This device is an electronic clinical thermometer) to measure and monitor body temperature from auditory canal for people of all ages in a home set environment.

Device Description

The Swaive Thermometer SWT1A is a hand-held, battery-powered electronic thermometer which uses an infrared sensor to detect body temperature from the auditory canal. It is an infrared ear thermometer with disposable probe cover. It measures the thermal infrared radiation emitted from the tympanic membrane and the surrounding tissue by the sensor inside the probe. The electronic signal of sensor is amplified, calculated, converted into temperature value, and then displayed on LED board by the electronic circuit inside. It only takes a few seconds for the whole measurement process. Besides the temperature measurement circuit, a Bluetooth circuit is embedded in SWT1A to transmit the temperature value to smart phone via the specified App "Swaive Thermometer". This App only stores the temperature value on the smart phone if needed and has no clinical intention. SWT1A is a stand-alone device. It measures ear temperature and displays on its LED display with or without connecting with smart phone.

AI/ML Overview

The provided text is a 510(k) summary for the Swaive Thermometer, Model SWT1A. It details the device's characteristics, its comparison to a predicate device, and the non-clinical and clinical testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Swaive Thermometer are primarily based on established industry standards, specifically ASTM E1965-98:2016 for infrared thermometers. The performance is assessed against the requirements of this standard.

Acceptance Criteria (from ASTM E1965-98:2016)	Reported Device Performance (Swaive Thermometer SWT1A)
Accuracy: ±0.2°C (0.4°F) for 36-39°C (96.8-102.2°F)±0.3°C (0.5°F) for ranges outside 36-39°C (96.8-102.2°F)	Accuracy: ±0.2°C (0.4°F) for 33.3-42.2°C (92.0-108.0°F) (Note: The subject device reports a tighter accuracy specification across its full measurement range compared to the predicate's reported accuracy breakdown, but both are stated to comply with ASTM E1965-98)
Measurement Range: Implicitly defined by the standard's scope for intermittent determination of patient temperature	Measurement Range: 33.3~~42.2°C (92.0~~108.0°F)
Laboratory Accuracy Test: Required by the standard	Result: Pass
Shock Test: Required by the standard	Result: Pass
Storage Test: Required by the standard	Result: Pass
Clinical Performance: Required by the standard	Result: Complied with the requirement of ASTM E1965-98 (2016)

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

Sample Size for Clinical Test Set: 165 subjects.
- This was divided into three age groups:
  - Infant (newborn to 1 year): More than 30 subjects
  - Children (greater than 1 to 5 years old): More than 30 subjects
  - Greater than 5 years old: More than 30 subjects
Data Provenance: The document does not explicitly state the country of origin for the clinical study. It implies a single, controlled human clinical study. The document does not specify if it was retrospective or prospective, but clinical studies for device clearance are typically prospective.

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

The document does not provide details on the number or qualifications of experts used to establish the ground truth for the clinical test set. In the context of clinical thermometer testing according to ASTM E1965, the ground truth is typically established by comparative measurements against a highly accurate reference thermometer (e.g., a rectal thermometer) under controlled clinical conditions, rather than expert judgment or interpretation of images. The standard itself outlines the methodology for establishing this ground truth.

4. Adjudication Method (for the test set)

The document does not describe an adjudication method for the test set. For clinical thermometers, the "ground truth" is typically a direct physiological measurement by a highly accurate reference method, not a subjective interpretation requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This section is not applicable to the Swaive Thermometer. This device is a standalone clinical thermometer for measuring body temperature, not an AI-assisted diagnostic imaging device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or would be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is inherently a standalone measurement device. The clinical testing described evaluates the device's performance in taking temperature measurements against a referent standard, which is effectively its "standalone" performance. The Bluetooth connectivity is for data transmission to a smartphone app, but the app "only stores the temperature value... and has no clinical intention," meaning it does not alter the core measurement performance or involve an algorithm with "human-in-the-loop" interaction in the diagnostic sense. So, yes, the study assessed its standalone performance.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established through comparative physiological measurements against an accepted reference method, as prescribed by ASTM E1965-98:2016. This standard details how to simulate "body temperature" or directly compare the device's readings to established core body temperature measurements in a clinical setting to assess accuracy. It is not expert consensus, pathology, or outcomes data in the typical sense of AI/imaging devices.

