Vitruvian Liposaber

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 13, 2024 Black & Black Surgical, Inc. Cynthia Rees Regulatory Manager 5175 South Royal Atlanta Dr. Tucker, Georgia 30084 Re: K240188 Trade/Device Name: Vitruvian LiposaberTM Regulation Number: 21 CFR 878.5040 Regulation Name: Suction Lipoplasty System Regulatory Class: Class II Product Code: QPB, Dated: January 23, 2024 Received: January 24, 2024 Dear Cynthia Rees: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2}------------------------------------------------ # Sincerely, Alicia Hemphill -S Digitally signed by Alicia Hemphill -S Date: 2024.09.13 18:03:30 -05'00' Alicia Hemphill, MS Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K240188 Device Name Vitruvian LiposaberTM Indications for Use (Describe) Aesthetic Body Contouring | 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." {4}------------------------------------------------ ## 510(k) Summary ## In accordance with SMDA 1990, 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Vitruvian Liposaber™ is provided below. - 1. Submitter Information: Prepared: 12/08/2023 Est. Reg. #: 3006142527 Norman M. Black, CEO, normanblack@blackandblacksurgical.com Black & Black Surgical, Inc. 5175 South Royal Atlanta Dr. Tucker, GA 30084 770-414-4880 T / 770-414-4879 F Contact Person: Cynthia Rees, Regulatory Manager, crees@blackandblacksurgical.com #### 2. Device Identification: Trade/Proprietary Name: Vitruvian Liposaber™ Common/Usual Name: Suction Lipoplasty System Classification Name: System, Suction, Lipoplasty for Removal Regulation Number: 878.5040 Product Code: QPB Device Class: Class II Classification Panel: General & Plastic Surgery #### Substantial Equivalence: 3. The Vitruvian Liposaber™ is substantially equivalent to the devices listed below in terms of use, design, operating principles, materials, and performance. MicroAire PAL System, K212024 #### 4. Device Description: The Vitruvian Liposaber™ consists of a control unit with an interconnecting cable to power and control a handpiece. The handpiece employs a motor intended to imitate the surgeons repetitive back and forth motions used during the liposuction procedure. The handpiece holds the cannula and the vacuum tubing. The handpiece is controlled by the user through the interaction with the control unit. The control unit controls the speed of the motor in the handpiece which provides the reciprocating motion of the cannula. The speed of the motor is variable between 3000 and 5000 RPM. The nominal speed is 4000 which can be adjusted using the controls on the handpiece between 3000 and 4000 RPM. Adjustments higher than 4000 must be performed through the user interface on the control unit. {5}------------------------------------------------ The Vitruvian Liposaber is a pre-assembled device consisting of: Control Unit: Turns device power on and off and is attached to handpiece with a 10 ft cable. The Control Unit includes an interface to allow the user to change the motor speed between 3000 to 5000 RPM at 100 RPM steps and start and stop the cannula motion. The Control Unit is outside the sterile field. - . Power Operation: 100-240VAC, 50-60Hz, 0.1-0.2A - . Handpiece: Anodized aluminum body with stainless steel shaft to drive the cannula in a reciprocating motion. The handpiece is a reusable sterile component. The handpiece includes a user interface to allow the user to control the speed between 3000 – 4000 RPM and start and stop the canula motion. - Display: LED - Connecting Cable: Connects handpiece to control unit. - Power Cord: Hospital Grade IEC 60320 . - . Motor: DC - ട. Indications for Use: Aesthetic Body Contouring - 6. Comparison to Predicate ## Control Unit Comparison Chart | Item | Predicate Device | Subject Device | Similarity | |---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | MicroAire PAL System | Vitruvian Liposaber | N/A | | Device Manufacturer | MicroAire Surgical Instruments, LLC | Black & Black Surgical, Inc. | N/A | | 510(k) Reference | K212024 | K240188 | N/A | | Image | Image: MicroAire PAL System | Image: Vitruvian Liposaber | N/A | | FDA Product Code | QPB | QPB | Same | | FDA Classification | System, Suction, Lipoplasty for<br>Removal | System, Suction, Lipoplasty for<br>Removal | Same | | FDA Regulation # | 21 CFR 878.5040 Class II | 21 CFR 878.5040 Class II | Same | | Indication for Use /<br>Intended Use | For Aesthetic body contouring. | Aesthetic body contouring. | Same | | Device Overview | | | | | User | Only trained and experienced<br>healthcare providers/professionals<br>should use this medical equipment. | Should only be handled and<br>operated by healthcare<br>professionals completely familiar<br>with use of the device. | Same | | Mechanism of Action | MicroAire power assisted liposuction<br>is an electronic control system<br>designed to reciprocate a cannula in<br>lipoplasty applications. | The Vitruvian Liposaber is an<br>electronic control system<br>designed to reciprocate a<br>cannula in lipoplasty applications. | Same | | Item | Predicate Device | Subject Device | Similarity | | Display | The color touch screen display<br>provides an intuitive graphical user<br>interface that allows users to view<br>system status and set parameters<br>with a touch of the screen. | LED Display of the speed of the<br>motor in stroke per minute (RPM) | Similar | | Speed Control | Touch screen Handpiece | Control Unit Buttons Handpiece | Similar | | Physical Characteristics | | | | | Dimensions | 304.8 mm x 355.6 mm x<br>152.4 mm | 168 mm x 125 mm x 185 mm | Different - Dimensional<br>physical characteristics do not<br>affect the safety and<br>effectiveness of the<br>device. | | Weight | 6.35 kg | 1.7 kg | Different - Weight variance<br>related to physical<br>characteristics does not affect<br>the safety and effectiveness<br>of the device. | | Display | Color Touchscreen Display | LED Display | Similar | | AC Powered | 100 VAC - 240 VAC, 50/60 Hz | 100-240 VAC, 50/60Hz | Same | | Number of Attachable<br>Devices | Two (2) Handpieces | One (1) Handpiece | Different - A single<br>handpiece connects to the<br>Vitruvian Liposaber System to<br>perform liposuction<br>procedures only. This<br>difference does not affect<br>Safety and effectiveness due<br>to the mode of operation. | | Safety and Performance Testing | | | | | Electrical<br>Safety<br>Tests Passed | IEC/EN 60601-1-2:2014<br>IEC 60601-1:2005<br>IEC 60601-1-6:2013<br>IEC 62366: 2015 | IEC60601-1-2:2014+A1:2020<br>AAMI ES 60601-1:2005<br>IEC 60601-1-6:2010 AMD1:2013<br>IEC 62366:2007 A1: 2014 | Same | | Performance | 4000 - 5000 strokes/min. | 3000 - 5000 strokes/min. | Different - This difference<br>does not affect Safety and<br>effectiveness due to the<br>mode of operation. The<br>device is intended to replace<br>the same manual motions<br>made by the physician during<br>a liposuction procedure. | | Reuse | | | | | Cleaning/Disinfecting | Validated germicidal wipe down<br>method in IFU | Mild non-abrasive cleaner wipe<br>down in IFU | Similar | | Operating Environment | | | | | Temperature | 15°C to +24°C | 0 deg C to + 40 deg C | Similar | | | | | | | Item | Predicate Device | Subject Device | Similarity | | Humidity | 20%-60% | <80% | Similar | | Handpiece Comparison | | | | | Item | Predicate Device | Subject Device | Similarity | | Device name | PAL-650 Handpiece and 5006-PAL<br>Cable | Vitruvian Liposaber Handpiece<br>and Cable | N/A | | Device Manufacturer | MicroAire Surgical Instruments, LLC | Black & Black Surgical, Inc. | N/A | | Device Overview | | | | | Image | Image: PAL-650 Handpiece | Image: Vitruvian Liposaber Handpiece | N/A | | User | Use of this device is limited to those<br>physicians who, by means of formal<br>professional training or sanctioned<br>continuing medical education<br>(including supervised operative<br>experience), have attained<br>proficiency in suction Lipoplasty. | Use of this device is limited to<br>those physicians who, by means<br>of formal professional training or<br>sanctioned continuing medical<br>education (including supervised<br>operative experience), have<br>attained