(89 days)
The Braun ThermoScan® PRO 3000 Infrared Thermometer is intended for the intermittent measurement and monitoring of human body temperature, by medical professionals. It is intended for use on people of all ages.
The Braun ThermoScan® PRO 3000 Infrared Thermometer is a hand held instrument that measures temperature through the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.
This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Braun ThermoScan® PRO 3000 Infrared Thermometer.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (ASTM Laboratory Accuracy Requirements for IR Thermometers in the range 36°C-39°C) | Reported Device Performance (Accuracy characteristics) |
|---|---|
| ±0.2°C (±0.4°F) | For patient temperature range 96.8°F to 102.2°F (36°C to 39°C): ±0.4°F (±0.2°C) |
| Outside this range: ±0.5°F (±0.3°C) |
The device also states it "meets the requirements established in ASTM Standard E 1965-98, 'Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature'."
2. Sample size used for the test set and the data provenance
- Sample Size: "Approximately 39% of the patients participating in the study were considered febrile." While a specific total number of patients is not provided, the study indicates it covered four age groups: 0-3 yrs, 4-10 yrs, 11-65 yrs, and >65 yrs.
- Data Provenance: Not explicitly stated, but based on the submitter's address (San Diego, CA) and assuming a clinical trial setting, it is likely prospective data collected in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study compared the PRO-3000 to a predicate device (ThermoScan® IR-2000) rather than establishing ground truth against a specific expert reference.
4. Adjudication method for the test set
This information is not provided in the document. The study was a "comparison study" and "clinical repeatability testing."
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
A MRMC comparative effectiveness study was not performed. The device is a standalone thermometer, not an AI-assisted diagnostic tool. The study was a comparison of the new device against a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a form of standalone performance was done for the device's accuracy characteristics, as it is a medical device that provides a direct measurement. The "Accuracy characteristics" table directly reports the device's accuracy against defined temperature ranges. The "Five Environment Accuracy Test" is also a standalone test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the accuracy assessment seems to be a comparison against the predicate device (ThermoScan® IR-2000) and adherence to ASTM laboratory accuracy requirements. The clinical study specifically states: "The comparison study demonstrated that the Braun ThermoScan® PRO-3000 Instant Thermometer measured ear temperature equivalently to the ThermoScan® IR-2000(PRO-1) in all age groups." For laboratory accuracy, it refers to "ASTM laboratory accuracy requirements."
8. The sample size for the training set
This device does not utilize a "training set" in the context of machine learning or AI. It is a measurement device, and its performance is based on inherent design and calibration, not learned parameters.
9. How the ground truth for the training set was established
Not applicable as there is no training set for this type of device.
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OCT 20 1999
BRHUN K992468 Thermoscan.
10421 Pacific Center Court San Diego, CA 92121 Telephone: (619) 550-2100 (619) 535-0566 Telefax:
510(k) SUMMARY
| Submitter's Name | Braun Thermoscan |
|---|---|
| Address | 10421 Pacific Center CourtSan Diego, CA 92121 |
| Phone | (858) 550-2100 |
| Contact | Laura Guy |
| Date of Summary | July 21, 1999 |
| Name of Device | Braun ThermoScan® PRO 3000 Infrared Thermometer |
| Predicate Device | Braun ThermoScan® IRT 3020/3520 One Second EarThermometerThermoScan® Instant Thermometer, ModelIR-2000(PRO-1) |
| Device Description | The Braun ThermoScan® PRO 3000 InfraredThermometer is a hand held instrument that measurestemperature through the opening of the auditory canal.Operation is based on measuring the natural thermalradiation emitted from the tympanic membrane andadjacent surfaces. |
| Intended Use | The Braun ThermoScan® PRO 3000 InfraredThermometer is intended for the intermittentmeasurement and monitoring of human bodytemperature, by medical professionals. It is intended foruse on people of all ages. |
| Technological Characteristics | The Braun ThermoScan® thermometers, Models PRO3000 and IRT 3020/3520 have the same general design,incorporate similar materials and components, and usesimilar technology. |
| The primary function of the Braun ThermoScan® PRO3000 Infrared Thermometer is the same as the Braun |
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ThermoScan® IRT 3020/3520 and the ThermoScan® Instant Thermometer, Model IR-2000(PRO-1). The device is to be used for the measurement of body temperature. The PRO 3000 raise no new questions of safety and effectiveness.
