The Braun Thermoscan® IRT 4000 series and Braun Thermoscan® PRO 4000 series Clinical Infrared Ear Thermometers is indicated for the intermittent measurement and monitoring of human body temperature by consumers of all ages in a home use/professional use environment respectively. The probe cover is used as a sanitary barrier between the infra-red thermometer and the ear canal.

Device Description

The Braun Thermoscan® Pro/IRT 4000 series thermometer is a hand held instrument (thermometer) that measures the natural thermal infrared radiation emitted from the tympanic membrane and adjacent surfaces with a built-in compensation algorithm to compensate the influence of ambient temperature using a heated tip. The Pro 4000 series thermometer is meant for professional use in hospitals and professional office settings, while the IRT 4000 series is meant for home use. The thermometer includes a probe cover that is used as a sanitary barrier between the thermometer and the ear canal to prevent any ear secretions or particulates from being transferred between different users.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the KIU3800 (Braun Thermoscan® IRT 4000 Series/PRO 4000 Series) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Statistical Equivalence (using Blackwelder method): A tolerance (delta) of ± 0.04 (20% of the tolerance or range of 0.2 deg C) for the difference between the two set populations. If the 95% confidence intervals for the difference between the two populations fall within this delta, the two sets are considered equivalent.	For the gold standard samples (from Walldurn) and new probe covers (from Juarez), 95% and 90% confidence intervals for the difference between the biases and standard deviation were calculated. These confidence intervals "were within the chosen acceptance of process and acceptance criteria," indicating device equivalence between current and new thermometers in terms of their reading.
Process Validation (IQ, OQ, PQ): Acceptance Criteria were as defined in the process validation (IQ, Process OQ, PQ) Protocols.	The IQ, OQ, and PQ implementation met the acceptance criteria listed in the protocols.

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

Sample Size: The document does not explicitly state the exact sample size used for the statistical equivalency test. It mentions that readings were taken using "gold standard samples" and "new thermometers manufactured by the s. Mexico" (likely referring to the Juarez facility). The "Blackwelder method" for statistical equivalency was employed, which typically involves comparing two sets of measurements.
Data Provenance: The data used for comparison came from two manufacturing sites:
- Walldurn, Germany: Referred to as the "current" or "old" manufacturing site, providing the "gold standard samples."
- Juarez, Mexico: The "new" manufacturing site.
- The study is retrospective in the sense that the "gold standard samples" represent existing product batches, while the "new thermometers" were prospectively manufactured at the new site for the purpose of the study.

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 use of experts to establish ground truth for temperature measurements. The "ground truth" in this context is implicitly the measurements from the "gold standard samples" (thermometers from the original manufacturing site).
This study is focused on demonstrating statistical equivalence between two manufacturing processes, not on the accuracy of the thermometer itself against a human physiological "ground truth."

4. Adjudication Method for the Test Set:

Not applicable. There was no expert review or adjudication of temperature readings. The comparison was statistical between two sets of device measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This device is an infrared ear thermometer, and the study described is a manufacturing site change validation study. It does not involve human readers, AI, or comparative effectiveness in that context.

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

Not applicable in the conventional sense of a standalone algorithm for diagnostic interpretation. The device itself (the thermometer) operates without human interpretation of its measurement, directly displaying a temperature. The study focuses on the equivalence of the device's measurement performance from two different manufacturing sites, not an algorithm's standalone diagnostic capability. The internal compensation algorithms are part of the device's core function.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this study was the performance of the predicate device (Braun Thermoscan® IRT 4000/PRO 4000 Series Thermometer K031928/K101747) when manufactured at the original site (Walldurn, Germany), referred to as "gold standard samples" and tested against a blackbody reference. The study's goal was to show that the new manufacturing site produced statistically equivalent thermometers.

8. The Sample Size for the Training Set:

Not applicable. This study is a post-market submission for a manufacturing site change for an existing device. There is no mention of a "training set" as it would apply to machine learning algorithms. The device's internal algorithms were already developed and validated on prior data.

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

Not applicable. See point 8. The existing device's ground truth for its operational algorithms would have been established during its initial development and clearance, likely through extensive clinical testing and calibration against known temperature references and potentially human body temperature data. The provided document does not detail this historical data.

