K030624 · Draeger Medical, Inc. · BSZ · Mar 17, 2004 · Anesthesiology
Device Facts
Record ID
K030624
Device Name
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
Applicant
Draeger Medical, Inc.
Product Code
BSZ · Anesthesiology
Decision Date
Mar 17, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 868.5160
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Fabius GS is indicated as a continuous flow anesthesia system. The Fabius GS can be used for spontaneous, manually assisted, automatic or pressure support ventilation, and monitoring oxygen concentration, breathing pressure, and respiratory volume of patients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.
Device Story
Fabius GS is a continuous flow anesthesia system used in clinical settings by physicians to deliver gases and provide respiratory support during anesthesia. The device monitors inspired oxygen concentration, breathing pressure, and respiratory volume. The modified system incorporates Pressure Support Ventilation (PSV), which is flow-triggered and flow-cycled, similar to the Evita 4 ventilator. The system provides clinicians with adjustable ventilation settings, including trigger level and support pressure, to assist patient breathing. Output is displayed on an operator control panel, allowing the physician to adjust ventilation parameters to manage patient respiratory status during anesthesia delivery.
Clinical Evidence
No clinical data provided. Evidence consists of hazard analysis, system-level qualification, and verification/validation testing.
Technological Characteristics
Continuous flow anesthesia system. Features include flow-triggered and flow-cycled Pressure Support Ventilation (PSV). Hardware includes an operator control panel with an added hard key for PSV. Monitors oxygen concentration, breathing pressure, and respiratory volume. Software includes ventilation control algorithms for spontaneous, manual, automatic, and pressure support modes.
Indications for Use
Indicated for patients requiring anesthesia during spontaneous, manually assisted, automatic, or pressure support ventilation. Prescription use only.
Regulatory Classification
Identification
A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).
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MAR 1 7 2004
# SUMMARY OF SAFETY AND EFFECTIVENESS DATA RELATING TO SUBSTANTIAL EQUIVALENCE
| Proprietary Name: | Fabius GS Anesthesia System |
|---------------------------------------------------------|------------------------------------------------------------------------------------|
| Classification Name: | Gas Machine, Anesthesia - 73 BSZ |
| Device Class: | Class II |
| Initial Distributor: | Draeger Medical, Inc.<br>3135 Quarry Road<br>Telford, Pennsylvania 18969 USA |
| Establishment Registration No.: | 2517967 |
| Devices to which substantial<br>equivalence is claimed: | Fabius GS Anesthesia System -- K011404<br>Evita 4 Continuous Ventilator -- K961687 |
### Device Description:
The modified Fabius GS is a continuous flow gas anesthesia system.
### Intended Use:
The modified Fabius CS may be used for spontaneous, manually assisted, automatic, or The modified i dolus of patients during anesthesia, and delivery of gases and pressure support venthanon of partins GS can monitor inspired oxygen concentration, breathing pressure, and respiratory volume.
### Substantial Equivalence:
The current Fabius GS Anesthesia System (K011404) is being modified to include The current Paoras OS Incounted a Joional ventilation mode. The addition of Pressure Fressure Support Ventiation is an opportune change. The only hardware change was the Support Venthanon is essenzary hard key on the operator control panel. With the exception of minor incremental changes that did not require a 510(k) notification, the exception of inmor merentental sixtingle, alarm strategies, fault detection circuitry, and basic infrastration operating printesp within the Fabius GS remain unchanged from the initially released Fabius GS. Adjustable ventilation settings available in Pressure Support mittany released i ublis Sb. Frigger Level (sensitivity level at which a breath is mode at Support Pressure 2017) ----------------------------------------------------------------------------------------------------------------------------------------------uctected), Maximum mopiratevel are new settings. Maximum Inspiratory Flow and I Tessure Ecver and Trigger 2017 are ventilation settings already available to the user in the current automatic ventilation modes.
Like the Evita 4 Continuous Ventilator (K961687), Pressure Support Ventilation (PSV) in the Fabius GS is flow triggered and flow cycled.
Qualification of the modified Fabius GS included hazard analysis, system level qualification, and verification/validation tests.
K030624
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Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with stylized wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2004
Mr. Michael A. Kelhart Regulatory Affairs Project Manager Draeger Medical Incorporated 3135 Quarry Road Telford, PA 18969
Re: K030624
Trade/Device Name: Fabius GS Anesthesia System Regulation Number: 868.5160 Regulation Name: Gas Machine, Anesthesia Regulatory Class: II Product Code: BSZ Dated: February 18, 2004 Received: February 19, 2004
Dear Mr. Kelhart:
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 may or dayer to our it of 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease or as mode a determination that your device complies with other requirements of the Act than + Federal statutes and regulations administered by other Federal agencies. You must
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Page 2 - Mr. Michael Kelhart
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 CFK Fart 807), labeling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This production control pro histor pro raise (ing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematication. The PDF intellig of cation 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 If you desire specific at 100 100 100 100 (301) 594-4646. Also, please note the regulation entitled, Comation of Collied of Collier of Commarket notification" (21CFR Part 807.97). You may obtain Misoranums of reference to presence to promosibilities under the Act from the Division of Small other general 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,
J.H. Wubben
\$\beta_1\$
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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of Page -
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________ K030624
Device Name: ______________Fabius GS Anesthesia System
Indications for Use:
The Fabius GS is indicated as a continuous flow anesthesia system. The Fabius GS can The I ablus OD is manually assisted, automatic or pressure support ventilation, be used for sponancous, manaary assemant and monitoring oxygen concentration, breathing denvory of gases and ancellers in potients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ V (Per 21 CFR 801.109)
OR
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________
# (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrerice of CDRH, Office of Device Evaluation (ODE)
ivision Sian-Off rision of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number
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.
