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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CliniCloud Non-Contact Thermometer, Model SPL1024, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the ASTM E1965-98 standard for infrared thermometers.

Acceptance Criteria (from ASTM E1965-98)	Reported Device Performance (CliniCloud Non-Contact Thermometer)
Measurement Accuracy
For a measuring range of 32.2°C - 43.3°C (90.0°F - 109.9°F)	± 0.2ºC (0.4ºF)
Environmental Operating Conditions
Temperature Range	15°C to 40.0°C (59°F to 104.0°F)
Relative Humidity	<85%, non-condensing
Display Resolution	0.1ºC (0.1ºF)

Note on Measurement Accuracy: The document states that the sensor is "factory calibrated to meet consensus standard ASTM E1965-98" and also lists the measuring accuracy as ± 0.2ºC (0.4ºF) in the comparison table, which is a common accuracy requirement within that standard for clinical electronic thermometers.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 60 subjects.
Data Provenance: The document does not explicitly state the country of origin.
Retrospective or Prospective: Prospective, as it was a "Validation study... performed to clinically validate the CliniCloud thermometer."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the number of experts used to establish ground truth or their specific qualifications.
Instead of expert consensus for ground truth, the study utilized 4 calibrated reference devices (same model) used as gold standard. These would typically be high-precision, clinically validated thermometers.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving experts. The ground truth was established by calibrated reference devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for a non-contact thermometer, which measures a physical parameter (temperature) and does not involve human readers interpreting images or data that an AI would assist with.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance assessment was conducted for the device. The "Validation study" in point 9 of the K510 summary refers to the clinical accuracy of the CliniCloud thermometer itself, comparing its measurements to the gold standard reference devices. While the device works "in conjunction with the CliniCloud app," the core measurement accuracy is evaluated independently of human interpretation of the results through an AI.

7. The Type of Ground Truth Used

Gold Standard Reference Devices: The ground truth for the clinical validation study was established using "4 calibrated reference devices (same model) used as gold standard." This implies a comparison to highly accurate and independently verified temperature measurement tools.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms. The device is a thermometer that relies on a physical sensor and conversion algorithms, not a learned model (like an AI).
The "factory calibrated" statement for the sensor implies calibration data, but not a "training set" in the typical AI sense.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, there isn't a "training set" in the conventional AI sense for this device. The sensor itself is "factory calibrated to meet consensus standard ASTM E1965-98." This calibration process, which likely involves proprietary methods by the sensor manufacturer and CliniCloud, establishes the accuracy of the sensor and its algorithms to convert raw infrared readings into a human body temperature.

Summary of the Study Proving Acceptance Criteria:

The key study mentioned is a "Validation study" conducted to clinically validate the CliniCloud thermometer (Model SPL1024) according to ASTM E1965-98.

Study Design: The study involved 60 subjects and compared the CliniCloud thermometer's readings against 4 calibrated reference devices (gold standard). A predicate device was also included for comparison.
Result: The study "demonstrated that the clinical accuracy of the CliniCloud thermometer and the predicate devices yielded equivalent accuracy," implying that the CliniCloud device met the accuracy requirements of ASTM E1965-98, which typically involves a mean difference and standard deviation within specified limits when compared to a reference thermometer. The stated accuracy is ± 0.2ºC (0.4ºF).
Non-Clinical Tests: Additional non-clinical tests were performed (e.g., IEC standards for electrical safety and EMC, FCC, biocompatibility, risk management, wireless functionality) to ensure the device met all safety and performance specifications.

Summary

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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.

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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 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,

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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

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Indications for Use

510(k) Number (if known)

K161325

Device Name

CliniCloud Non-Contact Thermometer, Model SPL1024

Indications for Use (Describe)

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)

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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.

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5. Device Description

6. Indication for Use Statement

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.

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Manufacturer	StethoCloud Pty. Ltd (CliniCloud)	Shenzhen Jumper MedicalEquipment Co., Ltd.
Trade Name	CliniCloud Non-ContactThermometer, Model SPL1024	Non-contact Infrared ThermometerJPD-FR100
510(k) Number	K161325	K131243
Product Code	FLL - clinical electronicthermometer	FLL - clinical electronic thermometer
Regulation Number	880.2910	880.2910
Regulation Name	Clinical Electronic Thermometer	Clinical Electronic Thermometer
Indications for Use	The CliniCloud Non-ContactThermometer is an infraredthermometer intended for theperiodic measurement of humanbody temperature for persons of allages, to be used in conjunction withthe CliniCloud app.	The non-contact infraredthermometer, model JPD-FR100, canmeasure body temperature forinfants and adults without contact tohuman body. It can be used byconsumers in householdenvironment and doctor in clinic asreference.
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
Recommendedmeasurement distance	0.1-5cm	1-6cm
Display	Smartphone device Display	LCD display
Working voltage	3V	3V
Memory	Readings are stored on smartphonevia app and limited by smartphonehard-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 MedicalEquipment Co., Ltd.
Trade Name	CliniCloud Non-ContactThermometer, Model SPL1024	Non-contact Infrared ThermometerJPD-FR100
Waterproof	No	No
Dimension	115 x 36 x 25 mm	145 x 60 x 50 mm
Weight	80g	180g
Recommended operatingcondition	15°C to 40.0 (59°F to 104.0°F)<85%, non-condensing	10°C - 40.0°C (50°F - 104.0°F)<95% humidity, non-condensing
Signal transmission	Wireless 2.4G Bluetooth LE	None

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As seen in the comparison table, the subject and predicate devices have similar design features and performance specifications. One of the main technological differences between the subject and predicate devices are related to the wireless transmission characteristics in which a reference device was used to support the Bluetooth connectivity. A reference device, K132761, Raiing Wireless Thermometer WT701 was used to demonstrate equivalence for the Bluetooth connectivity. Another technological difference is the display. The subject device uses a smartphone display via the CliniCloud App whereas the predicate device uses a built-in LCD display.

These differences, however, do not raise different questions of safety or effectiveness. As demonstrated in the non-clinical testing, the different technological characteristics do not affect the safety and effectiveness of the CliniCloud Non-Contact Thermometer.

8. Non-Clinical Performance Data

Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC60601-1:2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2007 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests
. FCC Part 15 Subpart C test FCC Part 15.247
ASTM E1965-98: (R 2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
. Biocompatibility testing standards for components that have limited skin contact for the user only, including, "ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation

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and testing within a risk management process", "ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity" and "ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization"

ISO 14971:2007 Medical devices - Application of Risk Management to Medical Devices
The proposed device also passed performance testing, which included wireless coexistence testing, transmission distance testing, measuring distance testing, device accuracy testing and comparison testing to the predicate device under use case environment. The software was assessed according to "Guidance for the Content of Premarket Submissions for Software in Medical Devices, issued on May 11, 2005". The overall level of concern was found to be moderate, with verification and validation testing confirming that the software performs as intended and is compliant to requirement and specification documents.

9. Clinical Performance Data

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.

Both the clinical and non-clinical testing detailed in this submission supports the substantial equivalence of the device.

10. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics, but can be demonstrated that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).

The CliniCloud Non-Contact Thermometer, as designed and manufactured, is determined to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.