(136 days)
Not Found
No
The summary describes a device that uses radiofrequency energy and vacuum based on a predefined protocol, with no mention of AI or ML in the device description, performance studies, or key metrics.
Yes
The device is indicated for non-invasive lipolysis and reduction in abdominal circumference, which are therapeutic functions.
No.
The SlimShape System is indicated for non-invasive lipolysis and reduction in circumference, which are therapeutic interventions rather than diagnostic processes.
No
The device description explicitly states it is comprised of a console and an applicator that delivers radiofrequency energy and applies mechanical vacuum, indicating it includes hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue samples, etc., to provide information about a person's health status.
- The SlimShape System is a non-invasive device that applies energy and vacuum directly to the body. It is used for lipolysis and circumference reduction of the abdomen, not for analyzing biological samples.
The description clearly indicates a device that interacts with the body externally for a therapeutic/cosmetic purpose, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The SlimShape System is indicated for non-invasive lipolysis (breakdown of fat) of the abdomen. The device is indicated for reduction in circumference of the abdomen.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The SlimShape System is comprised of a console and an applicator that delivers radiofrequency energy to the fat tissue and also applies mechanical vacuum to the treatment area. The SlimShape System is designed to enable hands-free abdominal treatment that is based on a predefined user protocol. The system also incorporates a skin temperature control mechanism as a safety feature during treatment. Users interface with and control the SlimShape System via the touch-screen panel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen
Indicated Patient Age Range
≥ 18 and ≤ 65 years of age at the time of enrollment.
Intended User / Care Setting
Not Found
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)
Clinical Studies:
Study type: single-arm, prospective, selfcontrolled study
Sample size: 52 subjects
Key results: The study met its primary efficacy endpoint, with an average of 1.98 +/- 2.53 cm reduction in abdominal circumference and an average of 6.03 +/- 3.09 mm reduction (-24.5% +/- 11.3%) in fat thickness measured by ultrasound at 12 weeks follow-up compared to baseline. Secondary effectiveness endpoints demonstrated that pre- and post-treatment photographs of the subjects were correctly identified in 86% of the photographs by blinded reviewers. Additional analysis demonstrated reductions in abdomen circumference and fat thickness over time and reductions in circumference at upper and lower abdomen. Responder analysis showed that 64% of the subjects at 12 week follow up achieved at least 1.5 cm of circumference reduction. In addition, 59% of subjects were very satisfied or satisfied with the treatments at 12 week follow up, and 77% of subjects would recommend the procedure. Furthermore, 91% of the subjects reported none to moderate pain. Out of a total of 144 treatment sessions, 6 subjects reported on 8 mild adverse events. There were no reports of serious or unanticipated adverse events. No subjects discontinued from the study due to adverse events.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Primary: Statistically significant abdominal circumference and fat reduction post SlimShape treatment at the final follow-up compared to baseline, based on tape measurements and ultrasound imaging.
Secondary: Correct identification of the pre- and post-treatment photos as demonstrated in at least 70% or greater of treated subjects. Abdominal circumference reduction at each visit, based on tape measurements. Abdominal fat reduction at each visit, measured by Ultrasound. Subject's self-assessment for satisfaction and recommendation. Subject satisfaction self-assessment. Subject's discomfort (pain) level after each treatment.
Results: Primary: Met endpoint; Both the midline reduction in abdominal circumference and the reduction in abdominal fat layer were statistically significant at the final follow-up compared to baseline. Secondary: The blinded reviewers assessed correctly 86% of the photographs. The amount of circumference reduction was statistically significant compared to baseline at each visit, as well as at the upper and lower abdomen. The majority of the subjects were satisfied (53% at treatment 3, 62% at 4 week follow up, 59% at 8 week follow up and 59% at 12 week follow up). Most of the subjects reported they will recommend this procedure (75%, 76%, 76% and 77% reported they recommended at treatment 3, 4, 8 and 12 weeks follow up, respectively). Most subjects (91%) reported none to moderate pain for each treatment.
Safety Results: There were no reports of serious or unanticipated adverse events, with 8 mild adverse events after 144 treatments. No subjects discontinued from the study due to adverse events. The immediate responses included erythema and edema, which resolved completely within several hours without any intervention.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with three heads. The eagle is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2017
Syneron Medical Ltd. % Ms. Janice Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K163415
Trade/Device Name: SlimShape System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 30, 2017 Received: March 30, 2017
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 of medical devicerelated 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.