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This is a medical device (thermometer) that performs direct physical measurement based on infrared sensing, not a machine learning or AI model that typically requires a large training dataset. The device's calibration and internal algorithms are based on fundamental physics and engineering principles, validated through non-clinical and clinical testing, rather than being "trained" on a dataset in the AI sense.

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

Since there is no "training set" in the context of an AI/ML model for this device, this question is not applicable. The device's accuracy is a function of its hardware design, calibration, and firmware, all of which are verified against standards rather than being "trained" on a specific dataset.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 25, 2018

E-Care Technology Co., Ltd. Mr. K.Y. Ko Engineer 8F-11, No. 35, Hsin-Tai Road Chubei City, Hsinchu 302 Taiwan

Re: K170723

Trade/Device Name: Swaive Thermometer, Model: SWT1A Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 20, 2018 Received: September 24, 2018

Dear Mr. K.Y. Ko:

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 (OS) 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 mediation-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,

Alan M.
Stevens -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) K170723

Device Name Swaive Thermometer, Model: SWT1A

Indications for Use (Describe)

This device is an electronic clinical thermometer) to measure and monitor body temperature from auditory canal for people of all ages in a home set environment.

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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Image /page/3/Picture/0 description: The image shows a logo with the word "Care" in a stylized font. The "C" is represented by a blue swirl, and the rest of the word is in purple. A blue line runs horizontally through the word, adding a modern touch to the design. The logo appears to be for a company or organization named "Care."

8F-11, NO. 35, Hsintai Road, Chubei City, Hsinchu County 302, Taiwan TEL: 886-3-5534996 FAX: 886-3-5534980 E-MAIL: service@e-care.com.tw

510(k) SUMMARY

1. Submitter Information:

E-Care Technology Co., Ltd. 8F-11, No.35, Hsin-Tai Road Chubei City, Hsinchu County 302 Taiwan Contact: Mr. K.Y. Ko e-mail:service(@e-care.com.tw Tel:886-3-5534996 Fax:886-3-5534980 Date Prepared: October 25, 2018 Name of Device: Trade name: Swaive Thermometer, Model: SWT1A Common name: Infrared ear thermometer Classification name: Thermometer, electronic, clinical (21 CFR 880.2910, Product code: FLL)

3. Predicate Device:

AViTA Infrared Thermometer with Bluetooth, Model no.: TS28B (510(k) no .: K110559)

4. Device Description:

Besides the temperature measurement circuit, a Bluetooth circuit is embedded in SWT1A to transmit the temperature value to smart phone via the specified App "Swaive Thermometer". This App only stores the temperature value on the smart phone if needed and has no clinical intention. SWT1A is a stand-alone device. It measures ear temperature and displays on its LED display with or without connecting with smart phone.

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Image /page/4/Picture/0 description: The image shows a logo with the word "Care" in a stylized font. The "C" is a blue swirl, and the rest of the letters are purple. A blue line runs horizontally through the word, adding a modern touch to the design. The logo appears to be for a company or organization named "Care."

8F-11, NO. 35, Hsintai Road, Chubei City, Hsinchu County 302, Taiwan TEL: 886-3-5534996 FAX: 886-3-5534980 E-MAIL: service@e-care.com.tw

ನ. Indications for Use:

This device is an electronic clinical thermometer (infrared ear thermometer) to measure and monitor body temperature from auditory canal for people of all ages in a home set environment.

Comparison of Technology Characteristics with the Predicate Device: 6.

