(171 days)
The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
Fever Scout Continuous Monitoring thermometer is an ambulatory continuous body temperature monitor designed for armpit location, and uses Bluetooth Low Energy (BLE) for wireless communication with the Smartphone app for temperature display, trending and alert. This product is composed of The Fever Scout VV-200 patch, The Smartphone app (supporting iOS), AAA charging system with BLE relay function, and Eight adhesives. The patch hardware primarily includes the following function modules: 1) temperature sensor, 2) control module, 3) Bluetooth Low Energy (BLE) communication module and 4) battery. All are integrated onto a flexible electronic printed circuit board. A MS Lithium rechargeable battery is attached to the board to supply 3.0V DC internal power. The app includes 1) User account, profile and alert temperature setup and 2) GUI for temperature display, trending and alerts. The charging system provides a cordless charging method to the patch, a storage to the replaceable double-sided adhesives, as well as an alternative BLE communication channel from the patch to the charger and then to the iPhone, in order to extend communication range. This product contains Type B applied part (per IEC 60601-1: 2012). All components, the patch, charger and adhesives are all user accessible parts. However, the user is only expected to change the charger AAA batteries, but not to open or modify any other parts of the product.
Here's a breakdown of the acceptance criteria and the study information for the "Fever Scout™ Continuous Monitoring thermometer," based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Metric | Acceptance Criteria (from predicate comparison) | Reported Device Performance (Fever Scout™) |
|---|---|---|
| Measurement Range | Covers range needed per ASTM_1112 (Predicate 1: 30-42.4°C; Predicate 2: 25-45°C) | 35 ~ 42°C |
| Accuracy | Meets maximum error temperature ranges per ASTM_1112 (Predicate 1: ±0.1°C between 30-42.4°C; Predicate 2: ±0.05°C (35-38.5°C), ±0.1°C otherwise) | ±0.1°C from 37 ~ 39°C, ±0.2°C from 35 ~ 37°C and 39 ~ 42°C |
| Operating Condition | Compliant with ASTM_1112 (Predicate 1: 16-40°C, 15-95% humidity; Predicate 2: 5-40°C, 15-85% humidity) | 10~40°C, 15-85% humidity |
| Biocompatibility | Conformed to ISO 10993-1, ISO 10993-5, and ISO 10993-10 | Conformed to ISO 10993-1 (Implied by "Test against the same standards for safety and performance") |
| Electrical Safety | Conformed to IEC 60601-1 | Conformed to IEC 60601-1 (Implied by "Test against the same standard for safety and performance") |
| EMC | Conformed to IEC 60601-1-2 and FCC | Conformed to IEC 60601-1-2 (Implied by "Test against the same standard for safety and performance") |
| Performance | Conformed to ASTM E1112 | Conformed to ASTM E1112 (Implied by "Test against the same standard for safety and performance") and additionally IEC 60601-1-11 and IEC 62304 for software and home healthcare environment |
Note on Acceptance Criteria and Performance: The document mainly uses the phrase "Equivalent" or "Identical" when comparing to predicates, and then states that the device "meets" or "conforms" to specific standards. The specific numerical acceptance criteria for the predicates (where available) are inferred here to represent the bar the Fever Scout had to meet for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
- The document mentions "product verification, software verification, user/usability validation, biocompatibility test, mechanical hazards test, EMC test and IEC 60601-1 safety compliance test" as the performance data.
- Specific sample sizes for a clinical test set are not explicitly mentioned in this 510(k) summary. It refers to compliance with standards like ASTM E1112, which typically involve specific test methodologies and potentially human subjects for accuracy testing, but the number of subjects or samples is not provided here.
- Data Provenance: Not explicitly stated as retrospective or prospective for a specific clinical study related to accuracy with human subjects. The tests mentioned are performance and safety engineering tests. No country of origin for specific human subject data is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. For a thermometer, "ground truth" for accuracy is typically established by comparing the device's readings to a highly accurate reference thermometer in a controlled environment or in vivo with a controlled reference method. Experts would likely be involved in designing and executing such tests, but their number and qualifications are not detailed.
