BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT)
K031928 · Braun GmbH · FLL · Oct 24, 2003 · General Hospital
Device Facts
Record ID
K031928
Device Name
BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT)
Applicant
Braun GmbH
Product Code
FLL · General Hospital
Decision Date
Oct 24, 2003
Decision
SESE
Submission Type
Abbreviated
Regulation
21 CFR 880.2910
Device Class
Class 2
Attributes
Pediatric
Indications for Use
Intermittent measurement and monitoring of human body temperature on people of all ages. IRT 4000 series - consumers in a home use environment. PRO 4000 series professionals in a professional environment.
Device Story
Hand-held, battery-powered infrared ear thermometer; measures infrared energy emitted from tympanic membrane and surrounding tissue. Features probe with integrated heating element to warm tip to ~37°C, reducing blackbody effect and improving repeatability. Includes ExacTherm positive feedback system to signal correct probe placement; displays position error if placement is incorrect. Used by professionals in clinical settings or consumers at home. Provides temperature output to user; assists in clinical decision-making by providing accurate, repeatable body temperature readings.
Clinical Evidence
Clinical comparison and repeatability study conducted across four age groups (0-3, 4-10, 11-65, >65 years). Results demonstrated IRT 4000 measures ear canal temperature equivalent to IRT 3000. Ear temperatures showed high correlation with oral and axillary sites; differences within clinical acceptability. Repeatability statistically and clinically acceptable. Consumer vs. professional comparability study showed no significant difference in measurements or repeatability between user groups.
Technological Characteristics
Hand-held infrared ear thermometer. Materials: thermometer case, speculum, buttons, and lens filters/probe covers same as predicate. Sensing: infrared sensor with integrated ambient sensor and heating element. Connectivity: none. Power: battery. Standards: ASTM E1965-98, IEC 60601-1, IEC 60601-1-4, IEC 60601-1-2, AAMI/ISO 14971.
Indications for Use
Indicated for intermittent measurement and monitoring of human body temperature in patients of all ages. PRO 4000 series for professional use; IRT 4000 series for home use by consumers.
Regulatory Classification
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.
Braun Thermoscan PRO 3000 infrared ear thermometer
Submission Summary (Full Text)
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Ko3 1928
## 510(k) Summary
## Summary of Safety and Effectiveness
#### Company information
Braun GmbH Frankfurter Strasse 145 D-61476 Kronberg Germany
#### Device Identification
Trade Name - Braun Thermoscan® IRT 4000 series - Braun Thermoscan® PRO 4000 series Classification Name - Thermometer, Clinical, Electronic Classification - Class II Product Code - 80 FLL
#### Predicate Devices
Braun Thermoscan IRT 3000 infrared ear thermometer (consumer) Braun Thermoscan PRO 3000 infrared ear thermometer (professional)
#### 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 enerqy 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.
- . IRT 4000 series - consumers in a home use environment.
- PRO 4000 series professionals in a professional environment. 피
## Comparison of the Braun ThermoScan IRT/PRO 4000 and the Braun Thermoscan IRT/PRO 3000 infrared ear thermometers
The basic design of the Braun ThermoScan IRT/PRO 4000 and the Braun Thermoscan IRT/PRO 3000 are similar. The fundamental scientific technology of the new devices has not changed from that of the predicate devices. The materials used to fabricate the thermometer case, speculum, buttons and Lens Filters/Probe Covers are the same as the IRT/PRO 3000 series thermometers.
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The following are the primary differences between the IRT/PRO 4000 and the IRT/PRO 3000 series thermometers.
- 1. The IRT/PRO 4000 series thermometer family incorporates a new probe design that contributes to increased repeatability of temperature measurements. The infrared sensor has been repositioned from the base of the IR wave-guide closer to the interior tip of the probe.
- 2. Integrated into the IR sensor are the ambient sensor and a heating element. The heating element warms the probe tip close to the most likely temperature within the range of the intended target temperatures, (i.e., human body temperature 37°C) and results in a reduction of the blackbody effect and increased repeatability of successive temperature measurements.
