(301 days)
The welloStationX is a non-contact infrared forehead thermometer intended for use to measure the body 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.
The welloStationX uses an infrared sensor to measure human body temperature. It is offered as a desktop or kiosk model. 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. 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.
Here's a breakdown of the acceptance criteria and study information for the welloStationX device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
Device: welloStationX (K180298)
Predicate Device: Caregiver Professional Clinical Thermometer (K131771)
| Feature / Performance Metric | Acceptance Criteria (Predicate or Standard based) | Reported Device Performance (welloStationX) | Comparison |
|---|---|---|---|
| Intended Use | Measuring body temp of individuals >5 years old, by medical professionals or laypersons in indoor facilities (10°C to 40°C, <85% RH). | Measuring body temp of individuals >5 years old, by medical professionals or laypersons in indoor facilities (15°C to 28°C, 20-70% RH non-condensing). | Substantially similar, slight difference in environmental conditions. |
| Technology | Non-contacting IR sensor | Non-contacting IR sensor | Identical |
| Accuracy (Body Temp) | Predicate: | ±0.2°C (±0.4°F) across 95°F to 107.6°F (35°C to 42°C) | Better/More Consistent: welloStationX has constant accuracy across its entire body temperature range, unlike the predicate which has varying accuracy across different sub-ranges. |
| ±0.2°C (±0.4°F) for 96.8-102.2°F (36-39°C) | |||
| ±0.3°C (±0.54°F) for 94.0-96.7°F, 102.3-108.0°F | |||
| Displayed Temp Range | Predicate: Body: 94°F-108°F (34.4°C-42.2°C) | Body: 95°F-107.6°F (35°C-42°C) | Slightly different, but both cover typical fever/hypothermia ranges. |
| Reading Time | 1-2 seconds | 3 seconds | Similar, within acceptable range for quick measurements. |
| Interval between measurements | 20 seconds | 10 seconds | Faster |
| Startup/Acclimation Time | Patient Acclimation: 20 min, Thermometer Acclimation: 20 min | Startup: 30 seconds (includes self-test and calibration) | Significantly faster device acclimation for welloStationX. |
| Compliance Standards | ASTM E1965-98, IEC 60601-1-2 (among others) | ASTM E1965-98, IEC 60601-1-2 (among others) | Identical/Similar (both claim compliance) |
The primary acceptance criteria for clinical accuracy would be the ASTM E1965-98 standard for infrared thermometers and the ISO 80601-2-56 standard for clinical thermometers. The document states that the clinical accuracy validation was "equivalent to the oral thermometer and reported values for the predicate device," implying it met the accuracy requirements set by these standards and/or demonstrated comparable performance to the predicate and a validated oral thermometer.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 110 males and females.
- Data Provenance: Not explicitly stated, but the study was a "Clinical accuracy validation... conducted in 110 males and females aged 5 years of age and older." This phrasing suggests a prospective clinical study. The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications: "a trained technician" was responsible for recording measurements. The ground truth was established by a Welch Allyn SureTemp oral thermometer, which is a legally marketed device itself. Therefore, the "experts" for ground truth are the technicians following the instructions for use of the oral thermometer, rather than medical experts interpreting data like in imaging studies.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the traditional sense. This was a direct comparison study of two temperature measurement devices against each other (welloStationX vs. Welch Allyn SureTemp).
- Each measurement (by welloStationX and the oral thermometer) was recorded by a single trained technician. There's no mention of multiple readers or an adjudication process for discrepancies in temperature readings; rather, the agreement between the devices was assessed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. This device is a measurement tool, not an interpretation tool where human readers would typically improve with AI assistance. The study focused on the accuracy of the device itself.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was done. The "Clinical accuracy validation" directly assessed the welloStationX's ability to measure temperature when compared to a reference standard (Welch Allyn SureTemp oral thermometer). The stated accuracy for the welloStationX (±0.2°C (±0.4°F)) is a standalone performance metric. The entire 510(k) process for a thermometer focuses on the device's inherent accuracy.
7. Type of Ground Truth Used
- Ground Truth: A reference medical device (Welch Allyn SureTemp oral thermometer) and its measurements, which are themselves validated against established clinical standards for body temperature measurement. This can be considered a form of clinical reference standard. The study report compared the welloStationX measurements to those obtained from the oral thermometer.
8. Sample Size for the Training Set
- Not Applicable / Not Provided. This document does not suggest the welloStationX uses machine learning or AI that would require a separate "training set" in the context of typical AI device development. It's a sensor-based device with embedded software for calculation. The "software" mentioned refers to operational and control functions, not necessarily AI requiring a training data set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided (as no training set for AI was indicated).
