(41 days)
No
The description mentions a "well-known heat loss equation" used for temperature conversion, which is a deterministic algorithm, not AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
The device is solely for temperature measurement and does not provide any treatment or therapy.
Yes
Explanation: The device is intended for "periodic measurement of human body temperature," and while it doesn't provide a diagnosis itself, temperature measurement is a key step in diagnosing various medical conditions. Devices that measure physiological parameters to aid in medical assessment are generally considered diagnostic devices.
No
The device description clearly details a physical hardware component (infrared thermometer) that takes the temperature readings and transmits them to the software. The software is used in conjunction with the hardware, but the device itself is not solely software.
Based on the provided information, the CliniCloud Non-Contact Thermometer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality.
- CliniCloud Thermometer Function: The CliniCloud Non-Contact Thermometer measures human body temperature by detecting infrared radiation emitted from the forehead. It does not analyze any biological specimens from the body.
Therefore, its function falls outside the scope of an IVD device. It is a medical device used for direct measurement of a physiological parameter.
N/A
Intended Use / Indications for Use
The CliniCloud Non-Contact Thermometer is an infrared thermometer intended for the periodic measurement of human body temperature for persons of all ages, to be used in conjunction with the CliniCloud app.
Product codes
FLL
Device Description
The CliniCloud Non-Contact Thermometer Model SPL1024 (abbreviated 'CliniCloud Non-Contact Thermometer') is a battery powered Bluetooth Low Energy (BLE) enabled portable infrared thermometer intended for the measurement of human body temperature for persons of all ages. It features no physical buttons or a display and must be used in conjunction with the CliniCloud App on a compatible BLE enabled smartphone. The CliniCloud App is free to download.
When power is applied to the device via 2 AAA batteries, the CliniCloud Non-Contact Thermometer starts to advertise via BLE, and can establish a BLE connection with BLE enabled smart phones with the CliniCloud app. The user could then request the CliniCloud non-contact thermometer to take temperature readings from within the CliniCloud app. The measured temperatures are sent back to the smart phone via the established Bluetooth link and displayed on the smartphone's display in the CliniCloud app. The CliniCloud Non-Contact Thermometer uses a medical grade MLX90614ESF-DCC thermopile sensor supplied by Melexis to passively measure object surface temperature using infrared radiation emitted by patients. The sensor also measures the ambient temperature with a built-in thermistor. The sensor is factory calibrated to meet consensus standard ASTM E1965-98. Upon receiving a request from the CliniCloud APP over the established BLE connection the onboard Nordic Semiconductor NRF51822 BLE SOC microcontroller communicates with the thermopile (MLX90614ESF-DCC) over the I2C bus and sends the received temperature readings including the object surface temperature and the ambient temperature to the CliniCloud app via the established BLE connection. On the smartphone app, the well-known heat loss equation is used to perform conversion of forehead surface temperature to oral equivalent temperature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead
Indicated Patient Age Range
persons of all ages
Intended User / Care Setting
Not Found
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)
Validation study was performed to clinically validate the CliniCloud thermometer, Model SPL1024, per the specification of ASTM E1965-98, under three (3) different environment settings. This validation study includes data from 60 subjects, 1 subject device, 1 predicate device and 4 calibrated reference devices (same model) used as gold standard. Study included 85% males and 15% females. The validation study demonstrated that the clinical accuracy of the CliniCloud thermometer and the predicate devices yielded equivalent accuracy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of three faces in profile, stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 22, 2016
StethoCloud Pty. Ltd. c/o Mr. Dave Yungvirt Third Party Review Group, LLC. The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041
Re: K161325
Trade/Device Name: CliniCloud Non-Contact Thermometer, Model SPL1024 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: May 30, 2016 Received: June 1, 2016
Dear Mr. Yungvirt:
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.
1
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 device-related 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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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,
Image /page/1/Picture/8 description: The image shows a signature of a person named Tina Kiang. The signature is written in black ink and is on a white background. The signature is illegible, but the name Tina Kiang is clearly visible above the signature. The signature appears to be authentic.
for Erin I. Keith, M.S. 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)
K161325
Device Name
CliniCloud Non-Contact Thermometer, Model SPL1024
Indications for Use (Describe)
The CliniCloud Non-Contact Thermometer is an infrared thermometer intended for the periodic measurement of human body temperature for persons of all ages, to be used in conjunction with the CliniCloud app.
Type of Use (Select one or both, as applicable)
X 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
CliniCloud Non-Contact Thermometer
K161325
1. Submission Sponsor
StethoCloud Pty. Ltd (CliniCloud) Level 5, 141 Flinders Lane Melbourne VIC, 3000 Australia Contact: Andrew Lin Title: CEO
2. Submission Correspondent
Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (561)305-5075 Contact: Diane Sudduth, Senior Consultant, RA Email: project.management@emergogroup.com
3. Date Prepared
June 22, 2016
4. Device Identification
| Trade/Proprietary Name: | CliniCloud Non-Contact Thermometer, Model SPL1024 |
|---|---|
| Common/Usual Name: | Forehead Thermometer |
| Classification Name: | Clinical Electronic Thermometer |
| Regulation Number: | 880.2910 |
| Product Code: | FLL – clinical electronic thermometer |
| Device Class: | Class II |
| Review Panel: | General Hospital |
Legally Marketed Predicate Device(s)
K131243, Non-contact Infrared Thermometer JPD-FR100, Shenzhen Jumper Medical Equipment Co., Ltd.
