Quantum Ventilation Module

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 18, 2018 Spectrum Medical Ltd Mark Drain Chief Financial Officer Harrier 4. Meteor Business Park, Cheltenham Road East Gloucester Gloucestershire GL2 9QL GB Re: K181942 Trade/Device Name: Quantum Ventilation Module Regulation Number: 21 CFR 870.4300 Regulation Name: Cardiopulmonary Bypass Gas Control Unit Regulatory Class: Class II Product Code: DTX Dated: July 19, 2018 Received: July 20, 2018 Dear Mark Drain: 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. 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 located 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. {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Fernando Aguel -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular 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) K181942 Device Name Quantum Ventilation Module Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. Indications for Use (Describe) The Quantum Ventilation Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Ventilation Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Ventilation Module include: - · Measurement of up to three blood flow channels and arterial and venous flow differential - Indication of gas bubbles - · Extracorporeal gas flow measurements (02, CO2, gas flow, and CO2 removal) - · Predicted PO2 and PCO2 - · Temperature - · Up to three circuit pressure channels - · Reservoir level indication - Two channels of vacuum - · Blend and control gas flow (air/O2/CO2) The Quantum Ventilation Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel. Type of Use (Select one or both, as applicable) | | <span> <span style="font-size:100%;"> <svg height="15" width="15"> <rect height="15" style="stroke-width:1;stroke:rgb(0,0,0);fill:none" width="15" x="0" y="0"></rect> <path d="M2,2 L13,13 M13,2 L2,13" style="stroke-width:2;stroke:rgb(0,0,0)"></path> </svg> </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) | |--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | <span> <span style="font-size:100%;"> <svg height="15" width="15"> <rect height="15" style="stroke-width:1;stroke:rgb(0,0,0);fill:none" width="15" x="0" y="0"></rect> </svg> </span> </span> 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.qov "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}------------------------------------------------ SpectrumMedical #### I. SUBMITTER Spectrum Medical Ltd Harrier 4, Meteor Business Park Cheltenham Road East Gloucester GL2 9QL United Kingdom Phone: +44 (0) 1242 650 120 Fax: +44 (0) 8452 808 127 Contact Person: Mr. Mark Drain, Chief Financial Officer Date Summary Prepared: July 19, 2018 ## II. DEVICE | Proprietary Name: | Quantum Ventilation Module | |----------------------|------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Gas blender for heart lung machine | | Classification Name: | Gas Control Unit, Cardiopulmonary Bypass<br>(21 CFR 870.4300) | | Regulatory Class: | II | | Product Code: | DTX | | Panel: | Office of Device Evaluation (ODE) /<br>Division of Cardiovascular Devices (DCD)<br>Circulatory Support Devices Branch (CSDB) | #### III. PREDICATE DEVICES The primary predicate device is Spectrum Medical's Quantum Diagnostic Module (K173591) and an additional predicate device is LivaNova's Stöckert Gas Blender (K101046). These predicates have not been subject to a design-related recall. # IV. DEVICE DESCRIPTION The Quantum Ventilation Module provides gas blending and continuous non-invasive monitoring of critical clinical parameters in extracorporeal circuits used in cardiopulmonary bypass (CPB) or extracorporeal membrane oxygenation (ECMO) procedures. The Quantum Ventilation Module is an accessory to the Quantum Workstation or can be used in place of the Quantum Diagnostic Module as part of the Quantum Pump Console. When paired with the Quantum Workstation, the Traditional 510(k) Application July 19, 2018 Quantum Ventilation Module 510(k) Summary K181942 Page 1 of 4 {4}------------------------------------------------ Spectrum Medical Traditional 510(k) Application July 19, 2018 Quantum Ventilation Module 510(k) Summary combination of the Quantum Workstation and Quantum Ventilation Module is known as the Quantum Ventilation System. The Quantum Ventilation Module performs five functions: - 1. Provides measurements from embedded and attached sensors to monitor gases into and out of a blood oxygenator. - 2. Provides measurements from attached sensors