The SteadyTemp system is a wireless thermometer intended to provide precise body temperature for users of all ages. The SteadyTemp system comprises a single-use temperature measuring sensor, the SteadySense Patch, and the SteadyTemp application. SteadySense Patch measures and stores axillary skin temperature data up to 10 days. The typical application duration when using the system is 7 days.

Device Description

SteadyTemp is a wireless thermometer designed to provide users of all ages with information about their body temperature. The device has two components, the SteadyTemp app, and the battery operated SteadySense patch. Both are required to measure temperature.

The SteadySense patch is a non-invasive, non-sterile, active temperature measurement device capable of detecting sub-degree (< 0.18°F/ 0.1°C) changes in body temperature by continuously measuring armpit temperature. The SteadySense patch is a disposable bandage product that is applied only to healthy skin under the arm. The top is flexible textile over insulating foam and the bottom is a thin adhesive layer to adhere the thermal sensor to the axilla for measurement recording.

SteadySense temperature measurement is a direct mode, solid state contact temperature transducer embedded in the patch. The patch records up to the last 77 hours of temperature data for download to the SteadyTemp app.

The typical application duration is 7 days. The SteadySense patch continuously records body temperature.

The SteadyTemp app serves as an interface for the user and for interacting with the SteadySense patch and displaying the measured temperature data. The data measured by the patch is transmitted via near-field communication (NFC).

AI/ML Overview

The provided text is a 510(k) summary for the SteadyTemp device, a wireless thermometer. While it describes performance testing and comparisons to a predicate device, it does not contain the detailed acceptance criteria or a comprehensive study plan with the specific information requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (TempTraq) based on technological characteristics and general conformance to various IEC and ISO standards. It mentions "Performance testing was conducted to demonstrate..." for several aspects, but does not provide the specifics of these tests in terms of acceptance criteria, sample sizes, or ground truth establishment.

Therefore, I cannot extract the requested information from the provided text.

Here's a breakdown of why and what information is missing:

1. A table of acceptance criteria and the reported device performance: The document states that "Performance testing was conducted to demonstrate the subject device conforms with IEC 80601-2-56 for absolute temperature accuracy" and mentions an accuracy of "+/- 0.3°C. 30-42 °C". This is a performance metric and a potential acceptance criterion. However, a full table of all acceptance criteria for various aspects (e.g., memory function, run time, signal transmission, biocompatibility) and their corresponding reported performance is not presented in a systematic way. For example, for "Memory Function," it only says "Performance testing was conducted to demonstrate this difference does not affect safety and effectiveness," but no specific numerical acceptance criterion or result is given.
2. Sample sized used for the test set and the data provenance: This information is completely absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a thermometer that measures a physical quantity directly (body temperature). The ground truth would typically be established by a reference thermometer with a known higher accuracy. The text mentions "Biocompatibility testing" and "Software documentation following enhanced documentation level of FDA guidance," which might involve expert review, but details are missing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a thermometer's direct measurement performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is a direct measurement device, not an image interpretation or diagnostic aid involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone measurement device (with an app for display and interface). The performance metrics would inherently be standalone. However, the details of how the standalone performance was measured (e.g., against what reference, under what conditions) are not specified beyond compliance with IEC 80601-2-56.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For temperature accuracy, the ground truth would be a highly accurate reference thermometer. The document implies compliance with IEC 80601-2-56, which would dictate the method for establishing ground truth, but doesn't explicitly describe it here. For biocompatibility, the ground truth comes from standard biological tests.
8. The sample size for the training set: Not applicable. This is a medical device, not a machine learning model where a "training set" in that sense would be used for its core temperature measurement function. It has software, which undergoes "Software Verification and Validation," but this is different from an AI/ML training set.
9. How the ground truth for the training set was established: Not applicable for the reasons mentioned above.

In summary, the provided FDA document is a regulatory submission summary that asserts compliance with various standards and provides comparisons to a predicate device. It does not provide the granular detail of the study design, acceptance criteria, sample sizes, and ground truth establishment that would be present in a full clinical study report or a more detailed technical file.

Summary

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June 21, 2024

SteadySense GmbH % Brodie Pedersen Chief Regulatory Officer Borderless MedDev LLC 7118 Teakwood Cir Maple Grove, Minnesota 55369

Re: K233280

Trade/Device Name: SteadyTemp Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: May 23, 2024 Received: May 24, 2024

Dear Brodie Pedersen:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Daniel Walloschek

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors

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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) K233280

Device Name SteadyTemp

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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

(as required by 21CFR 807.92)

K233280

I. SUBMITTER

SteadySense GmbH Kärntner Strasse 518 Seiersberg Pirka 8054 Austria Phone: +43 660 8850100 Phone: 612-272-5541 Contact: Brodie Pedersen Bropdiecp@BorderlessMD.com Phone: 612-272-5541 Date Prepared: May 31, 2024

DEVICE II.