Item	Subject Device:Swaive ThermometerModel: SWT1A	Predicate Device:AVITA InfraredThermometer withBluetoothModel: TS28B	Comparison
510 (k) #	K170723	K110559	N/A
Thermometertype	Infrared ear thermometerwith Bluetooth	Infrared ear thermometerwith Bluetooth	Same
Indications foruse	This device is an electronicclinical thermometer(infrared ear thermometer)to measure and monitorbody temperature fromauditory canal for people ofall ages in a home setenvironment.	This device is an infraredthermometer intended forthe intermittentmeasurement of human bodytemperature for people of allages.	Similar
Sensor	Infrared(thermopile+ thermistor)This thermometer uses aninfrared sensor to detect theinfrared radiant from	Infrared(thermopile+ thermistor)This thermometer uses aninfrared sensor to detect theinfrared radiant from	Same
Principal ofoperation	auditory canal and convertinto electrical signal forcalculation of auditorycanal temperature.The temperature value canbe transferred to smartphone via Bluetooth circuit.	auditory canal and convertinto electrical signal forcalculation of auditorycanal temperature.The temperature value canbe transferred to smartphone via Bluetooth circuit.	Same
Measurementrange	33.3~~42.2°C (92.0~~108.0°F)	34~~43°C (93.2~~109.4°F)	Similar

	±0.2°C (0.4°F):	±0.2°C (0.4°F): 36~39°C
	33.3~~42.2°C(92.0~~108.0°F)	(96.8~~102.2°F)±0.3°C (0.5°F): 34~~36°C &39~~43°C (93.2~~96.8°F &102.2~109.4°F)	Complies withASTM E1965-98
Accuracy
Operatingenvironment	16-40°C (60.8-104°F)≤95% Relative humidity	16-40°C (60.8-104°F)≤95% Relative humidity	Same
Storageenvironment	-20°C~50°C≤95% Relative humidity	-20°C~50°C≤95% Relative humidity	Same
Displayresolution	0.1°C or °F	0.1°C or °F	Same
Performance	Complies withASTM E1965-98	Complies withASTM E1965-98	Same
memory	none	10 sets	Different
Datatransmission	Bluetooth	Bluetooth	Same
Battery	2 x AA	2 x AAA	Similar
Disposable probecover	yes	no	Different
Materials	Patient contacting materialsinclude LDPE (probe cover)and ABS (device housing)	Patient contacting materialincludes ABS (devicehousing)	Different
Biocompatibility	Complies with ISO 10993-1, ISO 10993-5 &ISO 10993-10	Complies with ISO 10993-1, ISO 10993-5 &ISO 10993-10	Same
Safety	Complies with IEC60601-1	Complies with IEC60601-1	Same
EMC	Complies withIEC60601-1-2	Complies withIEC60601-1-2	Same

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Image /page/5/Picture/0 description: The image shows the word "Care" in a stylized font. The "C" is a blue swirl, and the rest of the letters are purple. A blue line runs through the middle of the word, connecting the "C" to the "e". The word is slightly tilted to the right.

8F-11, NO. 35, Hsintai Road, Chubei City, Hsinchu County 302, Taiwan TEL: 886-3-5534996 FAX: 886-3-5534980 E-MAIL: service@e-care.com.tw

The differences between 2 devices are:

The memory of subject device has zero, but the predict K110559 has 10 memories. The devices measure temperature independently every time. The previous measurement will not affect new measurement and whether the device stores temperature reading does not affect new measurement.

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Image /page/6/Picture/0 description: The image shows the word "Care" in a stylized font. The "C" is a blue swirl, and the rest of the letters are purple. A blue line goes through the middle of the word, adding a modern touch to the design. The overall impression is clean and professional.

8F-11, NO. 35, Hsintai Road, Chubei City, Hsinchu County 302, Taiwan TEL: 886-3-5534996 FAX: 886-3-5534980 E-MAIL: service@e-care.com.tw

The subject device uses disposable probe cover, but the predicate K110559 does not, and they have different patient-contacting materials. The subject device uses a disposable probe cover to provide a sanitary barrier between a subject and the probe. The non-clinical and clinical tests demonstrate the performance of this subject device using a probe cover complies with ASTM E1965-98 (2016) as the predicate device. According to ISO10993-1, the disposable probe cover has passed the relative biocompatibility tests and does not raise new biocompatibility issue.

From above discussion, the difference between these two devices does not raise any new performance issue.

