(67 days)
Not Found
No
The summary describes a computer-controlled device for delivering HIFU based on ultrasound and MRI imaging, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
Yes
The device is described as "ablating prostate tissue," which is a therapeutic intervention aimed at treating a medical condition.
No
The device description states its purpose is to "ablate prostate tissue" using HIFU, which is a therapeutic action, not a diagnostic one. While it mentions an "imaging system" within the probe, the overall function described is tissue destruction, not disease identification or assessment.
No
The device description explicitly lists hardware components (Therapy Control Module, Endorectal Probe, consumable Ablapak) and describes a physical process of delivering ultrasound energy via a probe.
No, the Ablatherm® Fusion device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Ablatherm® Fusion Function: The Ablatherm® Fusion device is a therapeutic device that uses High Intensity Focused Ultrasound (HIFU) to ablate (destroy) prostate tissue. It is a treatment, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states "transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue." This describes a therapeutic procedure.
- Device Description: The description details how the device delivers energy to heat and destroy tissue, which is a therapeutic action.
While the device uses imaging (Ultrasound and MRI) for guidance and planning, this is part of the therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Ablatherm® Fusion device is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue.
Product codes
PLP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, MRI (for fusion)
Anatomical Site
Prostate tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use, Minimally invasive, Outpatient procedures, Anesthesia required, Physician training required
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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 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.
1
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
2
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
3
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:
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.
4
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 for
transrectal high
intensity focused
ultrasound (HIFU)
ablation of prostate
tissue. | Indicated for
transrectal high
intensity focused
ultrasound (HIFU)
ablation of prostate
tissue. | Indicated for
transrectal high
intensity focused
ultrasound (HIFU)
ablation of prostatic
tissue. |
| Prescription use | Yes | Yes | Yes |
| Minimally invasive | Yes | Yes | Yes |
| Outpatient
procedures | Yes | Yes | Yes |
| Anesthesia required | Yes | Yes | Yes |
| Physician training | Yes | Yes | Yes |
| required | | | |
| General Description | | | |
| System
Components | Therapy Control
module, computers
and peripherals.
Treatment module,
(patient support),
endorectal probe,
cooling unit, probe
moment assembly
and holder,
movement detector,
ultrasound scanner,
Disposable
accessories | Control module,
computer and
peripherals.
Treatment module,
(patient support),
endorectal probe,
cooling unit, probe
moment assembly
and holder,
movement detector,
ultrasound scanner,
Disposable
accessories | Control module,
endorectal probe,
computer and
peripherals, cooling
fluid, probe moment
assembly and holder,
Disposable
accessories |
| Patient position | right lateral decubitus | right lateral decubitus | lithotomy |
| Performance characteristics | | | |
| Imaging modality for
localization,
treatment and
control | Ultrasound | Ultrasound | Ultrasound |
| Fusion of
ultrasound with
other imaging
modalities (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) |
| Longitudinal
Imaging frame rate
(typical) | NA (Longitudinal
image is
reconstructed) | NA (Longitudinal
image is
reconstructed) | 2 FPS |
| Transverse Imaging
frame 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 mm
45 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 of
protocols | Pre-set algorithm | Pre-set algorithm | Manual Adjustment |
5
6
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.