The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The system consists of the following main sub-assemblies: Therapy Control Module, Endorectal Probe, and consumable Ablapak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.

AI/ML Overview

The provided text is a 510(k) summary for the Ablatherm® Fusion device, which is an add-on feature, not a standalone AI device. Therefore, a direct response to all requested fields about standalone AI performance or MRMC studies is not fully applicable. However, I will extract the relevant information regarding the performance data provided to support the 510(k) submission for the AblaFusion feature, which allows for elastic fusion between MR images/biopsies locations and ultrasound.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices and does not explicitly list "acceptance criteria" in a quantitative performance metric format for the AblaFusion feature. Instead, it states that "Fusion accuracy assessment through bench testing" was provided. The key "performance" for the AI/fusion component is the ability to perform elastic fusion accurately.

Acceptance Criteria (Implied)	Reported Device Performance
Fusion accuracy	Demonstrated through bench testing (Specific quantitative metrics are not detailed in this summary). The device "performs as intended."

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

The document mentions "bench testing" for fusion accuracy assessment. It does not specify:

The sample size of cases/images used for this bench testing.
The data provenance (e.g., country of origin of data).
Whether the data was retrospective or prospective.

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

The document does not mention the use of experts to establish ground truth for the fusion accuracy assessment. Bench testing typically involves comparison against known physical phantoms or simulated data with precise, known transformations, rather than expert-derived ground truth.

4. Adjudication method for the test set:

Not applicable, as expert-driven ground truth establishment is 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:

No MRMC comparative effectiveness study is mentioned for the AblaFusion feature. The submission focuses on device safety and effectiveness in the context of substantial equivalence, not on quantifying human reader improvement with AI assistance.

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

The "Fusion accuracy assessment through bench testing" could be considered a standalone assessment of the algorithmic component's performance, as it likely evaluates the accuracy of the fusion process itself. However, specific standalone metrics like sensitivity, specificity, or AUC are not provided in this summary.

7. The type of ground truth used:

For the fusion accuracy assessment (bench testing), the ground truth was likely established using physical phantoms or simulated data with known, precise transformations that the fusion algorithm was expected to replicate. The document does not explicitly state "pathology" or "outcomes data" for this specific feature's ground truth.

8. The sample size for the training set:

The document does not provide information on the sample size used for training the AblaFusion software for elastic fusion.

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

The document does not provide information on how the ground truth for the training set was established.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 3, 2017

EDAP Technomed, Inc. Hugo Embert CEO 5321 Industrial Oaks Blvd, Suite 110 Austin, TX 78735

Re: K172285 Trade/Device Name: Ablatherm® Fusion Regulation Number: 21 CFR& 876.4340 Regulation Name: High Intensity Ultrasound System for Prostate Tissue Ablation Regulatory Class: II Product Code: PLP Dated: July 28, 2017 Received: July 28, 2017
Dear Hugo Embert:

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. The general controls provisions of the Act include requirements for annual registration. Isting 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K172285

Device Name Ablatherm® Fusion

Indications for Use (Describe)

The Ablatherm® Fusion device is indicated for transrectal high intensity focused ultrasound (HIFU) ablation 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

PSC Publishing Services (301) 443-6740 EF

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510(k) SUMMARY

EDAP Technomed, Inc
5321 Industrial Oaks Blvd, Suite 110
AUSTIN, TX 78735
USA
Phone: 512 832 7956
Facsimile: 512 684 1313

Contact Person:	Hugo EMBERT
Date Prepared:	July 28, 2017

Proprietary Name:	Ablatherm® Fusion
Common Name:	High intensity ultrasound system for prostate tissue ablation
Regulatory Class:	II
Regulation:	21 CFR 876.4340
Product Code:	PLP

Predicate Devices

Ablatherm® Integrated Imaging (K153023), Sonablate® (K160942)

Intended Use:

The Ablatherm® Fusion device is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue.

Device Description:

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The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.

Technological characteristics

As previously cleared in the Ablatherm Integrated Imaging (K153023) predicate, the Ablatherm Fusion uses the same process and technology for delivering HIFU energy.

In addition, a dedicated software allowing elastic fusion between MR images /biopsies locations and ultrasound is integrated.

The purpose of this 510(k) submission is to add an optional feature that provides MRI images and/or biopsies positions fused with the system's live ultrasound imaging. This option is referred to as AblaFusion.

Performance Data

The following non-clinical testing was provided in support of this submission:

-Software Documentation
-Electrical safety & EMC test reports
-Fusion accuracy assessment through bench testing

Substantial Equivalence

	Ablatherm® Fusion	Ablatherm®Integrated Imaging	Sonablate
Manufacturer	EDAP TMS France	EDAP TMS France	SonaCare
510(k) No.	In progress	K153023	K160942
Product Code	PLP	PLP	PLP
Intended Use
Indications for Use	Indicated fortransrectal highintensity focusedultrasound (HIFU)ablation of prostatetissue.	Indicated fortransrectal highintensity focusedultrasound (HIFU)ablation of prostatetissue.	Indicated fortransrectal highintensity focusedultrasound (HIFU)ablation of prostatictissue.
Prescription use	Yes	Yes	Yes
Minimally invasive	Yes	Yes	Yes
Outpatientprocedures	Yes	Yes	Yes
Anesthesia required	Yes	Yes	Yes
Physician training	Yes	Yes	Yes
required
General Description
SystemComponents	Therapy Controlmodule, computersand peripherals.Treatment module,(patient support),endorectal probe,cooling unit, probemoment assemblyand holder,movement detector,ultrasound scanner,Disposableaccessories	Control module,computer andperipherals.Treatment module,(patient support),endorectal probe,cooling unit, probemoment assemblyand holder,movement detector,ultrasound scanner,Disposableaccessories	Control module,endorectal probe,computer andperipherals, coolingfluid, probe momentassembly and holder,Disposableaccessories
Patient position	right lateral decubitus	right lateral decubitus	lithotomy
Performance characteristics
Imaging modality forlocalization,treatment andcontrol	Ultrasound	Ultrasound	Ultrasound
Fusion ofultrasound withother imagingmodalities (DICOM)	Yes	Not available	Yes
Probe type	Curved array	Curved array	Linear Mechanical
Imaging Frequency	7.5 MHz	7.5 MHz	4.0 MHz Nominal(3.5-8 MHz Range)
LongitudinalImaging frame rate(typical)	NA (Longitudinalimage isreconstructed)	NA (Longitudinalimage isreconstructed)	2 FPS
Transverse Imagingframe rate (typical)	25 FPS	25 FPS	3 FPS
Image size	8.0 x8.0 cm	8.0 x8.0 cm	4.5 x 6.25 cm
Field of view	130°	130°	112°
Ablation modality	HIFU	HIFU	HIFU
Ablation Frequency	3.0 MHz	3.0 MHz	4.0 MHz
Focal Distance	45 mm ± 2 mm	45 mm ± 2 mm	30 mm ±1 mm45 mm ±2 mm
Probe length	60.9 mm	60.9 mm	58.7 mm
Probe diameter	38.4 mm	38.4 mm	33 mm
Probe neck diameter	19.5 mm	19.5 mm	18 mm
Management ofprotocols	Pre-set algorithm	Pre-set algorithm	Manual Adjustment

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Conclusion

Software, technical and user manual changes do not constitute a new intended use, and any differences in technological characteristics do not raise new types of safety or effectiveness questions when compared to the predicate devices. Data is provided to assess the effects of the changes.

These data demonstrate that the device performs as intended and support a finding of substantial equivalence.

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.