Name of Device: SteadyTemp Classification Name: Clinical electronic thermometer. Common or Usual Name: Thermometer, Electronic, Clinical Device Panel: General Hospital Devices, and Human Factors Regulation Number: 880.2910 Regulatory Class: Class 2 Product Code: FLL

III. PREDICATE DEVICE

The Steady Temp system is similar in technological characteristics to the predicate device except in the communication technology, NFC vs BLE in the predicate. This yields a difference in the distance of transmission and the reduction in the power consumption of the Steady Temp versus the predicate. These differences do not impact safety or effectiveness.

Name of Device: TempTraq, Model: TT-100, TT-200, TT-300 Predicate submission number: K201977 Regulation Number: 880.2910 Product Code: FLL

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IV. DEVICE DESCRIPTION

The typical application duration is 7 days. The SteadySense patch continuously records body temperature.

V. INDICATIONS FOR USE

SUMMARY OF TECHNOLIGICAL CHARACTERISTICS WITH VI. THE PREDICATE DEVICE

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Item	Predicate DeviceTempTraq, modelsTT-100, TT-200 and TT-300K201977	Subject DeviceSteadyTempK233280	Comparison
Indications forUse	The Wireless thermometers arebattery-operated electronicdevices with intended use ofmeasuring human bodytemperature precisely. Thedevices are single-use andintended for armpittemperature measurement forpersons of all ages.	The SteadyTemp system is awireless thermometer intendedto provide precise bodytemperature for users of allages. The SteadyTemp systemcomprises a single-usetemperature measuring sensor,the SteadySense Patch, and theSteadyTemp application.SteadySense Patch measuresand stores axillary skintemperature data up to 10days. The typical applicationduration when using thesystem is 7 days.	SimilarSee Note 1.
ProductCode	FLL	FLL	Identical
Regulation #	21CFR880.2910	21CFR880.2910	Identical
Display UseSpecification	iOS device display, Androiddevice display, Web based	iOS device display, Androiddevice display	SimilarSee Note 2.
WorkingVoltage	3.0V DC	3.0V DC	Identical
Battery	Two (2) Blue Spark 1.5 Vbatteries (103-UT1) zincmanganese dioxide	3.0 V manganese dioxidelithium button cell battery	SimilarSee Note 3.
MeasurementRange	30 - 42 °C (86 °F ~ 108°F)	30 - 42 °C (86 °F ~ 108°F)	Identical
Accuracy	+/- 0.1 °C between30 °C ~ 42.4 °C	Measurement accuracy of +/-0.3°C. 30-42 °C	SimilarSee Note 4.
TemperatureUnit	°C or °F	°C or °F	Identical
SignalTransmission	Wireless Bluetooth BLE 4.0operating at 2.4Ghz	Near-Field-Communication(NFC): For data transmissionbetween Patch and softwareapplication	DifferenceSee Note 5.
Receiver	Wireless Bluetooth BLE 4.0enabled smart devices runningApple operating system iOS orAndroid operating system	Near Field Communication(NFC) enabled smart devicesrunning Apple operatingsystem iOS or Androidoperating system	SimilarSee Note 5.
ValidTransmission	Up to 40 feet	2.5 cm	DifferenceSee Note 5.
Item	Predicate DeviceTempTraq, modelsTT-100, TT-200 and TT-300K201977	Subject DeviceSteadyTempK233280	Comparison
OperatingTemperature	16 C ~ 40 °C (60.8 °F ~ 104 °F)	15 C ~ 40 °C (59 °F ~ 104 °F)	Similar SeeNote 12.
OperatingHumidity	15%-95% RH	5%-95% RH	Similar SeeNote 12.
AnatomicalApplication	Armpitpeel-and-stick contactthermometer sensor	Armpitpeel-and-stick contactthermometer sensor	Identical
PatientUsage	Single-Use	Single-Use	Identical
TemperatureMeasurementInterval	Continuous-transmitter measuresbody temperatureevery 10 seconds	Continuous-transmitter measuresbody temperatureEvery 300 seconds	Similar SeeNote 6.
MemoryFunction	TT-100: Can store up to 24hours of readings.TT-200: Can store up to 48hours of readings.TT-300: Can store up to 72hours of readings	SteadySense Patch: can store upto 77 hours of readings.	Similar SeeNote 6.
Storage	Data back-up- Stored in appand optionally TempTraqConnect	Data back-up- Stored in app.	Similar SeeNote 7.
Run Time	TT-100: 24-HoursTT-200: 48-HoursTT-300: 72-Hours	SteadySense Patch: 10 days	DifferenceSee Note 8.
PatientContactingMaterials	ISO 10993-1:Compliant Silicone GelAdhesive	ISO 10993-1:Compliant adhesive and bandagematerial	Similar SeeNote 9.
Applications	TempTraq Consumer MobileApplicationTempTraq Patient MobileApplicationTempTraq Clinician MobileApplication	STEADYTEMP Application	Similar SeeNote 10.
Dimensions	Length: 100.0 mmHeight: 50.0 mmThickness: 2.0 mmWeight: 5.1 g	Length: 65 mmHeight: 60 mmThickness: 3 mmWeight: 3 g	Similar SeeNote 11.
PrintedCircuit	Printed circuit	Printed circuit	Similar SeeNote 12.
StorageTemperature	-4 to 122 °F (-20 °C to 50 °C)	+0°C to +40°C	Similar SeeNote 12
Item	Predicate DeviceTempTraq, modelsTT-100, TT-200 and TT-300K201977	Subject DeviceSteadyTempK233280	Comparison
StorageHumidityRange	15 - 95% RH (non-condensing)	15 to 95% RH (non-condensing)	Identical

