(171 days)
No
The description focuses on standard hardware components (temperature sensor, BLE, battery) and a basic smartphone app for display and alerts. There is no mention of AI/ML terms or functionalities like learning, prediction, or complex data analysis beyond simple trending and alerts.
No.
The device is described as a non-invasive and re-usable electronic device for continuous body temperature monitoring, specifically for the armpit. Its purpose is to display, trend, and alert users about temperature, not to treat or alleviate a medical condition.
Yes.
The device is intended for "continuous armpit body temperature monitoring," which involves measuring and tracking a physiological parameter (temperature) to provide information that can be used to assess the patient's condition, identify fever, and generate alerts, thereby assisting in medical assessment.
No
The device description explicitly lists multiple hardware components including a patch with a temperature sensor, control module, BLE communication module, and battery, as well as a charging system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Fever Scout Continuous Monitoring thermometer measures body temperature externally and non-invasively. It does not analyze samples taken from the body.
- Intended Use: The intended use is for "non-urgent ambulatory continuous armpit body temperature monitoring." This is a physiological measurement, not an in vitro diagnostic test.
Therefore, the Fever Scout Continuous Monitoring thermometer falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Armpit peel-and-stick contact thermometer sensor
Indicated Patient Age Range
29 days and older
Intended User / Care Setting
Home use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The substantially equivalent performance of Fever Scout Continuous Monitoring thermometer has been demonstrated by product verification, software verification, user/usability validation, biocompatibility test, mechanical hazards test, EMC test and IEC 60601-1 safety compliance test. Performance data demonstrates conformance with 21 CFR Part 1020 or compliance with voluntary standards includes but not limited to the following: IEC 60601-1:2005/(R) 2012; IEC 60601-1-2:2014; IEC 60601-1-11: 2015; IEC 62304:2006; ISO 10993-1: 2009; ASTM E1112-2000 (Reapproved 2011).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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. #390 | |
| Santa Clara, CA 95054 USA | |
| Phone: 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 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. | |
| Device Description: | 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 patchThe Smartphone app (supporting iOS)AAA charging system with BLE relay function |
- . Eight adhesives
4
| | 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. |
| 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 | Proposed
Device
Fever Scout | Primary
Predicate
TempTraq
TT-100 | Reference
Predicate
iThermonitor
WT-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 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. | The Wireless
thermometer,
model TT-100,
is
a battery-
operated
electronic
device
with intended
use
of measuring
human body
temperature
precisely. This
device is single
use
and intended
for armpit
temperature
measurement for
persons of all
age. | The Wireless
Thermometer
is a battery
operated
electronic
device with
intended use
of measuring
human armpit
temperature
continuously
via wireless
signal
transmission
of the
measuring
results. This
system is
reusable and
intended for
armpit
monitoring for
persons over
two years old. | Equivalent.
All three devices
are for human
armpit
temperature
measurements.
Difference are
demonstrated to
not raise
questions of
safety and
effectiveness per
requirements set
forth in the
standards listed
in Section 5-
510(k)
Summary | |
| Display Use Specification | iOS device
display | iOS and
Android device
display | iOS device
display | Equivalent
iOS is what all
three devices
support. Not
supporting
Android will not
impact safety or
efficacy
concerns, but
limit market
share (number
of users who can
use this device). | |
| Working Voltage | 3.0 V DC | | | Identical | |
| Battery | MS Lithium
Rechargeable
Battery 3.0V | Two (2)
Blue
Spark 1.5 V
batteries
(103-
UT1) | The button
battery 3.0 V,
210mAh | Equivalent per
UL 1642 5th
Edition | |
| Reuse | Yes | No | Yes | Equivalent | |
| | | | | is demonstrated
to not raise
questions of
safety and
efficacy through
functional
verification and
cleaning testing. | |
| Measurement Range | 35 ~ 42°C | 30 ~ 42.4°C | 25 ~ 45° C | Equivalent
All three devices
cover the needed
range per
ASTM_1112
Temperature
range. | |
| Accuracy | ±0.1°C
From 37 ~
39°C, ±0.2°C
from 35 ~
37°C and 39 ~
42°C | ±0.1°C
between 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) | Equivalent
All three devices
meet the
maximum error
temperature
ranges per
ASTM_1112. | |
| Signal Transmission | Wireless 2.4G
Bluetooth
BLE | | | Identical | |
| Receiver | Wireless 2.4G
Bluetooth
BLE enabled
smart devices
running Apple
operating
system
iPhone 5S+ or
newer. | Wireless
2.4G
Bluetooth
BLE
enabled
smart
devices
running
Apple
operating
system iOS
7.1 through
8.1 or
Android
operating
system 4.3
through
4.4.4 | Wireless 2.4G
Bluetooth
BLE enabled
smart devices
running Apple
operating
system iPhone
4S, iPhone 5, iPad
(3rd
generation),
iPad (4th
generation),
iPad mini,
iPod (5th
generation) | Equivalent
All three devices
support 2.4G
BLE enabled
devices. The
difference in
supported
operating
systems doesn't
impact safety
and efficacy. | |
| Valid Transmission | Up to 40
meters (with
relay) | Up to 40
feet | Up to 5 meters | Equivalent
The device is
demonstrated to | |
| Operating Condition | 1040°C40°C
15-85%
humidity | 16
15 -95%
humidity | 5~40 °C
15-85% humidity | intended.
Equivalent
The operating
range is
compliant with
ASTM_1112. | |
| Anatomical Application | Armpit
peel-and-stick contact thermometer sensor | | | Identical/
Equivalent | |
| Temperature Measurement
Interval | Continuous
transmitter
measures body
temperature
every 15
seconds | Continuous
transmitter
measures
body
temperature
every 10
seconds | Continuous
transmitter
measures body
temperature every
4 seconds | Equivalent
The maximum
difference in
temperature
measurements is
11 seconds,
which does not
raise questions
of safety and
efficacy. | |
| Safety and
Performance | Biocompatibility | Conformed to ISO 10993-1, ISO 10993-5, and ISO 10993-10 | | Identical/
Equivalent
Test against the
same standards
for safety and
performance | |
| | Electrical Safety | Conformed to IEC 60601-1 | | Identical/
Equivalent
Test against the
same standard
for safety and
performance | |
| | Electromagnetic
Compatibility | Conformed to IEC 60601-1-2 and FCC | | Identical/
Equivalent
Test against the
same standard
for safety and
performance | |
| | Performance | Conformed to ASTM E1112 | | Identical/
Equivalent
Test against the
same standard
for safety and
performance | |
5
6
7
8
| Technological Characteristics: | Fever Scout Continuous
Monitoring thermometer is technologically substantially equivalent
to the predicate device. Both devices use equivalent temperature
technology to sense, process and transmit temperature data
continuously from the patch affixed to the skin under the armpit to
a mobile application. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | The substantially equivalent performance of Fever Scout
Continuous Monitoring thermometer has been demonstrated by
product verification, software verification, user/usability validation,
biocompatibility test, mechanical hazards test, EMC test and IEC
60601-1 safety compliance test. |
| | Performance data demonstrates conformance with 21 CFR Part
1020 or compliance with voluntary standards includes but not
limited 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: General
Requirements For Basic Safety And Essential Performance - Collateral
Standard: 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 and
medical 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 for
electronic thermometer for intermittent determination of patient
temperature. |
| Conclusion: | VivaLnk concludes that the device is substantially equivalent to
the currently legally marketed predicate devices. Fever Scout
Continuous Monitoring thermometer has equivalent indications for
use and technological characteristics, and does not introduce
different questions of safety and effectiveness. |