Ablatherm Integrated Imaging

K153023 · Edap Technomed, Inc. · PLP · Nov 6, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K153023
• Device Name: Ablatherm Integrated Imaging
• Applicant: Edap Technomed, Inc.
• Product Code: PLP · Gastroenterology, Urology
• Decision Date: Nov 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4340
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Computer-controlled HIFU system for prostate tissue ablation; utilizes endorectal probe for ultrasound imaging and therapeutic energy delivery. System components: treatment module, control module, endorectal probe, Ablapak. Physician operates system in outpatient setting; ultrasound imaging guides probe placement and monitors ablation. Energy propagates through rectal wall to focus on prostate tissue, generating heat to destroy targeted areas while preserving apex, sphincter, and rectum. Process repeated in stepwise fashion. Output includes real-time ultrasound visualization for planning and monitoring; clinical benefit is minimally invasive prostate tissue destruction. Healthcare providers use imaging to plan treatment and monitor PSA levels/biopsy results post-procedure to assess effectiveness.

Clinical Evidence

Prospective clinical study (n=136 enrolled, 135 treated). Primary endpoints: prostate volume reduction, PSA stability, and biopsy survival. Mean prostate volume decreased from 22.7 cc to 9.0 cc. Mean PSA reduction from baseline was 87.97% (nadir 0.53 ng/mL). 90.5% of subjects met Phoenix Biochemical Survival criteria. 59% negative post-ablation biopsy rate. Adverse events included erectile dysfunction (67.4%), urinary incontinence (38.5%), and urinary tract infection (34.1%).

Technological Characteristics

HIFU system; 3.0 MHz ablation frequency; 7.5 MHz imaging frequency. Curved array probe. Components: control module, treatment module, endorectal probe, cooling unit. Connectivity: computer-controlled. Standards: IEC 60601-1, IEC 60601-2-62, ISO 10993 series, IEC 62304. Sterilization: reusable medical device (AAMI TIR12, AAMI TIR30, ISO 17664).

Indications for Use

Indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue in patients requiring prostate tissue ablation.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the high intensity ultrasound system for prostate tissue ablation is subject to the following special controls:

*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.

Predicate Devices

• Sonablate 450 (DEN150011)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 6, 2015

EDAP Technomed, Inc. John C. Rewcastle, Ph.D. Medical Director 2201 Denton Dr., Suite 110 Austin, Texas 78758

Re: K153023

Trade/Device Name: Ablatherm Integrated Imaging Regulation Number: 21 CFR 876.4340 Regulation Name: High Intensity Ultrasound System For Prostate Tissue Ablation Regulatory Class: Class II Product Code: PLP Dated: October 15, 2015 Received: October 15, 2015

Dear Dr. Rewcastle:

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. 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 at its toll-free number [phone] or [phone] 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 at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# 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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# Indications for Use

510(k) Number (if known)

Device Name Ablatherm Integrated Imaging

Indications for Use (Describe)

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

× | Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(K) SUMMARY

The following information is provided as required by 21 CFR § 807.87 for Ablatherm Integrated Imaging 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.

| Applicant Name: | EDAP Technomed, Inc.<br>2201 Denton Dr Ste 110<br>Austin, Texas, 78758<br>Ph: 512 - 832-7956 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact name: | John C. Rewcastle, Ph.D.<br>Medical Director<br>Tel: [phone]<br>Mobile: [phone]<br>Fax: [phone]<br>E-mail address: [e-mail] |
| Date of Submission: October 15, 2015 | |

| Date of Submission: | October 15, 2013 |
|----------------------|---------------------------------------------------------------|
| Proprietary Name: | Ablatherm Integrated Imaging |
| Common Name: | High intensity ultrasound system for prostate tissue ablation |
| Regulatory Class: | II |
| Regulation: | 21 CFR 876.4340 |
| Product Code: | PLP |
| Predicate Device(s): | Sonablate 450 (DEN150011) |

The Ablatherm Integrated Imaging is a computer controlled medical Device Description: device intended to provide High Intensity Focused Ultrasound (also referred as HIFU) to ablate prostate tissue. The system consists of the following main sub-assemblies: Treatment Module, Control Module, Endorectal Probe, and 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.

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Intended Use: The Ablatherm® Integrated Imaging device is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue.

