The Exablate 2100 / 2100V1 Type 3.0 Prostate System (Trademark Name: Exablate Prostate System) is a high intensity Magnetic Resonance ("MR") image- guided focused ultrasound (MRgFUS) system intended for endorectal use that delivers focused ultrasound energy into the prostate in a minimally invasive manner by utilizing an endorectal probe transducer.

The Exablate Prostate System combines a multiple-channel phased-array Focused Ultrasound (FUS) transducer probe and magnetic resonance imaging ("MRI") in a closed- loop treatment for the thermal procedure of Prostatic Tissue while monitoring the procedure in real time.

The Exablate Prostate System is designed to work in conjunction with FDA cleared 1.5T and 3.0T MRI scanners with phased array torso cardiac coils that is used for guidance and procedure monitoring and control feedback. The Exablate Prostate System is fully integrated with the MRI scanner used to provide MR images of the patient's anatomy and prepare an appropriate procedure plan. Measured tissue temperature changes provide feedback on the procedure dose in the targeted area and its surroundings, allowing real- time monitoring to achieve safe and effective outcomes.

The intended users for the Exablate Prostate System are trained and certified physicians and/or technicians (clinicians) who are seeking to offer patients an incisionless, focal, and MR guided and controlled prostate tissue ablation and have successfully completed the Insightec Exablate training to operate the device.

The Exablate Prostate System platform is intended to ablate prostatic tissue with focused ultrasound and operates in conjunction with FDA cleared compatible MRI scanners for the purposes of real time procedure planning, MR based guidance of the focused ultrasound energy to the target region, MR thermal imaging and ablation monitoring. The procedure effect of the Exablate Prostate System is achieved by accurately guiding the focus of the ultrasound energy to the target region. The energy is then repeatedly transmitted to the target until the desired outcome is achieved. The targeted area is defined based on MR images taken during the procedure, while patient is in procedure position.

The procedure is constantly monitored in a real-time closed-loop MR thermal feedback. Once the targeting is complete, the outcome is confirmed with adequate post-procedure MR imaging sequences.

AI/ML Overview

This document appears to be a 510(k) summary for the Insightec Exablate Prostate System. It does not describe a clinical study for software performance and instead focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Therefore, many of the requested items related to a clinical study on device performance, particularly for AI/algorithm performance, are not applicable or cannot be found in this document.

Here's a breakdown based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific performance acceptance criteria for an AI or algorithm, nor does it list reported device performance in those terms. Instead, it states that non-clinical studies demonstrated the device "meets the acceptance criteria and is adequate for its intended use" for various engineering and safety aspects.

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

Not applicable. The document does not describe a test set or data provenance for an AI/algorithm performance study. The studies mentioned are non-clinical (e.g., system level testing, usability testing).

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

Not applicable. There is no mention of a test set with ground truth established by experts as this is not a study evaluating human or AI performance.

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

Not applicable.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The Exablate Prostate System did not require clinical study because substantial equivalence to the currently marketed predicate device was demonstrated with the following attributes: Indication for use; Technological characteristics; Non-clinical performance testing."

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

Not applicable. The document describes the Exablate Prostate System as a high-intensity MR-guided focused ultrasound (MRgFUS) system for prostate tissue ablation, not a standalone AI algorithm. It mentions "Software verification and validation testing were performed", but this is software engineering testing, not standalone AI performance evaluation.

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

Not applicable, as no algorithm performance study with ground truth is described. For the non-clinical studies (e.g., system level, electrical safety, EMC), the "ground truth" would be the engineering and safety standards themselves.

8. The sample size for the training set

Not applicable, as no AI model training is described.

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

Not applicable.

Summary

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October 30, 2023

Insightec. Ltd. % Nadir Alikacem, Ph.D. VP Regulated Clinical Affairs (US Agent) Insightec. Inc. 4851 LBJ Freeway, Suite 400 Dallas, TX 75244

K231378 Re:

Trade/Device Name: Exablate Prostate System Regulation Number: 21 CFR§ 876.4340 Regulation Name: High Intensity Ultrasound System For Prostate Tissue Ablation Regulatory Class: II Product Code: PLP Dated: September 28, 2023 Received: October 2, 2023

Dear Nadir Alikacem:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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. 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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 R. Kreitz -S

for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231378

Device Name Exablate Prostate System

Indications for Use (Describe)

The Exablate Prostate System is indicated for endorectal MR-Guided Focused Ultrasound (MRgFUS) ablation of Prostatic Tissue.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR ຮູ້807.92.

