WVSM (Wireless Vital Signs Monitor) RWC + miniCap

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services 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. January 29, 2020 Athena GTX Sean Mahonev VP of Operations and Regulatory Affairs 5900 NW 86th Street. Suite 300 Johnston, Iowa 50131 Re: K191989 Trade/Device Name: Wireless Vital Signs Monitor (WVSM) RWC + miniCap Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DQA, DXN, CCK Dated: December 23, 2019 Received: December 27, 2019 Dear Sean Mahoney: 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. 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 {1}------------------------------------------------ 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/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 medical devices and radiation-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, LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below 510(k) Number (if known) K191989 Device Name Wireless Vital Signs Monitor (WVSM) RWC + miniCap Indications for Use (Describe) The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or multi-parameter vital signs monitor for ECG, noninvasive blood pressure (NIBP) and SpO2, with an optional accessory for capnography (ETCO2, RR). It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer. The monitor is intended to be used by trained healthcare providers. 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 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF 4-1 {3}------------------------------------------------ ## 510(k) Summary I. SUBMITTER 807.92(a)(1)]: Athena GTX 5900 NW 86th Street, Suite 300 Johnston, lowa 50131 Phone: 515.288.3360 515.288.3394 Fax: Company Contact: Sean Mahoney (VP of Operations and Regulatory Affairs) 515.288.3360 x103 smahoney@athenagtx.com Date Prepared: January 29, 2020 II. DEVICE [807.92(a)(2)]: | Trade Name: | Wireless Vital Signs Monitor (WVSM) RWC + miniCap | |----------------------|--------------------------------------------------------------------------------| | Common Name: | Physiological Patient Monitor | | Classification Name: | Cardiac Monitor (21 CFR 870.2300) | | | NIBP Measurement System (21 CFR 870.1130) | | | Oximeter (21 CFR 870.2700) | | | Radiofrequency Physiological Signal Transmitter and Receiver (21 CFR 870.2910) | | | Carbon-Dioxide Gas Analyzer (21 CFR 868.1400) | Device Class: Class II Product Code: MWI, DXN, DQA, DRG, CCK Basis for Submission: Device Modification #### III. PREDICATE DEVICE [807.92(a)(3)]: Legally Marketed (Predicate) Device: Athena GTX, Wireless Vital Signs Monitor (WVSM) (K101674) #### IV. DEVICE DESCRIPTION [807.92(a)(4)]: #### Device Identification The WVSM Patient Monitor is a device that monitors physiological parameters associated with Electrocardiogram, Non-invasive Blood Pressure, pulse oximetry and carbon dioxide gas. ### Device Characteristics The WVSM Patient Monitor is a multi-patient use non-sterile device. It utilizes embedded firmware. Patient applied parts are needed for physiological measurement and are provided via FDA cleared OEM accessories to the WVSM monitor. {4}------------------------------------------------ # Environment of Use WVSM is intended to be used in hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. ### Principle of Operation The modification to the WVSM includes: - . Adding an indication for capnography by interfacing with a FDA cleared accessory. - Adding the capability to use the device while connected to the AC power adapter instead ● of only using the device on battery power. ## Materials The WVSM Patient Monitor enclosure is primarily plastic and does not contact the patient. The applied parts are OEM accessories that are FDA cleared and meet the biocompatibility requirements for intact skin contact. The Aux Battery enclosure is constructed of the same material as the WVSM and does not contact the patient. ### Kev Performance Specification Key performance specifications are listed in the table in section VI below. ### V. INDICATIONS FOR USE [807.92(a)(5)]: The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or multi-parameter vital signs monitor for ECG, noninvasive blood pressure (NIBP) and SpO2, with an optional accessory for capnography (ETCO2, FiCO2, RR). It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer. The monitor is intended to be used by trained healthcare providers. The Indications for Use statement for the device modification is not identical to the predicate previously cleared device; however, the differences do not alter the general intended use of the WVSM as a multi-parameter monitor nor affect the safety and effectiveness of the device relative to the predicate. The device modification to add an AC power mode does not affect the Indications for use. The modification to add an FDA cleared CO2 gas analyzer as an optional accessory added a capnography indication to the WVSM indications for use. ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE This device modification includes the following: - Adding capnography by interfacing with a FDA cleared accessory. . - Adding the capability to use the device while connected to the AC power adapter instead . of only using the device on battery power. The WVSM was originally designed to be a multi-parameter monitor and had the AUX port capability built in for future use. Since the capnography accessories are FDA cleared and specifically designed to be connected to a medical backboard (Medical Monitor), this device modification is largely an interface task to connect two cleared devices using a well-established I-2 {5}------------------------------------------------ interface protocol. Therefore the addition of the capnography accessory does not alter the fundamental scientific technology of the WVSM device. An AC power adapter was already used for charging the internal battery of the previously cleared device. The interface and specifications are the previously cleared device. This modification allows for the modified device to be used while the AC power adapter remains plugged into the monitor. An equivalent and updated AC adapter is used for the modified device. The previously cleared device was used only while on battery power. The addition of this AC power mode does not alter the fundamental scientific technology of the WVSM device. At a high level, the subject and predicate devices are based on the following same technological elements: - The Athena GTX WVSM™ device modification and the previously cleared device have . the same physical characteristics, cleaning, and cannot be used near flammable anesthetics. - The Athena GTX WVSM™ device modification and the previously cleared device have the same electrical characteristics including: protection circuits, battery power, and use of AC power adapters. - . The Athena GTX WVSM™ device modification and the previously cleared device have the same environmental specifications for: Temperature, humidity, altitude, water intrusion, vibration, shock, drop, and EMC. - . The Athena GTX WVSM™ device modification and the previously cleared device use the same ECG monitoring circuitry. - The Athena GTX WVSM™ device modification and the previously cleared device ● integrate the same PureSAT® pulse oximetry technology to compute functional arterial hemoglobin saturation and pulse rate. - . The Athena GTX WVSM™ device modification and the previously cleared device utilize the same SunTech Advantage OEM Non-invasive Blood Pressure (NIBP) module for mean arterial pressure, and systolic and diastolic blood pressure measurements. - . The Athena GTX WVSM™ device modification and the previously cleared device integrate alarms functions in the monitors. - . The Athena GTX WVSM™ device modification and the previously cleared device utilize 802.11 wireless communications to connect with multiple patient vital signs monitoring devices for bi-directional data transfer. - . The Athena GTX WVSM™ device modification and the previously cleared device utilize software, installed on a PC, to allow for data management and display, alert/alarm management, and patient data review. - The Athena GTX WVSM™ device modification and the previously cleared device utilize mobile platforms. The following technological differences exist between the subject and predicate devices: - . The Athena GTX WVSM™ device modification adds an optional capnography accessory not supported in the previously cleared device. - . A different, but equivalent and improved AC power adapter is used with the modified device. - . The AUX Port was modified to be capable of input and output (Same as the DATA port) to support the connection to the capnography accessory. - Physiological and technical alarms for the capnography parameters (etCO2, FiCO2, RR) and sensor fault respectively were added. {6}------------------------------------------------ The following is provided as a summary of how the technological characteristics of the device compare to the predicate device: | Product Name | Athena GTX<br>WVSM RWC + miniCap | Athena GTX<br>WVSM Cleared Device | Comments | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | Manufacturer | Athena GTX | Athena GTX | Same | | Trade/Device Name | WVSM RWC + miniCap | WVSM | Different -<br>Device<br>Modification | | 510(k) Number | Pending - Modified Device | K101674 | | | Product Code | MWI, DXN, DQA, DRG, CCK | MWI, DXN, DQA, DRG | Different<br>Added CCK | | Regulation Number | 870.2300, 870.1130; 870.2700;<br>870.2910, 868.1400 | 870.2300, 870.1130; 870.2700;<br>870.2910 | Different<br>Added<br>868.1400 | | Prescription Device | YES | YES | Same | | Physiological<br>Parameters | ECG, heart rate, systolic and<br>diastolic blood pressure;<br>functional oxygen saturation,<br>pulse rate, etCO2, FICO2,<br>respiration rate | ECG, heart rate, systolic and<br>diastolic blood pressure;<br>functional oxygen saturation,<br>pulse rate | Different -<br>Added etCO2,<br>FICO2,<br>respiration rate | | Displays | Displays ECG, systolic, diastolic<br>BP, SpO2, pulse rate, etCO2,<br>FICO2, respiration rate | Displays ECG, systolic, diastolic<br>BP, SpO2, pulse rate | Different -<br>Added etCO2,<br>FICO2,<br>respiration rate | | Patient Population | Adult | Adult | Same | | Product Name | Athena GTX<br>WVSM RWC + miniCap | Athena GTX<br>WVSM Cleared Device | Comments | | Indications | The Wireless Vital Signs Monitor<br>(WVSM) is