Basic, Dominant Flex, KV-6

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Medela Ag % Adrienne Lenz Member Pathway Regulatory Consulting, LLC W324 S3649 County Road E Dousman, Wisconsin 53118 Re: K150134 Trade/Device Name: Basic, Dominant Flex, KV-6 Regulation Number: 21 CFR 878.5040 Regulation Name: Suction lipoplasty system Regulatory Class: Class II Product Code: QPB Dear Adrienne Lenz: 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 21, 2015. Specifically, FDA is updating this SE 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 June 9, 2021 {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three profiles facing right, stacked on top of each other, representing the department's focus on people and health. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002 April 21, 2015 Medela AG % Ms. Adrienne Lenz Pathway Regulatory Consulting, LLC W324S3649 Country Road E Dousman. Wisconsin 53118 Re: K150134 Trade/Device Name: Basic and Dominant Flex Suction Pumps Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: BTA . MUU. HDB Dated: January 16, 2015 Received: January 21, 2015 Dear Ms. Lenz: 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}------------------------------------------------ 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/ResourcesforYou/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 {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) #### K150134 Device Name Basic and Dominant Flex Suction Pumps #### Indications for Use (Describe) The Basic Suction Pump is indicated for vacuum extraction, aspiration during flexible endoscopy, and aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system either during surgery or at the bedsic Pump can also be used to provide the vacuum required for use with cardiac tissue stabilizers used in off-pump coronary artery bypass and for use with epicardial ablation probes. The Dominant Flex Suction Pump is indicated for vacuum extraction, aesthetic body contouring, aspiration during flexible endoscopy, and aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system either during surgery or at the bedside. The Dominant Flex Pump can also be used to provide the vacuum required for use with cardia tissue stabilizers used in off-pump coronary artery bypass and for use with epicardial ablation probes. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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}------------------------------------------------ #### Medela AG Basic and Dominant Flex Suction Pumps #### 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: DATE: January 16, 2015 #### SUBMITTER: Medela AG Lättichstrasse 4b 6341 Baar / Switzerland Phone +41 (0)41 769 51 51 Fax + 41 (0)41 769 51 00 PRIMARY CONTACT PERSON: Adrienne Lenz, RAC Member Pathway Regulatory Consulting, LLC T 262-290-0023 #### SECONDARY CONTACT PERSON: Orlando Antunes Vice President Regulatory Affairs Medela AG #### DEVICE: TRADE NAME: Basic, Dominant Flex COMMON/USUAL NAME: Powered Suction Pump CLASSIFICATION NAMES: 21 CFR 878.4780 Powered Suction Pump PRODUCT CODE: BTA #### SECONDARY CLASSIFICATIONS: System, suction, lipoplasty - MUU, 21 CFR 878.50406 Extractor, vacuum, fetal- HDB, 21 CFR 884.4340 {5}------------------------------------------------ #### Medela AG Basic and Dominant Flex Suction Pumps #### PREDICATE DEVICE(S): Main Predicate: K130123 Basic and Dominant Flex Suction Pumps K063336 Medela Dominant 50 Lipo, model 600-570628 K051749 Cobra Surgical System Octopus Evolution AS 2010, Class 1 510(k) exempt Urchin Evo Stabilizer, Class 1 510(k) exempt #### DEVICE DESCRIPTION: The Medela" Basic and Dominant Flex are high vacuum and high flow, AC-powered suction pumps that can be used when large quantities of fluid must be suctioned quickly in the hospital, ambulatory surgery center, clinic, and doctors' practice. Their construction includes a piston and cylinder system which provides strong suction performance and quiet, dependable operation and a microcontroller which is used to control motor speed and the user interface. Additional advantages of the Medela " Basic and Dominant Flex are user friendliness and simple cleaning. Medela" Basic and Dominant Flex cover the 4 main functions of - . Powerful and high suction capacity - . Rapid vacuum build-up - . Low vibrations and quiet - . Design; smooth surface and easy to use and clean The Medela" Basic provides a fixed airflow of 30 l/m and the Medela" Dominant Flex offers the innovative function of selectable airflow of 40, 50 or 60 l/m. All operating elements for nurses or doctors are located on the front side of both pumps. These include the vacuum gauge, vacuum regulator knob, operating elements and Safety Set. The Safety Set consists of a 0.25l jar, lid and float and prevents an overflow into the pump. The Medela" Basic and Dominant Flex suction pumps can be operated via capacitive sensors (called "CleanTouch") to turn the pumps on/off. Additionally the Dominant Flex has capacitive sensors for adjusting the flow between 40, 50 and 60 l/m. Both pumps have a knob for the vacuum regulator. The vacuum inside the tubing is displayed on the vacuum gauge. The Medela " Basic and Dominant Flex use three indicator lights to provide information to the user on the status of the pump. All operating elements for the biomedical technicians are located on the back side. This is where the appliance inlet for plugging in the power cord is located. {6}------------------------------------------------ ## Basic and Dominant Flex Suction Pumps Both pumps are available either as rack or portable version can be combined with the trolley to create a mobile version. A variety of reusable and