Date Prepared:	May 10, 2023
Manufacturer:	Insightec, Ltd.5 Nachum Heth St., PO Box 2059Tirat Carmel 39120, Israel
Contact Person:	Inbal Ben-TzviVP Regulatory AffairsPhone: 972-54-244-5822Fax: 972 4 813 1322
Device:	Trade Name:	Exablate Prostate System
	Common name	Ultrasound System (MRgFUS)
	Classification Name:	High Intensity Ultrasound System for ProstateTissue Ablation
	Classification Regulation:	21CFR §876.4340
	Classification Panel:	Gastroenterology/Urology
	Device Class:	Class II
	Product Code:	PLP
Predicate Device:	Trade Name:	Exablate Prostate System
	Manufacturer:	Insightec, Ltd.
	510(k) Clearance:	K212150 (November 23, 2021)
	Classification Name:	High intensity ultrasound system for prostate tissueablation
	Classification Regulation:	21CFR §876.4340
	Classification Panel:	Gastroenterology/Urology
	Device Class:	Class II
	Product Code:	PLP
Device description:	The Exablate 2100 / 2100V1 Type 3.0 Prostate System (Trademark Name:Exablate Prostate System) is a high intensity Magnetic Resonance ("MR")image- guided focused ultrasound (MRgFUS) system intended for endorectaluse that delivers focused ultrasound energy into the prostate in a minimallyinvasive manner by utilizing an endorectal probe transducer.
	The Exablate Prostate System combines a multiple-channel phased-arrayFocused Ultrasound (FUS) transducer probe and magnetic resonance imaging("MRI") in a closed- loop treatment for the thermal procedure of ProstaticTissue while monitoring the procedure in real time.
	The Exablate Prostate System is designed to work in conjunction with FDAcleared 1.5T and 3.0T MRI scanners with phased array torso cardiac coils that isused for guidance and procedure monitoring and control feedback. The ExablateProstate System is fully integrated with the MRI scanner used to provide MRimages of the patient's anatomy and prepare an appropriate procedure plan.Measured tissue temperature changes provide feedback on the procedure dose inthe targeted area and its surroundings, allowing real- time monitoring to achievesafe and effective outcomes.
	The intended users for the Exablate Prostate System are trained and certifiedphysicians and/or technicians (clinicians) who are seeking to offer patients anincisionless, focal, and MR guided and controlled prostate tissue ablation andhave successfully completed the Insightec Exablate training to operate thedevice.
	The Exablate Prostate System platform is intended to ablate prostatic tissue withfocused ultrasound and operates in conjunction with FDA cleared compatibleMRI scanners for the purposes of real time procedure planning, MR basedguidance of the focused ultrasound energy to the target region, MR thermalimaging and ablation monitoring. The procedure effect of the Exablate ProstateSystem is achieved by accurately guiding the focus of the ultrasound energy tothe target region. The energy is then repeatedly transmitted to the target until thedesired outcome is achieved. The targeted area is defined based on MR imagestaken during the procedure, while patient is in procedure position.
	The procedure is constantly monitored in a real-time closed-loop MR thermalfeedback. Once the targeting is complete, the outcome is confirmed with adequatepost-procedure MR imaging sequences.
Indications for Use:	The main purposes of this 510(k) submission include enhancements to thesecondary water system operation and a reduction of treatment time.The Exablate Prostate System is indicated for endorectal MR-Guided FocusedUltrasound (MRgFUS) ablation of Prostatic Tissue.
	Based on the information provided above, the Exablate Prostate System isconsidered substantially equivalent to the currently marketed predicate device interms of Indications for Use.
Effective Date: 11-May-2023 (0
Technologicalcharacteristics:	Comparisons with the predicate devise show the technological characteristics ofthe proposed Exablate Prostate System to be substantially equivalent to thepredicate device. The proposed device is functionally identical to the predicatedevice.Based on the information provided above, the Exablate Prostate System isconsidered substantially equivalent to the currently marketed predicate device interms of fundamental scientific technology.
Summary of Non-Clinical PerformanceData:	The following non-clinical studies were conducted on the Exablate ProstateSystem to support substantial equivalence to the predicate device:System level and Secondary Water System testing Techno-Clinical and Image Quality testing Usability testing Bioburden testing Shelf life testing of the treatment kit containing single use components Software verification and validation testing were performed in accordance with the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" guidance documented issued on May 11, 2005, and IEC 62304.Electrical safety, electromagnetic compatibility, and usability testing were tested by an accredited laboratory and demonstrated to be in accordance with the following standards: IEC 60601-1-2 IEC 60601-2-62 IEC 60601-1 IEC 60601-1-6 Risk management was done in accordance with ISO 14971. All tests were used to support substantial equivalence of the subject device and demonstrate that the Exablate Prostate System: complies with the above mentioned international and FDA-recognized consensus standards and FDA guidance documents, and meets the acceptance criteria and is adequate for its intended use. Therefore, Exablate Prostate System is substantially equivalent to the predicate device in terms of safety and effectiveness.
Summary of ClinicalPerformance Data:	The Exablate Prostate System did not require clinical study because substantial equivalence to the currently marketed predicate device was demonstrated with the following attributes: Indication for use; Technological characteristics; Non-clinical performance testing

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Substantial equivalency was demonstrated by nonclinical performance tests Conclusion: provided in this 510(k) premarket notification. These tests demonstrate that the Exablate Prostate System complies with the requirements specified in the international and FDA-recognized consensus standards.
Although there are differences in technological characteristics between the subject and predicate devices, these differences do not raise different questions of safety or effectiveness.

In conclusion, the Exablate Prostate System is substantially equivalent to the currently marketed predicate device K212150 in terms of indications for use, technological characteristics, and safety and effectiveness.

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.