Summary

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KIU3800

510(K) STATEMENT / SUMMARY - 310(K) STATEMLAY / DOSE

AS REQUIRED BY SECTION 807.92(c)

JAN 2 6 2011

Braun Thermoscan® IRT 4000 Series/Pro 4000 Series un Thermoscan® INT 4000 Berrer
Infra-Red Ear Thermometers with Probe Cover

1. SUBMITTED BY:

CONTACT PERSON: Raj S. Kasbekar

Kaz, USA Inc 250 Turnpike Road Southborough, MA 01772 Tel (508) 490-7280 Fax (508) 490-7270

2. DATE OF SUMMARY PREPARATION: December 22, 2010

3. DEVICE NAME AND PREDICATE DEVICES:

Proprietary Name	Device	Accessory
	Braun Thermoscan® Pro 4000 Series/IRT4000 Series Thermometers	Probe Cover
Common/Usual Name	Infra Red Ear Thermometer	Probe Cover
Classification Name	Clinical Electronic Thermometer	Probe Cover

Table 1: Device and Accessory Names

PREDICATE DEVICES:

Braun Thermoscan® IRT4000/PRO 4000 Series Thermometer K031928/101747
000 Series The Second @ RT2000 Series Thermometer K983295

Braun Thermoscan® IRT4000/PRO 4000 Series Thermometer K983295
Braun Thermoscan® IRT3000 Series Thermometer K983295

2.

4. DEVICE CLASSIFICATION:

DEVICE CLASSIFICATION:
Clinical Electronic Thermometer (21CFR 880.2910 Product Code FFL), has been classified
Particles (12) of the Ast as Class II by the General Hospital De Clinical Electronic Thermometer (21CFR 880.2910 Frouner South 2010)
under section 513 of the Act as Class II by the General Hospital Devices Panel.

5. DEVICE DESCRIPTION:

Devies = 1000 Series Thermometer :
The Braun Thermoscan® Pro/IRT 4000 series thermometer is a hand beld instrument The Braun Themoscal® Pro/IT 4000 series thermoneter is a national of the auditory
(the Braun Themoscal® Pro/IT 4000 series the mark the world of the addid The Brain Themiscanes Triman body temperature the opening of the armany.
(themometer) that measures that measures the natural themal infrarcuration
canal. It is a single more (themoment) that incuration in themometer that measures the hautar themismal in the mostion
emitted from the tympanic membrane and adjacent surfaces with a built-in com-secti

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algorithm to compensate the influence of ambient temperature using a heated tip. The algorithm to compensate the influence of ambient temperation and and the many of the mater is
difference between the momenter is meant for professional use in hospitals and alportime to compensate is meant for professional use in hospitals and hosmothere
difference between the moment is meant for professional use in hospitals and between and that the Pro 4000 series themselves is meant for professional use in noophales infre
or professional office setimes, while the IRT 4000 series is meant for home infraire that the Frometer a probe cover that is used as a sanitary between the mint and the red
thermometer a probe cover that is used as asatiany barticulates from being or professional office cover that is used as a sanitary battler between as includes from the more
thermometer and the ear canal to prevent any ear secretions or particulates thermometer and the car com-

transferred between unferent possible in the manufacturing site for the IRTPro 4000 series .
This submission Parts a change in Wolldurn, Germany to Keytronics in Juarez, Mexi This submission supports a change in the manufacturing site for use and in the

6. Device Technological Characteristics

DENNED of the the infrased radiation emitted by the tympanic membration in the The IRT/Pro 4000 Series themometer is an ear thermometer than makes a compenses in the ear.
determination based on the probe tip to a temperature close to the norther is The IR I Pro 4000 Berror in
determination based on the probe tip to a temperature close to the nombred.
This thermometer aso warms the probe tip to a temperature close to the determination based on the probe tip to a temperature close to die nonal over and repeating that is only
This thermometer also warms the high clinical accuracy and repeatabil temperature; of this device.

Starting with a warmed-up probe tip:
onations.
There are two major goals of operating with a warmed-up probe tip: re two major goals of operating with a warmed-up probe up.
First is the reduction with a warmed-up probe up.
First is the reduction ature and the human body temperature). .
- First is the reduction of the so called blackbody chool (emperature).
  the ambient room temperature and the human body temperaturent re First is the reduction be and the human body temperature).
  The second goal is to increase the repeatability of measurement results in application
  The second post to another a
- . I he second goal goal tory canal.

to the numan authory caran.
Both of these address the Infrared ear thermometer a very accurate and Both of these address the limitations of Infrared ear thermometer a very accurate and
ear measurements making the IRT/Pro 4000 series thermometer a very accurate and eal measte thermometer.

repeatable themnonice: .

