WiCap

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 2, 2016 Athena GTX Sean Mahoney V.P. Regulatory Affairs 5900 NW 86th Street, Suite 300 Johnston, IA 50131 Re: K160582 Trade/Device Name: WiCap™ Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, CCK Dated: August 4, 2016 Received: August 5, 2016 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. 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 devicerelated 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. {1}------------------------------------------------ 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" (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 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. Sincerely yours, # Michael J. Ryan -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental 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 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below 510(k) Number (if known) Device Name WiCap™ Patient Monitor #### Indications for Use (Describe) The WiCap™ patient monitor is intended for the continuous or spot-check monitoring of carbon dioxide concentration of the expired (EtCO2) and inspired (FiCO2) breath and respiration rate (RR), and functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Intended patient populations include: Adult, Pediatric, and Neonate patients. The device is for use in hospitals, healthcare facilities and clinics, nursing home facilities, and other healthcare environments. The WiCap™ patient monitor is 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 (8/14) PSC Publishing Services (301) 443-6740 EF 4 - {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 Fax: 515.288.3394 Company Contact: Sean Mahoney (VP of Regulatory Affairs) 515.288.3360 x103 smahoney@athenagtx.com Date Prepared: August 31, 2016 II. DEVICE [807.92(a)(2)]: | Trade Name: | WiCapTM | |----------------------|----------------------------| | Common Name: | Patient Monitor | | Classification Name: | Oximeter (21 CFR 870.2700) | | Device Class: | Class II | |-----------------------|------------| | Product Code: | CCK, DQA | | Basis for Submission: | New Device | #### III. PREDICATE DEVICE [807.92(a)(3)]: Legally Marketed Oridion Medical 1987 Limited, Capnostream 20 (K060065) (Predicate) Device: #### IV. DEVICE DESCRIPTION [807.92(a)(4)]: #### Device Identification The WiCap Patient Monitor is a device that monitors physiological parameters associated with carbon dioxide gas and pulse oximetry. #### Device Characteristics The WiCap 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 WiCap monitor. #### Environment of Use WiCap is intended to be used in hospitals, healthcare facilities and clinics, nursing home facilities, and other healthcare environments. \$\qquad 5-1\$ {4}------------------------------------------------ # Principle of Operation WiCap uses non-dispersive infrared (NDIR) infrared spectroscopy to perform the capnography function (measuring carbon dioxide in exhaled breath (etCO2)). It is a side stream monitoring technique that utilizes a sample of the inhaled/exhaled patient's breath aspirated via a sample line (nasal cannula) to the CO2 OEM Module. The sample is drawn into the measurement module via DC driven pump. Pulse oximetry measures the functional oxygen saturation of arterial hemoglobin. The patient's tissue is interrogated optically and the difference in the absorption of red and infrared light (spectrophotometry) by oxyhemoqlobin and deoxyhemoglobin is analyzed. This measurement is also done non-invasively via light emitting diodes (LEDs) in the sensors applied to the patient. ## Materials The WiCap 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. ## Key Performance Specification Key performance specifications are listed in the table in section VI below under capnography and pulse oximeter. Specific accuracy specifications for sensors that are compatible with the XPod pulse oximeter OEM module, are listed in the table below. | | Accuracy (± X