truSculpt RF Device; truSculpt; truSculpt 3D

{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. June 6, 2018 Cutera, Inc. Raymond Lee Vice President, Regulatory Affairs and Quality Assurance 3240 Bayshore Blvd. Brisbane, California 94005 Re: K180709 Trade/Device Name: truSculpt RF Device; truSculpt; truSculpt 3D Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX, GEI Dated: March 16, 2018 Received: March 19, 2018 Dear Raymond Lee: 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, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). > 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K180709 Device Name(s) truSculpt RF Device; truSculpt; truSculpt 3D #### Indications for Use (Describe) The truSculpt RF energy is intended to provide topical heating tissue temperature for the treatment of selected medical conditions, such as relief of pain and increase in local circulation. Additionally, the 2 MHz setting for the 40 cm handpiece is indicated for reduction in circumference of the abdomen and non-invasive lipolysis (breakdown of fat) of the abdomen. The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X 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 reqarding 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." {3}------------------------------------------------ # Section 5 510(k) Summary This 510(k) Summary of safety and effectiveness for the truSculpt RF Device is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(k) summary. | Applicant: | Cutera, Inc. | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | 3240 Bayshore Blvd.<br>Brisbane, CA 94005 | | Contact Person: | Raymond Lee | | Telephone: | 415-657-5539 | | Fax: | 415-715-3539 | | Email: | rlee@cutera.com | | Preparation Date: | March 16, 2018 | | Device Trade<br>Names: | truSculpt RF Device;<br>truSculpt; truSculpt 3D | | Common Name: | Massager, Vacuum, Radio Frequency Induced Heat | | Classification<br>Name: | Electrosurgical cutting and coagulation device and accessories<br>PBX, GEI, 21 CFR 878.4400 | | Legally Marketed<br>Predicate Devices: | truSculpt RF Device (K162512)<br>Syneron SlimShape System (K163415) | | Intended Use: | The truSculpt RF Device is intended to generate heat within body tissues for<br>the treatment of selected medical conditions, such as the relief of minor<br>aches, pain, and muscle spasms; an increase in local circulation; a reduction<br>in circumference of the abdomen; and non-invasive lipolysis (breakdown of<br>fat) of the abdomen. The truGlide roller is intended to provide temporary<br>reduction in the appearance of cellulite. | | Indications for Use: | The truSculpt RF energy is intended to provide topical heating for the purpose<br>of elevating tissue temperature for the treatment of selected medical<br>conditions, such as relief of pain and muscle spasms and increase in local<br>circulation.<br>Additionally, the 2 MHz setting for the 40 cm² handpiece is indicated for<br>reduction in circumference of the abdomen and non-invasive lipolysis<br>(breakdown of fat) of the abdomen.<br>The truSculpt massage device is intended to provide a temporary reduction<br>in the appearance of cellulite. | | Device Description: | The truSculpt RF Device consists of a console, one or more RF handpieces<br>that connect to the console with an umbilical cable, and a truGlide massage<br>roller. All system functions are controlled through the console. The<br>handpieces deliver RF energy to generate a heating profile that produces a<br>moderate temperature rise in the subcutaneous tissue, while monitoring<br>epidermal temperature. The truGlide is a separate mechanical roller that can<br>be used as a massager. | {4}------------------------------------------------ Summary of The truSculpt RF Device that is the subject of this submission has identical Technological technological characteristics as the previously cleared truSculpt RF Device Characteristics: and very similar technological characteristics as the Syneron SlimShape System. All three devices are comprised of a console and RF applicator(s). The consoles for all devices consist of a mechanical enclosure, an RF generator, control electronics, a touch-screen user interface, and a control microprocessor. Although the truSculpt RF Device no longer includes an optional vacuum feature (removed in K133739), this difference does not alter the therapeutic effect for the intended use of the device, nor does it raise new types of safety or effectiveness questions, as demonstrated by the clinical study results. The shape and dimensions of the RF applicators of the truSculpt RF Device that is the subject of this submission are identical to those of the previously cleared truSculpt RF Device. Differences in the shape and dimensions