For the measurement of the target human body core temperature, the theme with forest radiation For the measurement of the target human body on the mohomas and For the measurement of the test is the probest in the probet in the more in and themometer. The thermopile sensor is the key sensor measures the sensor
thermometer. The thermopile sensor is the ear and the other sensor
emitted by the tympanic argeming of thermoment. The membrane in the ear and the other sensof measure in someoned
emitted by the tympanic membrane in The warming of the probe tip is minuted
temperature due to th emitted by the tympunt themes and limit.

lin addition the thermometer has a third sensor within the body that measures the ambient In addition the thermometer has a third sensor within the body that measures are manion.
temperature which is integral to the algorithm used to do the temperature in signi

temperature which is integral to an electric voltage signal which is then subjected to signal in the many The senors convert the signal to an electric voltage signal which is tuch subjects.
conditioning and the signals and adjusts them to take into account forcessor uses studio The sensors convert the signals and adjusts them to take into account errors due to
conditioning and then fed to the microprocessor. Them to take into account errors due to

positional feedback, .
positionalism gradients and .
clinical offsets. .

CONFIDENTIAL

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The algorithm compensates for these three kinds of errors and using the calibration
ing and which along of any the calibration of the thermometer gives a target The algorithm compensates for these three kinds of errors and go
parameters obtained from the calibration of the thermomet I he algoritimi octing the calibration of the themometer gross a lags of the more of

temperation the key technological characteristics for this themometer include the sensing, the Therefore, the key technological characteristics for the compensation of the compensation of various
signal conditional faschiesed femnerature gradients and clinical offeets. I signal conditioning, and algorithmic computation based on the oblig.
errors due to positional feedback, temperature gradients and clinical offsets.
There due to positional

enors due to positions: recober, in the printiple, algorithm or device software has changed as a None of the hardware, main operating principle, a relocation of the manufacturing facility and
part of this change only involves a relocation of the manufacturing facility an None of this change, This change only involves a relocation of the manufacturing world.
part of this change. This change only involves a relocation process and alternate vend

7. STATEMENT OF INTENDED USE / INDICATIONS FOR USE:

CORDENT OF INTENDED USE 4000 ceries and Braun Thermosco

STATEMENT OF INTENDED USE / INDICATIONS FOR OSE.
The Braun Thermoscan® IRT 4000 series and Braun Thermoscan® PRO 4000 series Clinical The Braun Thermoscan® IRT 4000 series and Braun Thermitten measurements of the Braum The of the Braum The I he brain i normotive by consumers of all ages in a home users of any and Infrared bar i nemioners of all ages in a home use processional as a submit and themometer
human body temperature by consumers of all ages in a home user the infra red themom and the ear canal.

8. SUMMARY OF VERIFICATION ACTIVITIES

John will and that the IRT/Pro 4000 Series the mometers manufactured at the new In order to show that the IRTPro 4000 Series the validated process are the the the In order to show that the Increased the validated process to squirities were
manufactures ite (in Juaned the Vallam (Germany), verifical processor of the opter of the opfored manufacturing site (in Jaros) in Wallactured using the newly refered to releved arocess
current the themmeters manufactured wing the newilly refered to as intel carried out to show that the themometers manufactured use a memor por as the as the as the as the as the as the as the as the as the as the as the carried only equivalent to the themoments was carried out your comment.
were statistically equivalent to the the was was carried out be the "gold standard samples"). This statistical andysis was carried on the many and the
statistical contractor independent from Kaz. In addition process opletations in the lindin "gold standard samples"). This scheel in addition process valiation roll be aro
statistical contractor installation qualification, operational qualification and
manufacturin statistical comprising installation qualification, operations of the monization in the contribution in the constitution in ask Force
performance qualification was successfull performance qualification in accordance with the Green and and

Test Methods
A. To show statistical equivalency, the Black welder method for showing statistical t Methods
To show statistical equivalency, the Black welder method for showning the was the was in the was in the was in the was in the seperated in the separated To show statistical equivals were taken using the gold samples (on one same for
equivalency was used. Realing the blackbody as a reference. This was and tot Wallam) to get a sample bias using the blackbody as a referent per AST, Mexico, Mexico, Mexico, Mexico, Mexico, Mexico, Mexico, Mexico, Mexico, Mexico, Mexico, Mexico, Mexico Welloum) o get a sampe and the new the momenters mambetured by the s. Mexico
5 different combing the new the new the momenters manufactured by armen SE
Readings were then tak 5 different combinations of the new the may the black body as a reference for starts and SE
Readings were then taken using the black body as a reference the states was si Readings were then taken using the black body as felerediter in the even the med then
and the sample bias was salculated deviation between the more of the and the sample blas was caronials and sevaliation between the realigns. Using
test continues in bias and starter the old and the mew the successorial. test on these tata of these tation range and a standard deviation based on bistorical
eduction is 10% of the specification range and a standard deviation based on bistorical calculated tor each of these und posses and a standard devilation based on 2011
a delta that is 10% of the specification range and a standard new devices) was
data, a sample data, a sample size equivalence.
- estimated to show can and in materials in contact with the human body were
  s and the formancingly between the old and the new devices, no biocompatibility test Biocompatibility Testing: Since the materials in contact with the numble over
  identical or equivalent between the old and the new devices, no biocompatibility testing
  the sta was required.

