The Cellfina System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 25, 2016 Ulthera, Inc. Suzon Lommel Vice President, Regulatory & Ouality Affairs 1840 S Stapley Dr. Suite 200 Mesa, Arizona 85204 Re: K153677 Trade/Device Name: The Cellfina System Regulation Number: 21 CFR 878.4790 Regulation Name: Powered Surgical Instrument for Improvement in the Appearance of Cellulite Regulatory Class: Class II Product Code: OUP Dated: January 29, 2016 Received: February 1, 2016 Dear Suzon Lommel: 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 device {1}------------------------------------------------ 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/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 vours. # 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 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K153677 Device Name Cellfina™ System Indications for Use (Describe) The Cellfina™ System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 2 vears of observation. | 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 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." {3}------------------------------------------------ ## 10. 510(k) Summary This 510(k) Summary for the Cellfina System is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) summary. | Applicant: | Ulthera, Inc. | |-----------------------------|-----------------------------------------------------------------------------------| | Address: | 1840 South Stapley Drive<br>Suite 200<br>Mesa, AZ 85204 | | Contact Person: | Suzon Lommel, Vice President Regulatory and Quality Affairs | | Telephone: | (408) 336-1761 | | Fax: | (480) 619-4071 | | Submission Date: | December 17, 2015 | | Device Trade Name: | The Cellfina System | | Common Name: | Powered surgical instrument for improvement in the appearance of<br>cellulite. | | Classification: | Regulatory Class II | | Classification Name: | Powered surgical instrument for improvement in the appearance of<br>cellulite. | | Regulation Number: | 21CFR 878.4790 | | Product Code: | OUP | | Legally Marketed Predicate: | The Cellfina System, 510(k): K150505 | | Applicable Guidance: | The following guidance special controls are applicable to the Cellfina<br>System: | #### Class II (special controls). The special controls for this device are: (1) Non-clinical testing must be performed to demonstrate that the device meets all design specifications and performance requirements, and to demonstrate durability and mechanical integrity of the device. (2) In vivo evaluation of the device must demonstrate device performance, including the safety of the release methodology and blood loss at the treatment sites. (3) All elements of the device that may contact the patient must be demonstrated to be biocompatible. (4) Electrical safety and electromagnetic compatibility of the device must be demonstrated. (5) The labeling must include a summary of in vivo evaluation data and all the device specific warnings, precautions, and/or contraindications. {4}------------------------------------------------ (6) Sterility and shelf-life testing for the device must demonstrate the sterility of patient contacting components and the shelf life of these components. - The Cellfina System is intended to provide precise focal release of Device Description: subcutaneous tissue for improvement in the appearance of cellulite. The system consists of a sterile, single-use, disposable kit (CK1) and an electromechanical, non-sterile, 15-use motor module (CM1). - Current Indications for Use: The Cellfina System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 2 year of observation. #### Substantial Equivalence Comparison: | Predicate Device<br>(K150505) | Subject Device | Equivalence<br>Discussion | | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Cellfina System | Cellfina System | | | | Regulation | 878.4790 | 878.4790 | Same | | Product Code | OUP | OUP | Same | | Intended Use/<br>Indications for Use | The Cellfina System is<br>intended for long term<br>improvement in the<br>appearance of cellulite in<br>the buttocks and thigh<br>areas of adult females as<br>supported by clinical data<br>demonstrating no<br>significant reduction in<br>treatment benefits up to 2<br>years of observation. | The Cellfina System is<br>intended for long term<br>improvement in the<br>appearance of cellulite in<br>the buttocks and thigh<br>areas of adult females as<br>supported by clinical data<br>demonstrating no<br>significant reduction in<br>treatment benefits up to 2<br>years of observation. | Same | | Where Used | Clinic/doctor's office | Clinic/doctor's office | Same | | Anatomical Site | Buttocks and thighs | Buttocks and thighs | Same | | Type of<br>Energy/Mechanism<br>of Action | Mechanical movement<br>driven by battery operated<br>motor module | Mechanical movement<br>driven by battery operated<br>motor module | Same | | Biological Effect | Controlled mechanical<br>cutting of the fibrous tissue<br>(septae) which contributes<br>to the appearance of<br>cellulite.<br><br>The Cellfina System<br>controls and stabilizes the<br>cutting motion used by<br>physicians with the needle<br>based release procedure. | Controlled mechanical<br>cutting of the fibrous tissue<br>(septae) which contributes<br>to the appearance of<br>cellulite.<br><br>The Cellfina System<br>controls and stabilizes the<br>cutting motion used by<br>physicians with the needle<br>based release procedure. | Same | {5}------------------------------------------------ | | Predicate Device<br>(K150505)<br>Cellfina System | Subject Device<br>Cellfina System | Equivalence Discussion | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | Patient Contact Material | Biocompatible | Biocompatible | Same | | EMC/Safety Standards | Compliant<br>60601-1<br>60601-1-2 | Compliant<br>60601-1<br>60601-1-2 | Compliance to<br>IEC 60601-1 and<br>IEC 60601-1-2 | | Sterile Barrier/Packaging - CK1 | • Single thermoformed tray with a Tyvek sealed outer tray.<br>• Foam insert within outer corrugated shipper<br>• Outer corrugated shipper | • Single thermoformed tray with a Tyvek sealed outer tray.<br>• Foam insert within outer corrugated shipper<br>• Outer corrugated shipper | Same | | Shelf Life - CK1 | 6 months | 12 months | CK1 shelf life extension from 6 months to 12 months; shelf life and packaging testing demonstrates stability of CK1 out to 12 months of shelf life | | Motor Module Device Design | 2 piece plastic enclosure to eliminate seams and remove possibly difficult to disinfect areas around the toggle switch. A single LED push button on/off switch located on as switch PCB underneath: 15 uses | 2 piece plastic enclosure to eliminate seams and remove possibly difficult to disinfect areas around the toggle switch. A single LED push button on/off switch located on as switch PCB underneath: 15 uses | Same | #### Non-clinical Performance Data: The subject device of this Special 510(k) submission was tested to IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and was found to be in compliance with the requirements of this standard. Additionally, ship testing, simulated use, structural integrity, verification of physical characteristics and primary functionality on 12 month aged product demonstrates that the CK1 disposable kit is stable out to 12 months of shelf life. All other non-clinical tests required per the Special Controls (biocompatibility, sterility, EMC, bench testing, etc.), are provided within the predicate device under K150505 and remain applicable to this Special 510(k) submission; see the 510(k) summary for K150505 for additional information. #### In-vivo Testing: {6}------------------------------------------------ The in-vivo evaluation (clinical trial data) information provided within the predicate device under K150505 is applicable to this Special 510(k) submission; see the 510(k) summary for K150505 for additional information. #### Conclusion: This Special 510(k) Premarket Notification is for an extension of shelf life (from 6 months to 12 months) for the sterile, single-use, disposable kit (CK1), and for labeling changes required for compliance to IEC 60601-1, 3td Edition. These changes do not alter the device design and do not pose any new questions of safety, product output or efficacy. As demonstrated through bench testing, the subject device Cellfina System is as safe, as effective, and performs as well as the legally marketed predicate device (K150505), and as such, is substantially equivalent.