4. Adjudication Method for the Test Set:
- This information is not provided as there is no mention of a traditional expert-adjudicated test set in the context of diagnostic performance (e.g., medical image interpretation). For a thermometer, accuracy is typically determined through direct comparison with a traceable reference, not through adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical cases with and without AI assistance. This device is a thermometer, and the evaluation focuses on its direct measurement accuracy and safety, rather than its impact on human reader performance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- Yes, a standalone performance was done for the thermometer's core function. The accuracy, measurement range, and operating conditions are assessed directly for the device itself, conforming to standards like ASTM E1112. The "algorithm" here is the temperature sensing and processing, and its output (temperature reading) is evaluated against reference standards. The device is intended for continuous monitoring and displays information via a smartphone app. Its performance is inherent to the device's measurement capabilities.
7. Type of Ground Truth Used:
- The ground truth for thermometer performance (e.g., accuracy) is typically established by comparing the device's measurements to that of a traceable reference thermometer or a recognized standard temperature source in a controlled laboratory setting, as defined by standards like ASTM E1112. For biocompatibility and electrical safety, the ground truth is adherence to the specified international standards (e.g., ISO 10993, IEC 60601-1).
8. Sample Size for the Training Set:
- This information is not applicable and not provided. The "Fever Scout™ Continuous Monitoring thermometer" is a sensor-based medical device, not an AI/ML diagnostic algorithm that requires a separate "training set" of data in the conventional sense. Its temperature sensing and processing are based on established physics and sensor technology, verified through engineering tests and adherence to standards.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable and not provided for the same reason as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2017
Vivalnk Inc. Christine Kuo Director, RA/QA 4655 Old Ironsides Dr. #390 Santa Clara, California 95054
Re: K162137
Trade/Device Name: Fever Scout™ Continuous Monitoring thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 20, 2016 Received: December 23, 2016
Dear Christine Kuo:
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.
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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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,
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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162137
Device Name
Fever ScoutTM Continuous Monitoring thermometer
Indications for Use (Describe)
The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpir body temperature monitioring from ages 29 days and older.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
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Section 5 – 510(k) Summary
K162137
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92.
| Type of Submission: | Traditional 510(k); this is the first submission for this device |
|---|---|
| 510(k) Submitter: | VivaLnk Inc.4655 Old Ironsides Dr. #390Santa Clara, CA 95054 USAPhone: 408-868-2898 |
| Contact Person: | Christine Kuo |
| Date Prepared: | January 19, 2017 |
| Device Identification: | |
| Trade Name: | Fever Scout™ Continuous Monitoring thermometer |
| Device Common Name: | Armpit thermometer |
| Classification: | 21 CFR Sec. 880.2910, Clinical electronic thermometer |
| Product Code: | FLL |
| Classification Panel: | General Hospital |
| Class: | II |
| Indications for Use: | The wireless Fever Scout™ Continuous Monitoring thermometeris a non-invasive and re-usable electronic device for home use.This product is intended for non-urgent ambulatory continuousarmpit body temperature monitoring from ages 29 days and older. |
| Device Description: | Fever Scout Continuous Monitoring thermometer is an ambulatorycontinuous body temperature monitor designed for armpit location,and uses Bluetooth Low Energy (BLE) for wirelesscommunication with the Smartphone app for temperature display,trending and alert. |
| This product is composed of The Fever Scout VV-200 patchThe Smartphone app (supporting iOS)AAA charging system with BLE relay function |
- . Eight adhesives
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| The patch hardware primarily includes the following functionmodules: 1) temperature sensor, 2) control module, 3) BluetoothLow Energy (BLE) communication module and 4) battery. All areintegrated onto a flexible electronic printed circuit board. A MSLithium rechargeable battery is attached to the board to supply3.0V DC internal power. | |
|---|---|
| The app includes 1) User account, profile and alert temperaturesetup and 2) GUI for temperature display, trending and alerts. | |
| The charging system provides a cordless charging method to thepatch, a storage to the replaceable double-sided adhesives, as wellas an alternative BLE communication channel from the patch tothe charger and then to the iPhone, in order to extendcommunication range. | |
| This product contains Type B applied part (per IEC 60601-1:2012). All components, the patch, charger and adhesives are alluser accessible parts. However, the user is only expected to changethe charger AAA batteries, but not to open or modify any otherparts of the product. | |
| Predicates: | TempTraq Model TT-100 by Blue Spark Technologies (K143267) |
| Trade Name: | TempTraq Model TT-100 |
| Device Common Name: | Armpit thermometer |
| Classification: | 21 CFR Sec. 880.2910, Clinical electronic thermometer |
| Product Code: | FLL |
| Classification Panel: | General Hospital |
| Class: | II |
Summary of Substantial Equivalence:
Fever Scout Continuous Monitoring thermometer is substantially equivalent to the predicate, TempTraq TT-100.
