MICROAIRE SURGICAL INSTRUMENTS LLC

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Microaire Surgical Instruments, LLC Darren Reeves Consultant 7305 Hancock Village Dr Suite 109 Chesterfield, Virginia 23832 June 9, 2021 Re: K113128 Trade/Device Name: Microaire Surgical Instruments Llc Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB Dear Darren Reeves: 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 August 17, 2012. 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}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 AUG 1 7 2012 MicroAire Surgical Instruments, LLC % DP Distribution & Consulting, LLC Mr. Darren Reeves Consultant 15637 Fox Cove Circle Moseley, Virginia 23120 Re: K113128 Trade/Device Name: MicroAire LipoTower System Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: MUU Dated: July 5, 2012 Received: July 9, 2012 Dear Mr. Reeves: 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 {2}------------------------------------------------ ## Page 2 - Mr. Darren Reeves 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 Mark A. Millman 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 11/3/28 510(K) Number known: Device Name: MicroAire LipoTower System #### Indications for Use: The MicroAire LipoTower System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired: - -Neurosurgery - Gastrointestinal and Affiliated Organ Surgery - - ー Urological Surgery - Plastic and Reconstructive Surgery - - -General Surgery - Orthopedic Surgery - - Gynecological Surgery l - Thoracic Surgery - - Laparoscopic Surgery The MicroAire LipoTower System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired. Prescription use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel Krave for MM (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K113128 {4}------------------------------------------------ ## 11 3 2 8 ## Section 5: 510(k) Summary - 1) Preparation Date: October 12, 2011 - 2) Submitted by: MicroAire Surgical Instruments LLC 1641 Edlich Drive Charlottesville, Virginia 22911 Owner/Operator #: 9004658 Contact Person/Prepared by: Darren Reeves Phone: (804) 307-7706 Fax: Email: dreeves@dpdconline.com 3) Device Identification: Trade Name: MicroAire LipoTower System Common Name: Lipoplasty Suction System Classification: Lipoplasty Suction System (21 CFR 878.5040, Product Code MUU) - 4) Predicate Device: Sound Surgical Technologies LLC - SoundVaser System (K022051) - 5) Device Description: The MicroAire LipoTower System is a modular wheeled cart that contains an adjustable vacuum source and a tumescent pump (110/120 VAC, 60 Hz). The vacuum source is a rotary vane type pump that delivers 0-29 inHG vacuum and drives the suction of tissue. The tumescent pump is a peristaltic type that delivers 50-600 ml/min of fluid as required. The system includes a control module with an LCD touch screen for control and status of the system and foot controls for controlling the vacuum pump and tumescent pump. Accessories include a bag holding pole, canister rack and shelves with are included. The system requires a biofilter (non-sterile) on the vacuum inlet and collection canisters (non-sterile - 1200ml and 2000ml) which are available separately. #### 6) Indications for Use: The MicroAire LipoTower System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired: - l Neurosurgery - -Gastrointestinal and Affiliated Organ Surgery - Urological Surgery l - Plastic and Reconstructive Surgery - - General Surgery | - Orthopedic Surgery 1 - -Gynecological Surgery - Thoracic Surgery - - Laparoscopic Surgery - The MicroAire LipoTower System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired. AUG 1 7 2012 {5}------------------------------------------------ ## 7) Comparison to Predicate: ', : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : - . | General Technical | Predicate - Sound Surgical Technologies, LLC | Proposed device | | |------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|------------------| | Characteristics | (K022051) | | | | Indications for use | The MicroAire LipoTower System is indicated for use in<br>the following surgical specialties when the<br>fragmentation, emulsification, and aspiration of soft<br>tissue is desired:<br>- Neurosurgery<br>- Gastrointestinal and Affiliated Organ Surgery<br>- Urological Surgery<br>- Plastic and Reconstructive Surgery<br>- General Surgery<br>- Orthopedic Surgery<br>- Gynecological Surgery<br>- Thoracic Surgery<br>- Laparoscopic Surgery<br>The System is indicated for use when