(120 days)
Not Found
No
The device description details a simple thermistor and ASIC-based system for temperature measurement, with no mention of AI, ML, or complex data processing beyond basic signal processing and calculation. The testing focuses on standard performance and safety metrics for thermometers.
No
The device is a digital thermometer, intended for measuring body temperature, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended for "measuring human body temperature", which is a diagnostic function as it provides information about the body's current state. While it doesn't diagnose a specific disease, temperature measurement is a fundamental diagnostic tool used to assess health status and identify fever or hypothermia.
No
The device description explicitly lists hardware components such as a thermistor, reference resistor, buzzer, ASIC, and LCD, indicating it is a physical device with embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure human body temperature (Armpit or Oral). This is a direct measurement of a physiological parameter within the body.
- Device Description: The device description details components that measure temperature directly from the body (thermistor, ASIC, LCD).
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
This device measures temperature in vivo (within the living body), not in vitro (outside the living body).
N/A
Intended Use / Indications for Use
Ageless Health Medical Digital Thermometers are intended for use in measuring human body temperature (Armpit or Oral).
Product codes (comma separated list FDA assigned to the subject device)
FLL
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Armpit or Oral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Ageless Health Medical Digital Thermometer has been evaluated the 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
The same tests on Ageless Health Medical Digital Thermometer and the predicate device demonstrate the substantial equivalence of the two.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: 35.0 ~ 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.
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
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
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.
1
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
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.
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 of
| Comparison | Subject Device | Predicate Device | Conclusion |
|---|---|---|---|
| Company | Ageless Health Industrial Ltd. | SHENZHEN PUMP MEDICAL | |
| SYSTEM CO., LTD. | -- | ||
| Name and | |||
| Model | Ageless Health Medical Digital | ||
| Thermometer, models: BT-301, | Electronic thermometer, models: | ||
| TF3100, TF3101, TF3102 | -- | ||
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Conclusion |
| BT-302, BT-303, BT-305, BT-306, | |||
| BT-308, BT-311, BT-318 | |||
| 510(k) Number | Applying | K131210 | -- |
| Thermometer | |||
| Type | Digital Thermometer | Digital Clinical Thermometer | SE |
| Intended Use | Ageless Health Medical Digital | ||
| Thermometers are intended for use | |||
| in measuring human body | |||
| temperature (Armpit or Oral). | It is intended for use in measuring | ||
| temperature in human body | |||
| (Armpit or Oral). | SE | ||
| Indication for | |||
| Use | Ageless Health Medical Digital | ||
| Thermometers are intended for use | |||
| in measuring human body | |||
| temperature (Armpit or Oral). | It is intended for use in measuring | ||
| temperature in human body | |||
| (Armpit or Oral). | SE | ||
| Sensor | 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. | SE | ||
| Power | |||
| Requirements | 1.5V button battery | 1.5V button battery | SE |
| Measurement | |||
| Temperature | |||
| Range | 32.0°C ~ 42.9°C | 32.0°C ~ 42.0°C | SE |
| Note 1 | |||
| Accuracy | 35.0 ~ 39.0°C : +/- 0.1°C | ||
| The rest: +/- 0.2°C | 0.05°C (35.30 ~ 39.00°C ) | ||
| 0.1°C ( 39.0°C ) | SE | ||
| Note 1 | |||
| Ambient | |||
| temperature | 10~35°C | 5~40°C | SE |
| Note 1 | |||
| Response Time | 60s | 5min | SE |
| Note 1 | |||
| Protection | |||
| Degree against | |||
| Ingress of Water | |||
| and Particulate | |||
| Matter | IP22 | IP22 | SE |
| Patient | |||
| Contacting | ABS plastic and stainless steel | ABS plastic and stainless steel | SE |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Conclusion |
| Material | |||
| 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 60601-1-2, IEC | ||
| 60601-1-11, ASTM E1112, ISO | |||
| 10993-5, 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