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.

AI/ML Overview

Here's an analysis of the provided text regarding the 3M™ SpotOn™ temperature monitoring system, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the device's performance in terms of accuracy (e.g., a specific delta or range). Instead, it relies on a comparison to established standards and the substantial equivalence to a predicate device.

Acceptance Criteria Category	Specific Acceptance Criteria (Implied/Referenced)	Reported Device Performance
Safety	Compliance with applicable standards (e.g., IEC 60601-1, ISO 10993 for biocompatibility)	Multiple tests confirmed safety and compliance.
Effectiveness/Accuracy	Substantial equivalence to predicate device (Thermo-Finer CoreTemp K760948); Agreement with reference clinical thermometers (oral/rectal); Performance referenced to ISO 80601-2-56 and ASTM E1965-98.	Clinical data showed "substantial equivalence in the performance" to predicate device. Mean bias observed in any subgroup was "no worse than the bias between axillary and bladder temperatures." Agreement with predictive oral/rectal thermometry is "roughly equivalent to the agreement between direct or indirect tympanic thermometry and brain parenchyna or pulmonary artery blood temperature."
Non-Clinical Performance	Compliance with specific standards (e.g., ISO 80601-2-56, EN 12470-4, ASTM E1112-00, IEC 60601-1-2) for laboratory accuracy, time response, EMC, long-term stability, adhesive testing.	Multiple tests performed to confirm compliance with these standards.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "method comparison trial design" and "mean bias observed in any subgroup," which implies a cohort of patients was included, but the specific number is omitted.
Data Provenance: The document does not specify the country of origin for the clinical trial data. It does state that the clinical tests were a "method comparison trial design," which generally implies prospective data collection, but this is not explicitly confirmed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the involvement of experts for establishing ground truth in the clinical study. The reference temperature was obtained using "a standard clinical thermometer" at "either oral or rectal sites."

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. Ground truth was established by direct measurement with standard clinical thermometers, not by expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not performed. The study described is a method comparison trial for device performance against traditional thermometers, not an evaluation of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the clinical "method comparison trial" evaluates the standalone performance of the 3M™ SpotOn™ system against reference thermometers. The device's output (temperature measurement) is directly compared to the reference measurement. There is no human interpretation of the device's output mentioned as part of this performance evaluation.

7. The Type of Ground Truth Used

The ground truth used was direct measurement from standard clinical thermometers at either oral or rectal sites. This is a form of reference standard measurement.

8. The Sample Size for the Training Set

Not applicable/Not mentioned. The 3M™ SpotOn™ temperature monitoring system is an electronic thermometer, not a machine learning or AI-based device that would typically have a "training set" in the context of algorithm development. Its function is based on direct-connection, zero-heat-flux thermometry.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not mentioned, as there is no indication of a training set for an AI/ML algorithm.

Summary

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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
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MAY 3 0 2012

K120412

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Description of Device

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 FeaturesSpotOn temperature
Features	monitoring system	Thermo-Finer CoreTemp
Signal processingand display	Microprocessor, LCD display	Analog circuitry, LED display, Alarmindicator
Technology	Direct-connection, zero-heat-fluxthermometry	Direct-connection, zero-heat-fluxthermometry
Display methods	1 channelNumerical LCDTime-series graph	2 channelsNumerical LED displayTime-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-101chart 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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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.

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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 (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

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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

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.