proficiency in suction<br>Lipoplasty. | Same | | Mechanism of Action | The PAL-650 is a powered surgical<br>instrument that reciprocates a<br>cannula used in liposuction<br>procedures. | The Vitruvian Liposaber<br>handpiece is a powered surgical<br>instrument that reciprocates a<br>cannula used in liposuction<br>procedures. | Same | | Technology<br>Overview | The reciprocating output shaft of the<br>handpiece drives the cannula<br>through a stroke distance of 2.8 mm<br>(±0.4 mm) at a rate of 4,000 to 5,000<br>strokes/minute. | The reciprocating output shaft of<br>the handpiece drives the cannula<br>through a stroke distance of 2.90<br>mm (+/- 0.3mm) at a rate of<br>3,000 to 5,000 strokes/minute. | Similar | | Physical Characteristics | | | | | Dimensions | 25 mm x 38 mm x 250 mm (width x<br>thickness x length) [45.5 mm x 250<br>mm ~ equivalent diameter x length<br>envelope] | 30 mm x 40 mm x 250<br>mm (WxHxD) | Similar | | Weight | 0.5 kg (Handpiece) | 0.8 kg (Handpiece and Cable) | Similar | | | 0.28 kg (Cable) | | | | Power Source | Console, detachable cable. | Console, detachable cable. | Same | | Performance | | | | | Duty Cycle | Duty cycle of 2 hours continuous<br>use/ 2 hours. | Continuous | Different - non-clinical<br>performance test<br>demonstrates ability to<br>perform continuously.<br>Difference does not raise new<br>issues of safety and<br>performance. | | Item | Predicate Device | Subject Device | Similarity | | Patient Contacting<br>Surface Temperature<br>during Operation | <41°C | <41°C | Same | | Reuse | | | | | Cleaning | Manual<br>Automated | Manual | Similar | | Sterilization | Handpiece and cable are<br>Autoclavable by end user, steam<br>sterilization | Handpiece and cable are<br>Autoclavable by end user, steam<br>sterilization | Same | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ #### 7. Non-Clinical Performance Data To demonstrate substantial equivalence of the Vitruvian Liposaber System to the predicate device, Black & Black Surgical completed the following non-clinical tests. The results confirm the design inputs and performance specifications for the device are met. The Vitruvian Liposaber System was tested according to the internal design requirements, national standards, and international standards referenced below, supporting that the device is substantial equivalence to the predicate device. - Biological evaluation per ISO 10993 – 1: The Vitruvian Liposaber instrument cable was considered biocompatible for the intended use. - -Electrical safety testing per IEC 60601-1 – the Vitruvian Liposaber System was found to comply with the requirements of the electrical safety standard. - -Electromagnetic Compatibility testing per IEC 60601-1-2: The Vitruvian Liposaber System demonstrated compliance to complied with the requirements of IEC 60601-1-2 - -Software verification and validation per IEC 62304/FDA Software Guidance - -Functionality Verification Testing - Stroke Rate/RPM Display Calibration Validation Pass O - O Stroke Distance Validation - Pass - Dynamic and Static Load Validation Pass O - Surface Temperature Validation Pass O - -Cleaning, Disinfection and Sterilization demonstrate the process produces a reusable sterile handpiece and cable with a SAL of 10-6 #### 8. Clinical Performance Data No clinical testing was required to support the medical device as the indications for use are equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for years. The non- clinical testing details in this submission support the substantial equivalence of the device. ### Statement of Substantial Equivalence The Vitruvian Liposaber System, the subject device, has the same intended use and similar technological characteristics have been compared and contrasted with the predicate device. Nonclinical testing demonstrates the Vitruvian Liposaber System is substantially equivalent to the predicate device. Therefore, with the same intended use, similar technology and performance, the Vitruvian Liposaber System is substantially equivalent to the predicate device.