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C. Safety and EMC Testing: Since there was no change to the product circuit or
eas and EMC and for as EMC testing was necessary. Safety and EMC Testing. Shice there was necessary.
specifications, no safety or EMC testing was necessary.

Acceptance Criteria:

Acceptance Criteria:
A. A tolerance (delta) of ± 0.04 (20% of the tolerance or range of 0.2 deg C) as required by a eptaine Chiterial the Blackwelder method was deemed adequate to show equilibre the two
set populations. If the 95% confidence intervals for the difference between the two the Diactiveles in the 95% confidence intervals for the difference of the can be
set populations. If the 95% confidence interia, the two sets of the confi
considered to be equivalent.
B. Process Validation: Acceptance Criteria were as defined in the process validation (IQ, Process Validation (IQ, Process Validation (IQ, Process OQ, PQ) Protocols.

Statistical Analysis

Statistical Analysis
A. For the gold standard samples as well as for the new probe covers made at the new site, tistical standard samples as well as for the new probe cover calculated for the ninety five (9) % and ninety (90%) confidence intervais were catediations
difference between the bisandard deviation for the two data. Since the more of the more of the more difference between the biases and standard deviation in the two data of the these 99% and
between the thermoments at the current site and the new site. Since these 99% and between the thermometers at the current site and the new site: incolners and 60%confidence intervals were within the chosen acceptance of process and
90%confidence intervals were within the chosen acceptance of process and
acceptance criteria were wer 9076-01-12-2017-01-2017-01-2017-07-2014-08-2019-01-2019-01-2019-01-2019-01-2010-01-20
device equivalence between current and new thermometers in terms of their reading
devi device equivalentation met the acceptance criteria listed in the protocols.
B. The IQ, OQ and PQ implementation met the acceptance criteria listed in the protocols.
B. The IQ

Conclusion
Based on these results, we can conclude that the thermometers made using the new process
t the by and concerners fastyring site will not affect the temperature mea Conclusion
Based on these results, we can conclude that the the thermoments in the prothe thermometer.

9. SUBSTANTIAL EQUIVALENCE:

SUBSTANTIAL EQUIVALENCE:
There is no change to the intended use, indications for use, product specifications of Section of the intended us, indications for use, product spoolices and Braun
technology or operating principle of the Braun Thermoscan® PRO 4000 series and Braun There is no change to the Braun Thermoscan® PRO 4000 second PRO 4000 second of the problem
Themnoscan® IRT 4000 series Clinical Infrared Ear Thermometers or that of the probe FReirs (K031928/K101747).

covers (KUS 928/ATV / //)
The manufacturing site for the IRT/Pro 4000 series there was no change to the The manufacturing site for the IRTPro 4000 series there was no change to the Walldurn in Germany to Keytronics EMS in Juanez Mexico. There and

manufacturing site for the probection at the new manufacturing site showed that there are no
A process validation of the operation at the prodicate device of the product A process validation of the operation at the new manufacturing site stice (IRTPro
new questions of safety and effectiveness when compared to the production of A process of safety and effectived in K0319287 (10747). There is no charges the product
4000 series thermoment described in K0319287 (1074). There is nother has and 4000 series themoment described in K031928K10174). There is not in the many of the many of the many of the many of the many of the new site is 4000 sense merhivalency testing. Hence the new themometer manufactured at the new site is
and device equivalency testing. Hence the new themometer manufactured at the new sit and device equivalency tosting. In the predicate device.

substantially equivalent to the predicate de

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Raj Kasbekar Vice President, Regulatory Affairs Kaz USA. Incorporated 250 Turnpike Road Southborough, Massachusetts 01772

JAN 2 6 201

Re: K103800

Trade/Device Name: Braun Thermoscan® IRT 4000 series and Braun Thermoscan® PRO 4000 series Clinical Infrared Ear Thermometer Regulation Number: 21 CFR 880,2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 12, 2011 Received: January 18, 2011

Dear Mr. Kasbekar:

the control controller

100 Children

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. Register

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Page 2- Mr. Kasbekar

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Wh for

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: Braun Thermoscan® IRT 4000 series and Braun Thermoscan® PRO 4000 series Clinical Infrared Ear Thermometer

Indications For Use:

The probe cover is used as a sanitary barrier between the infra-red thermometer and the ear canal.

Prescription Use (Part 21 CFR 801 Subpart D) ANDIOR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mhd C. Chyn 1/26/11

(Division Sign-Off) neral Hospital Division of Anesthesiolo Infection Control, Dental

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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.