3M SPOTON TEMPERATURE MONITORING SYSTEM

{0}------------------------------------------------ # 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 {1}------------------------------------------------ ## 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 {2}------------------------------------------------ ## 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 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract image of an eagle. #### 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. {4}------------------------------------------------ ## 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 (800) 638-2041 or (301) 796-7100 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 {5}------------------------------------------------ # 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 Page 1 of (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K120412 Arizant Healthcare Inc. 4-1 ## Section 4: Indications for Use