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Note 1. The Indications for Use of the predicate TempTraq System, models TT-100, TT-200 and TT-300, is similar to the proposed subject device, and is inclusive of both parts of the system. This difference does not affect safety and effectiveness.
Note 2. The Display Use Specification for the predicate TempTraq System is similar to the proposed device, with an additional web-based display use specification. Software Verification and Validation and Performance testing was conducted to demonstrate this difference does not affect safety and effectiveness.
Note 3. The battery used in the proposed SteadyTemp System differs from the predicate device, with two discrete 1.5V cells vs. a single 3V cell. This difference does not affect safety and effectiveness. Electrical safety testing was conducted in accordance with IEC 60601-1:2021 3rd Edition with amendment 1 and 2.
Note 4. The temperature accuracy for the proposed system SteadyTemp differs from the predicate Temp Traq device. Performance testing was conducted to demonstrate the subject device conforms with IEC 80601-2-56 for absolute temperature accuracy. The difference does not raise new or different safety and effectiveness questions.
Note 5. The signal transmission for the proposed system (NFC) differs from the predicate Temp Traq device (BLE). Performance testing was conducted to demonstrate this difference does not affect safety and effectiveness. The NFC communication is passive and much lower power the BLE.
Note 6. The Memory Function for the proposed SteadyTemp system differs from the predicate device. Performance testing was conducted to demonstrate this difference does not affect safety and effectiveness.
Note 7. The Storage for the proposed SteadyTemp system differs from the predicate device. Software Verification and Validation and Performance testing was conducted to demonstrate this difference does not affect safety and effectiveness.
Note 8. The Run Time for two new models (TT-200 and TT-300) of the predicate TempTraq System differs from the proposed SteadyTemp system. Performance testing was conducted to demonstrate this difference does not affect safety and effectiveness.
Note 9. The patient contacting material for the proposed SteadyTemp system differs from the predicate device. Biocompatibility testing was conducted in accordance with ISO 10993-1 to demonstrate this difference does not affect safety and effectiveness.
Note 10. The Applications for the proposed SteadyTemp system differ from the predicate device. Software Verification and Validation and Performance testing was conducted to demonstrate this difference does not affect safety and effectiveness.

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Note 11. The dimensions for the proposed SteadyTemp system differ from the predicate device. This difference does not have any impact on safety or effectiveness.
Note 12. The Printed Circuit for the proposed SteadyTemp system is similar to the predicate device. Storage temperature difference is due to the battery in the device for optimal life and safe storage. Electrical Safety (IEC 60601-1 Edition 3.2) and EMC testing (JEC 60601-1-2 4.1 Edition) was conducted to demonstrate these differences do not impact safety and effectiveness.

VII. PERFORMANCE TESTING

The following non-clinical performance tests have been passed successfully:

ISO 80601-2-56:2018 Medical electrical equipment Part 2-56: . Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
IEC 60601-1:2021 3rd Edition with amendment 1 and 2. Medical . electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2: 2021 4th Edition with amendment 1, Medical . Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-1-11:2021 Edition 1.2, 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 in the home healthcare environment.
IEC 62304:2016 Edition 1.1, Medical device software Software life ● cycle processes.
Biocompatibility testing of patient contacting materials according to ISO 10993-1 including Irritation, Sensitization and Cytotoxicity.
Bench test results verify that SteadyTemp system can continuously ● record temperature, store temperature data in the device memory, and transmit recordings to the SteadyTemp app via NFC app connection for display by the user. Test results verify that all requirements were met and that the SteadyTemp System performs as designed.
Software documentation following enhanced documentation . level of FDA guidance and prepared in accordance with IEC 62304 to verify and validate software performance of the SteadyTemp system.
Cyber Security of the system has been addressed following FDA . guidance assessing threats and addressing the subsequent potential risk to the system through design controls, access limitation and monitoring of software components for new threats.

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VIII. CONCLUSIONS

The analysis of the differences between SteadyTemp and the predicate device does not raise new questions of safety and effectiveness. Based on device technological characteristics comparison, analysis, and performance test results, SteadySense determines that the SteadyTemp system performs within its design specifications and is substantially equivalent to the predicate device.

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.