(175 days)
The Braun ThermoScan IRT 3020/3520 One Second Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home. It is intended for use on people of all ages.
The Braun Thermoscan IRT 3020/3520 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.
Here's a breakdown of the acceptance criteria and study information for the Braun Thermoscan IRT 3020/3520 Thermometer, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (from ASTM E1965-98) | Reported Device Performance |
|---|---|---|
| Accuracy (Patient temperature range 96.8°F to 102°F / 36°C to 39°C) | ± 0.4°F (± 0.2°C) for IR thermometers | Meets criteria: ± 0.4°F (± 0.2°C) |
| Accuracy (Outside patient temperature range 96.8°F to 102°F) | Not explicitly stated in ASTM context, but device reports: | Meets criteria: ± 0.5°F (± 0.3°C) |
| Five Environment Accuracy Test | Pass (implied by "meets requirements established in ASTM Standard E1965-98") | Pass |
| Thermometer Operating Life Test | Pass | Pass |
| Cleaning Test | Pass | Pass |
| Acoustic Noise Test | Pass | Pass |
| Altitude Test | Pass | Pass |
| Electromagnetic Compatibility | Pass | Pass |
| Software Validation | Validated (implied) | Validated |
| Clinical Repeatability | Statistically and clinically acceptable | Statistically and clinically acceptable |
Note on Accuracy: The summary explicitly states that the device "meets the requirements established in ASTM Standard E1965-98" for infrared thermometers, which requires ± 0.2°C (± 0.4°F) in the 36°C to 39°C range. The provided device performance directly matches this.
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the clinical comparison study and clinical repeatability testing. The document only mentions that the study was performed on four age groups: 0-3 yrs, 4-10 yrs, 11-65 yrs, and >65 yrs.
- Data Provenance: Not explicitly stated, but the submission is from Braun AG, 61476 Kronberg, Germany, implying the general origin of the product. The document does not specify whether the clinical data was retrospective or prospective, or the specific country of origin for the clinical study participants.
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 summary. For a thermometer, "ground truth" typically refers to core body temperature, often measured via a highly accurate reference thermometer (e.g., rectal or arterial line), rather than expert interpretation of an image or signal.
4. Adjudication method for the test set:
- This information is not provided in the summary. Adjudication methods (like 2+1 or 3+1) are typically used for subjective assessments (e.g., image interpretation), which is not directly applicable to a thermometer's output. The "ground truth" for a thermometer would be a physical measurement.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI (or computer-aided detection/diagnosis) impacts human performance in tasks like image interpretation. This is not relevant for a standalone temperature measuring device like the Braun Thermoscan thermometer. The clinical study was a comparison study to a known predicate device (IR-4000) and clinical repeatability testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment was done. The entire submission details the performance of the device itself (the thermometer) independent of human interpretation or collaboration, as evidenced by the "Summary of Testing" for both non-clinical and clinical results. The accuracy and repeatability are inherent to the device's function.
7. The type of ground truth used:
- The ground truth for accuracy and comparison would implicitly be reference measurements of body temperature (e.g., from a highly accurate thermometer or standard clinical methods) against which the Braun Thermoscan IRT 3020/3520's readings were compared. The summary does not explicitly detail the method for establishing this ground truth but implies it through the accuracy specifications and comparison study to the IR-4000.
8. The sample size for the training set:
- This information is not applicable/not provided for a traditional training set as seen in machine learning. The Braun Thermoscan is a device based on a physical measurement principle (infrared radiation), not a machine learning algorithm that is "trained" on a dataset in the conventional sense. Any "calibration" or internal adjustments would be part of the device's design and manufacturing process, not a data training set.
9. How the ground truth for the training set was established:
- As mentioned above, this concept is not applicable to this type of device.