ThermoScan® concludes that the Braun Braun ThermoScan® PRO 3000 Infrared Thermometer is substantially equivalent to the Braun ThermoScan® 3020/3520 and the ThermoScan® Instant Thermometer, Model IR-2000(PRO-1).
PRODUCT SPECIFICATIONS
Model Number
3000
| Technical Characteristics | |
|---|---|
| Displayed temperature range: | 68°F-108°F (20°C-42.2°C) |
| Operating ambient temperature range: | 50°F-104°F (10°C-40°C) |
| Display resolution: | 0.1°F or °C |
| Temperature scales (user selectable): | °F or °C |
| Long term storage ranges: | |
| Temperature | -4 to 122°F (-20 to 50°C) |
| Humidity (max) | 95% noncondensing |
| Display modes: | EAR (The displayed temperature is the actual measured ear temperature plus a mathematical adjustment to approximate the familiar oral range. However, this is not |
Weight (without batteries): Memory recall:
3.5 oz (100q) One previous temperature
temperature taken at the same time.)
necessarily
the same as an
oral
Accuracy characteristics *: Applicable patient ages: Patient temperature range 96.8°F to 102.2°F (36 to 39°C) Outside this range
All ages Error °F Error °C + 0.2 + 0.4 + 0.3 + 0.5
*ASTM laboratory accuracy requirements in the display range of 36℃ to 39℃ (96.8 to 102 °F) for IR thermometers is + 0.2°C (+ 0.4°F), whereas for mercury-in-qlass and electronic thermometers, the requirement per ASTM Standards E667-86 and E1112-86 is + 0.1ºC (+ 0.2ºF).
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This infrared thermometer meets the requirements established in ASTM Standard E 1965-98, "Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature". Full responsibility for the conformance of this Product to the standard is assumed by Braun GmbH, 61476 Kronberg, Germany.
SUMMARY OF TESTING
Non-Clinical Results
| PERFORMANCE TEST | RESULTS |
|---|---|
| Five Environment Accuracy Test | Pass |
| Thermometer Operating Life Test (Reliabilityof keys, switch and probe cover ejector) | Pass |
| Cleaning Test | Pass |
| Acoustic Noise test | Pass |
| ENVIORNMENTAL | RESULTS |
| Altitude Test | Pass |
| Electromagnetic Compatibility | Pass |
Product performance specifications, features and software were validated.
Clinical Results
A comparison study and clinical repeatability testing was performed on the following four ages groups; 0-3 yrs, 4-10 yrs, 11-65 yrs, and >65 yrs. Approximately 39% of the patients participating in the study were considered febrile. The comparison study demonstrated that the Braun ThermoScan® PRO-3000 Instant Thermometer measured ear temperature equivalently to the ThermoScan® IR-2000(PRO-1) in all age groups. The clinical repeatability is statistically and clinically acceptable.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 20 1999
Ms. Laura Guy Senior Regulatory Affairs Specialist Braun ThermoScan® 10421 Pacific Center Court San Diego, CA 92121
Re : K992468
Trade Name: Braun ThermoScan® PRO 3000 Infrared Thermometer Regulatory Class: II Product Code: FLL Dated: July 22, 1999 Received: July 23, 1999
Dear Ms. Guy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Ms. Guy
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to one regaration" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Intended Use of the Braun ThermoScan Pro 3000
The Braun ThermoScan PRO 3000 is intended for the intermittent measurement and monitoring of human body temperature by medical professionals. It is intended for use on people of all ages.
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510k) N
§ 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.