of the RF applicators of the truSculpt RF Device and the Syneron SlimShape System do not raise any new or different safety or effectiveness questions, since the device RF applicators have the same or similar energy parameters, are intended for use in the same or similar treatment areas, and are intended for use on the same or similar population. The truSculpt RF Device that is the subject of this submission heats tissue through delivery of RF energy at 1 MHz and 2 MHz, which is identical to the previously cleared truSculpt RF Device. The Syneron SlimShape System also heats tissue through delivery of RF energy at 1 MHz but does not have a 2 MHz option. All three devices use temperature control mechanisms with redundant temperature sensors in the RF applicators to dynamically adjust the RF power delivered to first reach and then maintain therapeutic temperatures to achieve equivalent therapeutic effects, as demonstrated by the clinical study results. The clinical study results confirm that any technological differences between the truSculpt RF Device that is the subject of this submission and its predicates do not raise new types of safety or effectiveness questions. Performance Data: IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Safety (Edition 3.0, 2005 + AMD1:2012) including: IEC 60601-2-2 Medical Electrical Equipment – Part 2-2: Particular ● Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories - Test Report Attachment 5 IEC 60601-1-2 Medical Electrical Equipment – Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Disturbances (Edition 3, 2007) ## Software Verification and Validation Testing Report: truSculpt 3D ### V0005 rT-Addendum, truSculpt SW Release This document describes the specific tests that were used to verify and validate the software used in the truSculpt 3D. Testing included verification of correct Startup/Flash screens. Operating screens and {5}------------------------------------------------ | | screen selection; Software Version confirmation; Checksum verification;<br>clearing of log files; frequency verification for all handpieces and<br>operating modes; correct function of displays and indicators; correct<br>function of controls, buttons, and inputs; temperature limits; treatment<br>countdown indicator; calibrated delivery; screen data accuracy; date<br>and time entry; data pop-up screens; error conditions; induced fault<br>conditions; shot and error log capture and printing; and anomalies, if<br>any, encountered during testing. No anomalies were encountered<br>during testing. | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Results of Clinical<br>Studies: | Two prospective IRB-approved clinical studies were conducted with the<br>truSculpt RF Device on the intended population to gather clinical data needed<br>to support the revised indications for use. | ## Non-invasive Lipolysis Study, C-17-TS13 C-17-TS13 was a single-center, prospective, non-randomized, open-label study conducted to evaluate the safety and efficacy of treatment with the Cutera truSculpt RF Device for non-invasive lipolysis in the abdominal region. Twelve subjects, including Caucasian, Asian and African females (92%) and males (8%), aged 24-58 years (median age: 42), with Fitzpatrick skin types II-VI, who were scheduled to undergo an abdominoplasty surgery were enrolled and received one treatment with the truSculpt RF Device on one abdominal subarea, with the contralateral side abdominal subarea being left untreated to serve as a control. Subjects were assigned to 6 subgroups based upon the timing of their abdominoplasty surgery with respect to the RF treatment date. Up to 2 subjects were enrolled into each subgroup: D0, D10, D20, D30, D60 and D90, where the number refers to the days between RF treatment and the scheduled abdominoplasty surgery date. Biopsies were harvested from the treatment and control abdominal subareas during the abdominoplasty surgery. These biopsies were cultured, stained and examined by a board-certified dermatopathologist leading to the findings summarized below. Epidermal and dermal tissues were unaffected by RF treatment and were equivalent and indistinguishable in all subject biopsies. Biopsies from the control areas showed normal subcutaneous adipose tissue structures in all biopsies with no indication of changes from the contralateral RF treatment area. In contrast, biopsies from the truSculpt RF treatment abdominal areas showed adipocyte necrosis and/or inflammatory immune cell response to the subcutaneous fat. Necrosis was observed immediately and out to sixty days following treatment for six subjects. Necrosis was not present for five subjects, but four of the five subjects not showing necrosis did present inflammatory immune