K Number

Device Name

Ageless Health Medical Digital Thermometer

Manufacturer

Ageless Health Industrial Co., Ltd

Date Cleared

2018-08-08

(352 days)

Product Code

FLL

Regulation Number

880.2910

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K152508, K101387

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a simple thermistor and ASIC-based thermometer, and there is no mention of AI, ML, or related concepts in the summary.

Therapeutic

No
The device is a digital thermometer intended for measuring body temperature, which is a diagnostic function, not a therapeutic one. It does not provide treatment or therapy.

Diagnostic

Explanation: The device is a thermometer used for measuring and monitoring body temperature, which is a vital sign. While this information can be used in diagnosis, the device itself provides a measurement and does not interpret or diagnose a condition based on that measurement. Its stated "Intended Use / Indications for Use" is solely for "measurement and monitoring of human body temperature," not for diagnosing diseases or conditions.

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components such as a thermistor, reference resistor, buzzer, ASIC, and LCD, indicating it is a physical device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device function: The Ageless Health Medical Digital Thermometer measures human body temperature directly from the body (axillary, oral, rectal). It does not analyze any specimens taken from the body.

Therefore, based on the provided information, this device falls under the category of a general medical device for measuring a physiological parameter, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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. It can be used for axillary measurement, oral measurement and rectal measurement.

Product codes (comma separated list FDA assigned to the subject device)

FLL

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

axillary measurement, oral measurement and rectal measurement.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

doctor or consumers in the hospital or home.

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

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

. 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

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Measurement Accuracy:
35.0 C ~ 39.0 C : +/- 0.1 C
The rest: +/- 0.2 C

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K152508, K101387

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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

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

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

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:

. 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 of

Comparison	Subject Device	Predicate Device 1	Predicate Device 2	Remark
Company	Ageless Health
Industrial Co., Ltd.	Ageless Health
Industrial Co., Ltd.	Fudakang Industrial
Co., Ltd.	--
Name and
Model	Ageless Health Medical
Digital Thermometer,
models: BT-301, BT-
302, BT-303, BT-305,
BT-306, BT-308, BT-
311, BT-318	Ageless Health Medical
Digital Thermometer,
models: BT-301, BT-
302, BT-303, BT-305,
BT-306, BT-308, BT-
311, BT-318	Digital Thermometer
Model: BT-A11CN,
BT-A21CN, BT-A41
CN	--
510(k)
Number	K172508	K152508	K101387	--
Thermometer
Type	Digital Thermometer	Digital Thermometer	Digital Thermometer	SE
Intended Use
/ Indication
for Use	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.	Ageless Health Medical
Digital Thermometers
are intended for use in
measuring human body
temperature (Armpit or
Oral).	Fudakang Digital
Thermometers are
intended for the
measurement and
monitoring of human
body temperature by
doctor or consumers
in the hospital or	SE
Note 1
Elements of
Comparison	Subject Device	Predicate Device 1	Predicate Device 2	Remark
	It can be used for
axillary measurement,
oral measurement and
rectal measurement.		home.
BT-A11CN, BT-
A21CN, BT-A41CN
can be used for
axillary measurement,
oral measurement
and rectal
measurement.
Sensor	Thermistor	Thermistor	Thermistor	SE
Signal
Processing
and Display	Using the resistance
change of thermal
resistor to detect body
temperature and
displayed through the
LCD.	Using the resistance
change of thermal
resistor to detect body
temperature and
displayed through the
LCD.	Using the resistance
change of thermal
resistor to detect body
temperature and
displayed through the
LCD.	SE
Power
Requirement	1.5V button battery	1.5V button battery	1.5V button battery	SE
Measurement
Temperature
Range	32.0°C ~ 42.9°C	32.0°C ~ 42.9°C	32.0°C ~ 42.9°C	SE
Measurement
Accuracy	35.0 ~ 39.0°C : +/-
0.1°C
The rest: +/- 0.2°C	35.0 ~ 39.0°C : +/-
0.1°C
The rest: +/- 0.2°C	35.0 ~ 39.0°C: +/-
0.1°C
The rest: +/- 0.2°C	SE
Ambient
Temperature	10~35°C	10~35°C	0~40°C	SE
Response
Time	60s	60s	60s	SE
Complied
Standard	IEC 60601-1, IEC
80601-2-56, IEC
60601-1-2, IEC 60601-
1-11, ASTM E1112,
ISO 10993-5, ISO
10993-10	IEC 60601-1, IEC
80601-2-56, IEC 60601-
1-2, IEC 60601-1-11,
ASTM E1112, ISO
10993-5, ISO 10993-10	IEC 60601-1, IEC
80601-2-56, IEC
60601-1-2, IEC
60601-1-11, ASTM
E1112, ISO 10993-5,
ISO 10993-10	SE

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.

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

Please wait...

If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.

You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.

For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.

Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.