disposable accessories are available for use with the Medela" Basic and Dominant Flex suction pumps or are intended to be marketed with these pumps. #### INTENDED USE: The intended use for Medela's Basic and Dominant Flex Suction Pumps is to provide a vacuum source for use during surgery. #### INDICATIONS FOR USE: The Basic Suction Pump is indicated for vacuum extraction, aspiration during flexible endoscopy, and aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system either during surgery or at the bedside. The Basic Pump can also be used to provide the vacuum required for use with cardiac tissue stabilizers used in off-pump coronary artery bypass and for use with epicardial ablation probes. The Dominant Flex Suction Pump is indicated for vacuum extraction, aesthetic body contouring, aspiration during flexible endoscopy, and aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system either during surgery or at the bedside. The Dominant Flex Pump can also be used to provide the vacuum required for use with cardiac tissue stabilizers used in off-pump coronary artery bypass and for use with epicardial ablation probes. #### DETERMINATION OF SUBSTANTIAL EQUIVALENCE: #### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE The labeling of the Basic and Dominant Flex has been revised to include the following new indications: aesthetic body contouring (Dominant Flex only) and to provide the vacuum required for use with cardiac tissue stabilizers used in off-pump coronary artery bypass and for use with epicardial ablation probes. The Basic and Dominant Flex Suction Pumps are compared to the previously cleared versions (K130123, main predicate) as well as to the Medela Dominant 50 for aesthetic body contouring (K063336), the Estech Cobra Surgical Systems for the new indication to provide a vacuum source during epicardial ablation (K051749) and the Medtronic Octopus Evolution AS 2010 and Urcin Evo 2020 Tissue Stabilizers (Class 1) to provide vacuum during off-pump coronary artery bypass. The Basic and Dominant Flex only are providing a vacuum source that is used with ablation probes such asthe Estech System and with cardiac tissue stabilizers such as the Medtronic {7}------------------------------------------------ #### Medela AG #### Basic and Dominant Flex Suction Pumps stabilizers. The ablation probes and stabilizers do not provide vacuum, but the labelling, specifies the use of an operating room suction source. The Dominant Flex has equivalent specifications to the Dominant 50 Lipo (K063336) for the aesthetic body contouring indication. The Dominant Flex operates at 0.16 horsepower (hp) which provides equivalent performance to the Dominant 50 Lipo which operates at 0.2 hp. The Basic and Dominant Flex Suction Pumps use identical technology as the Basic and Dominant Flex Suction Pumps cleared in K130123. #### SUMMARY OF NON-CLINICAL TESTS: The Basic and Dominant Flex Suction pumps comply with voluntary standards for electrical safety, electromagnetic compatibility, and safety of electrically powered suction pumps. The changes to the product labeling for new indications for use did not impact compliance to standards as compared to the pumps cleared in K130123. Non-significant changes made to the Basic and Dominant Flex Suction Pumps since the original clearance were also described. One of these changes affected electromagnetic compatibility and therefore testing to IEC 60601-1-2:2007 was completed. For the new indications for the Basic and Dominant Flex Suction Pumps, Medela AG has completed bench testing to demonstrate the performance of the pumps in the new applications. For use for the indication of aesthetic body contouring, a comparison was made between the predicate Dominant 50 Lipo (cleared for aesthetic body contouring (K063336)) with the Dominant Flex to show their equivalence. Then the Dominant Flex was also compared to the HK Liposuction Aspirator Model AP-III which is also cleared for the indication of aesthetic body contouring (K032802). Testing showed equivalent free air flow, vacuum build up, and suctioning capacity of fluids with varying consistencies, including with various cannulas. The density of body fat varies due to the area suctioned and the technique. Sterile water, apple sauce and solidifier mix were used in the testing. Testing was performed to demonstrate the compatibility of Basic and Dominant Flex in combination with epicardial ablation probes. Testing was conducted with the Estech Cobra Fusion Ablation System (bipolar or monopolar) and demonstrated that when the pump is running the vacuum is maintained at -600 mmHg ± 10%. Testing was performed to demonstrate the compatibility of Basic and Dominant Flex in combination with cardiac tissue stabilizers used in off-pump coronary artery bypass (OPCAB). Testing was conducted with the Medtronic Octopus Evolution and Urchin Evo Positioners. The test results demonstrate that when the pump is running, the vacuum is maintained at settings of -250 or -400 mmHg for up to 8 hours. {8}------------------------------------------------ #### Medela AG Basic and Dominant Flex Suction Pumps #### SUMMARY OF CLINICAL TESTS: The Basic and Dominant Flex Suction Pumps have not been the subject of clinical testing. #### CONCLUSION: The new indications for use do not change the intended use of the pump, to provide a vacuum source for use during surgery, and do not raise new issues of safety and effectiveness as compared to the main predicate device, cleared in K130123. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, Medela AG concludes that the Basic and Dominant Flex are substantially equivalent to the legally marketed predicate device.