{0}------------------------------------------------
3/15/99
510(k) SUMMARY
Submitter's Name Braun Thermoscan 10421 Pacific Center Court Address: San Diego, CA 92121 (619) 550-2100 Phone: Frances E. Harrison Contact: September 10, 1998 Date of Summary: Braun Thermoscan ® IRT 3020/3520 Thermometer Name of Device: ThermoScan® Instant Thermometer, Model IR-4000 Predicate Device: ThermoScan® Instant Thermometer, Model IR-6000 Genius® First Temp Model 3000A The Braun Thermoscan IRT 3020/3520 Thermometer Device Description: 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. The Braun Thermoscan IRT 3020/3520 thermometer Intended Use: is intended for the intermittent measurement and monitoring of human body temperature in the home. It is intended for use on people of all ages. Technological The Braun Thermoscan thermometers, Models IRT 3020/3520 and IR-6000 have the same general Characteristics: design and incorporate similar materials and components. The Braun Thermoscan IRT 3020/3520 has the same sensor technology as the Genius® First Temp Model 3000A. The primary function of the Braun Thermoscan thermometer, Model is the IRT3020/3520 is the same as the ThermoScan Instant Thermometer, Models IR-4000 and IR-6000 for the measurement of body temperature and raise no new questions of safety and effectiveness.
{1}------------------------------------------------
Page 2 510(k) Summary Braun Thermoscan IRT 3020/3520 Thermometer
Braun Thermoscan concludes that the Braun Thermoscan IRT 3020/3520 is substantially equivalent to the ThermoScan IR-4000 and IR-6000.
PRODUCT SPECIFICATIONS:
| Model Number | 3020, 3520 |
|---|---|
| -------------- | ------------ |
Technical Characteristics:
| Displayed temperature range: | 93.2°F-108°F (34°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 necessarily the same as an oral temperature taken at the same time.) |
| Weight (without batteries): | 3.5 oz (100g) |
| Memory recall: | IRT3020, One previous temperatureIRT3520, Up to eight temperatures |
Accuracy characteristics*:
| Applicable patient ages: | All ages |
|---|---|
| -------------------------- | ---------- |
| Patient temperature range96.8°F to 102°F (36 to 39°C) | Error °F | Error °C |
|---|---|---|
| ± 0.4 | ± 0.2 | |
| Outside this range | ± 0.5 | ± 0.3 |
*ASTM laboratory accuracy requirements in the display range of 36℃ to 39℃ (98 to 102 °F) for IR thermometers is ± 0.2℃ (± 0.4℃), whereas for mercury-in-glass and electronic thermometers, the requirement per ASTM Standards E667-86 and E1112-86 is ± 0.1ºC (+ 0.2ºF).
{2}------------------------------------------------
Page 3 510(k) Summary Braun Thermoscan IRT 3020/3520 Thermometer
This infrared thermometer meets the requirements established in ASTM Standard E1965-98, "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 AG, 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 coverejector) | 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. The comparison study demonstrated that the BraunThermoscan IRT 3020/3520 Thermometer measured ear temperature equivalently to the IR-4000 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 circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular pattern around the edge. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 1999
Braun AG C/O Mr. Frances E. Harrison Braun Thermoscan 10421 Pacific Center Court San Diego, California 92121
K983295 Re : Braun ThermoScan IRT 3020/3520 One Second Trade Name: Ear Thermometer Requlatory Class: II Product Code: FLL September 18, 1999 Dated: September 21, 1999 Received:
Dear Mr. Harrison
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation 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 obligation you might have under sections 531 through 542 of
{4}------------------------------------------------
Page 2 - Mr. Harrison
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to beqin 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 regulation entitled, "Misbranding by reference to premarket notification" (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
Direc cor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Page .... of ...
510(k) Number (if known) :-
Device Name __________________________________________________________________________________________________________________________________________________________________
Indications Por Use:
The Braun ThermoScan IRT 3020/3520 One Second Ear Thermometer is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home. It is intended for use on people of all ages.
.. .. ... ... ................................................................................................................................................................
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Paltina Cusente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K483295
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use
(Optional Format 1-2-96)
§ 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.