digits) | | | |------------------|-----------------------|--------|---------------| | Sensor Model | No Motion | Motion | Low Perfusion | | Adult/Pediatric | | | | | 8000AA-1, -2, -3 | ± 2 | ± 3 | ± 2 | | 8000AP-1, -3 | ± 2 | ± 3 | ± 2 | | 8000SS-1, -3 | | | | | 8000SM-1, -3 | ± 2 | ± 3 | ± 2 | | 8000SL-1, -3 | | | | | 8000J-1, -3 | ± 2 | --- | ± 2 | | 8001J | ± 2 | --- | ± 2 | | 8008J | ± 2 | --- | ± 2 | | 8000Q2 | ± 3 | --- | ± 2 | | 8000R | ± 2 | --- | ± 2 | | 6000CA, CP, CI | ± 2 | ± 3 | ± 2 | | 7000A, P, I | ± 2 | ± 3 | ± 2 | | 6500MA, SA | ± 2 | ± 2 | ± 3 | | Neonate | | | | | 6000CN | ± 3 | --- | ± 2 | | 7000N | ± 3 | --- | ± 2 | {5}------------------------------------------------ # V. INDICATIONS FOR USE [807.92(a)(5)]: The WiCap patient monitor is intended for the continuous or spot-check monitoring of carbon dioxide concentration of the expired (EtCO2) and inspired (FiCO2) breath and respiration rate (RR), and functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Intended patient populations include: Adult, Pediatric, and Neonate patients. The device is for use in hospitals, healthcare facilities and clinics, nursing home facilities, and other healthcare environments. The WiCap patient monitor is to be used by trained healthcare providers. The Indications for Use statement for the WiCap device is not identical to the predicate device: however, the differences do not alter the key intended use of the device nor affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices measure the same physiological parameters, are to be used on the same patient populations and in the same environments and are for use by trained healthcare providers. # VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The WiCap Patient Monitor for monitoring end tidal CO2 and Pulse Oximetry employs the same technology principles as the predicate device. For CO2 measurements non-dispersive infrared (NDIR) infrared spectroscopy is used and for pulse oximetry functional oxygen saturation of arterial hemoglobin by analyzing the difference in the absorption of red and infrared light (spectrophotometry) by oxyhemoglobin and deoxyhemoglobin is used. At a high level, the subject and predicate devices are based on the following same technological elements: - . Uses OEM modules for Pulse Oximetry and Capnography (CO2 gas monitor) - Same measurement techniques are used for both oximetry and capnography . - Both have alarms - Both comply to the same industry and FDA recognized standards ● - Both use rechargeable lithium based batteries . The following technological differences exist between the subject and predicate devices: - Different OEM modules are used for Pulse Oximetry and Capnography (CO2 gas ● monitor) - . WiCap imparts a lower optical power to the patient - WiCap is smaller and lighter - WiCap has a lower battery/system voltage - . WiCap has been tested to more severe EMC requirements (Class B vs. Class A) {6}------------------------------------------------ The following is provided as a summary of how the technological characteristics of the device compare to the predicate device: | Product Element | WiCap | Capnostream20 | Comments | |-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------| | Manufacturer | Athena GTX | Oridion Capnography Inc. | - - - | | Model Number(s) | WiCap | Capnostream20 | - - - | | 510(k) Number | Pending - new device | K060065 | - - - | | Physiological Parameters | carbon dioxide analyzer (EtCO2)<br>and Pulse-Ox (SpO2 and Pulse<br>Rate) | carbon dioxide analyzer<br>(EtCO2) and Pulse-Ox (SpO2<br>and Pulse Rate) | Same | | Patient Population | Adult, pediatric and neonate<br>patients | Adult, pediatric and neonate<br>patients | Same | | Indications | The WiCap patient monitor is intended<br>for the continuous or spot-check<br>monitoring of carbon dioxide<br>concentration of the expired (EtCO2)<br>and inspired (FiCO2) breath and<br>respiration rate (RR), and functional<br>oxygen saturation of arterial<br>hemoglobin (SpO2) and pulse rate (PR)<br>measurements. Intended patient<br>populations include: Adult, Pediatric,<br>and Neonate patients. The device is for<br>use in hospitals, healthcare facilities and<br>clinics, nursing home facilities, and other<br>healthcare environments. The WiCap<br>patient monitor is to be used by trained<br>healthcare providers. | The Capnostream20 is intended for<br>CO2 and SPO2 indications. The<br>Capnostream20 combined<br>capnograph/pulse oximeter monitor<br>is intended to provide professionally<br>trained health care providers the<br>continuous, non-invasive<br>measurement and monitoring of<br>carbon dioxide concentration of the<br>expired and inspired breath and<br>respiration rate, and for the<br>continuous non-invasive monitoring<br>of functional oxygen saturation of<br>arterial hemoglobin (SpO2 and pulse<br>rate). It is intended for use with<br>neonatal, pediatric and adult patients<br>in hospitals, hospital type facilities,<br>intra hospital moves and home<br>environments. | Substantially<br>Equivalent | | Environment of Use | Hospitals, healthcare facilities<br>and clinics, nursing home<br>facilities, and other healthcare<br>environments | Hospitals, hospital type<br>facilities, intra hospital moves<br>and home environments. | Similar -<br>Capnostream<br>20 includes<br>home use. | | Product Element | WiCap | Capnostream20 | Comments | | Compliance | IEC 60601-1:2012 Basic safety<br>and essential performance | IEC/EN60601-1<br>UL 60601-1<br>CSA C22.2 No 601.1-M90 | | | | IEC 60601-1-2:2007-03 and<br>2014-02 EMC | IEC/EN60601-1-2 Class A<br>Radiated and Conducted<br>Emission | | | | IEC 60601-1-8:2012-11 Alarms | IEC 60601-1-8 (Audible and<br>Visual Alarms) | Same | | | ISO 80601-2-55:2011-12-15<br>Respiratory gas monitors | ISO 80601-2-55<br>(Capnography) | | | | ISO 80601-2-61:2011-04-01<br>Pulse oximeters | ISO 80601-2-61 (Pulse<br>Oximetry) | | | | IEC 60601-2-49:2011<br>Multifunction patient<br>monitoring equipment | IEC 60601-2-49 Multifunction<br>patient monitoring<br>equipment | | | Capnography | | | | | CO2, EtCO2, FiCO2 Range | 0 to 150 mmHg, 0 to 19.7% | 0-150 mmHg | Same | | CO2 Accuracy | 0 - 40 mmHg ± 2 mmHg<br>41 - 70 mmHg ± 5% of reading<br>71 - 100 mmHg ± 8% of reading<br>101 - 150 mmHg ± 10% of<br>reading<br>Above 80 breath per minute ±<br>12% of reading<br>* NOTE: Gas temperature at<br>25°C | 0-38 mmHg: ± 2 mmHg<br>39-150 mmHg: ± (5% of<br>reading + 0.08 x (expected<br>reading in mmHg -39mmHg)<br>Accuracy applies for breath<br>rates of up to 80 bpm. For<br>breath rates above 80 bpm,<br>accuracy is 4 mmHg or ±12 %<br>of reading whichever is<br>greater, for etCO2 values<br>exceeding 18 mmHg. | Substantially<br>Equivalent | | Respiration Rate Range | 2 to 150 breaths per minute<br>(bpm) | 0-150 bpm | Substantially<br>Equivalent | | Respiration Rate Accuracy | ± 1 breaths per minute (bpm) | 0-70 bpm: ±1 bpm<br>71-120 bpm: ±2 bpm<br>121-150 bpm: ±3 bpm | Substantially<br>Equivalent | | CO2 Alarms | No breath, etCO2 high, etCO2<br>low, FiCO2 high, FiCO2 low, RR<br>high, RR low | No breath, etCO2 high, etCO2<br>low, RR high, RR low, IPI low | Same | | Flow Rate | 50 ml/min ±10 ml/min | 50 (42.5 ≤ flow ≤ 65) ml/min,<br>flow measured by volume | Substantially<br>Equivalent | | Product Element | WiCap | Capnostream20 | Comments | | Pulse-Oximeter | | | | | SpO2 Measurement Range | 0-100% | 0-100% | Same | | SpO2 Accuracy | Varies per sensor type.<br>Typical specs | | | | 70%-100%<br>Adult & Pediatric<br>No Motion | ± 2 digits | ± 2 digits | Substantially<br>Equivalent | | Motion<br>Low Perfusion | ± 3 digits<br>± 2 digits | | | | Neonatal<br>No Motion | ± 3 digits | ± 3 digits | Equivalent | | Motion | --- | | | | Low Perfusion | ± 2 digits | | | | 0% - 69% | Unspecified | Unspecified | | | Pulse Rate Range | 30 to 250 beats per minute<br>(bpm) | 20-250 bpm | Substantially<br>Equivalent | | Pulse Rate Accuracy | Varies per sensor type.