Ageless Health Medical Digital Thermometer

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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: 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 {3}------------------------------------------------ ## 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 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. #### 5. 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. ## 6. Test Summary Ageless Health Medical Digital Thermometer has been evaluated the safety and performance by lab bench testing according to the following standards: {4}------------------------------------------------ - . 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<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Company | Ageless Health<br>Industrial Co., Ltd. | Ageless Health<br>Industrial Co., Ltd. | Fudakang Industrial<br>Co., Ltd. | -- | | Name and<br>Model | Ageless Health Medical<br>Digital Thermometer,<br>models: BT-301, BT-<br>302, BT-303, BT-305,<br>BT-306, BT-308, BT-<br>311, BT-318 | Ageless Health Medical<br>Digital Thermometer,<br>models: BT-301, BT-<br>302, BT-303, BT-305,<br>BT-306, BT-308, BT-<br>311, BT-318 | Digital Thermometer<br>Model: BT-A11CN,<br>BT-A21CN, BT-A41<br>CN | -- | | 510(k)<br>Number | K172508 | K152508 | K101387 | -- | | Thermometer<br>Type | Digital Thermometer | Digital Thermometer | Digital Thermometer | SE | | Intended Use<br>/ Indication<br>for Use | Ageless Health Medical<br>Digital Thermometers<br>are intended for the<br>measurement and<br>monitoring of human<br>body temperature by<br>doctor or consumers in<br>the hospital or home. | Ageless Health Medical<br>Digital Thermometers<br>are intended for use in<br>measuring human body<br>temperature (Armpit or<br>Oral). | Fudakang Digital<br>Thermometers are<br>intended for the<br>measurement and<br>monitoring of human<br>body temperature by<br>doctor or consumers<br>in the hospital or | SE<br>Note 1 | | Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | | | It can be used for<br>axillary measurement,<br>oral measurement and<br>rectal measurement. | | home.<br>BT-A11CN, BT-<br>A21CN, BT-A41CN<br>can be used for<br>axillary measurement,<br>oral measurement<br>and rectal<br>measurement. | | | Sensor | Thermistor | Thermistor | Thermistor | SE | | Signal<br>Processing<br>and Display | Using the resistance<br>change of thermal<br>resistor to detect body<br>temperature and<br>displayed through the<br>LCD. | Using the resistance<br>change of thermal<br>resistor to detect body<br>temperature and<br>displayed through the<br>LCD. | Using the resistance<br>change of thermal<br>resistor to detect body<br>temperature and<br>displayed through the<br>LCD. | SE | | Power<br>Requirement | 1.5V button battery | 1.5V button battery | 1.5V button battery | SE | | Measurement<br>Temperature<br>Range | 32.0°C ~ 42.9°C | 32.0°C ~ 42.9°C | 32.0°C ~ 42.9°C | SE | | Measurement<br>Accuracy | 35.0 ~ 39.0°C : +/-<br>0.1°C<br>The rest: +/- 0.2°C | 35.0 ~ 39.0°C : +/-<br>0.1°C<br>The rest: +/- 0.2°C | 35.0 ~ 39.0°C: +/-<br>0.1°C<br>The rest: +/- 0.2°C | SE | | Ambient<br>Temperature | 10~35°C | 10~35°C | 0~40°C | SE | | Response<br>Time | 60s | 60s | 60s | SE | | Complied<br>Standard | IEC 60601-1, IEC<br>80601-2-56, IEC<br>60601-1-2, IEC 60601-<br>1-11, ASTM E1112,<br>ISO 10993-5, ISO<br>10993-10 | IEC 60601-1, IEC<br>80601-2-56, IEC 60601-<br>1-2, IEC 60601-1-11,<br>ASTM E1112, ISO<br>10993-5, ISO 10993-10 | IEC 60601-1, IEC<br>80601-2-56, IEC<br>60601-1-2, IEC<br>60601-1-11, ASTM<br>E1112, ISO 10993-5,<br>ISO 10993-10 | SE | {5}------------------------------------------------ ## 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. {6}------------------------------------------------ ## 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. - 8. Summary Prepared Date - 15 August 2017 {7}------------------------------------------------ # Please wait... 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