantom study, the ground truth was MR thermometry measurements within the tissue-mimicking gel.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This is because the submission describes a software modification for an existing device, not a de novo AI/ML model that requires a new, explicit training phase for this specific submission. The "Thermal Boost" feature appears to be a modification to the control algorithm of an existing system, likely developed based on engineering principles and potentially internal performance data, rather than a separate, newly trained AI model.

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

As no specific "training set" for a new AI/ML model linked to this specific software feature is mentioned, the method for establishing its ground truth is not detailed. The software verification and validation activities are described as being performed in accordance with FDA guidance, comparing the modified software's performance to the predicate device. This implies that the "ground truth" for verifying the software's behavior would stem from its expected performance parameters, likely established during the original device development (K191200) and confirmed during the modification through non-clinical testing.

Summary

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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.

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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 -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

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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)

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K230692 Page 1 of 10

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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.

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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.

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Applicator, to deliver precise ablation of the prescribed prostate tissue defined by the physician in the treatment plan.

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.

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Table 1. Substantial equivalence table

	Subject Device(TULSA-PROSystem)	Predicate Device(TULSA-PROSystem)	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® isindicated fortransurethralultrasound ablation(TULSA) of prostatetissue.	The TULSA-PRO® isindicated fortransurethralultrasound ablation(TULSA) of prostatetissue.	Same
Prescription Use	Yes	Yes	Same
Non-surgical, minimallyinvasive	Yes	Yes	Same
Outpatient procedures	Yes	Yes	Same
Anesthesia required	Yes	Yes	Same
Physician trainingrequired	Yes	Yes	Same
System Components	Main consolecontaining electronicsandprogrammablehardware (SystemElectronics unit)PC computer, LCDdisplay, customablationdelivery software(TDC unit)Water cooling circuit(System Cart, FluidCircuit)TransurethralUltrasound Applicator(UA)Endorectal CoolingDevice (ECD)Positioning System	Main consolecontaining electronicsandprogrammablehardware (SystemElectronics unit)PC computer, LCDdisplay, customablationdelivery software(TDC unit)Water cooling circuit(System Cart, FluidCircuit)TransurethralUltrasound Applicator(UA)Endorectal CoolingDevice (ECD)Positioning System	Same
	Subject Device(TULSA-PROSystem)	Predicate Device(TULSA-PROSystem)	Comparison Results
	Disposableaccessories	Disposable accessories
Patient position	Head-first supine	Head-first supine	Same
Route of EnergyDelivery	Trans-urethral	Trans-urethral	Same
Prostate size limitation	Prostates up to 110cc	Prostates up to 110cc	Same
Ablation modality	High IntensityDirectionalUltrasound	High IntensityDirectional Ultrasound	Same
Imaging modality forlocalization, treatmentand control	MRI	MRI	Same
Ablation Frequency	Dual AblationFrequency:Low Frequencyrange: 4 – 4.8 MHzHigh Frequencyrange: 13.4 – 14.4 MHz	Dual AblationFrequency:Low Frequency range:4 – 4.8 MHzHigh Frequency range:13.4 – 14.4 MHz	Same
Total acoustic power	4 W per element (lowfrequency)2W per element (highfrequency)Max (10 elements):40W / 20W	4 W per element (lowfrequency)2W per element (highfrequency)Max (10 elements):40W / 20W	Same
Probe type	Linear array	Linear array	Same
UltrasoundTransducer/Probe	Linear array of 10planar rectangularultrasound transducerelements withindividuallycontrolled frequencyand power	Linear array of 10planar rectangularultrasound transducerelements withindividually controlledfrequency and power	Same
Probe Placement	Manual transurethraldevice insertion withguidewire.Probe attached tocustom Positioning	Manual transurethraldevice insertion withguidewire.Probe attached tocustom Positioning	Same
	Subject Device(TULSA-PROSystem)	Predicate Device(TULSA-PROSystem)	Comparison Results
	System arm mountedto MRI base plate (3-axis manualadjustment).Automated linearprobe adjustmentwithin urethra basedon MR imageguidance.	System arm mountedto MRI base plate (3-axis manualadjustment).Automated linearprobe adjustmentwithin urethra basedon MR imageguidance.
TransducerMovement/Ablationvolume	Automated devicerotation using customPositioning system.Transurethral proberotates 360° to ablateprescribed prostatevolume in one sweep.	Automated devicerotation using customPositioning system.Transurethral proberotates 360° to ablateprescribed prostatevolume in one sweep.	Same
Fusion of ultrasoundwith other imagingmodalities (DICOM)	No	No	Same
Ultrasound Duty cycle	Continuousultrasound delivery	Continuous ultrasounddelivery	Same
Lesion Shape	5mm-wide directionalbeam (candle flameshape). Ten adjacenttransducer elementsproduce overlappingheating pattern.Continuous volume ofthermal ablation isdelivered.	5mm-wide directionalbeam (candle flameshape). Ten adjacenttransducer elementsproduce overlappingheating pattern.Continuous volume ofthermal ablation isdelivered.	Same
Ablation planning	Sagittal, Coronal andAxial planes	Sagittal, Coronal andAxial planes	Same
Longitudinal motion	6.4 cm	6.4 cm	Same
Management ofprotocols	Close-loop controlalgorithm	Close-loop controlalgorithm	Same
	Subject Device(TULSA-PROSystem)	Predicate Device(TULSA-PROSystem)	Comparison Results
Software Feature
Thermal Boost	User-enabled feature,per ultrasoundelement, to usevariable controltemperature from57°C to 65°C (notintended for the wholegland). This feature isoptional and can beturned on to achievethe intended ablationwhen prostate radiusis >15 mm.	Fixed controltemperature at 57°Caround the wholegland	Modified: The methodand control of prostatetissue ablation remainsthe same. When prostateradius is > 15 mm andultrasound heating is notreaching the desiredboundary, this featurecan be enabled by theuser during treatmentdelivery in a user-selected region. Thesoftware verification andvalidation activitiesprovided under VOL_16and VOL_20 do notindicate change to theTULSA-PRO safety andeffectiveness.

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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

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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.

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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,

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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.

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.