SIMEX SUBGLOTTIC ASPIRATION SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 22, 2014 SIMEX Medizintechnik, GmbH FloSure Technologies LLC % Mr. Hamid Khosrowshahi President P.O. Box 123 Tarrytown, New York 10591 Re: K141255 Trade/Device Name: SIMEX Subglottic Aspiration System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: BTA Dated: August 19, 2014 Received: August 21, 2014 Dear Mr. Khosrowshahi: 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 {1}------------------------------------------------ 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 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K141255 Device Name SIMEX Subglottic Aspiration System #### Indications for Use (Describe) The SIMEX Subglottic Aspiration System models cuff M and cuff S are indicated for vacuum suction, extraction, aspiration and removal of surgical fluids, tissue (including bone), bodily fluids or infectious materials from wounds or from patient's airway or respiratory system, either during surgery or at the patient's bedside. Generally, the SIMEX Subglottic Aspiration System is intended for removing subglottic secretions from the patient's airway above the endotracheal or tracheal cuff using intermittent suction when used in ICU and acute care settings where the duration of mechanical ventilation is limited to a maximum of 4 weeks. Type of Use (Select one or both, as applicable) 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." FORM FDA 3881 (8/14) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ SIMEX Medizintechnik GmbH 510(k) Premarket Notification SIMEX Subglottic Aspiration System ## 510(k) Summary | Date Prepared: | September 15, 2014 | | | | | | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--| | Sponsor and<br>Manufacturer: | SIMEX Medizintechnik, GmbH<br>Post Box 1207<br>D-78649. Deisslingen, Germany<br>FDA Registration Number 3005813597 | | | | | | | 510(k) Contact: | Mr. Hamid Khosrowshahi<br>FloSure Technologies LLC<br>PO Box 123<br>Tarrytown, New York, 10591<br>Telephone: 914-772-7326<br>e-mail : hkhosrow@optonline.net | | | | | | | Trade Name: | SIMEX Subglottic Aspiration System<br>Models cuff M and cuff S | | | | | | | Classification: | Powered Suction Pump<br>FDA 21 CFR 878.4780<br>Class II | | | | | | | Product Code: | BTA - Pump, Portable, Aspiration (Manual or Powered) | | | | | | ## Predicate Devices: Medela® Vario 8/18/ci Secretion & Surgical Aspirator System 510(k) K061205 Medela AG Product Code BTA SIMEX Suction Pumps 510(k) K061133 Novaspine LLC Product Code BTA SIMEX EX200 and EX300 Negative Pressure Wound Therapy System 510(k) K113291 SIMEX Medizitechnik GmbH Product Code OMP ## Indications for Use: The SIMEX Subglottic Aspiration System models cuff M and cuff S are indicated for vacuum suction, extraction, aspiration and removal of surgical fluids, tissue (including bone), bodily fluids or infectious materials from wounds or from patient's airway or respiratory system, either during surgery or at the patient's bedside. Generally, the SIMEX Subglottic Aspiration System is intended for removing subglottic secretions from the patient's airway above the endotracheal cuff using intermittent suction when used in ICU and acute care settings where the duration of mechanical ventilation is limited to a maximum of 4 weeks. {4}------------------------------------------------ # Device Description: The SIMEX Subglottic Aspiration System models cuff S are lightweight portable or stationary suction/aspiration pumps for medical suction procedures where secretions, blood and other body fluids must be removed. The SIMEX cuff M and cuff S are designed for the application of intermittent aspiration of fluids which is particularly useful in the aspiration