PRO 4000 series: The Braun Thermoscan PRO 4000 series infrared ear thermometers are indicated for the intermittent measurement and monitoring of human body temperature by professionals in a professional use environment.
IRT 4000 series: The Braun Thermoscan IRT 4000 series infrared ear thermometers are indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment.

Device Description

Braun Thermoscan infrared ear thermometers are hand-held, battery-powered devices that are intended to be used for the intermittent measurement and monitoring of human body temperature of people of all ages. They measure infrared enerqy that is emitted from the tympanic membrane and surrounding tissue.

AI/ML Overview

Here's an analysis of the provided text regarding the Braun ThermoScan IRT/PRO 4000 series, addressing your specific points:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria (e.g., specific accuracy ranges, repeatability standard deviations) for the device's performance. Instead, it refers to compliance with consensus standards and clinical acceptability.

Acceptance Criteria (Implied/Referenced)	Reported Device Performance
Compliance with Consensus Standards	The Braun Thermoscan IRT/PRO 4000 series conform to: - ASTM E1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature - IEC 60601-1:1988 Cor 1 1995 Medical Electrical Equipment Part 1 General requirements for Safety - IEC 60601-1:1998 Medical Electrical Equipment Part 1 General requirements for Safety, 1998; Amendment 1, 1991-11, Amendment 2, 1995-03 - IEC 60601-1-4:2000 Medical Electrical Equipment Part 1-4 General requirements for Safety - Collateral Standard: Programmable Electrical Medical Electrical Systems - IEC 60601-1-2:2001 Medical Electrical Equipment Part 1 General requirements for Safety; Electromagnetic Compatibility - Requirements and Tests - AAMI/ISO 14971:2000 -- Medical Devices -- Application of Risk Management to Medical Devices - AAMI/ISO 14971-1:2000 - Medical Devices - Risk Management - Part 1: Application of Risk Analysis - EN 540:1993 Clinical Investigation of Medical Devices for Human Subjects - EN 980:1997+ A1:1999 Graphical Symbols for Use in the Labeling of Medical Devices - ISO 15223:2000 Symbols Used with Medical Device Labels, Labeling, and Information to be Supplied
Clinical Equivalence/Performance	"This clinical comparison study demonstrated that the Braun ThermoScan IRT 4000 measures ear canal temperature as well as the previously approved model IRT 3000 in all age groups." "The ear temperatures obtained with the IRT 4000 were highly related to temperatures measured at the oral and axillary sites. Differences were within clinical acceptability." "The clinical repeatability of the device is statistically and clinically acceptable."
Consumer vs. Professional Comparability	"Consumers' measurements obtained were comparable to the professional measurements, collectively, for pooled professionals, and each individual category of professionals." "The repeatability of temperatures obtained from the consumers was comparable to the repeatability of the temperatures obtained from the professionals."
Safety and Effectiveness	"Therefore the IRT/PRO 4000 series thermometers do not raise any significant questions of safety or effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document states that a comparison study and clinical repeatability testing were performed on "the following four age groups; 0-3 years, 4-10 years, 11-65 years, and >65 years." However, specific numerical sample sizes for each group or the total test set are not provided.
Data Provenance: The document does not specify the country of origin for the data.
Prospective/Retrospective: The language "A comparison study and clinical repeatability testing was performed" suggests a prospective study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document mentions "health care professionals" in the context of the consumer vs. professional comparability study, but does not specify the number or qualifications of experts (e.g., physicians, nurses) used to establish ground truth or conduct the clinical comparisons. It only states that "pooled professionals" and "each individual category of professionals" were compared.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method used for establishing ground truth or resolving discrepancies in measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: This is not applicable to this device. An infrared ear thermometer is a diagnostic tool that provides a direct measurement, and its operation does not involve "readers" in the sense of interpreting complex images or data fields that would typically require multi-reader studies or AI assistance for human improvement. The closest comparison is the "Consumer vs. Healthcare Professional Comparability Study," which assessed if different users (consumers vs. professionals) achieved comparable results, not how professionals improved with AI.
Effect Size of AI improvement: No AI component is described in the device, and therefore no effect size of AI assistance for human readers is mentioned or relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is an infrared ear thermometer, which is inherently a "standalone" device in its functional output of a temperature reading. It does not involve complex algorithms or human interpretation of an algorithm's output in the way that an AI diagnostic tool would. The device provides a direct measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document implicitly refers to traditional "gold standard" temperature measurement methods for comparison:

"The ear temperatures obtained with the IRT 4000 were highly related to temperatures measured at the oral and axillary sites." This implies that oral and axillary temperature measurements were used as a reference or a type of "ground truth" to which the ear thermometer's readings were compared.

8. The sample size for the training set

The document does not describe a "training set" as would be relevant for a machine learning model. This device is a physical measurement instrument, not an AI/ML system requiring a dedicated training phase with labeled data in the typical sense.

9. How the ground truth for the training set was established

As there is no described training set for an AI/ML model, this question is not applicable. The device's operation relies on established physics of infrared measurement and calibration, not on a data-driven training process.

Summary

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Ko3 1928

510(k) Summary

Summary of Safety and Effectiveness

Device Identification

Trade Name - Braun Thermoscan® IRT 4000 series - Braun Thermoscan® PRO 4000 series Classification Name - Thermometer, Clinical, Electronic Classification - Class II Product Code - 80 FLL

Predicate Devices

Braun Thermoscan IRT 3000 infrared ear thermometer (consumer) Braun Thermoscan PRO 3000 infrared ear thermometer (professional)

Device Description

Intended Use and Indications for Use

Intermittent measurement and monitoring of human body temperature on people of all ages.

