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 a customized volume of physician prescribed prostate tissue. The system consists of both hardware and software components.

Transurethral ultrasound ablation (TULSA) treatment ablates prostate tissue using inbore real-time MRI treatment planning, monitoring, visualization, and active temperature feedback control. The closed-loop features of the TULSA-PRO® software use a real-time MRI interface to process MRI prostate temperature measurements, and communicate with the 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 the urethra outwards into 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 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 to robotically position the UA in the prostate and plan the treatment by contouring the prescribed tissue on real time high-resolution crosssectional 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'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 intended 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

This document is a 510(k) Premarket Notification from the FDA regarding the TULSA-PRO System. It primarily addresses the substantial equivalence of an updated version of the TULSA-PRO System (K202286) to a previously cleared version (K191200).

The provided text does not contain acceptance criteria for device performance or a study demonstrating the device meets those criteria in the typical sense of a clinical trial or performance study with defined endpoints/metrics.

Instead, this 510(k) submission is a "Special 510(k)" application, which means the manufacturer is asserting that the changes made to the device do not affect its safety or effectiveness and that the modified device remains substantially equivalent to the cleared predicate device.

Therefore, many of the requested details about acceptance criteria, sample sizes for test sets, expert ground truth, MRMC studies, and standalone performance studies are not present in this document. The focus here is on demonstrating that the modifications made do not necessitate new clinical data or performance studies.

Based on the document, here's what can be extracted and what cannot:

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

Not provided in the document. The document focuses on showing the modified device is "the same" or has minor, non-impactful changes compared to the predicate. There are no performance acceptance criteria explicitly stated for the device's function (e.g., ablation efficacy, precision of tissue removal) in this submission.

2. Sample size used for the test set and the data provenance:

Not applicable/Not mentioned. This submission is not based on a new test set of clinical data for performance evaluation. It relies on non-clinical testing (bench performance, software validation, EMC, packaging) demonstrating that the minor changes (e.g., software version upgrade, packaging modifications) do not alter the established safety and effectiveness of the predicate device.
The document explicitly states: "The modifications of TULSA-PRO® System does not require additional clinical data to demonstrate substantial equivalence."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not mentioned. No new clinical test set with human-established ground truth was used for this Special 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable/Not mentioned. This device (TULSA-PRO System) is an ultrasound ablation system, not an AI-assisted diagnostic device typically evaluated with MRMC studies.

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

Not applicable/Not mentioned in the context of clinical performance. The "algorithm" here is the closed-loop process control software for ablation. Its performance is validated through bench testing and system validation in a simulated-use environment, not typically as an "algorithm-only" clinical performance study.

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

Not applicable for clinical performance. For the non-clinical testing mentioned:
- Bench Performance Testing: Verification against "design specifications" (internal standards).
- Software Information: Validation in accordance with FDA guidance for software in medical devices.
- EMC/Packaging/Biocompatibility/Sterilization/Electrical Safety: Conformance to recognized standards and previous testing from K191200.
- Animal Studies: Explicitly stated that this submission "does not rely on the assessment of animal data."

8. The sample size for the training set:

Not applicable/Not mentioned. There's no indication that a machine learning or AI model, requiring a "training set," was developed or updated as part of this submission. The "software" refers to control and processing software, not typically a learning algorithm.

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

Not applicable/Not mentioned.

Summary of what the document DOES state regarding "performance" and "meeting criteria":

The "acceptance criteria" here are effectively demonstrating substantial equivalence to the predicate device (K191200) despite minor modifications. The "study" proving this is a series of non-clinical tests and comparisons, rather than new clinical trials.

The document claims the device "meets the acceptance criteria" in the following ways:

Bench Performance testing: "All design specifications for components of TULSA-PRO® system are verified either by design or by test and are traceable to a verification report or other document." Also, "All the performance testing performed on the subject device remains the same when compared with the cleared device K191200." The system as a whole is "validated in a simulated-use environment."
Software Information: "Software validation activities were performed in accordance with the FDA Guidance..." (for "TDC software version has been upgraded from V2.8 to V2.9").
Electromagnetic Compatibility: "Changes to PSIB have been tested to conform with Electromagnetic test requirements by Nationally Recognized Testing Laboratory."
Packaging: "The packaging meets the transit performance test requirements of ASTM D4169."
Biocompatibility, Sterilization, Electrical Safety: "No change from K191200," implying they still meet prior criteria.

In essence, the "study" proving the device meets the (implied) acceptance criteria is the demonstration that the modifications are minor and do not alter the established safety and effectiveness of the predicate device, confirmed through documented non-clinical testing and adherence to relevant standards.

Summary

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September 16, 2020

Profound Medical, Inc. Goldy Singh VP Product Management & Regulatory Affairs 2400 Skymark Avenue, Unit 6 Mississauga. Ontario L4W 5K5 Canada

Re: K202286

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 13, 2020 Received: August 17, 2020

Dear Goldy Singh:

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

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

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

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

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

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

Sincerely,

Mark J. Antonino, M.S. 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

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Indications for Use

510(k) Number (if known) K202286

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)

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TULSA-PRO System Special 510(k) application

Image /page/3/Picture/1 description: The image shows the word "PROFOUND" in large, blue, sans-serif font. A thin blue line runs horizontally through the middle of the word, connecting the "O"s. In the upper right corner of the image, the text "K202286 Page 1 of 7" is printed in a smaller, black font.

