K Number
K233280
Device Name
SteadyTemp
Manufacturer
Date Cleared
2024-06-21

(266 days)

Product Code
Regulation Number
880.2910
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 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).
More Information

Not Found

No
The summary describes a standard digital thermometer with data storage and transmission capabilities. There is no mention of AI, ML, or any algorithms that would suggest learning or intelligent processing of the temperature data beyond simple display.

No
The device is described as a "wireless thermometer intended to provide precise body temperature" and is a "temperature measurement device". Its function is to measure and display temperature, not to treat or cure a condition.

No

The device is a thermometer, which measures body temperature. While temperature can be a diagnostic indicator, the device itself provides a measurement, not a diagnosis. Its intended use states "to provide precise body temperature for users," and it is described as a "wireless thermometer." Diagnostic devices typically analyze data to infer or determine a medical condition.

No

The device description explicitly states that the SteadyTemp system has two components: the SteadyTemp app and the SteadySense patch. It also states that "Both are required to measure temperature." The SteadySense patch is described as a "battery operated SteadySense patch" and an "active temperature measurement device," indicating it is a hardware component essential for the device's function.

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

Here's why:

  • IVDs analyze specimens from the human body. The SteadyTemp system measures body temperature directly from the skin (axilla). It does not analyze blood, urine, tissue, or any other biological specimen.
  • The intended use is for measuring body temperature. The description clearly states its purpose is to "provide precise body temperature." This is a physiological measurement, not an in vitro analysis.
  • The device description focuses on temperature measurement technology. The details about the sensor, patch, and app all relate to the process of measuring and displaying temperature.

Therefore, the SteadyTemp system falls under the category of a clinical thermometer or a similar type of medical device that measures a physiological parameter, rather than an IVD.

N/A

Intended Use / 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 duration when using the system is 7 days.

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

FLL

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 (

§ 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.

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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)

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: +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

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 (