## Non-clinical testing

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

- . Sterilization and Shelf Life
- . Biocompatibility
- o Reprocessing validation
- o Software Documentation
- . Electrical Safety and Electromagnetic Compatibility
- . IEC 60601-2-62: Medical electrical equipment Part 2 62 Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound HITU equipment.
- . Bench Testing - Technical and performance testing were performed to evaluate the transducer testing and calibration. The objectives of the tests were to calculate measurements for the following parameters: electrical impedance, transducer dimension, ultrasonic beam profile, acoustic intensity, radiation force, reference electrical power, and acoustical power stability verification.
- . Animal Studies -Animal studies were conducted on canine and rabbit models, as well as liver.

## Conformance to Recognized Standards

The Ablatherm® Integrated Imaging complies with applicable sections of the following recognized consensus standards:

- · ISO 10993-1, biological evaluation of medical devices part 1: evaluation and testing within a risk management process.
- · ISO 10993-5. Biological Evaluation of Medical Devices: Test for in vitro cytotoxicity
- ISO 10993-10, Biological evaluation of medical devices part 10: tests for irritation and skin sensitization
- ISO 10993-11, biological evaluation of medical devices part 11:tests for systemic toxicity
- · IEC 60601-1:2005- Corr 1:2006, Corr 2:2007, Medical Electrical Equipment Part 1: General Requirements For Safety
- IEC 60601-1-2:2007/AC:2010, Medical Electrical Equipment Part 1-2: General

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Requirements For Safety - Collateral Standard: Electromagnetic Compatibility -Requirements And Test

- · IEC 62304: 2006/AC:2006, Medical device software-Software life cycle processes.
- · IEC 60601-2-62:1.0 2013-07, medical electrical equipment; part 2-62: particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (hitu) equipment.
- AAMI TIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturer
- · AAMI TIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices,
- · ANSI/AAMI ST81:2004/(R)2010 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices
- ISO 17664:2004 Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices.

# Clinical Data

A clinical study was conducted that included 136 subjects who had not received provious prostate treatment, of which 135 underwent the HIFU procedure. One subject was enrolled but did not undergo HIFU due to calcifications in the prostate, an exclusion criterion, being observed immediately prior to the HIFU procedure. The first subject was enrolled on May 4, 2006 and the last subject was enrolled on June 30, 2010. All subjects underwent whole gland ablation. All adverse events were collected during the IDE study regardless of their relationship to the HIFU procedure. The majority of adverse events resolved within 2 years with the exception of erectile dysfunction and urinary incontinence.

All adverse events observed during the 2 years of follow-up are summarized in table 1, regardless of severity or relation to device or procedure.

| Adverse Event | Any Occurrence<br># Subjects (%)<br>(n=135) |
|----------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Any | 131 (97.0%) |
| Adverse Event | Any Occurrence<br># Subjects (%)<br>(n=135) |
| Erectile Dysfunction | 91 (67.4%) |
| Urinary Incontinence | 52 (38.5%) |
| Urinary Tract Infection | 46 (34.1%) |
| Hematuria | 44 (32.6%) |
| Bladder urgency | 39 (28.9%) |
| Perineal/penile/rectal/prostate pain | 37 (27.4%) |
| Urinary Obstruction | 33 (24.4%) |
| Slow stream | 33 (24.4%) |
| Bladder spasms | 31 (23.0%) |
| Dysuria | 31 (23.0%) |
| Urinary Retention not resolved by day<br>30 or onset ≥ 30 days | 28 (20.7%) |
| Stricture | 26 (19.3%) |
| Urinary frequency | 25 (18.5%) |
| Bladder Neck Contracture | 24 (17.8%) |
| Urethral sloughing | 17 (12.6%) |
| Urinary Retention Resolved by Day 30 | 12 (8.9%) |
| Bowel Injury | 4 (3.0%)* |
| Epididymitis | 4 (3.0%) |
| Sepsis | 2 (1.5%)** |
| * Anal tears<br>** Both cases of sepsis were not considered to be related to<br>either the device or procedure | |

Table 1: All adverse events regardless of relationship between device or procedure.

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The majority of adverse events summarized in Table 2 resolved within 2 years with the exception of erectile dysfunction and urinary incontinence. Persistence of erectile dysfunction was expected due to the intentional targeting of the lateral margins of the prostate. Of the 61 (45.2%) subjects with erectile dysfunction unresolved at 2 years, 12 had a pre HIFU history of erectile dysfunction, and the severity of unresolved erectile dysfunction in 9 subjects was reported as mild. Of the 21 (15.6%) subjects with unresolved urinary incontinence 16 were reported as mild.