cell response spanning zero to ninety days following treatment. One subject at ten days post treatment did not show any response to treatment. Acute inflammation was present immediately and out to 20 days following treatment. Peak adipocyte death and fat necrosis was observed 30 days post treatment with approximately 33% of adipocytes affected from just beneath {6}------------------------------------------------ the dermis up to approximately 1.5 cm beneath the skin surface with no damage seen at the base of the tissue sample (3 cm). Sixty days following treatment, fat necrosis is still present although confined to small, focal areas with less than 20% of the subcutaneous affected. At the final ninety day time point, there was minimal inflammation comprised of few lymphocytes and neutrophils. All subjects experienced transient mild to moderate erythema and edema post treatment. For eleven subjects, the mild to moderate erythema and edema resolved in 1-4 hours. One subject reported moderate erythema. mild edema and mild post-treatment pain, which persisted for 1 day. The study results demonstrate that RF treatment with the truSculpt RF Device consistently leads to discrete areas of fat necrosis within the subcutaneous tissue. The effect is present solely in the subcutaneous tissue, while the dermal and epidermal layers remain unaffected by treatment. | Study Design | A single-center, prospective, non-randomized, open-label study | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sample Size | 12 subjects enrolled | | Main Criteria for Inclusion | Male or Female, 24 to 58 years of age (inclusive); Fitzpatrick Skin Type I - VI; who are scheduled for abdominoplasty and willing to provide histology samples during the surgery from the intended to be harvested areas; has visible fat bulges on the abdomen and palpable fat pockets superior to iliac crest located bilaterally in the lower back flank region; has a Body Mass Index (BMI) $\geq$ 20 and $\leq$ 30 | | Follow-up Intervals | 1 follow-up on the day of planned abdominoplasty | The study design and results are summarized in the table below. {7}------------------------------------------------ | Endpoints | Efficacy | |-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Histological evaluation of tissue for selective fat necrosis, with sparing of the dermis and epidermis, following truSculpt treatment vs. untreated contralateral control | | | Safety | | | Incidence and severity of adverse device effects during the study period, including subject pain level during RF treatment | | Summary Results | Efficacy | | | Met endpoints. Epidermal and dermal tissues were unaffected by RF treatment and were equivalent and indistinguishable in all subject biopsies.<br>Biopsies from the control areas showed normal subcutaneous adipose tissue structures in all biopsies with no indication of changes from the contralateral RF treatment area. | | | Safety | | | No adverse events were observed. The immediate responses included mild to moderate erythema and edema, which resolved with no intervention. | ## Long-term Follow-up Circumferential Reduction Study, C-17-TS15 C-17-TS15 was a single-center, observational, prospective study of subjects, aged 24-60 years at the time of RF treatment, who completed participation in the Treatment Group of Protocol C-16-TS11 "Pivotal Study of the truSculpt Radiofrequency Device for Circumferential Reduction" (46 subjects in total; and the maximum potential enrollment for this study) for sustained long-term circumferential reduction. Data from protocol C-16-TS11 comparing subject outcomes from the treatment and sham treatment study arms were previously submitted under K162512, resulting in FDA clearance of a new indication for use for the truSculpt RF Device: "temporary reduction in circumference of the abdomen". {8}------------------------------------------------ All potential subjects were contacted in no fewer than five attempts by phone calls, emails, and/or texts and were invited to participate in a new study involving one study visit: 18 months ± 2 months following their original treatment under study Protocol C-16-TS11. Of the forty-six potential subjects: two were not able to be contacted; four were not interested in participating; six were unable to participate because of relocation, travel or work constraints; nine were excluded as they had elected to have additional truSculpt RF treatments of the abdomen and flanks for further circumferential reduction after being released from study C-16-TS11 restrictions; three were excluded for various exclusion criteria (pregnancy, medical condition, and abdominal surgerv. respectively): and the remaining twenty-two subiects were scheduled for screening