(104 days)
The UltraShape System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.
The UltraShape System is comprised of multiple components, including the control unit and two ultrasonic transducers. The UltraShape System selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducer is an electro-mechanical device that converts an electrical signal into mechanical (acoustical) energy. The operating parameters of the UltraShape System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle.
The purpose of this submission is to increase acoustic intensity and to add an additional smaller ultrasound transducer.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Syneron UltraShape System
Intended Use: The UltraShape System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" with numerical thresholds in a table format. However, it describes the effectiveness (circumference reduction) and safety outcomes that demonstrate the device's performance met the requirements for substantial equivalence.
| Performance Metric (Implicit Acceptance Criteria) | Reported Device Performance (Effectiveness) | Reported Device Performance (Safety) |
|---|---|---|
| Effectiveness: | ||
| Non-invasive reduction in abdominal circumference | Average -2.37 cm circumference reduction at the midline (at final follow-up, 12 weeks after last treatment). | Not applicable for effectiveness. |
| Maintain effectiveness in weight-stable subjects | Midline circumference reduction results in weight-stable subjects (-2.18 cm) were very similar to the overall population. | Not applicable for effectiveness. |
| Patient satisfaction | The majority of subjects in the UltraShape studies reported overall satisfaction with treatment. | Not applicable for effectiveness. |
| Safety: | Not applicable for safety. | Maintained safety profile through long-term follow-up. Only events were mild to moderate in severity and resolved within a few hours or days. No device-related serious adverse events. In a separate safety study, only one minor event occurred, from which the patient completely recovered without intervention. Subjects reported minimal discomfort. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size (Effectiveness & Safety Studies): 102 enrolled subjects (across "two, separate, prospective, single arm studies").
- Sample Size (Additional Safety Study): 21 patients.
- Data Provenance: The document does not explicitly state the country of origin of the data. The submitter, Syneron Medical Ltd., is located in Yokneam Illit, Israel. The studies were prospective clinical evaluations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not specify the number of experts used to establish a "ground truth" for the test set or their qualifications. The study primarily evaluated objective measurements (circumference reduction, weight) and patient-reported outcomes (satisfaction, adverse events) rather than expert interpretation of images or other data requiring "ground truth" consensus in the typical sense.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. Given the primary endpoints were objective measurements (circumference reduction) and patient-reported outcomes (satisfaction, adverse events), an adjudication process like "2+1" or "3+1" (common for expert interpretation of medical images) would not be directly applicable. Adverse events were likely reported and categorized by the clinical investigators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The studies were "single arm studies" and focused on the performance of the UltraShape device itself, not on comparing it to human reader performance or assessing human reader improvement with AI assistance. The device is a direct treatment modality, not an AI diagnostic aid for human interpretation.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the clinical studies described evaluate the standalone performance of the UltraShape System as a treatment device. This device is not an algorithm for diagnosis or interpretation that would typically involve a "human-in-the-loop" for performance evaluation. Its efficacy is measured directly by its effect on abdominal circumference and its safety profile.
7. The Type of Ground Truth Used
The "ground truth" for effectiveness was based on objective anatomical measurements (abdominal circumference reduction) and patient-reported outcomes data (satisfaction, discomfort). For safety, it was based on adverse event reporting and assessment.
It was not based on expert consensus, pathology, or direct "ground truth" in the diagnostic sense.
8. The Sample Size for the Training Set
The document does not mention a "training set" or its sample size. This is because the UltraShape System is a physical medical device that delivers focused ultrasound energy, not an AI/ML algorithm that requires a training dataset in the conventional sense. The "training" for such devices involves rigorous engineering, design, and internal testing before clinical studies.
9. How the Ground Truth for the Training Set Was Established
As stated above, this device is not an AI/ML algorithm that relies on a "training set" with ground truth in the typical fashion of machine learning. Therefore, the concept of establishing ground truth for a training set is not applicable to this device. Any "ground truth" for its development would be engineering specifications, physical principles, and non-clinical testing results (e.g., beam profile, acoustic power, in vitro and in vivo animal studies).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2014
Syneron Medical Ltd. c/o Ms. Janice Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103
Re: K141708
Trade/Device Name: Syneron UltraShape System Regulation Number: 21 CFR 878.4590 Regulation Name: Focused ultrasound stimulator system for aesthetic use Regulatory Class: Class II Product Code: OHV Dated: September 12, 2014 Received: September 12, 2014
Dear Ms. Hogan:
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
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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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Binita S. Ashar -S 2014.10.06 08:36:38 -04'00' Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement on last page |
|---|---|
| ------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
| Indications for Use |
|---|
| --------------------- |
| 510(k) Number (if known) | K141708 |
|---|---|
| Device Name | UltraShape System |
| Indications for Use (Describe) | The UltraShape System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference. |
| Type of Use ( Select one or both, as applicable ) | |
| Prescription Use (Part 21 CFR 801 Subpart D)Subpart C) | Over-The-Counter Use (21 CFR 801 |
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510(k) SUMMARY
Syneron Medical Ltd.'s UltraShape System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Syneron Medical Ltd. P.O.B. 550 Industrial Zone Tavor Building Yokneam Illit, 20692 Israel Ruthie Amir, MD, Global Vice President of Clinical and Regulatory Affairs Phone: 972-73-244-2200 Facsimile: 972-73-244-2202
Contact Person: Janice Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103 Phone: 267 675 4600 Facsimile: 267 675 4601
Date Prepared: October 2, 2014
Name of Device
Syneron UltraShape System
Common or Usual Name
Focused Ultrasound Stimulator System for Aesthetic Use
Classification
Focused Ultrasound Stimulator System for Aesthetic Use
21 CFR 878.4590, Class II, product code OHV
Predicate Devices
Syneron Contour I V3.1 (K133238)
Intended Use / Indications for Use
The UltraShape System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.