510(k) Summary

I. General Information
Applicant Name: Profound Medical Inc. ロ 2400 Skymark Avenue, Unit #6, Mississauga, ON L4W 5K5, Canada T: 647.476.1350 F: 647.847.3739
Contact Name: Goldy Singh VP Regulatory Affairs & Product Management 2400 Skymark Avenue, Unit #6, Mississauga, ON L4W 5K5, Canada Phone: 647.476.1350 × 403 Fax: 647.847.3739 Email: gsingh@profoundmedical.com
Date of Submission: August 10, 2020

II. Device Identification

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

III. Predicate Device Information

Predicate Device: TULSA-PRO System
High Intensity Ultrasound System for Prostate Tissue Ablation Common Name:
510(k) Number: K191200 ロ

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TULSA-PRO System Special 510(k) application

K202286 Page 2 of 7

Regulatory Class: Class II ロ
Regulation Number: 21 CFR 876.4340 ロ
Regulation Name: High Intensity Ultrasound System for Prostate Tissue Ablation
Product Code: PLP (High Intensity Ultrasound System for Prostate Tissue Ablation)
Decision Date: August 15, 2019
Manufacturer: Profound Medical Inc. ロ

IV. Device Description

The Device description of the modified TULSA-PRO® system is as follows and it is identical to the cleared TULSA-PRO system.

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TULSA-PRO® console to robotically position the UA in the prostate and plan the treatment by contouring the prescribed tissue on real time high-resolution crosssectional 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'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 intended regions of the prostate. Following completion 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.

Summary of Non-clinical testing VI.

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

a. Bench Performance testing: Hardware design and development follows Profound Medical internal design control process. All design specifications for components of TULSA-PRO® system are verified either by design or by test and are traceable to a verification report or other document. All the performance testing performed on the subject device remains the same when compared with the cleared device K191200. The system as a whole is

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validated in a simulated-use environment, which is a 3T MRI suite and 1.5T MRI suite with specified hardware and software parameters, identical to the system parameters of intended use.

b. Software Information: The Treatment Delivery Console (TDC) software version has been upgraded from V2.8 to V2.9. Software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Electromagnetic Compatibility: Changes to PSIB have been tested to ﻥ conform with Electromagnetic test requirements by Nationally Recognized Testing Laboratory
d. Packaging: There is no change in any sterile barrier packaging. The shipper boxes and foam insert sizes are modified for Positioning System (PS), Positioning System Interface Box (PSIB), Filter Box (FB) and Magnet Kit. The packaging meets the transit performance test requirements of ASTM D4169.
e. Biocompatibility: No change from K191200
f. Sterilization: No change from K191200
Electrical Safety testing: No change from K191200 g.
h. Animal Studies: This premarket notification submission does not rely on the assessment of animal data to demonstrate substantial equivalence.

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VII. Conformance to Recognized Standards
The TULSA-PRO® System complies with applicable sections of the following recognized consensus standards:
ロ IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances – Requirements and tests
ISO 14971 Medical devices Application of risk management to medical devices
ANSI/AAMI/IEC 62304 Medical device software Software life cycle processes
ISO 15223-1 Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied
ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating on a Near Passive Implants during Magnetic Resonance Imaging
ISO\TS 10974 Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active Implantable Medical Device
Clinical Data VIII.

The modifications of TULSA-PRO® System does not require additional clinical data to demonstrate substantial equivalence.

IX. Comparison to Predicate Device The indication for use of the subject device remains unchanged from the predicate TULSA-PRO System (K191200).

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	Predicate Device(TULSA-PRO System-K191200)	Subject Device(TULSA-PRO System)
Manufacturer	Profound Medical Inc.	Profound Medical Inc.
510(k) No.	K191200	Not assigned
Regulation Number	21 CFR 876.4340	Same
Product Code	PLP	Same
Indications for Use	TULSA-PRO® is indicatedfor transurethral ultrasoundablation (TULSA) ofprostate tissue.	Same
Prescription Use	Yes	Same
Non-surgical, Minimallyinvasive	Yes	Same
Outpatient procedures	Yes	Same
Anesthesia required	Yes	Same
Physician trainingrequired	Yes	Same
System Components	Main console containingelectronics andprogrammable hardware(System Electronics unit)PC computer, LCD display,custom ablation deliverysoftware (TDC unit)Water cooling circuit(System Cart, Fluid Circuit)	Same

	Transurethral UltrasoundApplicator (UA)Endorectal Cooling Device(ECD)Positioning SystemDisposable accessories
Route of Energy Delivery	Trans-urethral	Same
Ablation modality	High Intensity DirectionalUltrasound	Same
Imaging modality forlocalization, treatmentand control	MRI	Same
Ablation Frequency	Dual Ablation Frequency:Low Frequency range: 4.1 –4.5 MHz High Frequencyrange: 13.0 - 14.4 MHz	Same
Total acoustic power	4 W per element (lowfrequency) 2W per element(high frequency) Max (10elements): 40W / 20W	Same
MRI Compatibility	3T MRI scanners	1.5T & 3T MRI Scanners

Table1. Comparison of Predicate and Subject Device

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Conclusion:

The subject and predicate device share the same indications for use. Design differences between the subject and predicate device do not raise any new concerns or different questions of safety and effectiveness. The results of verification and validation activities demonstrate the substantial equivalence of the subject device to 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.