intended to be used<br>as an adult patient monitor. It is<br>indicated as a single or multi-<br>parameter vital signs monitor for<br>ECG, noninvasive blood<br>pressure (NIBP) and SpO2, with<br>an optional accessory for<br>capnography (ETCO2, FiCO2,<br>RR). It may be used in the<br>following locations: Hospitals,<br>healthcare facilities, emergency<br>medical applications, during<br>transport, and other healthcare<br>applications. The monitor uses<br>wireless communications to<br>transmit vital signs data to a<br>handheld or PC computer. The<br>monitor is intended to be used<br>by trained healthcare providers. | The Wireless Vital Signs Monitor<br>(WVSM) is intended to be used<br>as an adult patient monitor. It is<br>indicated as a single or multi-<br>parameter vital signs monitor for<br>ECG, noninvasive blood<br>pressure (NIBP) and SpO2. It<br>may be used in the following<br>locations: Hospitals, healthcare<br>facilities, emergency medical<br>applications, during transport,<br>and other healthcare<br>applications. The monitor uses<br>wireless communications to<br>transmit vital signs data to a<br>handheld or PC computer The<br>monitor is intended to be used<br>by trained healthcare providers. | Different -<br>Added, with<br>an optional<br>accessory for<br>capnography<br>(ETCO2,<br>FiCO2, RR) | | Scenario of Use | Continuous or spot monitoring by<br>licensed healthcare<br>professionals | Continuous or spot monitoring by<br>licensed healthcare<br>professionals | Same | | Networking/ Telemetry | WVSM may be used standalone<br>or via wireless network<br>(802.11b/g, 2.4GHz) to a<br>handheld or PC computer | WVSM may be used standalone<br>or via wireless network<br>(802.11b/g, 2.4GHz) to a<br>handheld or PC computer | Same | | Environment of Use | Emergency medical services,<br>Transport (including helicopter),<br>emergency departments,<br>hospital, other healthcare<br>applications | Emergency medical services,<br>Transport (including helicopter),<br>emergency departments,<br>hospital, other healthcare<br>applications | Same | | Physical | No Change | | No Changes | | Electrical | | | | | Power Modes | Operation: Battery or AC<br>Medical Grade Power Adapter<br>Charging: AC Medical Grade<br>Power Adapter | Operation: Battery Only<br>Charging: AC Medical Grade<br>Power Adapter | Different -<br>Added<br>Operational<br>AC Power<br>mode | | Battery | 7.4V, 2800 mAh, Li-Polymer | 7.4V, 2800 mAh, Li-Polymer | Same | | Power Adapter | Mean Well GSM36B09 | SL Power/Ault MW173KB Series | Different -<br>Equivalent,<br>meets latest<br>EMC<br>requirements | | Environmental | No Changes | | No Changes | | Product Name | Athena GTX<br>WVSM RWC + miniCap | Athena GTX<br>WVSM Cleared Device | Comments | | Physiological<br>Parameters | | | | | ECG | Internal Circuit | Internal Circuit | Same | | Pulse-Ox | Nonin OEM Module | Nonin OEM Module | Same | | NIBP | Suntech Medical OEM Module | Suntech Medical OEM Module | Same | | Capnography | Masimo OEM Gas Analyzers<br>IRMA (K123043) and<br>ISA (K103604) | NA | Different -<br>Added<br>Capnography | | Alarms | | | | | Operator Position<br>Primary | Patient Environment | Patient Environment | Same | | Secondary | Outside Patient Environment<br>(Distributed) | Outside Patient Environment<br>(Distributed) | Same | | Verify Alarm Function | 1 Second beep at start-up (after<br>menu section).<br>To verify activation at limits, user<br>must simulate alarm condition. | 1 Second beep at start-up (after<br>menu section).<br>To verify activation at limits, user<br>must simulate alarm condition. | Same | | Silence/Reset | 2 min or 30 min Does not affect<br>same or higher priority audible<br>alarm functions | 2 min. Does not affect same or<br>higher priority audible alarm<br>functions | Different -<br>Includes an<br>additional<br>silence time | | Audible Alarms | No Change | No Change | No Change | | Alarm Conditions and<br>Priority | | | | | Physiological | High and Low Priority based on<br>Alarm Limits set for each<br>parameter: %SpO2, HR/PR,<br>Systolic BP, Diastolic BP,<br>etCO2, FiCO2, RR | High and Low Priority based on<br>Alarm Limits set for each<br>parameter: %SpO2, HR/PR,<br>Systolic BP, Diastolic BP | Different -<br>Added etCO2,<br>FiCO2, RR | | Technical | Low Priority when a sensor fault<br>is detected: SpO2 and<br>Capnography | Low Priority when a sensor fault<br>is detected: SpO2 | Different -<br>Added<br>Capnography<br>sensor fault | | | Medium Priority below 5%<br>Battery Power remaining | Medium Priority below 5%<br>Battery Power remaining | | | Alarm System Delay<br>at the Monitor | | | | | HR/PR | No Change | No Change | No Change | | SpO2 | No Change | No Change | No Change | | NIBP | No Change | No Change | No Change | | Product Name | Athena GTX<br>WVSM RWC + miniCap | Athena GTX<br>WVSM Cleared Device | Comments | | IRMA Capnography | Alarm Condition delay <1 sec<br>Alarm Generation Delay 1 sec<br>Total Alarm System Delay <2<br>sec | NA | Different -<br>Added<br>Capnography | | ISA Capnography | Alarm Condition delay <3 sec<br>Alarm Generation Delay 1 sec<br>Total Alarm System Delay <4<br>sec | NA | Different -<br>Added<br>Capnography | | Interfaces | | | | | Data Port | Input…