LipoFilter - Hospital Pack, LipoFilter - Clinic Pack

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of a human figure, with three profiles merging to form a single, abstract shape. The emblem is meant to symbolize health and human services. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 22, 2015 MicroAire Surgical Instruments LLC Mr. Chris Spofford Regulatory Affairs and Compliance Officer 3590 Grand Forks Boulevard Charlottesville, Virginia 22911 Re: K150779 Trade/Device Name: Microaire LipoFilter System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: March 25, 2015 Received: March 26, 2015 Dear Mr. Spofford: 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 {1}------------------------------------------------ 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 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/Resourcesfor You/Industry/default.htm. 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 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. for Sincerely yours, # David Krause -S - 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) K150779 Device Name Microaire LipoFilter System Indications for Use (Describe) The MicroAire LipoFiter System is used in the aspiration, filtering and transferring of autologous adipose tissue for aesthetic body contouring. If the harvested fat is to be re-implanted fat is only to be used without any additional manipulation. | 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}------------------------------------------------ - 1) Preparation Date: March 24, 2015 2) Submitted by: MicroAire Surgical Instruments LLC 3590 Grand Forks Boulevard Charlottesville, Virginia 22911 Owner/Operator #: 9004658 3) Contact Person/Prepared by: Chris Spofford Regulatory Affairs and Compliance Officer MicroAire Surgical Instruments (434) 975-8344 Chriss@microaire.com 3590 Grand Forks Boulevard Charlottesville, Virginia 22911 - 4) Device Identification: Trade Name: MicroAire LipoFilter System Common Name: Lipoplasty Suction System Classification: Suction lipoplasty system (21 CFR 878.5040, Product Code MUU) - 5) Predicate Device: Sound Surgical Technologies - Origins LipoHarvesting System (K120328) Medical Device Resource Corporation - Lipisystems Aquavage Model AV2000 & 1200 (K092284) - 6) Device Description: The MicroAire LipoFilter System consists of a single use, closed loop tissue collection system comprised of a medical grade canister, vacuum port, collection port, tissue port and lid intended to be used with a standard liposuction aspiration system pump to collect fatty tissue for aesthetic body contouring. As the tissue is harvested from the patient, it enters the canister via the collection port in the canister lid. The physician removes unwanted waste materials from the collection system via the vacuum port by closing a valve. This process leaves fatty tissue that can be transferred to syringes via the tissue port for autologous fat re-injection. - 7) Intended Use: The MicroAire LipoFilter System is used in the aspiration, harvesting, filtering and transferring of autologous adipose tissue for aesthetic body contouring. If the harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation. {4}------------------------------------------------ ## 8) Comparison to Predicate: | FEATURES | DEVICES | | | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | MicroAire LipoFilter System | Origins LipoHarvesting System | Medical Device Resource Corp<br>Lipisystems Aquavage | | Device<br>Description: | The MicroAire LipoFilter<br>System consists of a single<br>use, closed loop tissue<br>collection system<br>comprised of a medical<br>grade canister, vacuum<br>port, collection port, tissue<br>port and lid intended to be<br>used with a standard<br>liposuction aspiration<br>system pump to collect<br>fatty tissue for aesthetic<br>body contouring. As the<br>tissue is harvested from the<br>patient, it enters the<br>canister via the collection<br>port in the canister lid. The<br>physician removes<br>unwanted waste materials<br>from the collection system<br>via the vacuum port by<br>closing a valve. This process<br>leaves fatty tissue that can<br>be transferred to syringes<br>via the tissue port for<br>autologous fat re-injection. | The Origins LipoHarvesting<br>System consists of a<br>reusable, closed loop<br>tissue collection system<br>comprised of a medical<br>grade canister, a drain<br>port and a lid intended to<br>be used with a standard<br>liposuction aspiration<br>pump to collect fatty<br>tissue for aesthetic body<br>contouring. As the tissue is<br>harvested from the<br>patient, it enters the<br>collection canister via a<br>port in the canister lid. The<br>physician removes<br>unwanted waste materials<br>from the collection system<br>via the drain port at the<br>base. This process leaves<br>fatty tissue that can be<br>transferred to syringes for<br>autologous fat re-<br>injection. | Device function:<br>1. Contains port<br>interfaces<br>between:<br>canister to<br>tubing and<br>aspirator to<br>canister.