(123 days)
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No
The document describes a standard infrared thermometer and its performance studies, with no mention of AI or ML technologies.
No.
The device is indicated for the intermittent measurement and monitoring of human body temperature, which is a diagnostic or monitoring function, not a therapeutic one.
No
Explanation: The device is described as measuring and monitoring human body temperature. While temperature can be a symptom of illness, the device's stated purpose is not to diagnose a disease but rather to measure a physiological parameter. The provided text does not indicate that the device interprets the measured temperature to provide a diagnosis.
No
The device description explicitly states it is a "hand-held, battery-powered device" that measures infrared energy, indicating it is a hardware device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Braun Thermoscan PRO/IRT 4000 series measures body temperature by detecting infrared energy emitted from the ear. This is a direct measurement of a physiological parameter within the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for "intermittent measurement and monitoring of human body temperature." This aligns with a general medical device for physiological monitoring, not an IVD for analyzing biological samples.
Therefore, based on the provided information, the Braun Thermoscan PRO/IRT 4000 series is a medical device for measuring body temperature, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
FLL
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
tympanic membrane and surrounding tissue / ear canal
Indicated Patient Age Range
all ages / 0-3 years, 4-10 years, 11-65 years, and >65 years
Intended User / Care Setting
IRT 4000 series - consumers in a home use environment.
PRO 4000 series professionals in a professional environment.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
Braun Thermoscan IRT 3000 infrared ear thermometer (consumer), Braun Thermoscan PRO 3000 infrared ear thermometer (professional)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Ko3 1928
510(k) Summary
Summary of Safety and Effectiveness
Company information
Braun GmbH Frankfurter Strasse 145 D-61476 Kronberg Germany
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
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.
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.
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- 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.
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- 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.
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- 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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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes forming its wings, symbolizing health, services, and people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The seal is presented in black and white.
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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109 OR
ﺔ Over the Counter