1
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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jennifer R. Stevenson -S
For 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
SlimShape System
Indications for Use (Describe)
The SlimShape System is indicated for non-invasive lipolysis (breakdown of fat) of the abdomen. The device is indicated for reduction in circumference of the abdomen.
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 Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
3
510(k) SUMMARY
Syneron Medical Ltd.'s SlimShape System
Submitted by:
Syneron Medical Ltd. P.O.B. 550 Industrial Zone Tavor Building Yokneam Illit, 20692 Israel
Contact Person:
Ruthie Amir, MD, Global Vice President of Clinical, Regulatory and Professional Education Syneron Medical Ltd. P.O.B. 550 Industrial Zone Tavor Building Yokneam Illit, 20692 Israel Phone: 972-73-244-2200 Facsimile: 972-73-244-2202
Submission Correspondent:
Janice Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103 Phone: 267 675 4600 Facsimile: 267 675 4601
Date Prepared: April 19, 2017
Name of Device
Syneron SlimShape System
Common or Usual Name
Electrosurgical, Cutting & Coagulation & Accessories
Classification
Electrosurgical, Cutting & Coagulation & Accessories
21 CFR 878.4400, Class II, product code GEI
Predicate Device
Syneron Medical Ltd.'s Transcend System (K120510)
Intended Use / Indications for Use
The SlimShape System is indicated for non-invasive lipolysis (breakdown of fat) of the abdomen. The device is indicated for reduction in circumference of the abdomen.
4
Device Description
The SlimShape System is comprised of a console and an applicator that delivers radiofrequency energy to the fat tissue and also applies mechanical vacuum to the treatment area. The SlimShape System is designed to enable hands-free abdominal treatment that is based on a predefined user protocol. The system also incorporates a skin temperature control mechanism as a safety feature during treatment. Users interface with and control the SlimShape System via the touch-screen panel.
Technological Characteristics
The SlimShape System has very similar technological characteristics compared to its predicate. The SlimShape and the predicate are both comprised of a system console and applicator(s). The console in both devices consists of the RF generator, vacuum pump, computer, and the touch-screen control panel. Although the SlimShape System does not include infrared light, this difference compared to the predicate does not alter the intended therapeutic effect of the device or raise new types of safety or effectiveness questions, as demonstrated in clinical and nonclinical performance testing. Further, technological differences in the shape and dimensions of the applicators of the SlimShape and predicate device also do not raise any different safety or effectiveness questions, given that the device applicators have the same or similar energy parameters with similar treatment areas. In addition, the applicators of both systems similarly apply the vacuum and RF energy to the treated area. Both devices use the 1 MHz bipolar sinusoidal RF signal. In addition, the power intensity level for SlimShape is within the maximum output power cleared for the predicate device. Both devices include a temperature control mechanism through temperature sensors in the applicator. Notably, the SlimShape System has been evaluated in clinical and bench testing, and the technological differences do not raise new types of safety or effectiveness questions compared to the predicate.
Therefore, the SlimShape System has similar technological characteristics compared to its predicate device.
Performance Data
Nonclinical Performance Testing: The following nonclinical performance testing was conducted to support the substantial equivalence of the SlimShape System to the predicate device. In all instances, the SlimShape System functioned as intended.
- Biocompatibility of the patient-contacting components of the device was established. Cytotoxicity testing per ISO 10993-5, sensitization testing per ISO 10993-10, and irritation testing per ISO 10993-10 were performed to further confirm the biocompatibility of the device.
- Software verification and validation was performed, and demonstrated that the software performs as intended.
- . Electrical safety (IEC 60601-1, IEC 60601-2-2), electromagnetic compatibility (IEC 60601-1-2) and electromagnetic immunity testing was conducted and results were passing.
5
Clinical Data: In addition, clinical evaluation of the intended population was performed in several separate prospective studies, including a single-arm, prospective, selfcontrolled study of the SlimShape device for non-invasive lipolysis and circumference reduction of the abdomen. The study enrolled 52 subjects who were treated with the SlimShape device. The study included Caucasian females (87%) and males (13%) across a range of ages and skin types. Mean age was 45 years. The baseline mean weight was 72±11 kg and mean BMI was 26.29±2.62 kg/m².
Forty subjects underwent 3 biweekly treatments using the Temperature Control mode on the abdomen. Subject follow up was conducted at 4 weeks, and 12 weeks after the last treatment. The study included circumference and fat thickness measurements of the post treatment abdomen compared to baseline measurements, as well as visual assessment of the before and after photographs by 2 blinded reviewers.