. IRT 4000 series - consumers in a home use environment.
PRO 4000 series professionals in a professional environment. 피

Comparison of the Braun ThermoScan IRT/PRO 4000 and the Braun Thermoscan IRT/PRO 3000 infrared ear thermometers

The basic design of the Braun ThermoScan IRT/PRO 4000 and the Braun Thermoscan IRT/PRO 3000 are similar. The fundamental scientific technology of the new devices has not changed from that of the predicate devices. The materials used to fabricate the thermometer case, speculum, buttons and Lens Filters/Probe Covers are the same as the IRT/PRO 3000 series thermometers.

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The following are the primary differences between the IRT/PRO 4000 and the IRT/PRO 3000 series thermometers.

1. The IRT/PRO 4000 series thermometer family incorporates a new probe design that contributes to increased repeatability of temperature measurements. The infrared sensor has been repositioned from the base of the IR wave-guide closer to the interior tip of the probe.
1. Integrated into the IR sensor are the ambient sensor and a heating element. The heating element warms the probe tip close to the most likely temperature within the range of the intended target temperatures, (i.e., human body temperature 37°C) and results in a reduction of the blackbody effect and increased repeatability of successive temperature measurements.
1. A positive feedback system (ExacTherm®) informs the user that the proper conditions and placement have been established to obtain an accurate temperature measurement. The user is signaled when the probe has been properly positioned in the ear canal and the conditions are correct for a complete measuring process. If the correct position is not obtained, a position error will be displayed.

Compliance with Consensus Standards

The Braun Thermoscan IRT/PRO 4000 series conform to Consensus Standards and other Standards that include:

ASTM E1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
IEC 60601-1:1988 Cor 1 1995 Medical Electrical Equipment Part 1 General requirements for Safety
IEC 60601-1:1988 Medical Electrical Equipment Part 1 General requirements for Safety, 1998; Amendment 1, 1991-11, Amendment 2, 1995-03
IEC 60601-1-4:2000 Medical Electrical Equipment Part 1-4 General requirements for Safety - Collateral Standard: Programmable Electrical Medical Electrical Systems
IEC 60601-1-2:2001 Medical Electrical Equipment Part 1 General requirements for Safety; Electromagnetic Compatibility - Requirements and Tests
AAMI/ISO 14971:2000 -- Medical Devices -- Application of Risk Management to Medical Devices

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AAMI/ISO 14971-1:2000 - Medical Devices - Risk Management - Part 1: Application of Risk Analysis

EN 540:1993 Clinical Investigation of Medical Devices for Human Subjects
EN 980:1997+ A1:1999 Graphical Symbols for Use in the Labeling of Medical Devices
ISO 15223:2000 Symbols Used with Medical Device Labels, Labeling, and Information to be Supplied

Clinical Results

A comparison study and clinical repeatability testing was performed on the following four age groups; 0-3 years, 4-10 years, 11-65 years, and >65 years. This clinical comparison study demonstrated that the Braun ThermoScan IRT 4000 measures ear canal temperature as well as the previously approved model IRT 3000 in all age groups. The ear temperatures obtained with the IRT 4000 were highly related to temperatures measured at the oral and axillary sites. Differences were within clinical acceptability. The clinical repeatability of the device is statistically and clinically acceptable.

Consumer vs. Healthcare Professional Comparability Study Results

The difference in measurements obtained by health care professionals and consumers with the Braun ThermoScan® IRT/PRO 4000 ear thermometer was tested. Consumers' measurements obtained were comparable to the professional measurements, collectively, for pooled professionals, and each individual category of professionals.

The repeatability of temperatures obtained from the consumers was comparable to the repeatability of the temperatures obtained from the professionals.

Conclusion

The Braun Thermoscan IRT/PRO 4000 series thermometers:

. conform to Consensus Standards that are applicable to infrared ear thermometers,
are technically and functionally substantiality equivalent to the predicate devices, . and
function similarly in the hands of consumers and healthcare professionals. .

Therefore the IRT/PRO 4000 series thermometers do not raise any significant questions of safety or effectiveness.

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Public Health Service

OCT 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Braun GmbH C/O Mr. Fred Schlador Regulatory Resources, LLC 6183 Paseo Del Norte, Suite 150 Carlsbad, California 92009

Re: K031928

Trade/Device Name: Braun Thermoscan PRO 4000 Series (Professional Use Environment) and Braun Thermoscan IRT4000 Series (Home Use Environment) Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 5, 2003 Received: September 8, 2003

Dear Mr. Schlador:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours, ·

Sinal Runny

Chiu Lin, Ph.D. 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 Statement

510(k) Number: K031928

Device Name:

Braun ThermoScan® PRO 4000 series and IRT 4000 series Infrared ear thermometer

Indications for Use:

PRO 4000 series

The Braun Thermoscan PRO 4000 series infrared ear thermometers are indicated for the intermittent measurement and monitoring of human body temperature by professionals in a professional use environment.

IRT 4000 series

The Braun Thermoscan IRT 4000 series infrared ear thermometers are indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment.

Patrice Cucenote

ivision of Anesthesiology. General Hospital. Infection Control. Dental Device

510(k) Number: K031928

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Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109 OR

ﺔ Over the Counter

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.

510(k) Summary

Summary of Safety and Effectiveness

Company information

Device Identification

Predicate Devices

Device Description

Intended Use and Indications for Use

Comparison of the Braun ThermoScan IRT/PRO 4000 and the Braun Thermoscan IRT/PRO 3000 infrared ear thermometers

Compliance with Consensus Standards

Clinical Results

Consumer vs. Healthcare Professional Comparability Study Results

Conclusion

Indications for Use Statement

IRT 4000 series

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§ 880.2910 Clinical electronic thermometer.