Device Description
The UltraShape System is comprised of multiple components, including the control unit and two ultrasonic transducers. The UltraShape System selectively targets subcutaneous
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adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducer is an electro-mechanical device that converts an electrical signal into mechanical (acoustical) energy. The operating parameters of the UltraShape System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle.
The purpose of this submission is to increase acoustic intensity and to add an additional smaller ultrasound transducer.
Technological Characteristics
The UltraShape System is comprised of the system console, including the computer, and two ultrasonic transducers. The transducers deliver the focused ultrasound energy beam to the targeted treatment area, and real-time optical and acoustic feedback (optional) on the treatment is provided via the tracking and quidance system. The transducers functionality is based on the piezoelectric effect implemented with the ceramic element.
Performance Data
The following nonclinical performance testing was conducted to support the substantial equivalence of the UltraShape System to the predicate device, consistent with FDA's "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use" (2011). In all instances, the UltraShape System functioned as intended.
- . Biocompatibility testing in accordance with ISO 10993 for skin irritation, sensitization, cytotoxicity testing supported the biocompatibility of the patient-contacting components of the device.
- Beam profile testing demonstrated that the acoustic energy is delivered and . concentrated in the desired target location, at a focal depth highly similar to that of the predicate device.
- Acoustic power testing demonstrated that the acoustic power of the transducers is highly predictable with low variability.
- . In vitro acoustic and thermal measurements demonstrated the safety of non-targeted tissues both proximal and distal to the targeted region.
- . Software verification and validation was performed, and demonstrated that the software performs as intended.
- . Electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2) and electromagnetic immunity testing was conducted and demonstrated the electrical safety of the device.
- In vivo testing in an animal model was performed which demonstrated the treatment effects of the UltraShape, and supported its safety and efficacy profile for the intended use.
In addition, clinical evaluation of the device in the intended population was performed in two, separate, prospective, single arm studies. The studies evaluated the safety and
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effectiveness of the UltraShape in 102 enrolled subjects. The majority of the subjects were female with mean age of 44 years. After baseline screening, patients underwent three treatments each at two weeks apart, with follow-up visits at 2, 4, 8 and 12 weeks after the The abdominal circumference reduction, weight, satisfaction and safety last treatment. results were assessed for the study subjects throughout the study visits. The results demonstrated that at final follow-up, subjects achieved an average of -2.37 cm circumference reduction at the midline. Similar treatment results were observed at the measurement points 2 cm above and 2 cm below the midline. It should also be noted that very little weight change was observed in the study subjects overall, with an average weight change measuring less than 1% at 12 weeks (or longer term follow up) for all subjects. Midline circumference reduction results in the weight stable subjects (-2.18 cm) were very similar to the results observed in the overall population. Therefore, the subject device demonstrated substantially equivalent performance over time compared to the predicate in the overall study population and in the weight stable subgroup. Additional sensitivity analyses, including last observation carried forward (LOCF) and worst case analyses, continue to demonstrate the robust treatment effect of the UltraShape in abdominal circumference reduction. The safety profile of the UltraShape device was maintained through long term follow up: the only events in the studies were mild to moderate in severity and resolved within a few hours or days. In addition, the majority of subjects in the UltraShape studies reported overall satisfaction with treatment. An additional prospective clinical study assessed the device safety profile in 21 patients. Subjects underwent 3 treatment sessions each 2 weeks apart; follow-up visits occurred at 2, 4, 8 and 12 weeks after the last treatment visit. The study results further supported the safety profile of device treatment with only one minor event from which the patient completely recovered without the need for any intervention. Subjects reported minimal discomfort and overall satisfaction with the treatments.
Therefore, multiple clinical studies with the UltraShape device demonstrated successful circumference reduction and a positive safety profile, with no device related serious adverse events. Thus, the clinical studies support substantial equivalence to the predicate.
Substantial Equivalence
The UltraShape has the same indications for use, similar technological characteristics and the same principles of operation as its predicate device. The technological differences between the UltraShape and the Contour I V3.1 mainly consist of differences in acoustic intensity and the addition of a smaller transducer. Nonclinical and clinical studies of the UltraShape have demonstrated the safety and effectiveness profile of the UltraShape in the intended population. Thus, the UltraShape is substantially equivalent to the predicate device.
Conclusion
Syneron's UltraShape System is a Focused Ultrasound Stimulator System for Aesthetic Use Class II device that has been evaluated in nonclinical testing in accordance with FDA's Special Controls Guidance Document. Testing demonstrated that the device performs as intended. The UltraShape device is substantially equivalent to its predicate device (K133238).
§ 878.4590 Focused ultrasound stimulator system for aesthetic use.
(a)
Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.