K011693 · Trumpf Medical Systems, Inc. · FSY · Jun 13, 2001 · General, Plastic Surgery
Device Facts
Record ID
K011693
Device Name
TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
Applicant
Trumpf Medical Systems, Inc.
Product Code
FSY · General, Plastic Surgery
Decision Date
Jun 13, 2001
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4580
Device Class
Class 2
Attributes
3rd-Party Reviewed
Indications for Use
The Trumpf surgical lights are intended to locally illuminate an operating or examination area of the patient's body with high intensity light.
Device Story
Trumpf Surgical Light models (301, 501, 701, 1001) provide high-intensity local illumination for surgical or examination areas. Devices feature halogen lamps in varying housing diameters (300-1000 mm) with ceiling, wall, or mobile configurations. Models 501, 701, and 1001 include a 635 nm laser pilot (<1 mW) to mark the center of the light field, activated during repositioning and remaining on for two seconds after movement stops. Model 1001 includes an anti-drift system using magnetic brakes that engage when the light is stationary and release upon contact with the handle. Operated by surgical staff in clinical/OR settings. Output is visual illumination; laser pilot assists in precise light field positioning. Benefits include improved visualization of small operating areas and stable, drift-free positioning.
Clinical Evidence
Bench testing only. Conformance to IEC 60601-2-41 (Particular Requirements for the safety of surgical luminaries) and IEC 601-1/EN 60601-1 (General requirements for safety) was demonstrated. No clinical data provided.
Technological Characteristics
Halogen lamp-based surgical luminaries. Configurations: ceiling, wall, or mobile. Features: laser pilot (635 nm, <1 mW) and magnetic brake anti-drift system (Model 1001). Standards: IEC 60601-2-41, IEC 601-1/EN 60601-1. Connectivity: None (standalone).
Indications for Use
Indicated for local illumination of operating or examination areas of the patient's body during surgical or examination procedures.
Regulatory Classification
Identification
A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.
Special Controls
*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
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## 510(k) Summary of Safety & Effectiveness
Trumpf Medical Systems, Inc. Submitter 415 Jessen Lane Wando, SC 29492 Mr. William Apperson Contact President and CEO (843) 534-0606 Fax: (843) 534-0206 BAPP1024@aol.com May 7, 2001 Date Device Trade Name: Trumpf Surgical Light . Common Name: Surgical Light, Examination Light Classification: 21 CFR 878.4580 - Surgical Light - Class II ● Product Code FSY ● Drager Sola Surgical Light legally marketed under 510(k) premarket Predicate Device notification K984611. The Trumpf surgical lights are intended to locally illuminate an operating or Indications for Use examination area of the patient's body with high intensity light. Device Four models of the Trumpf surgical lights will be available: 301, 501, 701 and 1001. The versions differ in the diameter of the lamp housing (300 mm, Description 500 mm, 700 mm and 1000 mm, respectively). All lights are equipped with one or two halogen lamps and are available in either ceiling-mounted ("D") or wall-mounted ("W") configurations. The Model 301 is also available in a floor standing/mobile ("S") configuration. The lights may be mounted individually, but more typically are mounted as two- or three-unit aggregates.
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011693
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## 510(k) Summary of Safety & Effectiveness, Continued
An optional laser pilot is available on the Models 501, 701 and 1001. The Device laser pilot exactly marks the center of the light field. This makes it easier for Description, the user to focus the light field with precision even if the operating area is continued very small. Whenever the operating light is moved/repositioned, the laser pilot is activated. When the operating light comes to a standstill, the laser pilot continues to be in operation for another two seconds. The laser pilot can be deactivated via the control panel. The laser wavelength is 635 nm with a nominal output power of < 1 mW. The Model 1001 is also equipped with an anti-drift system. As soon as the light comes to a standstill, it will be fixed in position by built-in magnetic brakes. The brakes are automatically released whenever the handrail surrounding the light (or central handle) is touched. The technological characteristics of the Trumpf Surgical Light are the same as Technological the predicate device, the Drager Sola Surgical Light. The physical Characteristics characteristics, performance specifications, materials, dimensions and all other characteristics of the Trumpf surgical lights are identical to the Sola surgical lights. Test Data Test data to support the conformance to: IEC 60601-2-41 Standard - Particular Requirements for the safety of . surgical luminaries and luminaries for diagnosis, First edition 2000-02 IEC 601-1/EN 60601-1 Medical electronic equipment, Part 1, General . requirements for safety, and software testing demonstrates that the lights perform as intended and are safe and effective. Based on the information provided herein and the 510(k) "Substantial Conclusion Equivalence" Decision Making Process Chart, we conclude that the Trumpf Surgical Light is substantially equivalent to the predicate device, the Drager Sola Surgical Light under the Federal Food, Drug and Cosmetic Act.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
JUN 1 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Trumpf Medical Systems, Inc. c/o Mr. Kent Donohue Senior Staff Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle, North Carolina 27709
Re: K011693
Trade/Device Name: Trumpf Surgical Light Models 301, 501, 701 and 1001 Regulation Number: 878.4580 Regulatory Class: II Product Code: FSY Dated: May 30, 2001 Received: May 31, 2001
Dear Mr. Donohue:
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 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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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.
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Page 2 - Mr. Kent Donohue
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 nothloate 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 11 you desire specific dains and on the devices), please contact the Office of Compliance at additionally 607.10 for in in 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsible free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Mark N Milkersen
elia M. Witten. Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number: k 011613
Device Name: Trumpf Surgical Lights Models 301, 501, 701 and 1001
Indications for Use:
The Trumpf surgical lights are intended to locally illuminate an operating or examination area of the patient's body with high intensity light.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use '/ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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(Division Sign Off)
Division of General, Restorative and Neurological Devices
510(k) Number K011693
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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.