<br>Typical specs | ± 3bpm | Substantially<br>Equivalent | | No Motion/Low Perfusion | ± 3 digits | | | | Motion | ± 5 digits | | | | Alarms | SpO2 high, SpO2 low, Pulse Rate<br>high, Pulse Rate low | Adjustable Alarm Limits<br>SpO2 high, SpO2 low, Pulse<br>Rate high, Pulse Rate low | Same | | Measurement Technology | | | | | CO2 Gas Detection OEM<br>Module | Yes | Yes | Same | | CO2 Measurement<br>Technique | Non-dispersive infrared (NDIR)<br>Infrared spectroscopy | Non-dispersive infrared<br>(NDIR) Infrared spectroscopy | Same | | Pulse-Ox OEM Module | Yes | Yes | Same | | Sp02 Measurement<br>Technique | Functional oxygen saturation of<br>arterial hemoglobin | Functional oxygen saturation<br>of arterial hemoglobin | Same | | Pulse-Ox Sensors<br>Red Wavelength<br>IR Wavelength | LED<br>660 nanometers<br>910 nanometers | LED<br>660 nanometers<br>900 nanometers | Substantially<br>Equivalent<br>wavelengths. | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ # VII. PERFORMANCE DATA [807.92(b)(1)]: ## Biocompatibility The WiCap patient monitor does not come in contact with the patient and was not tested for biocompatibility. OEM cleared accessories are specified for use that contact the patient. The 510(k) clearance information was provided as part of this submission. OEM in-cable oximeter has been tested for Biocompatibility since it may come in contact with the patient. These products comply with ISO 10993 for intact skin contact for greater than 30 days and were tested for compliance to requirements for - Cytotoxicity ● - . Sensitization - . Irritation # Industry Standards for Electrical Safety, EMC and Essential Performance Testing of the WiCap Patient Monitor has been completed to verify compliance with FDA guidance, recognized national and international standards for electrical safety and performance for medical devices, and particular requirements applicable to this device including: - Pulse Oximeters Premarket Notification Submissions [510(k)s] Guidance for Industry . and Food and Drug Administration Staff. Document issued on: March 4, 2013. - IEC 60601-1:2012 Basic safety and essential performance ● - IEC 60601-1-2:2007-03 and 2014-02 EMC ● - IEC 60601-1-8:2012-11 Alarms ● - IEC 60601-2-49:2011 Multifunction patient monitoring equipment - ISO 80601-2-55:2011-12-15 Respiratory gas monitors ● - ISO 80601-2-61:2011-04-01 Pulse oximeters - IEC 60601-1-6: 2010 + IEC 62366:2007 Usability ● #### Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern. #### Animal Study Data None. # Clinical Study Data [807.92(b)(2)]: OEM module and sensor clinical accuracy reports and manufacturer compliance statements were provided for the pulse oximeter parameter of the WiCap patient monitor that demonstrated compliance with the FDA Pulse Oximeter Guidance and ISO 80601-2-61 requirements. No further clinical testing was performed. Successful integration of the OEM module and sensor(s) was tested via a functional tester (pulse oximeter simulator) spanning the monitor's claimed range of pulse rate and saturation values. 5 - 7 {10}------------------------------------------------ SpO2 accuracy testing was conducted during induced hypoxia studies on healthy, non-smoking, light-to-dark-skinned subjects during motion and no-motion conditions in an independent research laboratory. The measured arterial hemoglobin saturation value (SpO2) of the sensors were compared to arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a laboratory co-oximeter. The accuracy of the sensors in comparison to the co-oximeter samples was measured over the SpO2 range of 70 - 100%. Accuracy data was calculated using the root-mean-squared (Arms value) for all subjects, per ISO 80601-02-61:2011, Standard Specification for Pulse Oximeters for Accuracy. # VIII. CONCLUSION [807.92(b)(3)]: The results for all safety, compliance, and non-clinical performance testing demonstrates that the Athena GTX WiCap Patient Monitor is as safe and as effective as the above listed predicate device, has the same performance characteristics and is substantially equivalent to the above listed predicate device.