Ageless Health Medical Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home. lt can be used for axillary measurement, oral measurement and rectal measurement.

Device Description

Ageless Health Medical Digital Thermometers comprises a thermistor for getting temperature signal, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC for processing the target temperature digitally, and a LCD for displaying the temperature result. The design principle of thermometer is based on thermos sensor and ASIC technology. A thermistor is used as thermos sensor. The ASIC gets the sensor's signal from human body, then processes the signal and calculates the result, after that displays the temperature result by a LCD.

AI/ML Overview

The provided document is a 510(k) summary for the "Ageless Health Medical Digital Thermometer." It details the device's characteristics and compares it to predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are largely based on adherence to recognized standards and specific performance metrics, particularly measurement accuracy and range.

Acceptance Criteria / Performance Metric	Reported Device Performance (Subject Device)
Safety and Essential Performance Standards:	Complies with IEC 60601-1, IEC 80601-2-56, IEC 60601-1-2, IEC 60601-1-11, ASTM E1112, ISO 10993-5, ISO 10993-10.
Thermometer Type:	Digital Thermometer
Intended Use / Indication for Use:	Measurement and monitoring of human body temperature by doctor or consumers in the hospital or home; for axillary, oral, and rectal measurement.
Sensor Type:	Thermistor
Signal Processing & Display:	Uses resistance change of thermal resistor to detect body temperature, displayed through LCD.
Power Requirement:	1.5V button battery
Measurement Temperature Range:	32.0°C ~ 42.9°C
Measurement Accuracy:	35.0 ~ 39.0°C: +/- 0.1°CThe rest of the range: +/- 0.2°C
Ambient Temperature for Operation:	10 ~ 35°C
Response Time:	60s

2. Sample size used for the test set and the data provenance

The document states that the device's safety and performance were evaluated by "lab bench testing" according to a list of standards. However, it does not provide details on the sample size used for these tests. There's also no explicit information on data provenance in terms of country of origin or whether the tests were retrospective or prospective, beyond being "lab bench testing." It is implied that these tests were conducted as part of the device development and verification process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts to establish ground truth for a test set. The validation appears to be based on engineering and performance testing against established standards for temperature measurement devices.

4. Adjudication method for the test set

Since there is no mention of experts or a subjective assessment test set, there is no adjudication method described. The evaluation is against objective engineering and performance standards.

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

This type of study is not applicable to a digital thermometer. The device is a direct measurement tool, not an AI-assisted diagnostic device requiring human interpretation of complex data. Therefore, an MRMC comparative effectiveness study was not performed, nor is there any mention of AI assistance.

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

The device is inherently a standalone measurement tool. Its performance is evaluated purely on its ability to accurately measure temperature according to the specified standards, without human intervention in the measurement process itself. So, in a sense, a "standalone" performance evaluation was done on the device's core function.

7. The type of ground truth used

The ground truth used for this type of device is established by:

Reference standards and calibrated equipment: The "lab bench testing" implicitly relies on highly accurate and traceable reference thermometers and controlled environmental conditions as the ground truth for temperature measurement.
Biological evaluation standards: ISO 10993-5 (in vitro cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) involve standardized biological assays where the "ground truth" is determined by the absence or presence of adverse biological reactions as defined by the standards.

8. The sample size for the training set

The concept of a "training set" is not applicable here as this is a traditional medical device (digital thermometer) and not an AI/machine learning device. The device's operation is based on fixed physical principles and programmed logic, not learned from data.

9. How the ground truth for the training set was established

As there is no training set for this device, this question is not applicable. The device's functionality is designed and verified against established engineering and medical standards, not by training on a 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.

August 8, 2018

Ageless Health Industrial Co., Ltd % Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou. 510000 China

Re: K172508

Trade/Device Name: Ageless Health Medical Digital Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: July 4, 2018 Received: July 9, 2018

Dear Cassie Lee:

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

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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 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 (QS) 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 medical devices and radiation-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.

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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K172508

510(k) Summary

This summary of 510(K) information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.

1. Submitter's Information

Sponsor Name: Ageless Health Industrial Co., Ltd. Address: 3/F, A1 Bldg, Dongshen Sima Industrial Area, No.33 Shenbei Road, Sima Village, Changping Town, Dongguan City, Guangdong Province, China Contact Person: Victor Wan (Vice-president) Phone: +86-769-81158038 Fax: +86-769-82289331 E-mail: victor@agelh.com

Application Correspondent:

Contact Person: Ms. Cassie Lee

Guangzhou GLOMED Biological Technology Co., Ltd.

Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China

Tel: +86-20-61099984

Email: regulatory@glomed-info.com

2. Subject Device Information

Type of 510(k):	Traditional
Common Name:	Thermometer, electronic
Trade Name:	Ageless Health Medical Digital Thermometer (models: BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)
Classification Name:	Thermometer, electronic, clinical
Review Panel:	General Hospital
Product Code:	FLL
Regulation Number:	880.2910
Regulation Class:	II

3. Predicate Device Information

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Predicate Device 1

510(K) Number: K152508 Sponsor: Dongguan Ageless Health Industrial Co., Ltd. Common Name: Thermometer, electronic Trade Name: Ageless Health Medical Digital Thermometer Classification Name: Thermometer, electronic, clinical Review Panel: General Hospital Product Code: FLL Regulation Number: 880.2910 Regulation Class: II

Predicate Device 2

510(K) Number: K101387 Sponsor: Fudakang Industrial Co., Ltd Classification Name: Thermometer, electronic, clinical Trade Name: Digital Thermometer Review Panel: General Hospital Product Code: FLL Regulation Number: 880.2910 Regulation Class: II

4. Device Description

5. Intended Use

6. Test Summary

Ageless Health Medical Digital Thermometer has been evaluated the safety and performance by lab bench testing according to the following standards:

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. IEC 60601-1 (2005 + CORR.1:2006 + CORR.2:2007 + AM1:2012) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
. IEC 80601-2-56 (2009) Medical Electrical Equipment - Part 2-56: Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement
. IEC 60601-1-2 (2007) Medical Electrical Equipment - Part 1-2: Collateral Standard: Electromagnetic Compatibility
. IEC 60601-1-11 (2010) 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
. ASTM E1112-00 (2006) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
. ISO 10993-5 (2009) Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro cytotoxicity
. ISO 10993-10 (2010) Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization

Comparison to Predicate Device 7.

Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards.

Elements ofComparison	Subject Device	Predicate Device 1	Predicate Device 2	Remark
Company	Ageless HealthIndustrial Co., Ltd.	Ageless HealthIndustrial Co., Ltd.	Fudakang IndustrialCo., Ltd.	--
Name andModel	Ageless Health MedicalDigital Thermometer,models: BT-301, BT-302, BT-303, BT-305,BT-306, BT-308, BT-311, BT-318	Ageless Health MedicalDigital Thermometer,models: BT-301, BT-302, BT-303, BT-305,BT-306, BT-308, BT-311, BT-318	Digital ThermometerModel: BT-A11CN,BT-A21CN, BT-A41CN	--
510(k)Number	K172508	K152508	K101387	--
ThermometerType	Digital Thermometer	Digital Thermometer	Digital Thermometer	SE
Intended Use/ Indicationfor Use	Ageless Health MedicalDigital Thermometersare intended for themeasurement andmonitoring of humanbody temperature bydoctor or consumers inthe hospital or home.	Ageless Health MedicalDigital Thermometersare intended for use inmeasuring human bodytemperature (Armpit orOral).	Fudakang DigitalThermometers areintended for themeasurement andmonitoring of humanbody temperature bydoctor or consumersin the hospital or	SENote 1
Elements ofComparison	Subject Device	Predicate Device 1	Predicate Device 2	Remark
	It can be used foraxillary measurement,oral measurement andrectal measurement.		home.BT-A11CN, BT-A21CN, BT-A41CNcan be used foraxillary measurement,oral measurementand rectalmeasurement.
Sensor	Thermistor	Thermistor	Thermistor	SE
SignalProcessingand Display	Using the resistancechange of thermalresistor to detect bodytemperature anddisplayed through theLCD.	Using the resistancechange of thermalresistor to detect bodytemperature anddisplayed through theLCD.	Using the resistancechange of thermalresistor to detect bodytemperature anddisplayed through theLCD.	SE
PowerRequirement	1.5V button battery	1.5V button battery	1.5V button battery	SE
MeasurementTemperatureRange	32.0°C ~ 42.9°C	32.0°C ~ 42.9°C	32.0°C ~ 42.9°C	SE
MeasurementAccuracy	35.0 ~ 39.0°C : +/-0.1°CThe rest: +/- 0.2°C	35.0 ~ 39.0°C : +/-0.1°CThe rest: +/- 0.2°C	35.0 ~ 39.0°C: +/-0.1°CThe rest: +/- 0.2°C	SE
AmbientTemperature	10~35°C	10~35°C	0~40°C	SE
ResponseTime	60s	60s	60s	SE
CompliedStandard	IEC 60601-1, IEC80601-2-56, IEC60601-1-2, IEC 60601-1-11, ASTM E1112,ISO 10993-5, ISO10993-10	IEC 60601-1, IEC80601-2-56, IEC 60601-1-2, IEC 60601-1-11,ASTM E1112, ISO10993-5, ISO 10993-10	IEC 60601-1, IEC80601-2-56, IEC60601-1-2, IEC60601-1-11, ASTME1112, ISO 10993-5,ISO 10993-10	SE

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Note 1

The subject device is exactly the same as predicate device K152508, which is also our company cleared device. The only difference for subject device is added rectal measurement function in Indications for Use.

So, we add predicate device K101387 which included rectal measurement function as additional predicate device. As the parameters of subject device are also very similar to additional predicate device K101387, and their Indications for Use are the same, so differences between them do not raise different questions of safety and effectiveness for the subject device.

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Conclusion

The subject device Ageless Health Medical Digital Thermometer has all features of the predicate devices. The few differences amongst the predicates and the subject do not raise different questions of safety and effectiveness.

1. Summary Prepared Date
- 15 August 2017

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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.