NC° Thermometer (Gen 3), Model Number: NCTG3

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June 20, 2023 Xiamen Intretech Inc. % Megan Callanan Regulatory and Compliance Manager Natural Cycles 510 5th Avenue 3rd Floor New York, New York 10036 Re: K223522 Trade/Device Name: NCº Thermometer (Gen 3), Model Number: NCTG3 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: May 19, 2023 Received: May 19, 2023 Dear Megan Callanan: 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. 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You must comply with all the Act's {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, David Walloschek David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223522 Device Name NCº Thermometer (Gen3), Model Number: NCTG3 #### Indications for Use (Describe) The NC Thermometer (Gen3) is used orally for the intermittent measurement and monitoring of human body temperature. The device can be used by adults and children over the age of 5 years old. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K223522 # 510(k) Summary: NC° Thermometer (Gen3) | Applicant: | Xiamen Intretech Inc.<br>No.100 Dongfu West Road<br>Haicang District, Xiamen<br>Fujian, China Zip:361027 | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant Contact: | Name: Sunny Sun<br>Phone: 86-15750706715<br>Email: xmshj@intretech.com | | Correspondent: | Name: Megan Callanan<br>Phone: (216)744-4524<br>Email: Megan.callanan@naturalcycles.com | | Date Prepared: | June 17, 2023 | | Trade Name: | NC° Thermometer (Gen3),<br>Model Number: NCTG3 | | Common Name: | Clinical electronic thermometer | | Proposed Class: | Class II | | Classification Name: | Clinical electronic thermometer | | Regulation Number: | 21 CFR 880.2910 | | Product Code: | FLL | | Predicate Device: | K173730 KSA-110 Clinical electronic thermometer from KINSA,INC ,<br>marketed as the Kinsa QuickCare Thermometer. | | Device Description: | The purpose of this traditional 510(k) premarket notification is to introduce<br>NC° Thermometer (Gen3). NC° Thermometer (Gen3) is a battery powered,<br>thermistor- based Bluetooth Low Energy (BLE) and Near Field<br>Communication (NFC) enabled adjusted mode digital thermometer that<br>uses a predictive algorithm for the measurement and monitoring of human<br>body temperature. Body temperature is measured orally with the NC°<br>Thermometer. Temperature measurements are displayed on the<br>thermometer and can also (optionally) be transmitted to the Natural Cycles<br>application on the user's smartphone by women over the age of 18. The<br>compatible application displays the thermometer temperature value. The | | | thermometer is reusable for home use on adults and children ages 5 and<br>above. The thermometer is made of biocompatible metals and resins. The<br>thermometer consists of a Negative Temperature Coefficient (NTC)<br>thermistor located in the probe tip to sense human body temperature,<br>three input user facing buttons, an output buzzer for audio indications, a<br>screen for user display, and back lights for illuminating the buttons. | | Indications for<br>Use: | The NC° Thermometer (Gen3) is used orally for the intermittent<br>measurement and monitoring of human body temperature. The device can<br>be used by adults and children over the age of 5 years old. | {4}------------------------------------------------ # Summary of Technical Characteristics: The technology of the NC° Thermometer (Gen3) is identical to the predicate device in terms of its principle of operation, thermistor, use of a prediction algorithm, and probe tip design. The industrial design is similar to the predicate except for the outer shell form. | Element of<br>comparison | Subject Device<br>NC° Thermometer (Gen3)<br>K223522 | Predicate Device<br>Kinsa QuickCare<br>Thermometer<br>K173730 | Verdict | |-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | Thermometer<br>type | Predictive digital | Predictive digital | Same | | Indications for<br>Use | The NC° Thermometer<br>(Gen3) is used orally for the<br>intermittent measurement<br>and monitoring of human<br>body temperature. The<br>device can be used by<br>adults and children over the<br>age of 5 years old. | The Kinsa QuickCare<br>Thermometer is used for the<br>intermittent measurement<br>and monitoring of human<br>body temperature, orally,<br>rectally and under the arm.