visits. Of the twenty-two subjects screened, seven had weight changes beyond ± 5% of baseline weight and were therefore deemed to have not met an inclusion criterion and excused prior to enrollment. The remaining fifteen subjects (32.6% of potential subjects) were enrolled. The circumferential measurements recorded during the 18-month follow-up visit for the 15 subjects enrolled in C-17-TS15, when compared with the subjects' baseline circumferential measurements recorded and reported in C-16-TS11, demonstrated a statistical-significant, sustained reduction in the circumference of the abdomen of 2.30 ± 0.51 cm (SEM; p < 0.001). No treatment-related adverse effects were observed or reported developing after the 12-week follow-up visit of C-16-TS11, at which point all treatmentrelated expected side effects had resolved without medical intervention. | Study Design | a single-center, observational, prospective study | | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sample Size | 46 subjects in total; 15 subjects enrolled for long-term circumferential reduction | | | Main Criteria for Inclusion | Completed participation in the Treatment Group of Protocol C-16-TS11; and maintained the same weight within ± 5% of the baseline | | | Follow-up Intervals | 18 months post treatment in C-16-TS11 | | | Endpoints | Efficacy<br>Difference in circumferential measurement at the 18-month follow-up visit when compared with the baseline and 12-week follow-up visits, as measured and reported in C-16-TS11 (K162512). | | | | | Safety | | | | Incidence and severity of treatment-<br>related adverse effects developing<br>after the final 12-week follow-up visit<br>of C-16-TS11. | | Summary Results | | Efficacy | | | | The difference between the<br>circumferential measurements<br>recorded during the 18-month<br>follow-up visit when compared with<br>the subjects' baseline<br>circumferential measurements<br>showed sustained reduction in the<br>circumference of the abdomen of<br>$2.30 \pm 0.51$ cm. | | | | The 18-month circumferential-<br>measurement data when compared<br>with the 12-week circumferential-<br>measurement data showed a $0.17 \pm$<br>0.49 cm increase in circumference<br>of the abdomen for this cohort of 15<br>subjects (p = 0.36). | | | | Safety | | | | No treatment-related adverse<br>effects were observed or reported<br>developing after the 12-week follow-<br>up visit of C-16-TS11, at which point<br>in time all treatment-related<br>expected side effects had resolved<br>without medical intervention. | | Conclusion: | The truSculpt RF Device that is the subject of this submission has identical<br>technological characteristics and principles of operation as the previously<br>cleared truSculpt RF Device and very similar technological characteristics<br>and principles of operation as the Syneron SlimShape System. | | | | Performance data and clinical study results demonstrate that any<br>differences between the truSculpt RF Device and its predicate devices do<br>not raise new types of safety or effectiveness questions. | | | | Clinical studies conducted with the truSculpt RF Device that is the subject of<br>this submission have demonstrated the safety and effectiveness profile of<br>the device in the intended population for the requested indications for use<br>held by the Syneron SlimShape System. | | | | The truSculpt RF Device is substantially equivalent to the predicate devices. | | The study design and results are summarized in the table below. {9}------------------------------------------------ {10}------------------------------------------------ # Section 5 510(k) Summary K180709 # Table 5A—Technical Specification Comparison | | Cutera truSculpt RF Device<br>(current submission) | Cutera truSculpt RF Device<br>(K162512) | Syneron SlimShape System<br>(K163415) | |---------------------------------------|----------------------------------------------------|------------------------------------------|---------------------------------------| | Energy Type | Radiofrequency | Radiofrequency | Radiofrequency + Infrared | | Massage | Yes | Yes | Yes | | Vacuum (suction) | No | No | Yes | | Temperature sensing | Yes | Yes | Yes | | Temperature sensing active<br>control | Yes | Yes | Yes | | Treatment activation | Fingerswitch | Fingerswitch | Control Screen Button | | Area treated | 16 cm² and 40 cm² | 16 cm² and 40 cm² | Unknown | | Electrode shape | Square or Rectangle | Square or Rectangle | Rectangle | | RF frequency | 1 MHz and 2 MHz | 1 MHz and 2 MHz | 1 MHz | | RF type | Bipolar / Monopolar | Bipolar / Monopolar | Bipolar | | Max RF power | 300 W | 300 W | Unknown | | Patient contact material | Polyethylene<br>(3M Tegaderm) and 316 SS | Polyethylene<br>(3M Tegaderm) and 316 SS | Unknown |