welloStationX

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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. November 30, 2018 Wello, Inc Alan C. Heller Chairman and CEO 800 East Campbell Road, Suite 202 Richardson, Texas 75081 Re: K180298 Trade/Device Name: welloStationX Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 29, 2018 Received: November 29, 2018 Dear Alan C. Heller: 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 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 {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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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. Geeta K. Pamidimukkala -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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K180298 Device Name welloStationX Indications for Use (Describe) The welloStationX is a non-contact infrared forehead thermometer intended for use to measure of individuals over 5 years of age and older. The welloStationX can be used by medical professionals or laypersons in any public or private indoor facility with environmental conditions maintained within 15°C to 28°C (59°F to 82.4°F), 20 -70% RH non-condensing. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) |X | 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}------------------------------------------------ # 510(k) SUMMARY | 510(k) Number: | K180298 | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Wello Inc.<br>3939 Belt Line Road, Suite 400<br>Addison, TX 75001 | | Contact Person: | Mr. Alan Camerik (Rik) Heller<br>Chairman and CEO<br>TEL: 469-518-1228<br>FAX: 469-522-5200<br>rik.heller@welloinc.com | | Date Prepared: | November 30, 2018 | | Proposed Device | Manufacturer: Wello, Inc.<br>Trade Name: welloStationXTM<br>Common Name: IR Thermometer<br>Classification Name: Clinical Electronic Thermometer<br>Product Code FLL<br>Regulation: 21 CFR 880.2910, Thermometer, Electronic, Clinical<br>Classification: Class II | | Predicate Device: | Clearance: K131771 dated Oct 07, 2013<br>Manufacturer: Thermomedics, Inc.<br>Trade Name: Caregiver Professional Clinical Thermometer<br>Common Name: IR Thermometer<br>Classification Name: Clinical Electronic Thermometer<br>Product Code FLL<br>Regulation: 21 CFR 880.2910, Thermometer, Electronic, Clinical<br>Classification: Class II | | Device<br>Description: | The welloStationX uses an infrared sensor to measure human body temperature. It is offered as a desktop or kiosk model.<br><br>The WSX consists of a display screen with an IR camera mounted to the top of the display screen. The display screen provides instructions to subjects being screened. Both the kiosk and desktop model operate in the same manner. The subject reads and follows the on-screen instructions to position themselves in the correct location approximately 10 inches from the WSX. In 3 seconds, the WSX provides output of the subject's core body temperature.<br><br>Each temperature reading will be output with either a green background or a red background. Temperature displayed with a red background will also include a prompt to obtain a second temperature evaluation using an alternate method. The facility can select the action threshold or use the default threshold above which the reading will be displayed with a red background. Users can receive email alerts for any subject with a temperature reading displayed with a red background. For some features, an active internet connection is required. | {4}------------------------------------------------ Indications for The welloStationX is a non-contact infrared forehead thermometer intended for use to measure the body Use Statement: temperature of individuals over 5 years of age and older. The welloStationX can be used by medical professionals or laypersons in any public or private indoor facility with environmental conditions maintained within 15°C to 28°C (59°F to 82.4°F), 20 - 70% RH non-condensing. ### Summary of Technological Characteristics: | Device & Predicate<br>Device(s): | K180298 | K131771 | Conclusion | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | General Device<br>Characteristics | | | | | Product Code(s) | FLL | FLL | Identical | | Regulation(s) | 880.2910 | 880.2910 | Identical | | Rx/OTC | OTC | OTC | Identical | | Features | Temperature & Photo Recall<br>Multiple Modes<br>°F/°C scale<br>Date and Time<br>Error Messages<br>Wi-Fi/Ethernet Connectivity<br>Online Storage/Notifications | Temperature Recall<br>Multiple Modes<br>°F/°C scale<br>Date and Time<br>Error Messages<br>Sleep/Auto Shutoff<br>Low Battery Indicator | Different | | Operational Mode(s) | Online Mode<br>Offline Mode<br>Standalone Mode | Body Temperature Mode<br>Surface Temperature Mode<br>Room Temperature Mode | Different | | Technology | Non-contacting IR sensor;<br>Freestanding | Non-contacting IR senor;<br>Handheld | Different | | Accessories | Thermal Printer (optional)<br>Mounting Hardware<br>WelloCloud/welloinc.net<br>(optional) | Protective Cap<br>Wall Mount (optional)<br>Security Tether (optional) | Different | | Displayed<br>Temperature Range(s) | Body: 95°F to 107.6°F (35°C to<br>42°C)<br>"Invalid Measurement"<br>Displayed if<br>temperature appear outside of the<br>body<br>temperature range. | Body: 94°F to 108.0°F (34.4°C<br>to 42.2°C)<br>"Lo" Temperatures <94°F<br>(34.4°C)<br>"Hi" Temperatures >108°F<br>(42.2°C)<br>"LOW Temps" Displayed<br>temperatures<br>appear to be too low<br>Surface: 32°F to 140°F (0°C to<br>60°C) | Different | | Displayed Accuracy | ±0.2°C (±0.4°F) | 96.8/102.2°F ±0.4°F (36/39°C<br>±0.2°C)<br>71.6/96.7°F ±0.5°F (22/35.9°C<br>±0.3°C)<br>102.3/108.0°F ±0.5°F<br>(39.1/42.2°C ±0.3°C)<br>Not specified below 71.6°F<br>(22°C) | Different | | Power Source | Mains 100-240 V / 50-60 Hz<br>NO BATTERIES | Two 1.5v "AA" Alkaline<br>Batteries | Different | | Dimensions | Desktop: 13.5 W x 13.25 H x 7<br>D (in)<br>Kiosk: 19.5 W x 57.5 H x 14.5 D<br>(in) | 150 L x 48.48 W x 55.16 H<br>(mm) | Different | | Field of View | ±5° cone angle | ±8° cone angle | Different | | Measuring Distance | 12 to 13 inches | 0.5 to 2.0 inches | Different | | Calibration | Factory Calibration Only<br>Start-up auto calibration | User Calibration Mode | Different | | Reading Time | 3 sec<br>10 sec between measurements | 1-2 sec<br>20 sec between measurements | Similar | | Start-up / Acclimation<br>Time | Start-up: 30 seconds<br>includes self-test and calibration | Patient Acclimation: 20 minutes<br>Thermometer Acclimation: 20<br>minutes | Different | | Cleaning Surface | Wipe with IPA | Wipe with IPA/Detergent | Identical | | Operation Conditions | 15°C to 28°C (59°F to 82.4°F)<br>20% to 70% RH non-condensing | 50°F to 104°F (10°C to 40°C)<br>< 85% RH | Similar | | Storage Conditions | -20°C to 50°C (-4°F to 122°F) | -4°F to 140°F (-20°C to +60°C) | Similar | | Technical<br>Specifications | ASTM E1965-98 | ASTM E1965-98 | Similar | | EMC/Electrical Safety | IEC 60601-1-2 | IEC 60601-1-2 | Identical | {5}------------------------------------------------ The WSX shares technological characteristics with the predicate device. The proposed device also has some differences in technological characteristics from those of the predicate device. Differences in the technological characteristics have been verified and validated as part of performance testing and do not impact the safety, effectiveness, or substantial equivalence of the device. Both the WSX and the predicate are indicated for OTC use for professionals and laypersons for measuring body temperature, utilize an IR sensor for non-contact temperature measurement, utilize LCD screens for output in either ℃ or °F, and utilize software to function. Differences in function exist between the proposed and predicate devices. The predicate includes nonmedical (Room and Surface) temperature measurements that the WSX does not offer. The body temperature ranges differ as does the accuracy. The WSX has the ±0.2℃ (±0.4ºF) accuracy across all temperatures (95°F to 107.6°F) while the predicate has ±0.2°C (±0.4°F) accuracy across a limited range (96.8ºF to 102.2ºF) with ±0.3ºC (±0.54ºF) accuracy over the remaining ranges (94.0ºF to 96.7ºF; 102.3°F to 108.0°F). The primary differences are in the form rather than function. The WSX is freestanding (desktop or kiosk) while the predicate is hand-held, therefore the WSX is larger and utilizes AC power. Summary of Tests were performed on the device which demonstrated that the device performs comparably to and is Performance substantially equivalent to the predicate device. Testing: > A Clinical accuracy validation of the welloStationX® based on ISO 80601-2-56 was conducted in 110 males and females aged 5 years of age and older. Temperature was measured using the WelloStationX and a Welch Allyn SureTemp oral thermometer. Each measurement was recorded by a trained technician following the instructions for use in the respective device labeling. The validation study {6}------------------------------------------------ demonstrated that the clinical accuracy of the welloStationX® was equivalent to the oral thermometer and reported values for the predicate device. Additional tests included verification testing to internal functional specifications (including software) and side-by-side bench accuracy testing of the new device and the predicate device. Documentation was provided demonstrating compliance to FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation plus traceability of verification/validation tests to software requirements and software hazards. Testing was also conducted for compliance to: - IEC 60601-1. Medical electrical equipment Part 1: General requirements for basic safety and . essential performance - IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety ● And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests - IEC 60601-1-6. Medical electrical equipment Part 1-6: General requirements for basic safety and ● essential performance - Collateral standard: Usability - IEC 62366, Medical Devices Application of usability engineering to medical devices ● - IEC 62304, Medical device software -- Software life cycle processes - ASTM E1965 - 98, Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature - ISO 80601-2-56 Medical electrical equipment -- Part 2-56: Particular requirements for basic safety ● and essential performance of clinical thermometers for body temperature measurement. - Conclusion: Wello Inc considers the welloStationX™ to be substantially equivalent to the predicate device listed above. This conclusion is based on the non-clinical data that demonstrates the device performs as intended in the specified use conditions and on the similarities in intended use, principles of operation, and functional design.