Quantum Ventilation Module

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October 16, 2020 Spectrum Medical Ltd Colleen Powell Director of Regulatory Affairs Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester, Gloucestershire GL2 9QL United Kingdom Re: K202733 Trade/Device Name: Ouantum Ventilation Module Regulation Number: 21 CFR 870.4300 Regulation Name: Cardiopulmonary Bypass Gas Control Unit Regulatory Class: Class II Product Code: DTX Dated: September 17, 2020 Received: September 18, 2020 Dear Colleen Powell: 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. 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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 {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202733 Device Name Quantum Ventilation Module #### Indications for Use (Describe) The Quantum Ventilation Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation 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 and gas bubbles - · Extracorporeal gas flow measurements that includes O2 & CO2 and calculated CO2 removal - · Predicted PO2 and PCO2 - Up to three temperature channels - · 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) | | 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}------------------------------------------------ SpectrumMedical K202733 Page 1 of 3 Quantum Ventilation Module 510(k) Summary # 510(k) Summary # I. SUBMITTER | Name: | Spectrum Medical Ltd | |------------------------|------------------------------------------------------------| | Address: | Harrier 4, Meteor Business Park | | | Cheltenham Road East Gloucester | | | GL2 9QL | | | United Kingdom | | Contact Person: | Colleen Powell, Director of Regulatory Affairs | | Phone: | +44 (0) 1242 387082 | | Fax: | +44 (0) 8452 808 127 | | Date Summary Prepared: | September 17, 2020 | | II. DEVICE | | | Proprietary Name: | Quantum Ventilation Module | | Common Name: | Gas blender for heart lung machine | | Classification Name: | Gas Control Unit, Cardiopulmonary Bypass (21 CFR 870.4300) | | Regulatory Class: | II | DTX Product Code: Office of Health Technology 2 (OHT2 Cardiovascular Devices) / Division of Health Technology 2B (Circulatory Support, Structural and Vascular Devices) ## III. PREDICATE DEVICE Panel: The predicate device for this submission is Spectrum Medical Ltd.'s Quantum Ventilation Module (K181942). This predicate has not been subject to a design-related recall. # IV. DEVICE DESCRIPTION The Quantum Ventilation Module is an on-line, cardiopulmonary bypass, blood gas monitor that is used for extracorporeal monitoring of blood oxygen (arterial and venous) saturation, hematocrit, and hemoglobin levels. 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. When paired with the Quantum Workstation, the combination of the Quantum Workstation and Quantum Ventilation Module (QVM2) 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. {4}------------------------------------------------ SpectrumMedical - 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, CO2 and sweep flow rates. - 4. Provides regulation of vacuum supply to provide two channels of vacuum. - 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 touchscreen 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 and qas bubbles - Extracorporeal gas flow measurements that includes O2 & CO2 and calculated CO2 removal - Predicted PO2 and PCO2 . - . Up to three temperature channels - . 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. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The cleared Quantum Ventilation Module (QVM) and proposed Quantum Ventilation Module (QVM2) have the same intended use as both are designed to monitor critical parameters in extracorporeal circuits. Both devices have the same clinical application, clinical setting, target user and target patient population and are powered from another device via cable. Both devices also have the same manufacturer, same diagnostic measurements, equivalent sensor performance and same principle of operation of its sensors. Both Quantum Ventilation Modules blend gas electronically and can blend air, oxygen, and carbon dioxide (air/O2/CO2). Both devices are part of the gas line to the oxygenator in an extracorporeal circuit and has two vacuum channels. Diagnostic measurements of blood flow, bubble detection, circuit pressure, blood reservoir level, and temperature can be made by both devices. {5}------------------------------------------------ SpectrumMedical Quantum Ventilation Module 510(k) Summary The proposed Quantum Ventilation Module has added a second vacuum supply wall port, in addition to an optional sample line for extracted gas analysis. Improvements to the user interface, including enhanced touchscreen capability, have been added to the modified device. The proposed Quantum Ventilation Module is substantially equivalent with regards to intended use, technology, and performance specifications to the currently cleared Quantum Ventilation Module. The differences between the devices 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 (QVM) to the Quantum Ventilation Module (QVM2). The following non-clinical testing was performed to support the substantial equivalence of the Quantum Ventilation Module (QVM2) to the legally marketed predicate device: - Electrical safety - . Electromagnetic compatibility (EMC) - Hardware testing - Software verification and validation ## VIII. PERFORMANCE DATA - CLINICAL TESTING No clinical data were submitted to support the substantial equivalence of the Quantum Ventilation Module (QVM2) to the Quantum Ventilation Module (QVM). ## IX. CONCLUSIONS Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to predicate devices, the Quantum Ventilation Module (QVM2) has been shown to be substantially equivalent to a legally marketed predicate device.