INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL
K070566 · Draeger Medical Systems, Inc. · MHX · Jun 4, 2007 · Cardiovascular
Device Facts
Record ID
K070566
Device Name
INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL
Applicant
Draeger Medical Systems, Inc.
Product Code
MHX · Cardiovascular
Decision Date
Jun 4, 2007
Decision
SESE
Submission Type
Special
Regulation
21 CFR 870.1025
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The Infinity Delta and Kappa series modular monitors are intended for multiparameter 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. 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 . tcp02/tcpC02 . t FiO2. SCIO gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, halothane, isoflurane, Enflurane, Sevoflurane 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 rate in either mainstream 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 parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.
Device Story
Modular patient monitors (Delta, Kappa, Vista, Gamma, SC series) collect physiological signals (ECG, pressure, SpO2, EEG, gas concentrations) for real-time display and alarm generation. System processes inputs to provide continuous monitoring of vital signs and respiratory mechanics; integrates with R50 bedside recorders and Infinity Network. Used in clinical environments by physicians, nurses, and technicians to assess patient status and trigger clinical interventions based on visual/audible alarms. Modifications include software updates and MIB (Medical Information Bus) protocol enhancements for third-party device interfacing. Device provides continuous data streams to support clinical decision-making and patient safety monitoring.
Clinical Evidence
Bench testing only. No clinical data provided. Substantial equivalence supported by verification and validation of software modifications.
Technological Characteristics
Modular physiological monitor system. Connectivity via Infinity Network and MIB protocol converter. Software-based signal processing for arrhythmia, ST segment, and respiratory gas analysis. Not MRI compatible.
Indications for Use
Indicated for multiparameter physiological monitoring of adult, pediatric, and neonatal patients in clinical settings by healthcare professionals. Specific parameters include HR, respiration, invasive/non-invasive pressure, arrhythmia, temperature, cardiac output, SpO2, pulse rate, apnea, ST segment, 12-lead ST, tcpO2/tcpCO2, FiO2, and anesthetic gases. Cardiac output, ST segment, and arrhythmia monitoring restricted to adult/pediatric populations. tcpO2 monitoring restricted to neonates not under gas anesthesia. Not MRI compatible.
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.
Predicate Devices
Infinity Delta and Kappa Series Monitors with VF6 Modifications (K060039)
Infinity Modular Monitors with SCIO Modifications (K051628)
Infinity Delta and Kappa Series Monitors with VF5 Modifications (K043439)
Submission Summary (Full Text)
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Special 510(k) Infinity Delta and Kappa Series Monitors Modifications
Image /page/0/Picture/1 description: The image shows the logo for Dräger medical, with the words "Dräger medical" in bold, black letters. Below the logo, it says "A Dräger and Siemens Company" in a smaller font. In the upper right corner of the image, there is a handwritten number, K070566.
JUN - 4 2007
as required per 807.92(c)
| Submitter's Name and Address: | Draeger Medical Systems, Inc.<br>6 Tech Drive<br>Andover, MA 01810 |
|-------------------------------|---------------------------------------------------------------------------------------------|
| Contact Person: | Mark Kieras<br>Sr. Regulatory Affairs Manager<br>Tel: (978) 379-8219<br>Fax: (978) 379-8330 |
Date submission was prepared: February 16, 2007
Device Name:
Common Name: Monitor, Physiological, Patient (with arrhythmia detection or alarms) Classification Name: MHX Regulation Number: 21 CFR 870.1025 Class: 2 Legally Marketed Device Identification: Infinity Delta and Kappa Series Monitors
# Device Description:
The intent of this 510(k) is to describe software modifications for the Infinity Delta and Kappa series modular monitors (Delta, Delta XL, Kappa, Vista XL, Gamma X XL, SC7000, SC8000, SC9000XL), including MIB modifications.
#### Intended Use:
The Infinity Delta and Kappa series modular monitors are intended for multiparameter 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.
#### Predicate Devices:
| Infinity Delta and Kappa Series Monitors with VF6 Modifications | K060039 |
|-----------------------------------------------------------------|---------|
| Infinity Modular Monitors with SCIO Modifications | K051628 |
| Infinity Delta and Kappa Series Monitors with VF5 Modifications | K043439 |
## Substantial Equivalence:
Verification and validation testing performed indicates that the software modifications described in this submission are as safe and effective as previous versions and have not altered the fundamental technology of the device(s).
Page 1 of 1
DRAEGER MEDICAL SYSTEMS, INC. 6 Tech Drive Andover, MA 01810 Tel: 978-379-8219 Fax:978-379-8330
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 2007
Draeger Medical Systems, Inc. c/o Mr. Mark Kieras Sr. Regulatory Affairs Manager 6 Tech Drive Andover, MA 01810
Re: K070566
Trade/Device Name: Infinity Delta and Kappa Series Modular Monitors (Infinity Delta/Delta XL/Kappa/Vista XL/Gamma X XL, SC7000, SC8000, SC9000XL) Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II Product Code: MHX Dated: May 1, 2007 Received: May 7, 2007
Dear Mr. Kieras:
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 - Mr. Mark Kieras
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 240-276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
H
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K070566
Device Name: Infinity Delta / Delta XL / Kappa / Gamma X XL / Vista XL / SC7000 / SC8000 / SC9000XL
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 .
- tcp02/tcpC02 .
- EEG signals .
- t FiO2
Prescription Use_ ~ (Per 21 CFR 801.109) OR
Over-The-Counter Use
Continued on page 2
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division | |
|---------------|------------|
| Division | Odor Devic |
| 510(k) Number | K070566 |
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## Indications for Use
SCIO gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, halothane, isoflurane, Enflurane, Sevoflurane 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 rate in either mainstream 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 parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.
#### MRI Compatibilitv Statement:
The INFINITY Modular Monitors are not compatible for use in a MRI magnetic field.
Concurrence of CDRH, Office of Device Evaluation (ODE)
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.
