FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

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.