- 3. A positive feedback system (ExacTherm®) informs the user that the proper conditions and placement have been established to obtain an accurate temperature measurement. The user is signaled when the probe has been properly positioned in the ear canal and the conditions are correct for a complete measuring process. If the correct position is not obtained, a position error will be displayed.
## Compliance with Consensus Standards
The Braun Thermoscan IRT/PRO 4000 series conform to Consensus Standards and other Standards that include:
- ASTM E1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
- IEC 60601-1:1988 Cor 1 1995 Medical Electrical Equipment Part 1 General requirements for Safety
- IEC 60601-1:1988 Medical Electrical Equipment Part 1 General requirements for Safety, 1998; Amendment 1, 1991-11, Amendment 2, 1995-03
- IEC 60601-1-4:2000 Medical Electrical Equipment Part 1-4 General requirements for Safety - Collateral Standard: Programmable Electrical Medical Electrical Systems
- IEC 60601-1-2:2001 Medical Electrical Equipment Part 1 General requirements for Safety; Electromagnetic Compatibility - Requirements and Tests
- AAMI/ISO 14971:2000 -- Medical Devices -- Application of Risk Management to Medical Devices
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AAMI/ISO 14971-1:2000 - Medical Devices - Risk Management - Part 1: Application of Risk Analysis
- EN 540:1993 Clinical Investigation of Medical Devices for Human Subjects
- EN 980:1997+ A1:1999 Graphical Symbols for Use in the Labeling of Medical Devices
- ISO 15223:2000 Symbols Used with Medical Device Labels, Labeling, and Information to be Supplied
## Clinical Results
A comparison study and clinical repeatability testing was performed on the following four age groups; 0-3 years, 4-10 years, 11-65 years, and >65 years. This clinical comparison study demonstrated that the Braun ThermoScan IRT 4000 measures ear canal temperature as well as the previously approved model IRT 3000 in all age groups. The ear temperatures obtained with the IRT 4000 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.
## Consumer vs. Healthcare Professional Comparability Study Results
The difference in measurements obtained by health care professionals and consumers with the Braun ThermoScan® IRT/PRO 4000 ear thermometer was tested. Consumers' measurements obtained were comparable to the professional measurements, collectively, for pooled professionals, and each individual category of professionals.
The repeatability of temperatures obtained from the consumers was comparable to the repeatability of the temperatures obtained from the professionals.
## Conclusion
The Braun Thermoscan IRT/PRO 4000 series thermometers:
- . conform to Consensus Standards that are applicable to infrared ear thermometers,
- are technically and functionally substantiality equivalent to the predicate devices, . and
- function similarly in the hands of consumers and healthcare professionals. .
Therefore the IRT/PRO 4000 series thermometers do not raise any significant questions of safety or effectiveness.
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Public Health Service
OCT 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Braun GmbH C/O Mr. Fred Schlador Regulatory Resources, LLC 6183 Paseo Del Norte, Suite 150 Carlsbad, California 92009
Re: K031928
Trade/Device Name: Braun Thermoscan PRO 4000 Series (Professional Use Environment) and Braun Thermoscan IRT4000 Series (Home Use Environment) Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: September 5, 2003 Received: September 8, 2003
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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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 (301) 594-4618. 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/cdrh/dsma/dsmamain.html
Sincerely yours, ·
Sinal Runny
Chiu 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 Statement
510(k) Number: K031928
Device Name:
Braun ThermoScan® PRO 4000 series and IRT 4000 series Infrared ear thermometer
Indications for Use:
PRO 4000 series
The Braun Thermoscan PRO 4000 series infrared ear thermometers are indicated for the intermittent measurement and monitoring of human body temperature by professionals in a professional use environment.
#### IRT 4000 series
The Braun Thermoscan IRT 4000 series infrared ear thermometers are indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment.
Patrice Cucenote
ivision of Anesthesiology. General Hospital. Infection Control. Dental Device
510(k) Number: *K031928*
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109 OR
ﺔ Over the Counter
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
