(35 days)
Not Found
No
The description details a closed-loop control system based on real-time sensor data (MR thermometry) and pre-programmed logic, not AI/ML algorithms. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML.
Yes
The device is indicated for transurethral ultrasound ablation of prostate tissue, which is a therapeutic intervention. It actively delivers precise thermal ablation to destroy targeted prostate tissue.
No
The TULSA-PRO® system is designed for thermal ablation of prostate tissue, which is a treatment modality, not a diagnostic one. While it uses MR imaging for planning and monitoring, its primary function is to deliver therapy.
No
The device description explicitly states that the TULSA-PRO® system consists of both hardware and software components, and the description details various hardware components like catheters, an Ultrasound Applicator, and an Endorectal Cooling Device.
Based on the provided information, the TULSA-PRO® device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. These tests are performed outside the body (in vitro).
- TULSA-PRO® Function: The TULSA-PRO® system is used for transurethral ultrasound ablation of prostate tissue. This is a therapeutic procedure performed inside the body (in vivo) to treat prostate tissue. It uses ultrasound energy to heat and destroy tissue, guided by real-time MRI.
- Lack of Sample Analysis: The description does not mention the device analyzing any biological samples. Its function is to deliver energy and monitor temperature within the body.
Therefore, the TULSA-PRO® falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TULSA-PRO® is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.
Product codes
PLP
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) imaging
Anatomical Site
prostate tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / hospital (in-bore MRI suite)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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."
c. Electromagnetic Compatibility: Changes to PSIB have been tested to 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
g. Electrical Safety testing: No change from K191200
h. Animal Studies: This premarket notification submission does not rely on the assessment of animal data to demonstrate substantial equivalence.
The modifications of TULSA-PRO® System does not require additional clinical data to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
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.
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, 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
2
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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3
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
4
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.
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
5
Image /page/5/Picture/0 description: The image shows the word "PROFOUND" in blue, with a line going through the middle of the word. In the upper right corner of the image, the text "K202286 Page 3 of 7" is visible. The text indicates that this is page 3 of a 7-page document, and the document number is K202286.
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
6
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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Image /page/7/Picture/1 description: The image shows the word "PROFOUND" in a stylized blue font. There is a horizontal line going through the word. The text "K202286 Page 5 of 7" is located in the upper right corner of the image.
-
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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Image /page/8/Picture/0 description: The image contains two lines of text. The first line reads "TULSA-PRO System". The second line reads "Special 510(k) application". The text is black and the background is white.
Image /page/8/Picture/1 description: The image shows the word "PROFOUND" in blue font. There is a horizontal line going through the middle of the word. In the upper right corner of the image, the text "K202286 Page 6 of 7" is visible.
| | 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 indicated
for transurethral ultrasound
ablation (TULSA) of
prostate tissue. | Same |
| Prescription Use | Yes | Same |
| Non-surgical, Minimally
invasive | Yes | Same |
| Outpatient procedures | Yes | Same |
| Anesthesia required | Yes | Same |
| Physician training
required | 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) | Same |
| | | |
| | Transurethral Ultrasound
Applicator (UA)
Endorectal Cooling Device
(ECD)
Positioning System
Disposable accessories | |
| Route of Energy Delivery | Trans-urethral | Same |
| Ablation modality | High Intensity Directional
Ultrasound | Same |
| Imaging modality for
localization, treatment
and control | MRI | Same |
| Ablation Frequency | Dual Ablation Frequency:
Low Frequency range: 4.1 –
4.5 MHz High Frequency
range: 13.0 - 14.4 MHz | Same |
| Total acoustic power | 4 W per element (low
frequency) 2W per element
(high frequency) Max (10
elements): 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.