SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Sound Surgical Technologies LLC. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 June 9, 2021 Re: K110255 Trade/Device Name: Sound Surgical Technologies Llc Powerx Lipo System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB Dear Mark Job: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 4, 2011. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, Cindy.Chowdhury@fda.hhs.gov. Sincerely. Cindy Chowdhury -S Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of three curved lines that form the body and wings of the bird. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Sound Surgical Technologies LLC % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313 APR - 4 2011 Re: K110255 Trade/Device Name: Sound Surgical Technologies LLC PowerX Lipo System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: March 18, 2011 Received: March 21, 2011 Dear Mr. Job: 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 {2}------------------------------------------------ Page 2 - Mr. Mark Job 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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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. Sincerely yours, Aling B. R. h for Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Indications for Use | 510(k) Number (if known): | K 0255 | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Sound Surgical Technologies LLC PowerX Lipo System | | Indications for Use: | The Sound Surgical Technologies LLC PowerX Lipo System is<br>intended for the removal of tissue or fluids from the body during<br>general surgical procedures including suction lipoplasty for the<br>purpose of aesthetic body contouring. | Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel Kane fan MXM (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K110255 {4}------------------------------------------------ K 110255 1084 ## 510(k) Summary y 'APR - 4 2011 | Submission Date: | 13 January 2011 | | | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------------------| | Submitter: | Sound Surgical Technologies LLC<br>357 South McCaslin Boulevard, Suite 100<br>Louisville, CO 80027 | | | | Submitter and<br>Official Contact: | Mr. Stephen C. Smith<br>Vice President of RA/QA<br>Sound Surgical Technologies LLC<br>357 South McCaslin Boulevard, Suite 100<br>Louisville, CO 80027<br>+1 (720) 240-2970<br>SSmith@soundsurgical.com | | | | Manufacturing Site: | Sound Surgical Technologies LLC<br>357 South McCaslin Boulevard, Suite 100<br>Louisville, CO 80027 | | | | Trade Name: | Sound Surgical Technologies LLC PowerX Lipo System | | | | Common Name: | Power-Assisted Aspiration Cannula System | | | | Classification Name: | System, Suction, Lipoplasty | | | | Classification<br>Regulation: | 21 CFR §878.5040 | | | | Product Code: | MUU | | | | Substantially<br>Equivalent Devices: | Sound Model | Predicate 510(k)<br>Number | Predicate Manufacturer<br>and Model | | | Sound PowerX<br>Lipo System | K012236 | KMI Kolster Methods, Inc.<br>Store2000 Power Cannula | {5}------------------------------------------------ K110255 2 of 4 | Device Description: | The Sound Surgical Technologies LLC (Sound) PowerX Lipo System<br>(PowerX) consists of three major components: (1) an electronic<br>Controller with software, (2) an electronic Handpiece, and (3) a<br>reusable, sterilizable Cannula. The Handpiece is connected to the<br>Controller and to an independent aspiration source. The Controller<br>sends electronic signals to the Handpiece and thereby controls the<br>motion of the cannula that is fitted to the distal end of the Handpiece.<br>The Sound PowerX is a prescription device, and is intended for use by<br>trained medical personnel. | | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | Intended Use: | The Sound Surgical PowerX Lipo System is intended for the removal<br>of tissue or fluids from the body during general surgical procedures<br>including suction lipoplasty for the purpose of aesthetic body<br>contouring. | | | Technology Comparison: | The Sound PowerX employs the same technological characteristics as<br>the predicate device with a few minor differences: | | | | Predicate Device | Sound PowerX Lipo System | | | Stepper motor in handpiece | Brushless DC motor in handpiece | | | Direct drive cannula | Motor/gearbox drive arrangement | | | Suction path through motor<br>shaft | Suction path offset from motor axis | | | Graphical user interface | Seven-segment LED display user<br>interface | | | Membrane switches/buttons | Rotary switches and knobs | | Performance Testing: | | | | Sterilization | The Sound PowerX Controller is not sterilized or sterilizable, and<br>therefore this section does not apply to the Controller. | | | | The Sound PowerX Handpiece and Cannulae are not provided sterile,<br>but are sterilized by the user prior to use. The sterilization of the<br>Handpiece and Cannulae was validated in accordance with: | | | | • ISO 17665-1: 2006, Sterilization of health care products - Moist<br>heat - Part 1: Requirements for the development, validation and<br>routine control of a sterilization process for medical devices. | | | | Test results indicate that the Sound PowerX complies with the standard. | | | Biocompatibility | The Sound PowerX Controller has no patient contact materials, and<br>therefore this section does not apply to the Controller.<br><br>The Sound PowerX Handpiece and Cannulae have patient contact<br>materials and are made from medical grade biocompatible materials.<br>Test results and analyses indicate that the Sound PowerX Handpiece<br>and Cannulae materials comply in accordance with:<br>ISO 10993-1: 2003, Biological evaluation of medical devices – Part<br>1: Evaluation and testing. | | | Software Testing | The Sound PowerX contains MODERATE level of concern software.<br>Software was designed and developed according to a robust software<br>development process, and was rigorously verified and validated.<br>Software information is provided in accordance with:<br>FDA guidance: The content of premarket submissions for software<br>contained in medical devices, 11 May 05; andFDA guidance: General principles of software validation; Final<br>guidance for industry and FDA staff, 11 Jan 02.Test results indicate that the Sound PowerX complies with its<br>predetermined specification. | | | Electrical Safety | The Sound PowerX was tested for patient safety in accordance with:<br>IEC 60601-1:1988, Aml: 1991, Am2: 1995, Medical electrical<br>equipment - Part 1: General requirements for basic safety and<br>essential performance.IEC 60601-1-8: 2006, Medical electrical equipment – Part 1-8:<br>General requirements for safety – Collateral standard: General<br>requirements, tests and guidance for alarm systems in medical<br>electrical equipment and medical electrical systemsTest results indicate that the Sound PowerX complies with the<br>standards. | | | Electromagnetic<br>Compatibility Testing | The Sound PowerX was tested for EMC in accordance with:<br>IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2:<br>General requirements for safety - Collateral standard:<br>Electromagnetic compatibility - Requirements and tests.Test results indicate that the Sound PowerX complies with the<br>Standard. | | | Performance Testing<br>- Bench | The Sound PowerX was tested for performance in accordance with its<br>predetermined specifications as specified in Section 11, Device<br>Description - Performance Specifications, of this submission. | | | | Test results indicate that the Sound PowerX complies with its<br>predetermined specification. | | | Conclusion | Verification and validation activities were conducted to establish the<br>performance and safety characteristics of the Sound PowerX. The<br>results of these activities demonstrate that the Sound PowerX is safe<br>and effective when used in accordance with its intended use and<br>labeling. | | | | Therefore, the Sound PowerX is considered substantially equivalent to<br>the predicate device. | | . り ﺎ ﺗﺄ {6}------------------------------------------------ K 110255 3.F4 {7}------------------------------------------------ ાન વિદ્યાર તેમ જ દિવેલા ગુજરાત રાજ્યના દિવસાય ખેતી ખેત ‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌‌ ﮯ ﻧ