(191 days)
No
The description focuses on closed-loop process control software adjusting parameters based on real-time measurements, which is a form of automation and control, not explicitly AI/ML. There is no mention of learning from data or using complex algorithms typically associated with AI/ML.
Yes
Explanation: The device is indicated for transurethral ultrasound ablation of prostate tissue, which is a therapeutic intervention aimed at treating medical conditions.
No
The device is described as an ablation system for treating prostate tissue, not for diagnosing conditions. Its primary function is therapeutic (heating and ablating tissue), even though it uses imaging and thermometry for guidance and control during the treatment.
No
The device description explicitly states that the TULSA-PRO system consists of both hardware and software components, and the submission describes a modification to the software component of an existing system that includes hardware.
Based on the provided information, the TULSA-PRO device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The TULSA-PRO system is used to directly treat prostate tissue within the patient's body using ultrasound ablation. It does not analyze samples taken from the patient.
- The intended use is therapeutic. The primary function of the TULSA-PRO is to ablate (destroy) prostate tissue, which is a treatment, not a diagnostic process.
- The device description focuses on energy delivery and tissue heating. This aligns with a therapeutic device, not a device for analyzing biological samples.
- The performance studies evaluate treatment outcomes and technical performance of the ablation process. They do not involve the analysis of biological markers or diagnostic results.
Therefore, the TULSA-PRO is a therapeutic 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 (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) imaging
Anatomical Site
Prostate tissue
Indicated Patient Age Range
Adult male patients
Intended User / Care Setting
Physician / Outpatient procedures (implies clinical setting)
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
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. Tissue temperature profiles were measured using MR thermometry, which is representative of clinical use.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing:
- Software verification and validation activities: 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 comparison: Compared the Thermal Boost enabled software to the predicate software during simulated prostate ablation in a tissue-mimicking gel phantom.
- Key results (non-clinical): 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. Specifications related to rectal cooling and treatment controller targeting statistics were met.
Clinical testing:
- Study type: Evaluation of clinical performance of the Thermal Boost feature.
- Sample size: 71 adult male patients.
- Data source: Patients treated with the commercially available TULSA-PRO system with Thermal Boost applied during the prostate ablation treatment.
- Key results (clinical):
- Safety: Adverse events reported with Thermal Boost were similar to those 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). No new complications observed.
- Technical treatment performance: 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.
- Usability: Usability questionnaire responses indicated that identification of the feature and training material was effective and no new use errors were identified.
- Overall conclusion: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Median (IQR) Dice Similarity Coefficient: 0.90 (0.88-0.92)
- Controller overshoot percentage: 6.4% (3.6%-10%)
- Controller undershoot percentage: 3.9% (1.7%-7.1%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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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.
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)
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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.
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
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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.
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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. |
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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.