K053484 · Draeger Medical Systems, Inc. · MHX · Feb 22, 2006 · Cardiovascular
Device Facts
Record ID
K053484
Device Name
INFINITY GAMMA / GAMMAXL, INFINITY VISTA
Applicant
Draeger Medical Systems, Inc.
Product Code
MHX · Cardiovascular
Decision Date
Feb 22, 2006
Decision
SESE
Submission Type
Special
Regulation
21 CFR 870.1025
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The intended use of this device is to monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, central apnea, end-tidal carbon dioxide*, and ST Segment Analysis. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders cither directly or via the Infinity network. * not available with the Infinity Vista monitor
Device Story
Infinity Gamma/GammaXL and Vista monitors are physiological patient monitors. Inputs include ECG, invasive/non-invasive pressure, temperature, SpO2, pulse, respiration, and gas concentrations (via Scio module). Device processes signals to provide real-time monitoring, arrhythmia detection, ST segment analysis, and gas measurement (CO2, N2O, O2, anesthetic agents). Outputs are visual/audible alarms, waveform displays, and recordings. Used in clinical environments by trained healthcare professionals to assess patient status and guide clinical decisions. Modifications include Pacer Fusion mode, new Scio gas module versions, and integration of Masimo SET pod. Device connects to R50 recorders directly or via Infinity network. Benefits include continuous patient surveillance and timely notification of parameter deviations.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Physiological patient monitor. Components include Scio gas module and Masimo SET pod. Connectivity via Infinity network or direct to R50 recorders. Software-based monitoring of vital signs and arrhythmia. Not MRI compatible.
Indications for Use
Indicated for monitoring heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, SpO2, pulse rate, central apnea, end-tidal CO2, and ST segment analysis in adult, pediatric, and neonatal populations. Arrhythmia and ST segment analysis are contraindicated for neonates. Intended for use by trained healthcare professionals (physicians, nurses, technicians) 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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KO5348(
## Special 510(k) Infinity Gamma Series VF6 Modifications
FEB 2 2 2006
### 510(k) SUMMARY
as required per 807.92(c)
| | Submitter's Name and Address: | Draeger Medical Systems, Inc.<br>16 Electronics Avenue<br>Danvers, MA 01923 | |
|-------------------------------|-------------------------------|--------------------------------------------------------------------------------|----------|
| Contact Person: | | Karen A. Iorio<br>Director QA/RA<br>Tel: (978) 907-7500<br>Fax: (978) 750-6879 | |
| Date submission was prepared: | | December 2, 2005 | |
| Device Name: | Common Name: | Monitor, Physiological, Patient<br>(with arrhythmia detection or alarms) | |
| | Classification Name: | MHX | |
| | Regulation Number: | 21 CFR 870.1025 | Class: 2 |
Legally Marketed Device Identification: - Infinity Gamma Series Monitors
#### Device Description:
The intent of this 510(k) is to describe modifications for the Infinity Gamma/GammaXL and Vista monitors, including Pacer Fusion mode, three new versions of the Scio gas module, and Draeger's Masimo SET pod.
#### Intended Use:
The intended use of this device is to monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, central apnea, end-tidal carbon dioxide*, and ST Segment Analysis. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders cither directly or via the Infinity network.
* not available with the Infinity Vista monitor
#### Predicate Devices:
Infinity Gamma Series & Vista with VF5 Infinity GammaXL & SC 6802XL with Scio Infinity Gamma
K042656 K033600, K040188 K041087
#### Substantial Equivalence:
Verification and validation testing performed indicates that the modifications implemented in the VF6 release of the Gamma series monitors are as safe and effective as previous versions and have not altered the fundamental technology of the device(s).
Page 1 of 1
## COMPANY CONFIDENTIAL
Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2006
Draeger Medical Systems, Inc. c/o Ms. Karen A. Iorio Director, QA/RA 16 Electronics Ave. Danvers, MA 01923
Re: K053484
.
K055464
Trade Name: Infinity Gamma / GammaXL, Infinity Vista Regulation Number: 21 CFR 870.1025 Regulation Number: 21 CFN 876.1025
Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Code: MHX Dated: January 25, 2006 Received: January 26, 2006
Dear Ms. Iorio:
We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section JTV(x) premainted is substantially equivalent (for the indications
referenced above and have determined the device is substantially interestate referenced above and nave determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices Mexico. Amendments for use stated in the enclosure) to regally manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment at the Federal Food. Drug commerce prior to May 28, 1970, the chacinene and othe provisions of the Federal Food. Drug, devices that have been reclassified in accordance what as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provinces of the Act . The and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The Act. The Act. The
You may, therefore, market the device, subject to the generation, l You may, therefore, market the device, subject to tirements for annual registration, listing of the general controls provisions of the 7tet merade requires 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 classified (see above) inlove in the major regulations affecting your device can
may be subject to such additional controls. Existing major regal In addi may be subject to such additional controls. Linking may be found in the Code of Federal Tregations, as a seeming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA S Issualice of a subscription with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA nas made a decemmation that your as rest works. The federal agencies. You must
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Page 2 -- Ms. Karen A. Iorio
comply with all the Act's requirements, including, but not limited to: registration and listing (21 Confory with an the 11et 31equirements)01); good manufacturing practice requirements as set CI K Fat 6077; adoling (2 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualis) by world provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
- production of to begin marketing your device as described in your Section 510(k) This letter with and in yourse of substantial equivalence of your device to a legally prematicated predicated. The 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 If you desire specific as not any and (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 other general miormational 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/industry/support/index.html.
Sincerely yours,
B Zimmerman for
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): __Ko53484
Device Name: INFINITY Gamma/GammaXL and Vista
Indications for Use:
This devices are capable of monitoring:
- Heart Rate .
- Respiration Rate .
- Invasive Pressure .
- Non-Invasive Pressure .
- Arrhythmia .
- Temperature ◆
- Arterial oxygen saturation .
- Pulse rate �
- central apnea .
- end-tidal CO2* .
- ST Segment Analysis .
This device will produce visual and audible alarms if any of these parameters vary beyond presel linits and I mo do roo alarin recordings. The devices will connect to R50 recorders either directly or via the Infinity network.
When a GammaXL is connected to a SCIO* module sampled breathing gases from adults and pediatrics can be displayed. The gas module continuously measures the content of CO2, N2O, O2 and one of the anestheic agents, Halothane, Isoflurane, Enflurane, Sevoflurane in any mixture and communicates real time and derived gas information to the GammaXL.
The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, 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 for use in the Adult, Pediatric and Neonatal populations, with the exception of Arrhythmia and ST Segment Analysis which are not intended for the neonatal population.
* not available with Infinity Vista
#### MRI Compatibility Statement:
The devices are not compatible for use in an MRI magnetic field.
) Prescription Use __ (Per 21 CFR 801.109) ાર
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)
Bummunma
Sign-On
Division of Cardiovascular Devices
510(k) Number K053484
Page 1 of 1
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.