Device Comparison
| Characteristics | ProposedDeviceFever Scout | PrimaryPredicateTempTraqTT-100 | ReferencePredicateiThermonitorWT-701 | Comparison | |
|---|---|---|---|---|---|
| 510(k) Number | NA | K143267 | K132761 | NA | |
| Product Code | FLL | Identical | |||
| Regulation # | 21CFR880.2910 | Identical | |||
| Class | Clinical electronic thermometers | Identical | |||
| Indications for Use | The wirelessFever ScoutContinuousMonitoringthermometeris a non-invasive andre-usableelectronicdevice forhome use.This productis intended fornon-urgentambulatorycontinuousarmpit bodytemperaturemonitoringfrom ages 29days andolder. | The Wirelessthermometer,model TT-100,isa battery-operatedelectronicdevicewith intendeduseof measuringhuman bodytemperatureprecisely. Thisdevice is singleuseand intendedfor armpittemperaturemeasurement forpersons of allage. | The WirelessThermometeris a batteryoperatedelectronicdevice withintended useof measuringhuman armpittemperaturecontinuouslyvia wirelesssignaltransmissionof themeasuringresults. Thissystem isreusable andintended forarmpitmonitoring forpersons overtwo years old. | Equivalent.All three devicesare for humanarmpittemperaturemeasurements.Difference aredemonstrated tonot raisequestions ofsafety andeffectiveness perrequirements setforth in thestandards listedin Section 5-510(k)Summary | |
| Display Use Specification | iOS devicedisplay | iOS andAndroid devicedisplay | iOS devicedisplay | EquivalentiOS is what allthree devicessupport. NotsupportingAndroid will notimpact safety orefficacyconcerns, butlimit marketshare (numberof users who canuse this device). | |
| Working Voltage | 3.0 V DC | Identical | |||
| Battery | MS LithiumRechargeableBattery 3.0V | Two (2)BlueSpark 1.5 Vbatteries(103-UT1) | The buttonbattery 3.0 V,210mAh | Equivalent perUL 1642 5thEdition | |
| Reuse | Yes | No | Yes | Equivalent | |
| is demonstratedto not raisequestions ofsafety andefficacy throughfunctionalverification andcleaning testing. | |||||
| Measurement Range | 35 ~ 42°C | 30 ~ 42.4°C | 25 ~ 45° C | EquivalentAll three devicescover the neededrange perASTM_1112Temperaturerange. | |
| Accuracy | ±0.1°CFrom 37 ~39°C, ±0.2°Cfrom 35 ~37°C and 39 ~42°C | ±0.1°Cbetween 30~ 42.4°C | ±0.05° C (35 -38.5° C);±0.1° C (25 -34.99° C);±0.1° C(38.51 -45° C) | EquivalentAll three devicesmeet themaximum errortemperatureranges perASTM_1112. | |
| Signal Transmission | Wireless 2.4GBluetoothBLE | Identical | |||
| Receiver | Wireless 2.4GBluetoothBLE enabledsmart devicesrunning AppleoperatingsystemiPhone 5S+ ornewer. | Wireless2.4GBluetoothBLEenabledsmartdevicesrunningAppleoperatingsystem iOS7.1 through8.1 orAndroidoperatingsystem 4.3through4.4.4 | Wireless 2.4GBluetoothBLE enabledsmart devicesrunning Appleoperatingsystem iPhone4S, iPhone 5, iPad(3rdgeneration),iPad (4thgeneration),iPad mini,iPod (5thgeneration) | EquivalentAll three devicessupport 2.4GBLE enableddevices. Thedifference insupportedoperatingsystems doesn'timpact safetyand efficacy. | |
| Valid Transmission | Up to 40meters (withrelay) | Up to 40feet | Up to 5 meters | EquivalentThe device isdemonstrated to | |
| Operating Condition | 10~40°C15-85%humidity | 16~40°C15 -95%humidity | 5~40 °C15-85% humidity | intended.EquivalentThe operatingrange iscompliant withASTM_1112. | |