The study met its primary efficacy endpoint, with an average of 1.98±2.53 cm reduction in abdominal circumference and an average of 6.03±3.09 mm reduction (-24.5%±11.3%) in fat thickness measured by ultrasound at 12 weeks follow-up compared to baseline.
Secondary effectiveness endpoints demonstrated that pre- and post-treatment photographs of the subjects were correctly identified in 86% of the photographs by blinded reviewers. Additional analysis demonstrated reductions in abdomen circumference and fat thickness over time and reductions in circumference at upper and lower abdomen. Responder analysis showed that 64% of the subjects at 12 week follow up achieved at least 1.5 cm of circumference reduction. In addition, 59% of subjects were very satisfied or satisfied with the treatments at 12 week follow up, and 77% of subjects would recommend the procedure. Furthermore, 91% of the subjects reported none to moderate pain.
Out of a total of 144 treatment sessions, 6 subjects reported on 8 mild adverse events. There were no reports of serious or unanticipated adverse events. No subjects discontinued from the study due to adverse events. The anticipated immediate responses after treatment (e.q., erythema, edema) were consistent with those observed with other similar devices. The immediate responses were transient and resolved completely within several hours without any intervention.
| Study Design | Prospective, single-arm, self-controlled, single-site clinical study |
|---|---|
| Sample size | 52 subjects at one site were enrolled and treated in the study |
| Principal | |
| Eligibility | |
| Criteria | • Healthy male or female, ≥ 18 and ≤ 65 years of age at the time of |
| enrollment. | |
| • Subject agrees to maintain their weight by not making any major | |
| changes in their diet or lifestyle during the course of the study. | |
| • General good health confirmed by medical history and skin examination | |
| of the treated area. | |
| Follow up | |
| intervals | 3 treatment visits and follow up visits at 4 weeks, 8 weeks, and 12 weeks. |
The study design and results are further summarized in the table below.
6
| Endpoints | Primary: Statistically significant abdominal circumference and fat reduction post
SlimShape treatment at the final follow-up compared to baseline, based on tape measurements and ultrasound imaging.
|
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Secondary:
- Correct identification of the pre- and post-treatment photos as
demonstrated in at least 70% or greater of treated subjects. - Abdominal circumference reduction at each visit, based on tape measurements.
- Abdominal fat reduction at each visit, measured by Ultrasound.
- Subject's self-assessment for satisfaction and recommendation.
- Subject satisfaction self-assessment.
- Subject's discomfort (pain) level after each treatment. |
| Effectiveness
Results | Primary: Met endpoint; Both the midline reduction in abdominal circumference and the reduction in abdominal fat layer were statistically significant at the final follow-up compared to baseline. |
| | Secondary: - The blinded reviewers assessed correctly 86% of the photographs.
- The amount of circumference reduction was statistically significant compared to baseline at each visit, as well as at the upper and lower abdomen.
- The majority of the subjects were satisfied (53% at treatment 3, 62% at 4 week follow up, 59% at 8 week follow up and 59% at 12 week follow up).
- Most of the subjects reported they will recommend this procedure (75%, 76%, 76% and 77% reported they recommended at treatment 3, 4, 8 and 12 weeks follow up, respectively).
- Most subjects (91%) reported none to moderate pain for each treatment. |
| Safety
Results | There were no reports of serious or unanticipated adverse events, with 8 mild adverse events after 144 treatments. No subjects discontinued from the study due to adverse events. The immediate responses included erythema and edema, which resolved completely within several hours without any intervention. |
Histology data from a study of 11 healthy subjects further confirm the safety profile of the device. The study results demonstrated that treatment consistently demonstrated discrete areas of fat necrosis within the subcutaneous tissue. The effect is present solely in the subcutaneous tissue, while the dermal and epidermal layers are intact with no adverse skin events.
Therefore, clinical evaluation of the SlimShape device demonstrated the favorable performance and safety profile of the device for lipolysis of the abdomen and non-invasive reduction of the circumference. Results thus further support substantial equivalence of the device compared to the predicate.
Conclusions
The SlimShape has the same intended use and similar indications for use, technological characteristics and principles of operation as its predicate device. Performance data demonstrate that the differences between the SlimShape and the predicate do not raise new
7
types of safety or effectiveness questions. Clinical studies of the SlimShape have demonstrated the safety and effectiveness profile of the device in the intended population.
Thus, the SlimShape is substantially equivalent to the predicate device.