(28 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Braun ThermoScan IRT 2000, based on the provided text:
Acceptance Criteria and Device Performance
The submission states that the Braun ThermoScan IRT 2000 has the same accuracy and reliability specifications as its predicate device, the Braun ThermoScan IRT 4000 Series. It also explicitly states: "The accuracy and reliability specifications are the same for the IRT 2000 and IRT 4000 series thermometers." The document does not provide specific numerical acceptance criteria (e.g., a ± tolerance for temperature readings). Instead, it relies on substantiating that the new device performs at least as well as the legally marketed predicate.
The primary performance claim is that the device "measures ear canal temperature as well as the previously 510(k) cleared IRT 4000 series thermometers in all age groups" and that "Differences were within clinical acceptability." Its clinical repeatability is also stated as "statistically and clinically acceptable."
While no explicit table is provided in the document, here's a representation of what can be inferred:
| Acceptance Criteria | Reported Device Performance (Braun ThermoScan IRT 2000) |
|---|---|
| Accuracy | Measures ear canal temperature as well as the predicate device (IRT 4000 series). Differences (compared to oral/axillary sites) within clinical acceptability. |
| Reliability | Same reliability specifications as the predicate device (IRT 4000 series). |
| Repeatability | Statistically and clinically acceptable. |
| Age Group Performance | Performance maintained across all four age groups (0-3 years, 4-10 years, 11-65 years, >65 years). |
| Consensus Standards Compliance | Conforms to relevant portions of ASTM E1965-98. Conforms to relevant ISO and IEC consensus standards. |
Study Details
The document describes a clinical comparison study rather than an isolated standalone performance study with predefined numerical thresholds. The study's main goal was to demonstrate equivalence to the predicate device.
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Sample sizes used for the test set and data provenance:
- Test set sample size: Not explicitly stated as a single number. The study was performed on "four age groups: 0-3 years, 4-10 years, 11-65 years, and >65 years." The exact number of participants within each group or total participants is not provided.
- Data provenance: Not explicitly stated, but clinical studies for medical devices are generally prospective when compared to a predicate like this. No mention of country of origin.
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Number of experts used to establish the ground truth for the test set and their qualifications:
- Not applicable/Not stated. The ground truth for this device (body temperature) is established through comparison with other established temperature measurement methods (ear canal, oral, and axillary sites), not through expert consensus on images or interpretations.
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Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used when subjective interpretations (e.g., image reading) need to be reconciled. For temperature measurements, the readings are direct.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study is not relevant for an infrared thermometer. The study performed was a clinical comparison of the new device to a predicate and to other established temperature measurement sites.
- Effect size of human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted device for interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The clinical comparison and repeatability testing described is the standalone performance of the device without human interpretation of its output (beyond reading the displayed temperature). The device itself measures and displays the temperature. While a human uses the device, the performance being evaluated is the device's accuracy and repeatability in measuring temperature.
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The type of ground truth used:
- The "ground truth" was established by comparing the IRT 2000's ear temperature readings to:
- Readings from the predicate device (Braun ThermoScan IRT 4000 Series).
- Temperatures measured at "oral and axillary sites." These are considered standard clinical methods for temperature measurement.
- The "ground truth" was established by comparing the IRT 2000's ear temperature readings to:
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The sample size for the training set:
- Not applicable. The Braun ThermoScan IRT 2000 is a hardware device that measures infrared energy; it does not utilize machine learning or AI that would require a "training set" in the conventional sense. Its "training" is inherent in its design and calibration processes.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of machine learning. The device's calibration and design would have been based on physical principles of infrared measurement and established temperature references, but not a data-driven "training set."
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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.
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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.
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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.
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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.
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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
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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
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Auther Vink
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ical Devices
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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.