K030580 · Welch Allyn, Inc. · FLL · May 6, 2003 · General Hospital
Device Facts
Record ID
K030580
Device Name
SURETEMP PLUS
Applicant
Welch Allyn, Inc.
Product Code
FLL · General Hospital
Decision Date
May 6, 2003
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.2910
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The Welch Allyn SureTemp® Plus thermometer enables the health care professional to make an accurate prediction of a febrile or hypothermic patient's oral temperature in approximately 4-6 seconds (in Normal mode). Pediatric Axillary (age 17 and younger) temperatures can be obtained in approximately 10-13 seconds. Adult Axillary temperatures (in Normal mode) can be obtained in approximately 12-15 seconds. Rectal temperatures (in Normal mode) can be obtained in approximately 10-13 seconds. Normal (predictive) mode is available for oral, rectal, and axillary use. In the Monitor mode, the instrument provides the capability of accurate, long-term monitoring of actual oral, rectal or axillary temperature, and of following the temperature whether constant, increasing, or decreasing. The SureTemp is a clinical grade thermometer intended for use by healthcare practitioners only; typically in a hospital, clinic, long- term care, or mobile health care environment. It is not intended for home use.
Device Story
SureTemp Plus is a clinical electronic thermometer; consists of elongated metal heat-conductive probe with internal thermistor connected to main body via coiled cord. Used by healthcare practitioners in hospitals, clinics, or long-term care facilities. Operation requires disposable plastic probe cover to prevent cross-contamination. Device functions in two modes: Normal (predictive) and Monitor (continuous). In Normal mode, algorithms process thermistor signals to predict final temperature within 4-15 seconds. In Monitor mode, device tracks actual temperature changes over time. Output displayed on screen; Model 692 includes backlit display, security features, and pulse timer; Model 690 is lower-cost version without these features. Provides rapid, accurate temperature assessment to assist clinical decision-making regarding patient febrile or hypothermic status.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Electronic thermometer; thermistor-based sensing; predictive and continuous monitoring modes; elongated metal probe; disposable plastic probe covers; Model 692 includes backlit display, security features, and pulse timer; Model 690 lacks these features; powered by main body unit.
Indications for Use
Indicated for healthcare professionals to measure oral, axillary, or rectal temperature in patients. Provides predictive readings (4-15 seconds) or continuous monitoring (approx. 3 minutes).
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.
Submission Summary (Full Text)
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#### 510(k) Summary Section 11:
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations Part 807 (21 CFR § 807), and in particular §807.92, the following summary of safety and effectiveness information is provided:
### Submitted By
MAY 0 6 2003
Debra L. Jackson, RAC Senior Manager, Quality Assurance & Regulatory Affairs Welch Allyn, San Diego 7420 Carroll Road San Diego, California 92121
Telephone: (315) 685-4133 Contact: Dave Klementowski Date Prepared: February 21, 2003
#### Device Name
Common or usual name: Thermometer, Electronic Thermometer, Predictive Thermometer
Classification Class: Il Panel: 80 Procode: FLL - clinical electronic thermometer
## Predicate Devices
The SureTemp® Plus clinical electronic thermometer consists of an elongated metal heat-conductive probe connected to the thermometer's main body through a coiled cord. The probe contains a thermistor that conveys temperature information to the main body for calculation of patient temperature.
Prior to use, a plastic probe cover must cover the probe. This cover must not be a significant barrier to the transfer of heat from the patient to the probe body (and thermistor). In addition, the disposable nature of the probe cover prevents microbiological cross-contamination amonq patients which might occur with a reuseable probe. Calculation of patient temperature may (in the normal or predictive mode) utilize algorithms that enable accurate temperature prediction within 4 to 15 seconds of probe placement (times vary based on the temperature mode selected).
There are two model designations for the SureTemp® Plus and they are the Model 692 and 690. The Model 690 is the lower cost version of the Model 692 and does not include the backlit display and security features or pulse timer.
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# Device Description
The SureTemp® Plus clinical electronic thermometer consists of an elongated metal heat-conductive probe connected to the thermometer's main body through a coiled cord. The probe contains a thermistor that conveys temperature information to the main body for calculation of patient temperature.
Prior to use, a plastic probe cover must cover the probe. This cover must not be a significant barrier to the transfer of heat from the patient to the probe body (and thermistor). In addition, the disposable nature of the probe cover prevents microbiological cross-contamination among patients which might occur with a reuseable probe. Calculation of patient temperature may (in the normal or predictive mode) utilize algorithms that enable accurate temperature prediction within 4 to 15 seconds of probe placement (times vary based on the temperature mode selected).
There are two model designations for the SureTemp® Plus and they are the Model 692 and 690. The Model 690 is the lower cost version of the Model 692 and does not include the backlit display and security features or pulse timer.
## Intended Use
The Welch Allyn SureTemp® Plus thermometer enables the health care professional to make an accurate prediction of a febrile or hypothermic patient's oral temperature in approximately 4-6 seconds (in Normal mode). Pediatric Axillary (age 17 and younger) temperatures can be obtained in approximately 10-13 seconds. Adult Axillary temperatures (in Normal mode) can be obtained in approximately 12-15 seconds. Rectal temperatures (in Normal mode) can be obtained in approximately 10-13 seconds. Normal (predictive) mode is available for oral, rectal, and axillary use.
In the Monitor mode, the instrument provides the capability of accurate, long-term monitoring of actual oral, rectal or axillary temperature, and of following the temperature whether constant, increasing, or decreasing.
The SureTemp is a clinical grade thermometer intended for use by healthcare practitioners only; typically in a hospital, clinic, long- term care, or mobile health care environment. It is not intended for home use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 6 2003
Ms. Debra L. Jackson Senior Manager, QA/RA Welch Allyn, Incorporated 7420 Carroll Road San Diego, California 92121
Re: K030580
Trade/Device Name: SureTemp® Plus Regulation Number: 880.2910 Regulation Name: Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 21, 2002 Received: February 24, 2003
Dear Ms. Jackson:
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 - Ms. Jackson
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,
Susan Punoe
Susan Runner, DDS, MA Interim 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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Page 1 of 1
510(k) NUMBER (IF KNOWN): K030580
DEVICE NAME: SureTemp® Plus
INDICATIONS FOR USE:
The Welch Allyn SureTemp Plus thermometer is intended to be used by healthcave professionals,
to provide an accurate prediction of patient temperature using the oval, axillary or reastal booky sives in 4 to 15 seconds , or to provide an actual temperature reading in the continuous monitor mode about 3 minutes . 11 =
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use
(Optional Format i-2-96)
Patricia Cuccente
(Division Sign-Off) Division of Anesthesiology, General I Infection Control, Dental Device
510(k) Number: K030580
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.
