3M SPOTON TEMPERATURE MONITORING SYSTEM

K120412 · Arizant Healthcare, Inc. · FLL · May 30, 2012 · General Hospital

Device Facts

• Record ID: K120412
• Device Name: 3M SPOTON TEMPERATURE MONITORING SYSTEM
• Applicant: Arizant Healthcare, Inc.
• Product Code: FLL · General Hospital
• Decision Date: May 30, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Measure, monitor, and trend body temperature of adult and pediatric patients.

Device Story

The 3M SpotOn temperature monitoring system is a clinical electronic thermometer utilizing zero-heat-flux thermometry to measure body temperature. The system comprises a disposable sensor, a control unit, a power supply, and an optional interface cable. It functions by measuring temperature and providing numerical data and time-series graphs on an LCD display. The device can transmit data to a standard YSI-400 input on a vital signs monitor. It is intended for use in clinical settings to assist healthcare providers in monitoring patient temperature trends. By providing continuous, non-invasive temperature data, the device aids in clinical decision-making regarding patient thermal status.

Clinical Evidence

Clinical performance was evaluated using a method comparison trial design comparing the Zero-Heat-Flux-Deep-Tissue-Thermometry (DTT) system against standard clinical thermometers at oral or rectal reference sites. The study followed ISO 80601-2-56 and ASTM E1965-98 guidelines. Results demonstrated that the agreement of the DTT system to predictive oral or rectal thermometry is comparable to the agreement between direct/indirect tympanic thermometry and brain parenchyma or pulmonary artery blood temperature. Mean bias observed in subgroups was no worse than the bias between axillary and bladder temperatures.

Technological Characteristics

Zero-heat-flux thermometry; microprocessor-based signal processing; LCD display; YSI-400 thermistor emulation; 25.0°C to 43.0°C range; 2-hour sensor memory storage. Standards: ISO 80601-2-56, EN 12470-4, ASTM E1112-00, IEC 60601-1, IEC 60601-1-2, ISO 10993.

Indications for Use

Indicated for measuring, monitoring, and trending body temperature in adult and pediatric patients.

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

• Terumo America, Inc. Thermo-Finer CoreTemp (K760948)

Submission Summary (Full Text)

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# 510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety & Effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. The device is a Class II device called the 3MTM SpotOn™ temperature monitoring system.

## Submitter

:; ﺳﺎ ﻣﯿﮟ ﻭﺍﻗﻊ ﮨﮯ۔

> Arizant Healthcare Inc., a 3M company 10393 West 70th Street, Eden Prairie, MN 55344

Date Prepared February 9, 2012

Trade/Proprietary Name 3MTM SpotOn™ temperature monitoring system

Common/Usual Name

Electronic thermometer

Classification Name Thermometer, electronic, clinical

#### Predicate Devices

Terumo America, Inc. Thermo-Finer CoreTemp (K760948)

## Intended Use

Measure, monitor, and trend body temperature of adult and pediatric patients.

## Contact

David Westlin Chief Compliance Officer and Senior Director of Regulatory Affairs

Arizant Healthcare Inc., a 3M company

Section 5: 510(k) Summary of Safety & Effectiveness င့္
ပါ

MAY 3 0 2012

K120412

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## Description of Device

The 3M™ SpotOn™ temperature monitoring system consists of a disposable sensor, a control unit, a power supply cord, and an optional interface cable that allows temperature data to be transmitted to a standard YSI-400 input on a vital signs monitor.

## Comparison of the Technological Characteristics of the New Device and Predicate Devices

The SpotOn temperature monitoring system is substantially equivalent to the Thermo-Finer CoreTemp (K760948).

| Comparison of Technological Features<br>SpotOn temperature | | |
|------------------------------------------------------------|--------------------------------------------------|----------------------------------------------------------|
| Features | monitoring system | Thermo-Finer CoreTemp |
| Signal processing<br>and display | Microprocessor, LCD display | Analog circuitry, LED display, Alarm<br>indicator |
| Technology | Direct-connection, zero-heat-flux<br>thermometry | Direct-connection, zero-heat-flux<br>thermometry |
| Display methods | 1 channel<br>Numerical LCD<br>Time-series graph | 2 channels<br>Numerical LED display<br>Time-series graph |
| Display ranges | 25.0°C to 43.0°C | 0°C to 50.0°C |
| Memory storage | 2 hour maximum stored on sensor | None; 14 day maximum on TFR-101<br>chart recorder |
| Other capabilities | YSI-400 thermistor emulation | 0-10mV analog output |

Arizant Healthcare Inc., a 3M company

5-2 Section 5: 510(k) Summary of Safety & Effectiveness

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## Discussion of Nonclinical Studies and Clinical Tests

Non-Clinical Tests: Multiple tests were performed with the SpotOn system to confirm safety, effectiveness and compliance with applicable standards. Testing included laboratory and instrument accuracy, time response, EMC, long term stability, biocompatibility and addesive testing. Applied or referenced standards included ISO 80601-2-56, EN 12470-4, ASTM E1112-00, IEC 60601-1, IEC 60601-1-2 and ISO 10993.

Clinical Tests: The agreement of temperature data from the Zero-Heat-Flux-Deep-Tissue-Thermometry (DTT) system and a commercial clinical thermometer was evaluated using a method comparison trial design. Either oral or rectal sites were used as the reference location, and temperature at those sites was measured with a standard clinical themoroneter. The trial design was referenced to ISO 80601-2-56 and ASTME1965-98, as recommended by the Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices in the Center for Devices and Radiological Health of the US Food and Drug Administration. The agreement of the DTT system to predictive oral or rectal thermometry is roughly equivalent to the agreement between direct or indirect tympanic thermometry and brain parenchyna or pulmonary artery blood temperature. The mean bias observed in any subgroup was no worse than the bias between axillary and bladder temperatures.

## Conclusion.

The 3M™ SpotOn™ temperature monitoring system has similar technological characteristics, components, materials, and the same intended use as devices currently on the market. Further, clinical data show a substantial equivalence in the performance of these devices. Therefore, because of the similarities to the predicate device, this new device does not present any new safety or effectiveness issues.

Arizant Healthcare Inc., a 3M company

5-3 Section 5: 510(k) Summary of Safety & Effectiveness

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Mr. David Westlin Director of Regulatory Affairs Arizant Healthcare Incorporated 10393 West 70th Street Eden Prairie, Minnesota 55344

MAY 3 0 2012

Re: K120412

Trade/Device Name: 3M™ SpotOn™ temperature monitoring system Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 5, 2012 Received: April 12, 2012

Dear Mr. Westlin:

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. 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.

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## Page 2 - Mr. Westlin

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Robert

throughout

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name:

3MTM SpotOnTM temperature monitoring system

Indications For Use:

Measure, monitor, and trend body temperature of adult and pediatric patients.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard C. Onye 5/29/12

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K120412

Arizant Healthcare Inc.

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## Section 4: Indications for Use