the<br>fragmentation, emulsification, and aspiration of soft<br>tissue is desired or subcutaneous fatty tissues for<br>aesthetic body contouring is desired | Same | | | | Size (cm) (H x W x D) | 89 x 46 x 43 | 106 x 56 x 69 | | | Input Power | 115 & 230 VAC. 50-60 Hz | 115VAC, 50-60 Hz | | | Handpiece | | N/A | | | Diameter (cm) | 2.5 | N/A | | | Length (cm) | 17.5 | N/A | | | Transducer | PZT crystal | N/A | | | Vibration Frequency | 36-55 kHz | N/A | | | Probes | | N/A | | | Material | Titanium alloy | N/A | | | Diameter (mm) | 2.9-3.7 | N/A | | | Length (cm) | 7.7-27.0 | N/A | | | Irrigation | | | | | Type | Adjustable Flow | Same | | | Pump Type | Peristaltic | Same | | | Flow Rate | | 50-600ml/min | | Suction | | | | | Vacuum | 24 in Hg | Adjustable up to 29 in Hg | | | Pump Type | | Rotary Vane | | | Sterilization | Steam | N/A | | | Sterilization Validation | | N/A | | | Residuals | | N/A | | | Accessories | | N/A | | | AC Power cord | 3 prong, Hosp Grade | Same | | | Handpiece cable | 3 m, silicone | N/A | | | Footswitch control | Yes | Yes | | | Collection Canister | 1250ml | 1200ml, 2000ml | | | Biofilter | N/A | Yes | | | Prescription | Yes | Yes | | | IEC Classification | Class I, Type BF | Class I, Type B | | | | Predicate Used | MicroAire | | | IEC EN 60601-1- Medical Electrical Equipment, Part 1: General Requirements for Safety - 2nd Edition | | | | | Radiated emissions | | | | | CISPR 11<br>for IEC 60601-1-2 clause 36.201.1 | Compliant | Compliant | | | Conducted emissions | | | | | CISPR 11<br>for IEC 60601-1-2 clause 36.201.1 | Compliant | Compliant | | | Harmonics | | | | | IEC 61000-3-2 for IEC 60601-1-2 clause 36.201.3.1 | N/A | Not applicable (to devices whose<br>voltage < 220V). | | | Flicker | | | | | IEC 61000-3-3 for IEC 60601-1-2 clause 36.201.3.2 | N/A | Not applicable (to devices whose<br>voltage < 220V or line-frequency of<br>60Hz | | | ESD immunity | | | | | IEC 61000-4-2 for IEC 60601-1-2 clause 36.202.2 | | | | | UL 801-2 | Compliant | Compliant to level of 2kV | | | Air ESD | Unknown | Compliant | | | Radiated immunity | | | | | IEC 61000-4-3 for IEC 60601-1-2 clause 36.202.3 | | | | | UL 801-3 | Compliant | Compliant | | | EFT immunity | | | | | IEC 61000-4-4 for IEC 60601-1-2 clause 36.202.4 | | | | | UL 801-4 | Compliant | Compliant to level of 1.65kV | | | Surge immunity | | | | | IEC 61000-4-5 for IEC 60601-1-2 clause 36.202.5 | | | | | UL 801-5 | Compliant | Compliant | | | Conducted immunity | | | | | IEC 61000-4-6 for IEC 60601-1-2 clause 36.202.6 | Unknown | Compliant | | | Voltage dips and short-interruptions immunity | | Compliant.Note: Using 1kVA<br>exclusion of 36.202.7 a)1) for 60%<br>voltage dip | | | IEC 61000-4-11 for IEC 60601-1-2 clause 36.202.7 | Unknown | | | | Power-frequency magnetic-field immunity | | | | | IEC 61000-4-8 for IEC 60601-1-2 clause 36.202.8.1 | Unknown | Compliant | | | CAN/CSA C22.2 No. 601.1 - Medical Electrical Equipment, Part 1: General Requirements for<br>Safety - 1st Edition | Compliant | Compliant | | | UL 60601-1- Medical Electrical Equipment, Part 1: General Requirements for Safety - 1st<br>Edition | Compliant | Compliant | | | ASME Y 14.5M-1994 - Mathematical Definition of Dimensioning and Tolerancing | Unknown | Compliant | | | ISO 10079-1 - Medical suction equipment -- Part 1: Electrically powered suction equipment --<br>Safety requirements | Unknown | Compliant | | | ISO 15223-1- Medical devices -- Symbols to be used with medical device labels, labelling and<br>information to be supplied -- Part 1: General requirements | Unknown | Compliant | | | ISO 13485 - Medical devices -- Quality management systems -- Requirements for regulatory<br>purposes | Unknown | Compliant | | | ISO 14971 - Medical devices -- Application of risk management to medical devices | Unknown | Compliant | | | IEC 62304- Medical device software - Software life cycle processes | Unknown | Compliant | | UII 3128 {6}------------------------------------------------ # UU3I28 1 - 3 of You : : {7}------------------------------------------------ UU 3128 Yofy ## 8) Conclusion: The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, materials, design and tested methods. ## 9) Similarities/Differences of the proposed device when compared to the predicate: The data within this submission demonstrates that there are no significant differences between the application device and the predicate, indicating that the application device is safe, effective and substantially equivalent for marketing in the U.S.