of subglottic secretions. Applications range from hospital, emergency care, and acute care facilities. These pumps are designed and engineered for the proper and effective aspiration of subglottic secretion via intermittent suction. The pump can be set to operate (aspirate) anywhere from 1-60 seconds and to pause from 1-60 minutes. The factory setting is 10 seconds of aspiration time and 10 minutes of pause time and pressure of 100 mbar vacuum. SIMEX cuff M and cuff S suction pumps remove oral and/or gastric secretions from above the tracheal and or endotracheal tube cuff before they can be aspirated by the patient, using intermittent suction to remove subglottic secretions. There are two models of the SIMEX Subglottic Aspiration System, Models cuff M and cuff S. The two models differ in their housing and collection canister configuration. Both models have the same overall system operation and software. The moving and electrical components of both models are housed in a molded, compact plastic housing. The units include attachment for an external power supply and/or a battery charger. # Non-Clinical Testing (Bench): The SIMEX Subglottic Aspiration System cuff M and cuff S are manufactured in accordance with FDA Quality System Regulations and EEC Directive 93/42/EEC Annex IX. Testing for electrical safety was conducted to ensure it meets the requirements for IEC 60601-1-2 including the National Differences for the US. Testing also demonstrated that the pumps meet the electromagnetic interference requirements of the above standards. Bench testing of the SIMEX Subglottic Aspiration Systems cuff M and cuff S demonstrated that pumps are capable of operating for more than 2000 hours and can adequately perform when tested in a simulated use environment across the operating parameters of the pumps. # Substantial Equivalence: The SIMEX Subglottic Aspiration System cuff M and cuff S are substantially equivalent to other powered suction pumps used for aspiration of secretions from the patient's airway or respiratory system. The SIMEX Subglottic Aspiration System, like it's predicates is used for aspiration of secretions from a patient's airway or respiratory system. The SIMEX system uses the same basic technology of other similar suction pumps and performs the same function by applying negative pressure to aspirate accumulated materials. {5}------------------------------------------------ | | SIMEX Subglottic<br>Aspiration System<br>cuff M and cuff S<br>SIMEX Medizintechnik<br>GmbH | SIMEX<br>Suction<br>pumps<br>(K061133)<br>NovaSpine<br>LLC | Medela®<br>Vario 8/18/ci<br>Secretion and<br>Surgical<br>Aspirator<br>(K061205)<br>Medela AG | SIMEX EX200 and EX300<br>NPWT pumps<br>(K113291)<br>SIMEX Medizintechnik<br>GmbH | | | | | | | | | | |---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------|----------|--|------|-------|------|-------|------| | Product Code | BTA | BTA | BTA | OMP | | | | | | | | | | | Technology | Vacuum pump transmits<br>negative pressure through<br>a tubing system and<br>collection container and<br>connects to a suction<br>catheter | Vacuum<br>pump<br>transmits<br>negative<br>pressure<br>through a<br>tubing system<br>and collection<br>container and<br>connects to a<br>suction<br>catheter | Vacuum pump<br>transmits<br>negative<br>pressure<br>through a<br>tubing system<br>and collection<br>container and<br>connects to a<br>suction<br>catheter | Vacuum pump transmits<br>negative pressure through<br>a tubing system and<br>collection container and<br>connects to a suction<br>catheter | | | | | | | | | | | Manual (Analog) /<br>Digital Operation | Digital Pressure Gauge and<br>Logic-microprocessor | Manual<br>(analog)<br>Suction<br>Pressure<br>Regulator | Manual<br>(analog)<br>Suction<br>Pressure<br>Regulator | Digital Pressure Gauge<br>and<br>Logic-microprocessor | | | | | | | | | | | Constant/Intermittent<br>Operation | Intermittent | Constant | Constant or<br>Intermittent | Constant or Intermittent | | | | | | | | | | | Intermittent Range<br>(On/Off time) | Programmed to:<br>1-60 sec On<br>1-60 min Off | N/A | 8 Seconds On<br>4 Seconds Off<br>16 Seconds On<br>8 Seconds Off<br>32 Seconds Off<br>16 Seconds Off | Programmed to:<br>2-10 min On<br>2-10 min Off | | | | | | | | | | | Max Pressure | 300 mbar (225 mmHg) | 600 mmHg<br>(801 mbar) | 563 mmHg<br>(751 mbar)<br>68 mmHg (91<br>mbar) | 200 (mmHg) (267 mbar) | | | | | | | | | | | Flow Rate<br>(liters/min) | 8 liters/min | 18-28<br>liters/min | 8 liters/min –<br>Vario 8<br>18 liters/min –<br>Vario 18 | 8 liters/min | | | | | | | | | | | Power (AC/DC,<br>Voltage/Hz) | 12 V DC<br>100/240<br>VAC,<br>50/60 Hz | 12 V DC<br>115/230<br>VAC,<br>50/60 Hz | 12 V DC<br>115/230<br>VAC,<br>50/60 Hz | 12 V DC<br>100/240<br>VAC,<br>50/60 Hz | | | | | | | | | | | Electrical Protection<br>Class | Type BF | Type BF | Type BF | Type BF | | | | | | | | | | | Rechargeable Battery | 7.4 V, 4.4 Ah – Lithium –<br>Ion | 12V, 2.1 Ah,<br>Ni-MH | 12V Ni-MH | 7.4 V, 4.4 Ah – Lithium –<br>Ion | | | | | | | | | | | Contains<br>Hydrophobic<br>Microbial Filter | Yes | Yes | Yes | Yes | | | | | | | | | | | Weight (kg) | cuff M<br>1.2 kg | cuff S<br>2.2 kg | 3.2 kg - 3.9<br>kg | 5.1 kg | EX200<br>1.2 kg | EX300<br>2.2 kg | | | | | | | | | Intake Hose | (mm ID) | cuff M | 4 mm | cuff S | 6 mm | | 6mm-10mm | | 6 mm | EX200 | 4 mm | EX300 | 6 mm | # Feature Comparison Chart {6}------------------------------------------------ ## SIMEX Medizintechnik GmbH 510(k) Premarket Notification SIMEX Subglottic Aspiration System | | SIMEX Subglottic<br>Aspiration System<br>cuff M and cuff S<br>SIMEX Medizintechnik<br>GmbH | | SIMEX<br>Suction<br>pumps<br>(K061133)<br>NovaSpine<br>LLC | Medela®<br>Vario 8/18/ci<br>Secretion and<br>Surgical<br>Aspirator<br>(K061205)<br>Medela AG | SIMEX EX200 and EX300<br>NPWT pumps<br>(K113291)<br>SIMEX Medizintechnik<br>GmbH | | |---------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Collection Container | cuff M | cuff S | Reusable<br>collection<br>containers and<br>disposable<br>collection<br>liners<br>(solidifier<br>available) | Reusable and<br>disposable<br>collection<br>containers and<br>disposable<br>collection<br>liners<br>(solidifier<br>available) | EX200 | EX300 | | | Disposable<br>canister<br>with gelling<br>agent and<br>integrated<br>filter and<br>suction<br>tubing | Reusable<br>(single<br>patient use)<br>outer<br>canister<br>with<br>disposable<br>liner<br>containing<br>gelling<br>agent and<br>integrated<br>filter.<br>Suction<br>tubing<br>provided<br>separately | Reusable<br>collection<br>containers and<br>disposable<br>collection<br>liners<br>(solidifier<br>available) | Reusable and<br>disposable<br>collection<br>containers and<br>disposable<br>collection<br>liners<br>(solidifier<br>available) | Disposable<br>canister<br>with<br>gelling<br>agent and<br>integrated<br>filter and<br>suction<br>tubing | Reusable<br>(single<br>patient use)<br>outer<br>canister<br>with<br>disposable<br>liner<br>containing<br>gelling<br>agent and<br>integrated<br>filter.<br>Suction<br>tubing<br>provided<br>separately | | Container Volume | cuff M | cuff S | 1000 cc | 1000 cc | EX200 | EX300 | | | 250 cc | 1000 cc | | | 250 cc | 1000 cc | | Carrying Bag for<br>transporting pump | Yes | | Yes | Yes | Yes | | # Conclusion: The SIMEX Subglottic Aspiration System Models cuff M and cuff S are substantially equivalent to the commercially marketed predicate devices and do not raise new issues of safety and effectiveness.