The INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices will connect to an R50 Bedside recorder, either directly or via the INFINITY Network.
Device Story
INFINITY Modular Monitors are multi-parameter patient monitoring systems used by physicians, nurses, and technicians in clinical environments. The system collects physiological data including ECG (arrhythmia/ST segment), pressure, temperature, cardiac output, SpO2, EEG, and respiratory gases via the Scio module. The Scio module samples breathing gases (CO2, N2O, O2, anesthetic agents) from adult and pediatric patients, providing real-time and derived gas information. The VF4 software update specifically enables dual-anesthetic agent display. The device processes these inputs to provide continuous monitoring, visual/audible alarms for out-of-limit parameters, and data recording. It interfaces with bedside recorders and the INFINITY network. Healthcare providers use the displayed data to assess patient status and make clinical decisions. The device benefits patients by providing continuous surveillance of vital signs and respiratory status, facilitating timely intervention.
Clinical Evidence
No clinical data. Bench testing only. Verification and validation testing of the VF4 software and hardware modifications confirmed safety and efficacy.
Technological Characteristics
Multi-parameter physiological monitor. Software-based (VF4 release). Connectivity via INFINITY Network and MIB protocol converter. Supports Scio gas module for continuous gas sampling (CO2, N2O, O2, anesthetic agents). Not MRI compatible.
Indications for Use
Indicated for multi-parameter monitoring of adult, pediatric, and neonatal patients. Parameters include heart rate, respiration, invasive/non-invasive pressure, arrhythmia, temperature, cardiac output, SpO2, pulse rate, apnea, ST segment analysis, 12-lead ST segment analysis, tcPO2/tcPCO2, EEG, FiO2, and respiratory gases (CO2, N2O, O2, anesthetic agents). ST segment and arrhythmia analysis are for adult use only; tcPO2/tcPCO2 is for neonatal use only (not under gas anesthesia). Used by healthcare professionals in clinical settings.
Regulatory Classification
Identification
The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
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K033957
#### Special 510(k) Notification INFINITY Modular Monitors VF4 Modifications with Scio
# MAY 1 4 2004
510(k) SUMMARY
as required per 807.92(c)
Submitters Name, Address:
Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: Connie Hertel, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: May 13, 2004
Trade Name, Common Name and Classification Name:
- A. Trade Name:
INFINITY Modular Monitors
- B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Product Code | Class | Regulation Number |
|-----------------------------------------------------------------------------|--------------|-------|-------------------|
| Monitor, Physiological, Patient<br>(with arrhythmia detection or<br>alarms) | MHX | II | 21 CFR 870.1025 |
| Arrhythmia detector & Alarm | 74DSI | II | 21 CFR 870.1025 |
Legally Marketed Device Identification:
INFINITY Modular Monitors with Scio K031340 INFINITY SC 8000 Monitor, K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, K031340, K003243/K982730/ K980882
Description of Modification:
The INFINITY Modular monitor VF4 software release includes a modification in support of the Scio gas module for dual-anesthetic agent display.
Testing in accordance with internal design control procedures has verified that the INFINITY Modular Monitors VF4 modifications with Scio are as safe and effective as the previous released versions of the monitors.
#### 1 of 2
Draeger Medical Systems, Inc.
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
{1}------------------------------------------------
### Special 510(k) Notification INFINITY Modular Monitors VF4 Modifications with Scio
Intended Use:
The INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices will connect to an R50 Bedside recorder, either directly or via the INFINITY Network.
Assessment of non-clinical performance data for equivalence:
Verification and validation testing of VF4 software, as well as testing applicable to the hardware modifications for the new Draeger look indicate no new issues relative to safety and efficacy.
Assessment of clinical performance data for equivalence: Not applicable
Biocompatability: Not applicable
Sterilization: Not applicable
IEEE 802.11 Standards and Guidances: Reviewer Guidance for Premarket Notification 510(k) Submissions, November 1993
Draeger Medical Systems, Inc.
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three stylized human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2004
Ms. Penelope H. Greco Regulatory Submissions Manager Siemens Medical Solutions USA, Incorporated 16 Electronics Avenue Danvers, MA 01923
Re: K033957
Trade Name: INFINITY Modular Monitors VF4 Modifications with Scio Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor, (W/ Arrhythmia Detection or Alarms) Regulatory Class: II Product Code: MHX Dated: April 14, 2004 Received: April 15, 2004
Dear Ms. Greco:
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 adultcration.
If your device is classified (sec 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. Penelope H. Greco
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DT 5 issualled on that your device complies with other requirements mean that ITDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal statues and regirements, including, but not limited to: registration You must comply with an the Fee o required (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Part 007), labeling (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality ison 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) This letter will anow you to begal mading of substantial equivalence of your device to a premarket notification. - The PD Printers 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), If you desire specific advice for your as at (301) 594-4646. 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 Inay obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Driston 01 01 01638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
{4}------------------------------------------------
## Indications for Use
510(k) Number (if known): Device Name:____ INFINITY Modular Monitors
Indications for Use:
The INFINITY Modular monitors are capable of monitoring:
- Heart rate .
- Respiration rate .
- Invasive pressure .
- Non-invasive pressure .
- Arrhythmia .
- Temperature .
- Cardiac output .
- Arterial oxygen saturation .
- Pulse rate .
- Apnea .
- ST Segment Analysis ●
- 12-Lead ST Segment Analysis �
- tcn02/tcp(02 .
- EEG signals .
- FiQ2 .
The SCIO and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas I he octo and ivalitious mancedo internet of CO2, NO, O2 and one of the anesthetic agents, halothane, inoduces continuously mousal rane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.
With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration with etCO2 and instream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored.
The monitors can interface with specific third party devices via an MIB protocol converter.
The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.
The devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the The devices are intended to ot Segment Analysis, and arrhythmia which are intended for use in the adult purameter Cardial Galph, and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.
#### MRI Compatibility Statement:
The INFINITY Modular Monitors are not compatible for use in a MRI magnetic field.
Prescription Use_Y (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
(
(SDL)
Division Sign-Off)
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.
