(171 days)
Not Found
No
The summary describes a system that uses MR imaging for guidance, planning, and real-time monitoring of focused ultrasound ablation. It mentions "closed-loop MR thermal feedback" and "real-time monitoring," but there is no mention of AI, ML, or any algorithms that would typically fall under those categories for image analysis, planning optimization, or feedback control beyond standard thermal monitoring. The "Mentions AI, DNN, or ML" section explicitly states "Not Found."
Yes
The device is indicated for "ablation of Prostatic Tissue," which is a medical procedure aimed at treating a condition, aligning with the definition of a therapeutic device.
No
The device is described as an ablation system for prostatic tissue, which is a therapeutic function, not diagnostic. It uses MRI for guidance and monitoring during the treatment.
No
The device description explicitly states it includes a "multiple-channel phased-array Focused Ultrasound (FUS) transducer probe" and is a "high intensity Magnetic Resonance ("MR") image- guided focused ultrasound (MRgFUS) system," indicating it is a hardware system with integrated software, not a software-only device.
Based on the provided information, the Exablate Prostate System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Exablate Prostate System Function: The Exablate Prostate System is a therapeutic device that uses focused ultrasound energy to ablate (destroy) prostatic tissue within the patient's body. It uses MRI for guidance and monitoring, but it does not analyze samples taken from the body.
Therefore, the Exablate Prostate System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Exablate Prostate System is indicated for endorectal MR-Guided Focused Ultrasound (MRgFUS) ablation of Prostatic Tissue.
Product codes
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) imaging
Anatomical Site
Prostatic Tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained and certified physicians and/or technicians (clinicians)
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
The following non-clinical studies were conducted on the Exablate Prostate System 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.
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
Key Metrics
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
1
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.
2
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
3
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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4
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 2059 | ||
| Tirat Carmel 39120, Israel | ||
| Contact Person: | Inbal Ben-Tzvi | |
| VP Regulatory Affairs | ||
| Phone: 972-54-244-5822 | ||
| Fax: 972 4 813 1322 | ||
| Device: | Trade Name: | Exablate Prostate System |
| Common name | Ultrasound System (MRgFUS) | |
| Classification Name: | High Intensity Ultrasound System for Prostate | |
| Tissue 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 tissue | |
| ablation | ||
| 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 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. | ||
| Indications for Use: | The main purposes of this 510(k) submission include enhancements to the | |
| secondary water system operation and a reduction of treatment time. | ||
| The Exablate Prostate System is indicated for endorectal MR-Guided Focused | ||
| Ultrasound (MRgFUS) ablation of Prostatic Tissue. | ||
| Based on the information provided above, the Exablate Prostate System is | ||
| considered substantially equivalent to the currently marketed predicate device in | ||
| terms of Indications for Use. | ||
| Effective Date: 11-May-2023 (0 | ||
| Technological | ||
| characteristics: | Comparisons with the predicate devise show the technological characteristics of | |
| the proposed Exablate Prostate System to be substantially equivalent to the | ||
| predicate device. The proposed device is functionally identical to the predicate | ||
| device. |
Based on the information provided above, the Exablate Prostate System is
considered substantially equivalent to the currently marketed predicate device in
terms of fundamental scientific technology. | |
| Summary of Non-
Clinical Performance
Data: | The following non-clinical studies were conducted on the Exablate Prostate
System 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 Clinical
Performance 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 | |
5
6
7
- 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.