<br>The device is for the adult<br>and pediatric population. | Similar1 | | Fundamental<br>technology &<br>Operating<br>principle | Utilizes an NTC thermistor<br>located in the probe tip to<br>sense human body<br>temperature when placed in<br>the desired measuring site<br>(mouth). The resulting<br>change in resistance is<br>sensed and monitored in<br>order to through use of | Utilizes an NTC thermistor<br>located in the probe tip to<br>sense human body<br>temperature when placed in<br>the desired measuring site<br>(mouth, underarm, and<br>rectum). The resulting change<br>in resistance is sensed and<br>monitored in order to through | Similar2 | | | | | | | | predictive algorithms<br>estimate human body<br>temperature. | use of predictive algorithms<br>estimate human body<br>temperature. | | | Sensor | Thermistor based | Thermistor based | Same | | Signal<br>processing<br>and display | Internal firmware and local<br>screen display<br>- Also able to transfer<br>transmit data to an auxiliary<br>device for secondary display | Internal firmware and local<br>LCD display<br>- Also able to transfer<br>transmit data to an auxiliary<br>device for secondary display | Same | | Wireless<br>Interface | Bluetooth Low Energy (BLE)<br>and Near Field<br>Communication (NFC) | Bluetooth Low Energy (BLE) | Different1 | | Compatible<br>Application<br>Name | Natural Cycles | Kinsa | Different2 | | Compatible<br>Application<br>Display of<br>Thermometer<br>Related Data | Temperature, timestamp | Temperature, timestamp, tips<br>from our in-house clinician,<br>share your illness timeline<br>with another caregiver or<br>your doctor | Different3 | | Power<br>requirements | Battery powered CR2032<br>(3V) | Battery powered (CR2032<br>(3V) | Same | | Patient<br>Contacting<br>Materials | SUS316L, ABS, PMMA,<br>ABS+SMMA | SU304 Stainless Steel, ABS,<br>PMMA | Similar3 | | Scale | °F / °C | °F / °C | Same | | Measurement<br>locations | Oral | Oral, Axillary and Rectal | Different4 | | Measurement<br>Range | 32 to 42 °C (89.6 to 107.6<br>°F) | 32 to 42.8 °C (89.6 to 109.2<br>°F) | Different5 | | Number of<br>measurements<br>that can be<br>saved and<br>viewed on<br>thermometer | 10 | N/A- No history button on<br>thermometer | Different6 | | Thermometer<br>Buttons | Power button, setting<br>button, history button | Power button | Different7 | | Operating<br>Environment | 15 to 40°C<br>< 95% relative humidity non- | 15 to 35 °C<br>15 to 85% Relative humidity | Different8 | | Storage<br>Environment | -25 to 50 °C<br>≤ 95% relative humidity<br>70kPa to 106kPa | -25 to 70 °C<br>Up to 90% relative humidity,<br>non-condensing, up to 50 hPa | Different9 | | Accuracy | ±0.2°C/0.3°F (Temperature less<br>than 37°C/98.0°F)<br>±0.1°C/0.2°F (Temperature<br>37.0°C to 39.0°C/98.0°F to<br>102.0°F)<br>±0.2°C/0.3°F (Temperature<br>greater than 39.0°C/102.0°F) | ± 0.2°C within measurement<br>range of 32 to 42.8°C (89.6<br>to 109.2°F) | Different10 | | Response<br>Time | 40 seconds nominally | 8 seconds nominally | Different11 | | Resolution of<br>Display | 0.01 °C / 0.01°F | 0.1 °C / 0.1°F | Different12 | | Performance | Meets ISO 80601-2-56:2017 | Meets ISO 80601-2-56 | Same | | Biocompatibility | Meets ISO 10993-1:2018,<br>ISO 10993-5:2009, ISO<br>10993-10:2010 | Meets ISO 10993-1:2009,<br>ISO 10993-5:2009, ISO<br>10993-10:2010 | Same | | Electrical<br>Safety | Meets AAMI/ANSI ES<br>60601-1:2005+A2:2020 | Meets AAMI/ANSI ES 60601-<br>1:2005+A1:2012 | Same | | Electromagnetic<br>Disturbances | Meets IEC 60601-1-2:2014 | Meets IEC 60601-1-2:2014 | Same | {5}------------------------------------------------ Traditional 510(k) {6}------------------------------------------------ Traditional 510(k) # Discussion of Similar Elements of Comparison: - 1. Similar indications for use: The subject device can only be used for adults and children over the age of 5. The predicate device indications for use do not specify a pediatric age limit. As the subject device is intended for oral use only, the intended user was limited to children over the age of 5 years old and adults. Performance testing demonstrates that the subject device meets ISO 80601-2-56 and the different pediatric age limit does not raise any new safety and effectiveness questions. - 2. Similar fundamental technology and operating principle: Similar hardware is used in both devices. Performance testing demonstrates that the subject device meets ISO 80601-2-56 and ASTM E1112. The differences in fundamental technology and operating principle do not raise any new safety and effectiveness questions. - 3. Similar patient contacting materials: The thermometer materials are similar except for the probe tip and buttons. The subject device probe tip uses an equivalent biocompatible stainless steel and the subject device buttons include an additional thermoplastic, SMMA. All skin contacting materials in the subject device have been tested successfully for biocompatibility: cytotoxicity in accordance with AAMI/ANSI/ISO 10993-5:2009/(R)2014, Biological Evaluation of {7}------------------------------------------------ Medical Devices Part 5: Tests for In Vitro Cytotoxicity, as well as irritation and sensitization in accordance with AAMI/ANSI/ISO 10993-10:2010/(R)2014. Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization. The materials used in the subject device do not raise any new questions of safety and effectiveness. ### Discussion of Different Elements of Comparison: - 1. Different wireless interface: The subject device has NFC interface in addition to BLE. while the predicate device has BLE. NFC is a widely used technology and the subject device has passed electrical safety and electromagnetic compatibility testing in accordance with the FDA recognized consensus standards: AAMI/ANSI ES 60601-1:2005/(R)2012 + A1:2012, C1:2009/(R)2012 + A2:2010/(R)2012, IEC 60601-1-2:2014, IEC60601-1-11 Edition 2.1 2020-07, FCC Part 15 Subpart C & 15.247, and FCC Part 15 Subpart C & 15.225. Additionally, performance data consisting of software verification, cybersecurity analysis, wireless coexistence testing, usability testing demonstrate the safe and effective use of this feature. The essential performance of the subject device is not compromised as the primary display of the temperature readings on the thermometer's local screen is independent of the wireless transmission. The addition of the NFC wireless interface does not raise different questions of safety and effectiveness. - 2. Different compatible application name: Subject and predicate thermometers are compatible with different applications. Both applications are downloaded onto smartphones and allow users to see temperature and timestamp. The essential performance of the subject device is not compromised as the primary display of the temperature readings on the thermometer's local screen is independent of the wireless transmission. The subject device has passed electrical safety and electromaqnetic compatibility testing in accordance with the FDA recognized consensus standards: AAMI/ANSI ES 60601-1:2005/(R)2012 + A1:2012, C1:2009/(R)2012 + A2:2010/(R)2012, IEC 60601-1-2:2014, IEC60601-1-11 Edition 2.1 2020-07, FCC Part 15 Subpart C § 15.247, and FCC Part 15 Subpart C § 15.225. Additionally, performance data consisting of software verification, cybersecurity analysis, wireless coexistence testing, usability testing demonstrate the safe and effective use of the subject device and compatible application. - 3. Different compatible application display of temperature related data: The predicate thermometer's compatible app provides more information regarding illness but both apps function equivalently when receiving temperature and timestamp data and displaying it on the phone. The predicate thermometer's compatible application has additional features related to illness such as tips from clinician and illness timeline but these features do not impact the safe and effective use of the thermometer. The subject thermometer compatible app is a medical device while the predicate is not but this does not impact the app with respect to the thermometer. The subject device has passed electrical safety and electromagnetic compatibility testing in accordance with the FDA recognized {8}------------------------------------------------ consensus standards: AAMI/ANSI ES 60601-1:2005/(R)2012 + A1:2012, C1:2009/(R)2012 + A2:2010/(R)2012, IEC 60601-1-2:2014, IEC60601-1-11 Edition 2.1 2020-07, FCC Part 15 Subpart C § 15.247, and FCC Part 15 Subpart C & 15.225. Additionally, performance data consisting of software verification, cybersecurity analysis, wireless coexistence testing, usability testing demonstrate the safe and effective use of the subject device and compatible application. - 4. Different measurement locations: The subject device is used for oral measurement only. The route of temperature measurement for the subject device is a subset of the routes available using the predicate device. Both the subject and predicate devices are used for oral measurements. The subject device meets the requirements of ISO 80601-2-56 and ASTM E1112 for oral use and the limitation on measuring routes does not raise any different questions of safety and effectiveness. - 5. Different measurement range: The subject device has a lower upper limit of measurement range than the predicate device. The ISO 80601-2-56 performance testing of the subject device demonstrated that the difference does not raise any new questions of safety and effectiveness. - 6. Different number of measurements that can be saved and viewed on thermometer: There is no history button on the predicate device and thus no measurements can be saved and viewed on the thermometer. The subject device has a history button, but this does not impact the essential performance of the subject device. Software verification, design verification, and usability testing demonstrates that the history button and display of previous measurements on the thermometer does not raise any new questions of safety and effectiveness. - 7. Different thermometer buttons: Compared to the predicate device, there are two more buttons (history button and settings button) on the subject device. The essential performance of the subject device is not compromised as temperature measurement and display of temperature readings is independent of History and Settings buttons. Performance data consisting of software verification, design verification, and usability testing demonstrates the safe and effective use of all buttons. It does not raise new questions of safety and effectiveness. - 8. Different operating environment: The subject device has larger operating range and higher humidity requirements than the predicate device. The operating environment requirements on the subject device and the predicate device both meet the IEC 60601-1-11 and ISO80601-2-56 standards and performance testing conducted according to these standards demonstrates that the