K012139 · Draeger Medical, Inc. · CCK · Jan 17, 2002 · Anesthesiology
Device Facts
Record ID
K012139
Device Name
VAMOS ANESTHETIC GAS MONITOR
Applicant
Draeger Medical, Inc.
Product Code
CCK · Anesthesiology
Decision Date
Jan 17, 2002
Decision
SESE
Submission Type
Abbreviated
Regulation
21 CFR 868.1400
Device Class
Class 2
Indications for Use
The Vamos Variable Anesthetic Gas Monitor is indicated for measuring and monitoring the CO2 concentration, functional oxygen saturation SpO2, pulse rate and the concentrations of N20, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. Federal law restricts this device to sale by or on the order of a physician.
Device Story
Vamos is an integrated monitoring system for anesthetic gas analysis (CO2, N2O, Halothane, Enflurane, Isoflurane, Sevoflurane, Desflurane) and pulse oximetry. It utilizes infrared absorption technology for gas analysis and an integrated pulse oximetry module. The device displays real-time CO2 waveforms, gas concentrations, SpO2, pulse rate, and alarms on an electroluminescent screen. Users control settings via a keypad and incremental encoder. It includes an optional battery backup providing one hour of reserve power. The device is intended for clinical use by healthcare professionals to monitor patient physiological status during anesthesia, aiding in clinical decision-making through continuous monitoring of gas and oxygenation levels.
Clinical Evidence
No clinical data provided. Evidence consists of bench testing, including hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing.
Technological Characteristics
Integrated monitoring system using infrared absorption technology for gas analysis. Features an electroluminescent display, keypad, and incremental encoder interface. Includes an optional battery backup system. Connectivity provided via RS-232 serial port. Pulse oximetry module is identical to the NPB4000. Sterilization method not specified.
Indications for Use
Indicated for measuring and monitoring CO2, N2O, and anesthetic agents (Halothane, Enflurane, Isoflurane, Sevoflurane, Desflurane), functional oxygen saturation (SpO2), and pulse rate in patients requiring anesthetic gas and pulse oximetry monitoring. Prescription use only.
Regulatory Classification
Identification
A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.
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# JAN 1 7 2002
K012/39
## SUMMARY OF SAFETY AND EFFECTIVENESS DATA RELATING TO SUBSTANTIAL EQUIVALENCE
| Proprietary Name: | Vamos Anesthetic Gas Monitor |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Analyzer, Gas, Carbon-Dioxide, Gaseous Phase - 73 CCK<br>Analyzer, Gas, Nitrous-Oxide, Gaseous Phase - 73 CBR<br>Analyzer, Gas, Enflurane, Gaseous Phase - 73 CBQ<br>Analyzer, Gas, Halothane, Gaseous Phase - 73 CBS<br>Oximeter - 74 DQA |
| Device Class: | Class II |
| Manufacturer: | Dräger Medizintechnik GmbH<br>53/55 Moislinger Allee<br>Lübeck, Germany 23558 |
| Establishment Registration No.: | 9611500 |
| Devices to which substantial<br>equivalence is claimed: | Vitalert 3000 Monitoring System - K913995<br>NPB4000 Pulse Oximeter - K962424 |
#### Device Description:
The Vamos is an integrated monitoring system used for multiple gas analysis (CO2, N2O, and anesthetic agent concentrations). Pulse oximetry may also be included as an option.
#### Intended Use:
The Vamos may be used for measuring and monitoring the functional oxygen saturation (SpO2), pulse rate and the concentrations of CO2, N2O and the following anesthestic agents; Halothane, Enflurane, Isoflurane, Sevoflurane, and Desflurane.
#### Substantial Equivalence:
Like the Vitalert 3000 (VA3000), the Vamos is an integrated monitoring system used for multiple gas analysis (CO2, N2O, and anesthetic agent concentrations) and Pulse oximetry. The VA3000 offers Non-Invasive Blood Pressure (NIBP) monitoring as an option while the Vamos does not.
The Vamos and VA3000 integrate the function of the electronic monitors. Measurement data, a real time CO2 waveform, and alarms are displayed. Both use an electro- luminescent display.
The Vamos and VA3000 use a combination of a keypad and incremental encoder to control screen formats and settings.
The Vamos offers an optional battery backup system, which is automatically enabled in the event of power failure and provides a one hour minimum power reserve time from full charge. The VA3000 does not have a battery backup system.
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The Vamos uses the same pulse oximetry module as the NPB4000 Pulse Oximeter (K962424).
The gas analyzer used in the Vamos is similar to that used in the VA3000 in that both utilize infrared absorption technology.
The Vamos and the VA3000 incorporate an RS-232 serial communication port.
Qualification of the Vamos included hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with a single snake winding around a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Mr. Michael A. Kelhart Draeger Medical Inc. 3135 Quarry Road Telford, PA 18969
K012139 Re:
> Vamos Anesthetic Gas Monitor Vallos Anesthere Gas Monton
> Regulation Number: 868.1400, 868.1700, 868.1500, 868.1620, and 870.2700 Regulation Name: 6001-000, 00017700, 00017700, 00011900, Oxide Gas Analyzer, Enflurane Gas Analyzer, Halothane Gas Analyzer, and Oximeter Regulatory Class: II (two) Regulatory Class: 11 (1.10)
> Product Code: 73 CCK, CBR, CBQ, CBS, NHO, NHP, NHQ, and 74 DQA Dated: October 23, 2001 Received: October 24, 2001
Dear Mr. Kelhart:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and have actions. In the enclicate devices marketed in interstate for use stated in the encreations) it regard) and entirent date of the Medical Device Amendments, or to connineres prior to May 20, 1978, as excordance with the provisions of the Federal Food, Drug, devices that have been received in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the Act include requirements for annual registration, listing of general controls provisions of the rice, 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 If your device is olassined (600 as 100 strols. Existing major regulations affecting your device can may or subject to such additions, 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 - Mr. Michael A. Kelhart
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I Dris issualites vour device complies with other requirements of the Act that I DA has made a acterimiations administered by other Federal agencies. You must of any irederal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) This iciticition. The FDA finding of substantial equivalence of your device to a legally premarket notincation: "The PPA miams of casification 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 If you desire specific ad 100 for in vitro diagnostic devices), please contact the Office of additionally 21 CHC Far 807.10 For questions on the promotion and advertising of Compliance at (301) 597-1810. I first of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation Chitica, "Misoranang of responsibilities under the Act may be obtained from the Outcl general information on your versational 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,
Qada Till
ram D. Zuckerman, M.D Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Page | | 1<br>ot | |
|------|---------------------------------------------------|---------|---|
| | A Market Pro and Collection Company of Concession | | - |
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _ Vamos Anesthetic Gas Monitor
Indications for Use:
STAKI NUmbe
The Vamos Variable Anesthetic Gas Monitor is indicated for measuring and monitoring the CO2 concentration, functional oxygen saturation SpO2, pulse rate and the concentrations of N20, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. Federal law restricts this device to sale by or on the order of a physician.
### (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) | <div>✓</div> |
|---------------------------------------|--------------|
|---------------------------------------|--------------|
OR
| Over-The-Counter-Use | |
|----------------------|--|
|----------------------|--|
(Optional Format 1-2-96)
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.