<br>2. Sterile tubing<br>to connect the<br>interfaces.<br>3. Funnel to<br>interface port<br>to tubing.<br>4. Syringe to<br>collect fat.<br>Device Design:<br>1. Contents<br>subjected to<br>sterility.<br>Material used:<br>Plastic canister,<br>syringe, silicone<br>tubing. | | Picture of<br>Product | Image: MicroAire LipoFilter System | Image: Origins LipoHarvesting System | Image: Medical Device Resource Corp Lipisystems Aquavage | | Intended Use: | The MicroAire LipoFilter<br>System is used in the<br>aspiration, harvesting,<br>filtering and transferring of<br>autologous adipose tissue<br>for aesthetic body<br>contouring. If the harvested<br>fat is to be re-implanted,<br>the harvested fat is only to<br>be used without any<br>additional manipulation. | The Origins LipoHarvesting<br>System is used in the<br>aspiration, harvesting,<br>filtering and transferring<br>of autologous tissue. If<br>harvested fat is to be re-<br>implanted, the harvested<br>fat is only to be used<br>without any additional<br>manipulation. | For use in aspirating<br>subcutaneous fatty<br>tissue including<br>autologous fat<br>collection. | | Technology<br>Comparison: | The MicroAire LipoFilter<br>System employs the same<br>technological characteristics<br>as the predicate device. | The Origins LipoHarvesting<br>System employs the same<br>technological<br>characteristics as the<br>predicate devices. | The Lipisytems<br>Aquavage employs the<br>same technological<br>characteristics as the<br>predicate device. | | Suction<br>Source(s) | Aspiration device | Aspiration device | Aspiration device | | Volume Range | Up to 2500mL | 100 to 2,000 mL | 2000cc or 1200cc | | Shipped sterile | Yes | No, sterilized by user prior to<br>use | Yes | | Initial method | Gamma radiation | Not applicable | Gamma radiation | | Sterility<br>assurance level | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ | | Disposable or<br>reusable | Single use, disposable | Reusable | Single use, disposable | | Resterilization<br>method | Not applicable | Autoclave | Not applicable | ## Table 1: Substantial Equivalence Comparison Chart {5}------------------------------------------------ ## 9) Pre-Clinical Testing The MicroAire LipoFilter System has been tested in various ways to demonstrate equivalence to the predicate devices including Gamma Radiation validation, shelf life validation, biocompatibility, and various performance testing. Specifics include the following: {6}------------------------------------------------ Validated for sterility using gamma radiation. Test results and analyses indicate that the MicroAire LipoFilter System sterility complies in accordance with ISO 11137-1:2006 and ISO 11137-2:2006. Validated for a 2 year shelf life. Test results and analyses indicate that the MicroAire LipoFilter System packaging complies in accordance with ISO 11607-1: 2006 and ISO 11607-2: 2006. The MicroAire LipoFilter System has patient contact materials and is made from medical grade biocompatible materials. Test results and analyses indicate that the MicroAire LipoFilter System materials' complies in accordance with ISO 10993-1: 2009. The MicroAire LipoFilter System was tested for performance in accordance with its predetermined specifications on file at MicroAire which includes functionality testing, ISO 10079-1 testing, tubing connection strength testing, vacuum leak testing, adipocyte viability testing, and Aging Studies. #### 10) Conclusion: The MicroAire LipoFilter System uses decantation to separate the tissue which is the same method as the two identified predicate devices. The MicroAire LipoFilter System does not have any new intended uses as compared to the two predicate devices. The MicroAire LipoFilter System has a slightly larger volume (2500 mL) whereas the predicate devices have a volume of up to 2000 mL which is insignificant given the intended use of the devices. The MicroAire LipoFilter System is provided sterile whereas the predicate devices are either provided sterile and/or sterilized by the user. The results of these activities demonstrate that the MicroAire LipoFilter System is considered substantially equivalent to the two predicate devices. The results of the evaluation above demonstrate that the MicroAire LipoFilter System is considered substantially equivalent to the two predicate devices.