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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
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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
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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)
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510(k) SUMMARY
| 510(k) Number: | K180298 |
|---|---|
| Submitter: | Wello Inc.3939 Belt Line Road, Suite 400Addison, TX 75001 |
| Contact Person: | Mr. Alan Camerik (Rik) HellerChairman and CEOTEL: 469-518-1228FAX: 469-522-5200rik.heller@welloinc.com |
| Date Prepared: | November 30, 2018 |
| Proposed Device | Manufacturer: Wello, Inc.Trade Name: welloStationXTMCommon Name: IR ThermometerClassification Name: Clinical Electronic ThermometerProduct Code FLLRegulation: 21 CFR 880.2910, Thermometer, Electronic, ClinicalClassification: Class II |
| Predicate Device: | Clearance: K131771 dated Oct 07, 2013Manufacturer: Thermomedics, Inc.Trade Name: Caregiver Professional Clinical ThermometerCommon Name: IR ThermometerClassification Name: Clinical Electronic ThermometerProduct Code FLLRegulation: 21 CFR 880.2910, Thermometer, Electronic, ClinicalClassification: Class II |
| DeviceDescription: | The welloStationX uses an infrared sensor to measure human body temperature. It is offered as a desktop or kiosk model.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.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. |
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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 & PredicateDevice(s): | K180298 | K131771 | Conclusion |
|---|---|---|---|
| General DeviceCharacteristics | |||
| Product Code(s) | FLL | FLL | Identical |
| Regulation(s) | 880.2910 | 880.2910 | Identical |
| Rx/OTC | OTC | OTC | Identical |
| Features | Temperature & Photo RecallMultiple Modes°F/°C scaleDate and TimeError MessagesWi-Fi/Ethernet ConnectivityOnline Storage/Notifications | Temperature RecallMultiple Modes°F/°C scaleDate and TimeError MessagesSleep/Auto ShutoffLow Battery Indicator | Different |
| Operational Mode(s) | Online ModeOffline ModeStandalone Mode | Body Temperature ModeSurface Temperature ModeRoom Temperature Mode | Different |
| Technology | Non-contacting IR sensor;Freestanding | Non-contacting IR senor;Handheld | Different |
| Accessories | Thermal Printer (optional)Mounting HardwareWelloCloud/welloinc.net(optional) | Protective CapWall Mount (optional)Security Tether (optional) | Different |
| DisplayedTemperature Range(s) | Body: 95°F to 107.6°F (35°C to42°C)"Invalid Measurement"Displayed iftemperature appear outside of thebodytemperature range. | Body: 94°F to 108.0°F (34.4°Cto 42.2°C)"Lo" Temperatures <94°F(34.4°C)"Hi" Temperatures >108°F(42.2°C)"LOW Temps" Displayedtemperaturesappear to be too lowSurface: 32°F to 140°F (0°C to60°C) | Different |
| Displayed Accuracy | ±0.2°C (±0.4°F) | 96.8/102.2°F ±0.4°F (36/39°C±0.2°C)71.6/96.7°F ±0.5°F (22/35.9°C±0.3°C)102.3/108.0°F ±0.5°F(39.1/42.2°C ±0.3°C)Not specified below 71.6°F(22°C) | Different |
| Power Source | Mains 100-240 V / 50-60 HzNO BATTERIES | Two 1.5v "AA" AlkalineBatteries | Different |
| Dimensions | Desktop: 13.5 W x 13.25 H x 7D (in)Kiosk: 19.5 W x 57.5 H x 14.5 D(in) | 150 L x 48.48 W x 55.16 H(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 OnlyStart-up auto calibration | User Calibration Mode | Different |
| Reading Time | 3 sec10 sec between measurements | 1-2 sec20 sec between measurements | Similar |
| Start-up / AcclimationTime | Start-up: 30 secondsincludes self-test and calibration | Patient Acclimation: 20 minutesThermometer Acclimation: 20minutes | Different |
| Cleaning Surface | Wipe with IPA | Wipe with IPA/Detergent | Identical |
| Operation Conditions | 15°C to 28°C (59°F to 82.4°F)20% to 70% RH non-condensing | 50°F to 104°F (10°C to 40°C)< 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 |
| TechnicalSpecifications | ASTM E1965-98 | ASTM E1965-98 | Similar |
| EMC/Electrical Safety | IEC 60601-1-2 | IEC 60601-1-2 | Identical |
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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
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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.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of 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,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.