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The number of subjects with unresolved urinary obstruction stricture, bladder neck contracture and sepsis was observed in 1 (0.7%), 3 (2.2%), 2 (1.5%), 1 (0.7%), and 1 (0.7%), respectively. All urinary tract infections and bowel injuries were resolved within 2 years.

Evidence of prostate tissue ablation is provided through post-HIFU ablation prostate volume reduction. PSA reduction and stability as well as biopsy survival rate.

#### Prostate Volume Reduction

The prostate volume reduction as measured at the first post-HIFU ablation is evidence of prostate tissue ablation. The mean prostate volume as measured post-HIFU ablation at the first biopsy that included a volume measurement is 9.0 cc (95% CI: 7.9, 10.2) compared to 22.7 cc (95% CI: 20.5, 24.8), at baseline, and the mean volume decrease from baseline was 13.6 cc (95% CI: 10.9, 16.3).

#### Stability of PSA Following HIFU Procedure

Decreased and subsequently stable PSA post-HIFU provides additional evidence of prostate tissue ablation. PSA decrease and stability is demonstrated by PSA measurements at baseline and at each follow-up visit allowing for determination of PSA reduction from baseline. Additionally, Phoenix Biochemical Survival provides a context in which PSA can be interpreted. The Phoenix Biochemical Survival is the most frequent definition in the literature used to report biochemical survival post-HIFU ablation and interpret PSA measurements. A subject demonstrates biochemical survival if he did not have any PSA obtained between 6 and 24 months post-HIFU ablation that was greater than or equal to the PSA nadir + 2 ng/ml:

No PSA between 6 and 24 months post-HIFU procedure ≥ PSA Nadir + 2

Using a PSA nadir definition of the lowest PSA achieved during the first 6 months of follow-up after HIFU, the mean PSA nadir is 0.53 ng/mL (95% CI: 0.37, 0.69 ng/mL) and the mean reduction from baseline to nadir is 4.07 ng/mL (95% CI: 3.67, 4.47 ng/mL) and the mean % reduction from baseline is 87.97% (95% CI: 84.80. 91.15 %).

Prior to HIFU the mean PSA was 4.60 ng/mL (95% CI: 4.20, 5.00 ng/mL). Table 4 summarizes

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the PSA observations at 1-month. 1-year and 2-years and the percentage PSA reductions from baseline which were 78.14%, 80.34% and 82.25%, respectively.

| Visit month | n | Mean PSA<br>(ng/mL)<br>(95% CI) | Mean PSA<br>Reduction from<br>Baseline (ng/mL)<br>(95% CL) | Percentage PSA<br>Reduction from<br>Baseline<br>(95% CL) |
|-------------|-----|---------------------------------|------------------------------------------------------------|----------------------------------------------------------|
| 1 | 133 | 0.89±1.23<br>(0.68, 1.10) | 3.71±2.40<br>(3.30, 4.12) | 78.14%±30.28<br>(72.95, 83.34%) |
| 12 | 131 | 0.91±1.56<br>(0.64, 1.18) | 3.65±2.30<br>(3.25, 4.04) | 80.34%±26.44<br>(75.77, 84.91) |
| 24 | 107 | 0.72±1.20<br>(0.49, 0.94) | 3.52±2.20<br>(3.09, 3.94) | 82.25%±24.21<br>(77.61, 86.89%) |

Table 3: PSA reductions at 1-month, 1-year and 2-years

Maintaining biochemical survival post prostate tissue ablation demonstrates the effectiveness of ablation. In the 116 evaluable subjects, 90.5% (95% CI: 85.2, 95.8%) of subjects met the definition of the Phoenix Biochemical Survival.

#### Biopsy Survival Rate

Fifty-nine percent (59%) of the total cohort of 135 patients had a negative post-ablation biopsy (95% confidence limits = 50, 68). For this ITT analysis, 17 patients who did not have a biopsy performed during the 24-month follow-up period were considered "positive."

The data supports the substantial equivalence of the Ablatherm Integrated Imaging to the Sonablate 450.