for blood flow, bubble detection, pressure, level and temperature to monitor an extracorporeal blood loop. - 3. Provides gas blending to ensure the precision delivery of FiO₂ (21 to 100%), CO₂ and sweep flow rates. - 4. Provides regulation of vacuum supply to provide two channels of vacuum. One is flow-regulated to remove waste anesthesia gas, the other pressure-regulated for applications including Vacuum-Assisted Venous Drainage (VAVD) and hemoconcentration. - 5. Sends these physiological measurements to the Quantum Workstation for display to the user. The Quantum Ventilation Module, with its attached sensors, can measure flow, pressure, reservoir level, temperature and gas diagnostics, in addition to performing electronic gas blending of up to three gases and built-in vacuum management for the removal of waste anesthetic gas. The primary interface for controlling and displaying measurements is the Quantum Workstation: however, the Quantum Ventilation Module also contains a display with control knobs. The Quantum Ventilation Module only works with the Quantum Workstation. # V. INTENDED USE / INDICATIONS FOR USE The Quantum Ventilation Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Ventilation Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Ventilation Module include: - . Measurement of up to three blood flow channels and arterial and venous flow differential - . Indication of gas bubbles - . Extracorporeal gas flow measurements (O2, CO2, gas flow, and CO2 removal) - o Predicted PO2 and PCO2 - o Temperature - . Up to three circuit pressure channels - . Reservoir level indication - . Two channels of vacuum - . Blend and control gas flow (air/O2/CO2) The Quantum Ventilation Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel. {5}------------------------------------------------ SpectrumMedical Traditional 510(k) Application July 19, 2018 Quantum Ventilation Module 510(k) Summary # VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES The Quantum Ventilation Module, the Quantum Diagnostic Module and the Stöckert Gas Blender have the same intended use as all are designed to monitor critical parameters in extracorporeal circuits. All three devices have the same clinical application, clinical setting, target user and target patient population and are powered from another device via cable. Spectrum Medical Ltd's Quantum Diagnostic Module and Quantum Ventilation Module also have the same manufacturer, same diagnostic measurements, equivalent sensor performance and same principal of operation of its sensors. The Quantum Diagnostic Module does not have a display nor can it blend gas or perform vacuum management. The Quantum Ventilation Module and the Stockert Gas Blender both blend gas electronically and can blend air, oxygen and carbon dioxide. Both devices are part of the gas line to the oxygenator in an extracorporeal circuit and can display information on the module or a separate display. The Quantum Ventilation Module can make diagnostic measurements of blood flow, bubble detection, circuit pressure, blood reservoir level, and temperature while the Stöckert Gas Blender cannot. The Quantum Ventilation Module also has two vacuum channels while the Stöckert Gas Blender has none. These differences in technological characteristics do not raise new issues of safety or effectiveness. #### VII. PERFORMANCE DATA - NON-CLINICAL TESTING No animal testing was submitted to support the substantial equivalence of the Quantum Ventilation Module to the Quantum Diagnostic Module and Stöckert Gas Blender. The following non-clinical testing was performed to support the substantial equivalence of the Quantum Ventilation Module to the predicate devices: - . Electrical safety - Electromagnetic compatibility (EMC) - o Electrosurgery interference - Hardware testing of printed circuit boards ● - Software verification and validation - Usability validation #### VIII. PERFORMANCE DATA - CLINICAL TESTING No clinical data were submitted to support the substantial equivalence of the Quantum Ventilation Module to the Quantum Diagnostic Module and Stöckert Gas Blender. {6}------------------------------------------------ SpectrumMedical Traditional 510(k) Application July 19, 2018 Quantum Ventilation Module 510(k) Summary # IX. CONCLUSIONS Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to predicate devices, the Quantum Ventilation Module has been shown to be substantially equivalent to legally marketed predicate devices.