difference in operating environment does not raise any new questions of safety and effectiveness. - 9. Different storage environment: The subject device has a smaller storage range and higher humidity limitation. The storage environment requirements on the subject device and the predicate device both meet the IEC 60601-1-11 and ISO80601-2-56 standards and performance testing conducted according to these standards demonstrates that the difference in storage environment does not raise any new questions of safety and effectiveness. {9}------------------------------------------------ - 10. Different accuracy: The subject device meets ISO80601-2-56 and ASTM E1112 requirements, while the predicate device meets ISO80601-2-56. The subject device has higher accuracy than the predicate device from 37 to 39°C because ASTM E1112 has stricter accuracy requirements. Performance testing was conducted on the subject device according to ASTM E1112 and ISO80601-2-56. The difference does not raise any new performance or safety concerns. - 11. Different response time: The subject device has longer measurement time than the predicate device, but usability testing showed the measuring time is well within user expectations and far below the 3 minutes that would be required without a predictive algorithm. This specification has been validated by the testing per ISO 80601-2-56 and ASTM E1112. The difference does not raise any new questions of safety and effectiveness. - 12. Different resolution of display: The subject device has a higher resolution of display than the predicate device. Performance testing demonstrated that the subject device is in compliance with both ISO 80601-2-56 and ASTM E1112 requirements. The difference in resolution of display does not raise any new questions of safety and effectiveness. ## Testing to Demonstrate Substantial Equivalence: ### Non-clinical Testing Non-clinical performance reports were provided to document verification and validation activities intended to demonstrate substantial equivalence of the subject device to the predicate device: - 1. Design Verification results confirmed the device meets the product requirements set by and the performance standard requirements of ISO 80601-2-56:2017, Medical Electrical Equipment – Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement and ASTM E 1112-00 (2018) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature. - 2. Software Verification and Validation results confirmed the firmware and software units meet the software requirements specifications and the system performs as intended. Software documentation is provided in accordance with the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005). - 3. Cybersecurity hazards and risks associated with the thermometer have been evaluated. Cybersecurity information is provided in accordance with the FDA Guidance "Content of Premarket Submission for Management of Cybersecurity in Medical Devices" - 4. All skin contacting materials have been tested successfully for biocompatibility: cytotoxicity in accordance with AAMI/ANSI/ISO 10993-5:2009 /(R)2014, Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity, as well as irritation and sensitization in accordance with AAMI/ANSI/ISO 10993- {10}------------------------------------------------ 10:2010/(R)2014, Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization. - 5. Electrical and Mechanical Safety as well as essential performance was confirmed through compliance testing to AAMI/ANSI ES 60601-1:2005/(R)2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance and IEC 60601-1-11:2015, Medical Electrical Equipment Part 1-11: Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment. - 6. Electromagnetic Compatibility was confirmed through compliance testing to IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: Electromagnetic Disturbances – Requirements and Tests. - 7. FCC compliance was confirmed through testing to FCC Part 15 Subpart C §15.247/ RSS 247. - 8. Interoperability testing was completed to ensure that the thermometer is able to communicate with the Natural Cycles application as intended. ## Clinical Testing To support the performance of the NC° Thermometer (Gen3), a clinical validation study was performed. The study evaluated the clinical performance of the NC° Thermometer (Gen3) to a reference clinical thermometer in accordance with ISO 80601-2-56. Clinical validation study reports were provided with this submission. The pivotal clinical study included 105 participants, 32 (30%) were febrile. All participants were over the age of 5 years old. 64 participants (61%) were female and 41 participants (39%) were male. Based on the clinical performance as documented in the pivotal clinical study, the NC° Thermometers (Gen3) was found to meet the ISO 80601-2-56 requirements of clinical accuracy for an adjusted thermometer. ## Conclusion: Based on the design features, the use of established well known materials, feature comparisons, and indications for use, the NC° Thermometer (Gen3) has demonstrated substantial equivalence to the identified predicate device.