#### Substantial Equivalence

Both the subject and predicate devices are high intensity focused ultrasound devices and are indicated for the ablation of prostate tissue. Both devices are intended for use by physicians who have completed mandatory didactic and hands-on training for safe operation and use of the devices. Both the subject and predicate devices are intended for prescription use and are performed as minimally invasive, outpatient procedures.

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Both the subject and predicate devices use high intensity focused ultrasound (HIFU) to elevate the tissue temperature within a focal zone. Non-clinical performance of the Ablatherm demonstrates that the device performs as intended, with similar to characteristics of the Sonablate 450. Both the subject and predicate devices have similar operating principles. Both use ultrasound to monitor the ablation. Although there are some differences in technological features that could impact safety or effectiveness, they do not raise new types of safety or effectiveness questions. For example, there are some differences in the ultrasound frequency, duty cycle, lesion size and location, etc. The total acoustic power is similar to the predicate but slightly higher power is available. These differences have been assessed through bench, animal, and clinical studies, which demonstrate that the Ablatherm Integrated Imaging performs as intended and is substantially equivalent to the Sonablate 450.

| | Ablatherm Integrated<br>Imaging-subject device | Sonablate 450 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | EDAP | SonaCare |
| 510(k) No. | not yet assigned | DEN150011 |
| Product Code | PLP | PLP |
| Indications for Use | Indicated for transrectal high<br>intensity focused ultrasound<br>(HIFU) ablation of prostate<br>tissue. | Indicated for transrectal high<br>intensity focused ultrasound<br>(HIFU) ablation of prostatic<br>tissue. |
| Prescription use | Yes | Yes |
| Minimally invasive | Yes | Yes |
| Outpatient procedures | Yes | Yes |
| Anesthesia required | Yes | Yes |
| Physician training required | Yes | Yes |
| System Components | Control module, computer and<br>peripherals. Treatment<br>module, (patient support),<br>endorectal probe, cooling unit,<br>probe moment assembly and<br>holder, movement detector,<br>ultrasound scanner,<br>Disposable accessories | Control module, endorectal<br>probe, computer and<br>peripherals, cooling fluid,<br>probe moment assembly and<br>holder, Disposable accessories |
| Patient position | right lateral decubitus | lithotomy |

#### Intended Use and Design

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# Performance characteristics

| | Ablatherm<br>Integrated Imaging | Sonablate 450 |
|----------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Imaging modality for<br>localization, treatment and<br>control | Ultrasound | Ultrasound |
| Probe type | Curved array | Linear Mechanical |
| Imaging Frequency | 7.5 MHz | 4.0 MHz Nominal (3.5-8 MHz<br>Range) |
| Longitudinal Imaging frame<br>rate (typical) | NA (Longitudinal<br>image is<br>reconstructed) | 2 FPS |
| Transverse Imaging frame<br>rate (typical) | 5 FPS | 3 FPS |
| Image size | 8.0 x8.0 cm | 4.5 x 6.25 cm |
| Field of view | 130° | 112° |
| Ablation modality | HIFU | HIFU |
| Ablation Frequency | 3.0 MHz | 4.0 HMz |
| Focal Distance | 45 mm ± 2 mm | 40 mm ± 1 mm |
| Probe length | 60.9 mm | 58.7 mm |
| Probe diameter | 38.4 mm | 33 mm |
| Probe neck diameter | 19.5 mm | 18 mm |
| Duty cycle | 6 seconds "on"<br>and 4 seconds<br>"off" | 3 seconds "on" and 6 seconds "off" |
| HIFU total acoustic power | 35-48 W according<br>lesion length (19<br>to 24 mm) | 0-28 W, 24 W typical (3.0 cm focal<br>length transducer) 0-40 W, 37 W<br>typical (4.0 cm focal length<br>transducer) |
| Lesion height | 19-24 mm | 10 mm |
| Longitudinal lesion spacing | 1.7 mm | 3.0 mm |
| Transverse lesion spacing | 2.5° | 3° |
| Ablation planning | In transverse and<br>longitudinal planes | In longitudinal and transverse planes |
| Longitudinal motion | 8.0 cm max length<br>scanning | 4.5 cm |

#### Conclusion

Any differences between the subject device and predicate do not render the device NSE as the changes do not constitute a new intended use, and any differences in technological characteristics

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do not raise new types of safety or effectiveness questions. Data is provided to assess the effects of the technological differences, including bench, animal and clinical data. These data demonstrate that the device performs as intended and support a finding of substantial equivalence.