Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The device description mentions a "predictive algorithm" but does not explicitly state whether this algorithm utilizes AI or ML. The absence of mentions of AI, DNN, or ML, along with the lack of details on training or test sets, makes it impossible to definitively confirm the presence of AI/ML.

Therapeutic

No.
The device is a thermometer used for measuring and monitoring human body temperature, not for therapeutic purposes.

Diagnostic

No
The device is a thermometer used for measuring and monitoring human body temperature, which is a measurement tool rather than a diagnostic one. While temperature can be an indicator for health conditions, the device itself doesn't provide a diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components including a battery, thermistor, buttons, buzzer, screen, and backlights. While it interacts with software (the Natural Cycles application), the core device is a physical thermometer.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to diagnose, monitor, or screen for diseases.
Device Function: The NC Thermometer (Gen3) measures human body temperature directly from the body (orally). It does not analyze samples taken from the body.
Intended Use: The intended use is for the intermittent measurement and monitoring of human body temperature, which is a physiological measurement, not an in vitro diagnostic test.

Therefore, the NC Thermometer (Gen3) falls under the category of a medical device, specifically a thermometer, but not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

FLL

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

orally

Indicated Patient Age Range

adults and children over the age of 5 years old.

Intended User / Care Setting

home use

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)

Non-clinical Testing:

Design Verification: Confirmed compliance with ISO 80601-2-56:2017 and ASTM E 1112-00 (2018).
Software Verification and Validation: Confirmed firmware and software unit compliance with requirements per FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).
Cybersecurity: Hazards and risks evaluated per FDA Guidance "Content of Premarket Submission for Management of Cybersecurity in Medical Devices".
Biocompatibility: Skin contacting materials tested for cytotoxicity (AAMI/ANSI/ISO 10993-5:2009 /(R)2014) and irritation/sensitization (AAMI/ANSI/ISO 10993-10:2010/(R)2014).
Electrical and Mechanical Safety: Confirmed compliance with AAMI/ANSI ES 60601-1:2005/(R)2012 and IEC 60601-1-11:2015.
Electromagnetic Compatibility: Confirmed compliance with IEC 60601-1-2:2014.
FCC compliance: Confirmed compliance with FCC Part 15 Subpart C §15.247/ RSS 247.
Interoperability testing: Ensured communication with Natural Cycles application.

Clinical Testing:
Study type: Clinical validation study
Sample size: 105 participants (32 (30%) febrile)
Data source: Clinical study
Annotation protocol: Not Found
Key results: The NC° Thermometers (Gen3) was found to meet the ISO 80601-2-56 requirements of clinical accuracy for an adjusted thermometer.

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

Accuracy:
±0.2°C/0.3°F (Temperature less than 37°C/98.0°F)
±0.1°C/0.2°F (Temperature 37.0°C to 39.0°C/98.0°F to 102.0°F)
±0.2°C/0.3°F (Temperature greater than 39.0°C/102.0°F)

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.

K173730

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

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. To the left of the FDA logo is the Department of Health & Human Services logo.

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. 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

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

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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)

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K223522

510(k) Summary: NC° Thermometer (Gen3)

| Applicant: | Xiamen Intretech Inc.
No.100 Dongfu West Road
Haicang District, Xiamen
Fujian, China Zip:361027 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Contact: | Name: Sunny Sun
Phone: 86-15750706715
Email: xmshj@intretech.com |
| Correspondent: | Name: Megan Callanan
Phone: (216)744-4524
Email: Megan.callanan@naturalcycles.com |
| Date Prepared: | June 17, 2023 |
| Trade Name: | NC° Thermometer (Gen3),
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 ,
marketed as the Kinsa QuickCare Thermometer. |
| Device Description: | 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. |
| Indications for
Use: | 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. |

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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
comparison | Subject Device
NC° Thermometer (Gen3)
K223522 | Predicate Device
Kinsa QuickCare
Thermometer
K173730 | Verdict |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Thermometer
type | Predictive digital | Predictive digital | Same |
| Indications for
Use | 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 Kinsa QuickCare
Thermometer is used for the
intermittent measurement
and monitoring of human
body temperature, orally,
rectally and under the arm.
The device is for the adult
and pediatric population. | Similar1 |
| Fundamental
technology &
Operating
principle | Utilizes an NTC thermistor
located in the probe tip to
sense human body
temperature when placed in
the desired measuring site
(mouth). The resulting
change in resistance is
sensed and monitored in
order to through use of | Utilizes an NTC thermistor
located in the probe tip to
sense human body
temperature when placed in
the desired measuring site
(mouth, underarm, and
rectum). The resulting change
in resistance is sensed and
monitored in order to through | Similar2 |
| | | | |
| | predictive algorithms
estimate human body
temperature. | use of predictive algorithms
estimate human body
temperature. | |
| Sensor | Thermistor based | Thermistor based | Same |
| Signal
processing
and display | Internal firmware and local
screen display

Also able to transfer
transmit data to an auxiliary
device for secondary display | Internal firmware and local
LCD display
Also able to transfer
transmit data to an auxiliary
device for secondary display | Same |
| Wireless
Interface | Bluetooth Low Energy (BLE)
and Near Field
Communication (NFC) | Bluetooth Low Energy (BLE) | Different1 |
| Compatible
Application
Name | Natural Cycles | Kinsa | Different2 |
| Compatible
Application
Display of
Thermometer
Related Data | Temperature, timestamp | Temperature, timestamp, tips
from our in-house clinician,
share your illness timeline
with another caregiver or
your doctor | Different3 |
| Power
requirements | Battery powered CR2032
(3V) | Battery powered (CR2032
(3V) | Same |
| Patient
Contacting
Materials | SUS316L, ABS, PMMA,
ABS+SMMA | SU304 Stainless Steel, ABS,
PMMA | Similar3 |
| Scale | °F / °C | °F / °C | Same |
| Measurement
locations | Oral | Oral, Axillary and Rectal | Different4 |
| Measurement
Range | 32 to 42 °C (89.6 to 107.6
°F) | 32 to 42.8 °C (89.6 to 109.2
°F) | Different5 |
| Number of
measurements
that can be
saved and
viewed on
thermometer | 10 | N/A- No history button on
thermometer | Different6 |
| Thermometer
Buttons | Power button, setting
button, history button | Power button | Different7 |
| Operating
Environment | 15 to 40°C