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510(k) Data Aggregation
(209 days)
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.
The purpose of this traditional 510(k) premarket notification is to introduce NC° Thermometer (Gen3). NC° Thermometer (Gen3) is a battery powered, thermistor- based Bluetooth Low Energy (BLE) and Near Field Communication (NFC) enabled adjusted mode digital thermometer that uses a predictive algorithm for the measurement and monitoring of human body temperature. Body temperature is measured orally with the NC° Thermometer. Temperature measurements are displayed on the thermometer and can also (optionally) be transmitted to the Natural Cycles application on the user's smartphone by women over the age of 18. The compatible application displays the thermometer temperature value. The thermometer is reusable for home use on adults and children ages 5 and above. The thermometer is made of biocompatible metals and resins. The thermometer consists of a Negative Temperature Coefficient (NTC) thermistor located in the probe tip to sense human body temperature, three input user facing buttons, an output buzzer for audio indications, a screen for user display, and back lights for illuminating the buttons.
The context provided is for a clinical electronic thermometer, not an AI-powered medical device. Therefore, the information typically requested in questions related to acceptance criteria and study designs for AI/ML-based medical devices (such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not directly applicable or available in this document.
The document primarily focuses on demonstrating substantial equivalence of the NC° Thermometer (Gen3) to a predicate device (Kinsa QuickCare Thermometer) based on technical characteristics, non-clinical testing, and a clinical validation study for its accuracy as a thermometer.
However, I can extract the relevant information regarding the device's performance and the study that proves it meets acceptance criteria as per the provided text for a clinical electronic thermometer.
Device: NC° Thermometer (Gen3)
Device Type: Clinical electronic thermometer
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Specific Criterion / Requirement (Acceptance) | Reported Device Performance |
|---|---|---|
| Accuracy (Clinical) | Meets ISO 80601-2-56:2017 requirements for clinical accuracy of an adjusted thermometer. | The NC° Thermometer (Gen3) was found to meet the ISO 80601-2-56 requirements of clinical accuracy for an adjusted thermometer, as documented in the pivotal clinical study. |
| Accuracy (Technical) | ±0.2°C/0.3°F (Temperature 39.0°C/102.0°F) | |
| Meets ASTM E1112-00 (2018) and ISO 80601-2-56:2017. | Performance testing conducted on the subject device according to ASTM E1112 and ISO 80601-2-56 demonstrated that it meets these accuracy requirements. The device has higher accuracy than the predicate device from 37 to 39°C because ASTM E1112 has stricter accuracy requirements. | |
| Response Time | Specified (nominal 40 seconds) and validated by testing per ISO 80601-2-56 and ASTM E1112. User expectations considered. | Nominally 40 seconds. 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. |
| Resolution of Display | Specified (0.01 °C / 0.01°F) and meets ISO 80601-2-56 and ASTM E1112 requirements. | Performance testing demonstrated that the subject device is in compliance with both ISO 80601-2-56 and ASTM E1112 requirements for display resolution. |
| Biocompatibility | Meets ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010. | All skin contacting materials successfully tested for biocompatibility (cytotoxicity, irritation, sensitization) in accordance with AAMI/ANSI/ISO 10993-5:2009/(R)2014 and AAMI/ANSI/ISO 10993-10:2010/(R)2014. |
| Electrical Safety | Meets AAMI/ANSI ES 60601-1:2005+A2:2020 and IEC 60601-1-11:2015. | Confirmed through compliance testing to AAMI/ANSI ES 60601-1:2005/(R)2012 + A1:2012, C1:2009/(R)2012 + A2:2010/(R)2012, and IEC 60601-1-11:2015 (Edition 2.1 2020-07). |
| **Electromagnetic | ||
| Compatibility (EMC)** | Meets IEC 60601-1-2:2014 and FCC Part 15 Subpart C (§15.247 / RSS 247 and §15.225). | Confirmed through compliance testing to IEC 60601-1-2:2014, FCC Part 15 Subpart C § 15.247, and FCC Part 15 Subpart C § 15.225. |
| Software Performance | Firmware and software units meet software requirements specifications and system performs as intended. | Software Verification and Validation results confirmed the firmware and software units meet the software requirements specifications and the system performs as intended. Software documentation provided per FDA guidance. |
| Cybersecurity | Hazards and risks evaluated and managed. | Cybersecurity hazards and risks associated with the thermometer have been evaluated. Information provided per FDA Guidance "Content of Premarket Submission for Management of Cybersecurity in Medical Devices". |
| Wireless Interoperability | Able to communicate with the Natural Cycles application as intended. | Interoperability testing completed to ensure that the thermometer is able to communicate with the Natural Cycles application as intended. Performance data includes software verification, cybersecurity analysis, wireless coexistence testing, and usability testing. |
| Operating Environment | 15 to 40°C, |
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