(89 days)
ThermoScan® IR-2000(PRO-1)
No
The document describes a standard infrared thermometer and does not mention any AI or ML components or capabilities.
No.
The device is a thermometer used for measurement and monitoring of body temperature, not for treating or providing therapy for a medical condition.
No
The device is intended for the intermittent measurement and monitoring of human body temperature, which is a vital sign measurement rather than a diagnostic function.
No
The device description clearly states it is a "hand held instrument" that measures temperature through the auditory canal, indicating it is a physical hardware 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. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The Braun ThermoScan® PRO 3000 Infrared Thermometer measures temperature by detecting thermal radiation from the ear canal. This is a non-invasive measurement taken directly from the body, not a test performed on a sample taken from the body.
Therefore, based on the provided information and the definition of an IVD, the Braun ThermoScan® PRO 3000 is not an in vitro diagnostic device. It is a medical device used for measuring body temperature.
N/A
Intended Use / Indications for Use
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 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.
Product codes
FLL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auditory canal / ear
Indicated Patient Age Range
all ages / people of all ages
Intended User / Care Setting
medical professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Accuracy characteristics *: Applicable patient ages: All ages, Patient temperature range 96.8°F to 102.2°F (36 to 39°C) Error °F + 0.2 Error °C + 0.1, Outside this range Error °F + 0.4 Error °C + 0.2
Predicate Device(s)
Braun ThermoScan® IRT 3020/3520 One Second Ear Thermometer, ThermoScan® Instant Thermometer, Model IR-2000(PRO-1)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Court |
| San 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 Ear |
| Thermometer | |
| ThermoScan® Instant Thermometer, Model | |
| IR-2000(PRO-1) | |
| Device Description | 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. | |
| Intended Use | 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. | |
| Technological Characteristics | The Braun ThermoScan® thermometers, Models PRO |
| 3000 and IRT 3020/3520 have the same general design, | |
| incorporate similar materials and components, and use | |
| similar technology. | |
| The primary function of the Braun ThermoScan® PRO | |
| 3000 Infrared Thermometer is the same as the Braun |
1
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).
2
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 (Reliability | |
| of 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.
3
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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