← Product Code [FLL](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL) · K060006 # BRAUN THERMOSCAN IRT 2000 INFRARED EAR THERMOMETER (K060006) _Braun GmbH · FLL · Jan 31, 2006 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K060006 ## Device Facts - **Applicant:** Braun GmbH - **Product Code:** [FLL](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL.md) - **Decision Date:** Jan 31, 2006 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 880.2910 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Pediatric ## Indications for Use Intermittent measurement and monitoring of human body temperature on people of all ages by consumers in a home use environment. ## Device Story Hand-held, battery-powered infrared ear thermometer; measures infrared energy emitted from tympanic membrane and surrounding tissue. Used by consumers in home environment for intermittent temperature monitoring. Device features simplified mechanical design compared to predicate; lacks integrated heating element at probe tip; results in faster measurement cycle (≤1 second). Output displayed on LCD; single memory storage. Provides non-invasive temperature readings; aids in clinical decision-making regarding fever management. ## Clinical Evidence Clinical comparison and repeatability testing conducted across four age groups (0-3, 4-10, 11-65, >65 years). Study demonstrated IRT 2000 measures ear canal temperature equivalent to predicate IRT 4000. Ear temperatures showed high correlation with oral and axillary sites; differences within clinical acceptability. Repeatability statistically and clinically acceptable. ## Technological Characteristics Infrared ear thermometer; battery-powered. Materials: case, speculum, buttons, lens filters same as predicate. Sensing: infrared energy detection. Measurement cycle: ≤1 second. Conforms to ASTM E1965-98, ISO, and IEC standards. Design controls per 21 CFR 820.30; risk management per ISO 14971. ## Regulatory 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. ## Special Controls (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. ## Predicate Devices - Braun Thermoscan® IRT 4000 Series infrared ear thermometer ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K060006 page 1 of 3 JAN 3 1 2006 ## 510(k) Summary #### Summary of Safety and Effectiveness #### Company information Braun GmbH Frankfurter Strasse 145 61476 Kronberg Germany ### Device Identification Trade Name - Braun Thermoscan® IRT 2000, infrared ear thermometer Classification Name - Thermometer, Clinical, Electronic Classification - Class II Product Code - FLL #### Predicate Device Braun Thermoscan® IRT 4000 Series infrared ear thermometer #### 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 energy 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 by consumers in a home use environment. ### Comparison of the Braun ThermoScan IRT 2000 with the Braun ThermoScan IRT 4000 Series infrared ear thermometer The basic design and fundamental technology of the Braun ThermoScan IRT 2000 and the Braun Thermoscan IRT 4000 Series infrared ear thermometers are similar. The operating range, temperature display, speculum, and the lens filters are the same. The materials used to fabricate the thermometer case, speculum. buttons, and lens filters are the same. The accuracy and reliability specifications are the same for the IRT 2000 and IRT 4000 series thermometers. {1}------------------------------------------------ KAb0006 page 2 of 3 The primary differences between the Braun ThermoScan IRT 2000, and the IRT 4000 series thermometers include a simpler mechanical design that allows for the industrial design to be modified so that the thermometer case is a smaller package. The LCD placement has been modified. The integrated heating element has been deleted from the ambient sensor at the probe tip that results in a faster temperature measuring cycle (i.e., IRT 2000 = ≤1 second, IRT 4000 = 3 to 10 seconds). The IRT 2000 has a single memory while the IRT 4000 has up to eight memories. ## Compliance with Consensus Standards The Braun Thermoscan IRT 2000 conforms to Consensus Standards. It conforms to the relevant portions of ASTM E1965-98 - Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. In addition, the Braun ThermoScan IRT 2000 conforms to the relevant portions of ISO and IEC consensus standards that FDA has adopted and that are applicable to infrared ear thermometers. ## Compliance with Design Controls Design Control activities for these devices have been performed in conformance with the design control procedure requirements as specified in 21 CFR Part 820.30. Risks associated with each product family have been identified and evaluated using Failure Modes and Effects Analysis (FMEA) and, after mitigation, the risks fall into the "Broadly Acceptable Region" following ISO 14971. The modified device was subjected to the same series of laboratory tests to which the predicate device was subjected. The IRT 2000 will have passed each of the laboratory tests prior to commercial distribution of the device. #### Design Validation - Clinical Results Clinical comparison and repeatability testing was performed on the following four age groups; 0-3 years, 4-10 years, 11-65 years, and >65 years. The protocol that was used was essentially the same as the protocol used to demonstrate the clinical accuracy and repeatability of IRT 4000. This clinical comparison study demonstrated that the Braun ThermoScan IRT 2000 measures ear canal temperature as well as the previously 510(k) cleared IRT 4000 series thermometers in all age groups. The ear temperatures obtained with the IRT 2000 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. {2}------------------------------------------------ K060006 page 3 of 3 # Substantial Equivalence and Conclusion The Braun Thermoscan IRT 2000 infrared thermometer: - conforms to Consensus Standards that are applicable to infrared ear . thermometers, - is technically and functionally substantiality equivalent to the predicate device, . - . has the same intended use and indications for use, and - functions similarly in the hands of consumers. . Therefore, the Braun ThermoScan IRT 2000, infrared ear thermometer does not raise any significant new issues of safety or efficacy and, in the opinion of the submitter, is substantially equivalent to the predicate device. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around an abstract symbol. The symbol consists of four stylized human profiles facing to the right, stacked on top of each other. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 3 ] 2006 Braun GmbH C/O Mr. Fred Schlador President Regulatory Resources, LLC P.O. Box 1490 Eagle, Idaho 83616 Re: K060006 Trade/Device Name: Braun ThermoScan® IRT 2000 Infrared Ear Thermometer Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 30, 2005 Received: January 3, 2006 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. {4}------------------------------------------------ Page 2 - Mr. Schlador 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 (240) 276-0115. 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/cdrl/industry/support/index.html. Sincerely vours. Sutte y. Michiu Oms Ehíu 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 {5}------------------------------------------------ K060006 # Indications for Use 510(k) Number (if known): Device Name: Braun ThermoScan® IRT 2000 infrared ear thermometer Indications for Use: The Braun ThermoScan IRT 2000 infrared ear thermometer is indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment. Prescription Use _____________________________________________________________________________________________________________________________________________________________ x (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Auther Vink . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . logy, General Hospital, ical Devices Kul-charel --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K060006](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/FLL/K060006) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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