SteadyTemp

K233280 · Steadysense GmbH · FLL · Jun 21, 2024 · General Hospital

Device Facts

• Record ID: K233280
• Device Name: SteadyTemp
• Applicant: Steadysense GmbH
• Product Code: FLL · General Hospital
• Decision Date: Jun 21, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

SteadyTemp is a wireless, non-invasive, single-use clinical electronic thermometer for all ages. System consists of a disposable SteadySense patch and a mobile SteadyTemp application. Patch contains a solid-state contact temperature transducer; measures axillary skin temperature; records data locally for up to 77 hours. User applies patch to healthy axillary skin; data transmitted to app via Near-Field Communication (NFC). App displays temperature data to user. Device intended for home healthcare environment. Provides continuous temperature monitoring; aids in tracking body temperature trends. Benefits include non-invasive, continuous, precise temperature measurement without requiring frequent manual checks.

Clinical Evidence

Bench testing only. No clinical data. Performance verified against ISO 80601-2-56:2018 (clinical thermometer accuracy), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and IEC 60601-1-11 (home healthcare). Biocompatibility testing (irritation, sensitization, cytotoxicity) performed per ISO 10993-1. Software verified per IEC 62304.

Technological Characteristics

Solid-state contact temperature transducer; 3.0V lithium button cell battery; NFC connectivity (2.5 cm range); flexible textile/insulating foam patch with adhesive layer; dimensions 65x60x3 mm; weight 3g. Software follows IEC 62304. Compliant with ISO 10993-1 for patient-contacting materials.

Indications for Use

Indicated for users of all ages requiring precise body temperature measurement via axillary skin contact.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• TempTraq, Model: TT-100, TT-200, TT-300 (K201977)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| 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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# 510(k) SUMMARY

(as required by 21CFR 807.92)

## K233280

#### I. SUBMITTER

SteadySense GmbH Kärntner Strasse 518 Seiersberg Pirka 8054 Austria Phone: [phone] Phone: [phone] Contact: Brodie Pedersen [e-mail] Phone: [phone] 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

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).

#### V. INDICATIONS FOR USE

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 when using the system is 7 days.

### SUMMARY OF TECHNOLIGICAL CHARACTERISTICS WITH VI. THE 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.

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| Item | Predicate Device<br>TempTraq, models<br>TT-100, TT-200 and TT-300<br>K201977 | Subject Device<br>SteadyTemp<br>K233280 | Comparison |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Indications for<br>Use | The Wireless thermometers are<br>battery-operated electronic<br>devices with intended use of<br>measuring human body<br>temperature precisely. The<br>devices are single-use and<br>intended for armpit<br>temperature measurement for<br>persons of all ages. | The SteadyTemp system is a<br>wireless thermometer intended<br>to provide precise body<br>temperature for users of all<br>ages. The SteadyTemp system<br>comprises a single-use<br>temperature measuring sensor,<br>the SteadySense Patch, and the<br>SteadyTemp application.<br>SteadySense Patch measures<br>and stores axillary skin<br>temperature data up to 10<br>days. The typical application<br>duration when using the<br>system is 7 days. | Similar<br>See Note 1. |
| Product<br>Code | FLL | FLL | Identical |
| Regulation # | 21CFR880.2910 | 21CFR880.2910 | Identical |
| Display Use<br>Specification | iOS device display, Android<br>device display, Web based | iOS device display, Android<br>device display | Similar<br>See Note 2. |
| Working<br>Voltage | 3.0V DC | 3.0V DC | Identical |
| Battery | Two (2) Blue Spark 1.5 V<br>batteries (103-UT1) zinc<br>manganese dioxide | 3.0 V manganese dioxide<br>lithium button cell battery | Similar<br>See Note 3. |
| Measurement<br>Range | 30 - 42 °C (86 °F ~ 108°F) | 30 - 42 °C (86 °F ~ 108°F) | Identical |
| Accuracy | +/- 0.1 °C between<br>30 °C ~ 42.4 °C | Measurement accuracy of +/-<br>0.3°C. 30-42 °C | Similar<br>See Note 4. |
| Temperature<br>Unit | °C or °F | °C or °F | Identical |
| Signal<br>Transmission | Wireless Bluetooth BLE 4.0<br>operating at 2.4Ghz | Near-Field-Communication<br>(NFC): For data transmission<br>between Patch and software<br>application | Difference<br>See Note 5. |
| Receiver | Wireless Bluetooth BLE 4.0<br>enabled smart devices running<br>Apple operating system iOS or<br>Android operating system | Near Field Communication<br>(NFC) enabled smart devices<br>running Apple operating<br>system iOS or Android<br>operating system | Similar<br>See Note 5. |
| Valid<br>Transmission | Up to 40 feet | 2.5 cm | Difference<br>See Note 5. |
| Item | Predicate Device<br>TempTraq, models<br>TT-100, TT-200 and TT-300<br>K201977 | Subject Device<br>SteadyTemp<br>K233280 | Comparison |
| Operating<br>Temperature | 16 C ~ 40 °C (60.8 °F ~ 104 °F) | 15 C ~ 40 °C (59 °F ~ 104 °F) | Similar See<br>Note 12. |
| Operating<br>Humidity | 15%-95% RH | 5%-95% RH | Similar See<br>Note 12. |
| Anatomical<br>Application | Armpit<br>peel-and-stick contact<br>thermometer sensor | Armpit<br>peel-and-stick contact<br>thermometer sensor | Identical |
| Patient<br>Usage | Single-Use | Single-Use | Identical |
| Temperature<br>Measurement<br>Interval | Continuous-transmitter measures<br>body temperature<br>every 10 seconds | Continuous-transmitter measures<br>body temperature<br>Every 300 seconds | Similar See<br>Note 6. |
| Memory<br>Function | TT-100: Can store up to 24<br>hours of readings.<br><br>TT-200: Can store up to 48<br>hours of readings.<br><br>TT-300: Can store up to 72<br>hours of readings | SteadySense Patch: can store up<br>to 77 hours of readings. | Similar See<br>Note 6. |
| Storage | Data back-up- Stored in app<br>and optionally TempTraq<br>Connect | Data back-up- Stored in app. | Similar See<br>Note 7. |
| Run Time | TT-100: 24-Hours<br>TT-200: 48-Hours<br>TT-300: 72-Hours | SteadySense Patch: 10 days | Difference<br>See Note 8. |
| Patient<br>Contacting<br>Materials | ISO 10993-1:<br>Compliant Silicone Gel<br>Adhesive | ISO 10993-1:<br>Compliant adhesive and bandage<br>material | Similar See<br>Note 9. |
| Applications | TempTraq Consumer Mobile<br>Application<br>TempTraq Patient Mobile<br>Application<br>TempTraq Clinician Mobile<br>Application | STEADYTEMP Application | Similar See<br>Note 10. |
| Dimensions | Length: 100.0 mm<br>Height: 50.0 mm<br>Thickness: 2.0 mm<br>Weight: 5.1 g | Length: 65 mm<br>Height: 60 mm<br>Thickness: 3 mm<br>Weight: 3 g | Similar See<br>Note 11. |
| Printed<br>Circuit | Printed circuit | Printed circuit | Similar See<br>Note 12. |
| Storage<br>Temperature | -4 to 122 °F (-20 °C to 50 °C) | +0°C to +40°C | Similar See<br>Note 12 |
| Item | Predicate Device<br>TempTraq, models<br>TT-100, TT-200 and TT-300<br>K201977 | Subject Device<br>SteadyTemp<br>K233280 | Comparison |
| Storage<br>Humidity<br>Range | 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.