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 thermosensor and ASIC technology. A thermistor is used as thermosensor. 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 text is a 510(k) summary for the Ageless Health Medical Digital Thermometer, a medical device. It outlines the device's technical specifications and demonstrates its substantial equivalence to a predicate device. However, this document does not contain the information requested regarding acceptance criteria and the study that proves an AI/ML powered device meets those criteria.

Specifically, the document discusses:

Device identification: Ageless Health Medical Digital Thermometer.
Regulatory information: Class II medical device, product code FLL, regulation number 21 CFR 880.2910, 510(k) number K152508.
Intended Use: Measuring human body temperature (armpit or oral).
Device Description: It's a digital thermometer using a thermistor, reference resistor, buzzer, ASIC, and LCD display.
Predicate Device: SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. Electronic thermometer (K131210).
Test Summary: Mentions lab bench testing according to various IEC, ASTM, and ISO standards (e.g., IEC 80601-2-56 for clinical thermometers, ASTM E1112 for electronic thermometers, ISO 10993 for biocompatibility), but does not provide the results of these tests in detail or the specific acceptance criteria met. It only states that "The same tests on Ageless Health Medical Digital Thermometer and the predicate device demonstrate the substantial equivalence of the two."
Comparison to Predicate Device: A table comparing various elements, including measurement range, accuracy, ambient temperature, and response time. It notes some differences but concludes substantial equivalence because both comply with relevant performance standards.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the provided text, as this information is not present for an AI/ML powered device. The document relates to a traditional digital thermometer and focuses on substantial equivalence based on existing standards and predicate device comparison, rather than a novel AI/ML performance evaluation.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 31, 2015

Dongguan Ageless Health Industrial Co., Ltd c/o Ms. Cecilia Ceng Regulatory Manager Guangzhou Glomed Biological Technology Co., Ltd Suit 306, Kecheng Mansion. No.121 Science Road, Guangzhou Science Park Guangzhou. 510663 CHINA

Re: K152508

Trade/Device Name: Ageless Health Medical Digital Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: November 17, 2015 Received: November 23, 2015

Dear Ms. Ceng:

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 (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/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 yours,

Tina Kiang -S

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) K152508

Device Name

Device Name: Ageless Health Medical Digital Thermometer

Indications for Use (Describe)

Ageless Health Medical Digital Thermometers are intended for use in measuring human body temperature (Armpit or Oral).

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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510(k) Summary

K152508

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

1. Submitter Information

Sponsor Name: Dongguan 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. Cecilia Ceng / Mr. Tim Wong Guangzhou GLOMED Biological Technology Co., Ltd. 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
Classification Name:	Thermometer, electronic, clinical
Review Panel:	General Hospital
Product Code:	FLL

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Requlation Number: 880.2910

Regulation Class: 2

3. Predicate Device Information

Sponsor: SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. Classification Name: Thermometer, electronic, clinical Trade Name: Electronic thermometer 510(k) number: K131210 Review Panel: General Hospital Product Code: FLL Regulation Number: 880.2910 Regulation Class: 2

4. Device Description

5. Intended Use

Ageless Health Medical Digital Thermometers are intended for use in measuring human body temperature (Armpit or Oral).

6. Test Summary

Ageless Health Medical Digital Thermometer has been evaluated the 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 I 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
l ISO 10993-10 (2010) Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization

The same tests on Ageless Health Medical Digital Thermometer and the predicate device demonstrate the substantial equivalence of the two.

7. Comparison to Predicate Device

Compare with predicate device, the subject device is very similar in design principle, intended

Elements ofComparison	Subject Device	Predicate Device	Conclusion
Company	Ageless Health Industrial Ltd.	SHENZHEN PUMP MEDICALSYSTEM CO., LTD.	--
Name andModel	Ageless Health Medical DigitalThermometer, models: BT-301,	Electronic thermometer, models:TF3100, TF3101, TF3102	--
Elements ofComparison	Subject Device	Predicate Device	Conclusion
	BT-302, BT-303, BT-305, BT-306,BT-308, BT-311, BT-318
510(k) Number	Applying	K131210	--
ThermometerType	Digital Thermometer	Digital Clinical Thermometer	SE
Intended Use	Ageless Health Medical DigitalThermometers are intended for usein measuring human bodytemperature (Armpit or Oral).	It is intended for use in measuringtemperature in human body(Armpit or Oral).	SE
Indication forUse	Ageless Health Medical DigitalThermometers are intended for usein measuring human bodytemperature (Armpit or Oral).	It is intended for use in measuringtemperature in human body(Armpit or Oral).	SE
Sensor	Thermistor	Thermistor	SE
SignalProcessing andDisplay	Using the resistance change ofthermal resistor to detect bodytemperature and displayed throughthe LCD.	Using the resistance change ofthermal resistor to detect bodytemperature and displayedthrough the LCD.	SE
PowerRequirements	1.5V button battery	1.5V button battery	SE
MeasurementTemperatureRange	32.0°C ~ 42.9°C	32.0°C ~ 42.0°C	SENote 1
Accuracy	35.0 ~ 39.0°C : +/- 0.1°CThe rest: +/- 0.2°C	0.05°C (35.30 ~ 39.00°C )0.1°C (< 35.30°C or > 39.0°C )	SENote 1
Ambienttemperature	10~35°C	5~40°C	SENote 1
Response Time	60s	5min	SENote 1
ProtectionDegree againstIngress of Waterand ParticulateMatter	IP22	IP22	SE
PatientContacting	ABS plastic and stainless steel	ABS plastic and stainless steel	SE
Elements ofComparison	Subject Device	Predicate Device	Conclusion
Material
CompliedStandard	IEC 60601-1, IEC 80601-2-56, IEC60601-1-2, IEC 60601-1-11, ASTME1112, ISO 10993-5, ISO 10993-10	IEC 60601-1, IEC 60601-1-2, IEC60601-1-11, ASTM E1112, ISO10993-5, ISO 10993-10	SE

use, indications for use, functions, material and the applicable standards.

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Note 1

Although some specifications of Measurement Temperature Range, Accuracy, and Response Time are different for subject device and predicate device, they are both complied with related performance standards.

Conclusion

The subject device Ageless Health Medical Digital Thermometer has all features of the predicate device,only with few differences(accuracy, Ambient temperature, Response Time). The technological principle is also the same with the predicate device's. Thus, the subject device is substantially equivalent to the predicate device.

8. Summary Prepared Date

30 December 2015

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.