7. Non-Clinical Testing:

The following non-clinical tests were conducted according to FDA recognized consensus standards or USA regulations, and software verification and validation data was completed as recommended in the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices dated May 11, 2005". All these tests results are provided in support of the substantial equivalence determination.

Standard name	Test name & report no.	result
IEC 60601-1:2005+AM1(2012)Medical electrical equipment -Part 1:General requirements for basic safetyand essential performance	UT104079:IEC 60601-1: 2005+AM1(2012) testreport	pass
IEC 60601-1-2 Edition 3:2007Medical Electrical Equipment - Part 1-2:General Requirements for Basic Safetyand Essential Performance - CollateralStandard: Electromagnetic Compatibility- Requirements and Tests	1560372R-ITCEP15V00:IEC 60601-1-2:2007 test report	pass
ASTM E1965-98:2016Standard Specification for InfraredThermometers for IntermittentDetermination of Patient Temperature	SWT1A Performance check listShock test, Storage test,Laboratory accuracy test,	pass
Bluetooth qualification process	Bluetooth Qualification test report	pass
FCC 47 CFR Part 15B:Radio Frequency Devices-Unintentional	EM-F140674:FCC 47 CFR Part 15B test report	pass
Radiators
FCC 47 CFR Part 15C:Radio Frequency Devices-IntentionalRadiators	1550091R-RFUSP01V00FCC 47 CFR Part 15C test report	pass
ISO 10993-5:2009: Biologicalevaluation of medical devices: part 5:Tests for in vitro cytotoxicity	SDWH-M201701064-1:In vitro cytotoxicity test of probe coverSDWH-M201801942-1(E):In vitro cytotoxicity test of SwaiveThermometer, Model SWT1A	pass
ISO 10993-10, Biological evaluation ofmedical device – Part 10: Tests forirritation and skin sensitization.	SDWH-M201701064-2:Skin sensitization test of probe cover (1)SDWH-M201701064-3:Skin sensitization test of probe cover (2)SDWH-M201701064-4:Skin irritation test of probe cover (1)SDWH-M201701064-5:Skin irritation test of probe cover (2)DWH-M201801942-2 (E):Skin sensitization test of SwaiveThermometer, Model: SWT1A (1)DWH-M201801942-3 (E):Skin sensitization test of SwaiveThermometer, Model SWT1A (2)DWH-M201801942-4 (E):Skin irritation test of SwaiveThermometer, Model SWT1A (1)DWH-M201801942-5 (E):Skin irritation test of SwaiveThermometer, Model SWT1A (2)	pass

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Image /page/7/Picture/0 description: The image shows a logo with the word "Care" in a stylized font. The "C" is represented by a blue swirl, and the rest of the word is in purple. A horizontal blue line runs through the middle of the word, adding a modern touch to the design. The logo has a glossy, three-dimensional appearance, giving it a polished and professional look.

8F-11, NO. 35, Hsintai Road, Chubei City, Hsinchu County 302, Taiwan TEL: 886-3-5534996 FAX: 886-3-5534980 E-MAIL: service@e-care.com.tw

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Image /page/8/Picture/0 description: The image shows the word "Care" in a stylized font. The "C" is a blue swirl, and the rest of the letters are purple. A blue line runs through the middle of the word, adding a modern touch to the design. The overall design is eye-catching and professional.

8F-11, NO. 35, Hsintai Road, Chubei City, Hsinchu County 302, Taiwan TEL: 886-3-5534996 FAX: 886-3-5534980 E-MAIL: service@e-care.com.tw

8. Clinical Testing:

Controlled human clinical study was conducted in accordance with ASTM E1965-98:2016. Clinical tests were conducted on the subject device SWT1A. The clinical tests evaluated 165 subjects which were divided into three group age ranges-infant (new born to 1 year), children (greater than 1 to 5 years old) and greater than 5 years old. There are more than 30 subjects for each group. The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2016). The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).

9. Conclusions:

The subject device SWT1A and the predicate device K110559 have similar indications for use. They use the same technology and have the same principal of operation. These performance tests demonstrate the differences between the subject device and predicate K110559 do not raise new performance question. Based on the comparison and analysis above, the subject device is 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.