| Anatomical Application | Armpitpeel-and-stick contact thermometer sensor | Identical/Equivalent | |||
| Temperature MeasurementInterval | Continuoustransmittermeasures bodytemperatureevery 15seconds | Continuoustransmittermeasuresbodytemperatureevery 10seconds | Continuoustransmittermeasures bodytemperature every4 seconds | EquivalentThe maximumdifference intemperaturemeasurements is11 seconds,which does notraise questionsof safety andefficacy. | |
| Safety andPerformance | Biocompatibility | Conformed to ISO 10993-1, ISO 10993-5, and ISO 10993-10 | Identical/EquivalentTest against thesame standardsfor safety andperformance | ||
| Electrical Safety | Conformed to IEC 60601-1 | Identical/EquivalentTest against thesame standardfor safety andperformance | |||
| ElectromagneticCompatibility | Conformed to IEC 60601-1-2 and FCC | Identical/EquivalentTest against thesame standardfor safety andperformance | |||
| Performance | Conformed to ASTM E1112 | Identical/EquivalentTest against thesame standardfor safety andperformance |
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| Technological Characteristics: | Fever Scout ContinuousMonitoring thermometer is technologically substantially equivalentto the predicate device. Both devices use equivalent temperaturetechnology to sense, process and transmit temperature datacontinuously from the patch affixed to the skin under the armpit toa mobile application. |
|---|---|
| Performance Data: | The substantially equivalent performance of Fever ScoutContinuous Monitoring thermometer has been demonstrated byproduct verification, software verification, user/usability validation,biocompatibility test, mechanical hazards test, EMC test and IEC60601-1 safety compliance test. |
| Performance data demonstrates conformance with 21 CFR Part1020 or compliance with voluntary standards includes but notlimited to the following: | |
| IEC 60601-1:2005/(R) 2012: Medical Electrical Equipment -- Part 1:General Requirements For Basic Safety And Essential Performance | |
| IEC 60601-1-2:2014: Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And Essential Performance - CollateralStandard: Electromagnetic Compatibility – Requirements And Tests | |
| IEC 60601-1-11: 2015 Medical electrical equipment - Part 1-11:General requirements for basic safety and essential performance -Collateral standard: Requirements for medical electrical equipment andmedical electrical systems used in the home healthcare environment | |
| IEC 62304:2006 Medical Device Software – Software lifecycle Processes | |
| ISO 10993-1: 2009 Biological Evaluation of Medical Devices - Part 1:Evaluation and Testing Within a Risk Management Process | |
| ASTM E1112-2000 (Reapproved 2011), standard specification forelectronic thermometer for intermittent determination of patienttemperature. | |
| Conclusion: | VivaLnk concludes that the device is substantially equivalent tothe currently legally marketed predicate devices. Fever ScoutContinuous Monitoring thermometer has equivalent indications foruse and technological characteristics, and does not introducedifferent questions of safety and effectiveness. |
§ 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.