The Wireless Thermometer WT701 by Raiing Medical Company (K132761) is used as the Reference Device. The Raiing Medical Thermometer provides an example of a cleared device that communicates wirelessly to a smart phone application as the receiver.
4
5. Device Description
The CliniCloud Non-Contact Thermometer Model SPL1024 (abbreviated 'CliniCloud Non-Contact Thermometer') is a battery powered Bluetooth Low Energy (BLE) enabled portable infrared thermometer intended for the measurement of human body temperature for persons of all ages. It features no physical buttons or a display and must be used in conjunction with the CliniCloud App on a compatible BLE enabled smartphone. The CliniCloud App is free to download.
When power is applied to the device via 2 AAA batteries, the CliniCloud Non-Contact Thermometer starts to advertise via BLE, and can establish a BLE connection with BLE enabled smart phones with the CliniCloud app. The user could then request the CliniCloud non-contact thermometer to take temperature readings from within the CliniCloud app. The measured temperatures are sent back to the smart phone via the established Bluetooth link and displayed on the smartphone's display in the CliniCloud app. The CliniCloud Non-Contact Thermometer uses a medical grade MLX90614ESF-DCC thermopile sensor supplied by Melexis to passively measure object surface temperature using infrared radiation emitted by patients. The sensor also measures the ambient temperature with a built-in thermistor. The sensor is factory calibrated to meet consensus standard ASTM E1965-98. Upon receiving a request from the CliniCloud APP over the established BLE connection the onboard Nordic Semiconductor NRF51822 BLE SOC microcontroller communicates with the thermopile (MLX90614ESF-DCC) over the 12C bus and sends the received temperature readings including the object surface temperature and the ambient temperature to the CliniCloud app via the established BLE connection. On the smartphone app, the well-known heat loss equation is used to perform conversion of forehead surface temperature to oral equivalent temperature.
6. Indication for Use Statement
The CliniCloud Non-Contact Thermometer is an infrared thermometer intended for the periodic measurement of human body temperature for persons of all ages, to be used in conjunction with the CliniCloud app.
7. Substantial Equivalence Discussion
The following table compares the CliniCloud Non-Contact Thermometer to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. A reference device was used to support substantial equivalence since the subject device does not have the same technological characteristics (i.e. Bluetooth connectivity and display) as the predicate device. Aside from minor differences in the indications for use statements, i.e. the use environment is not included in the indications for use statement; the CliniCloud Non-Contact Thermometer has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device and conclude that these differences do not alter the intended use of the device.
5
| Manufacturer | StethoCloud Pty. Ltd (CliniCloud) | Shenzhen Jumper Medical
Equipment Co., Ltd. |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | CliniCloud Non-Contact
Thermometer, Model SPL1024 | Non-contact Infrared Thermometer
JPD-FR100 |
| 510(k) Number | K161325 | K131243 |
| Product Code | FLL - clinical electronic
thermometer | FLL - clinical electronic thermometer |
| Regulation Number | 880.2910 | 880.2910 |
| Regulation Name | Clinical Electronic Thermometer | Clinical Electronic Thermometer |
| Indications for Use | The CliniCloud Non-Contact
Thermometer is an infrared
thermometer intended for the
periodic measurement of human
body temperature for persons of all
ages, to be used in conjunction with
the CliniCloud app. | The non-contact infrared
thermometer, model JPD-FR100, can
measure body temperature for
infants and adults without contact to
human body. It can be used by
consumers in household
environment and doctor in clinic as
reference. |
| Measurement method | Infrared radiation detection | Infrared radiation detection |
| Measurement mode | Forehead measure mode | Forehead measure mode |
| Measuring Range | 32.2°C - 43.3°C (90.0°F - 109.9°F) | 32.2°C - 43.3°C (90.0°F - 109.9°F) |
| Display resolution | 0.1ºC (0.1ºF) | 0.1°C (0.1°F) |
| Measuring accuracy | ± 0.2ºC (0.4ºF) | ± 0.2ºC (0.4ºF) |
| Standards met | ASTM E1965-98 | ASTM E1965-98 |
| C/F switchable | Yes | Yes |
| Recommended
measurement distance | 0.1-5cm | 1-6cm |
| Display | Smartphone device Display | LCD display |
| Working voltage | 3V | 3V |
| Memory | Readings are stored on smartphone
via app and limited by smartphone
hard-drive capacity | 20 sets |
| Battery | 2 x 1.5V AAA | 2 x 1.5V AAA |
| Low battery indication | Yes | Yes |
| Manufacturer | StethoCloud Pty. Ltd (CliniCloud) | Shenzhen Jumper Medical
Equipment Co., Ltd. |
| Trade Name | CliniCloud Non-Contact
Thermometer, Model SPL1024 | Non-contact Infrared Thermometer
JPD-FR100 |
| Waterproof | No | No |
| Dimension | 115 x 36 x 25 mm | 145 x 60 x 50 mm |
| Weight | 80g | 180g |
| Recommended operating
condition | 15°C to 40.0 (59°F to 104.0°F)