K952054 · Siemens Medical Solutions USA, Inc. · DSI · Jun 7, 1996 · Cardiovascular
Device Facts
Record ID
K952054
Device Name
SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960)
Applicant
Siemens Medical Solutions USA, Inc.
Product Code
DSI · Cardiovascular
Decision Date
Jun 7, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.1025
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The 960/1260/1280 Series Neonatal Monitoring is an enhanced software version of the 960/1260/1280 Series monitors. The enhanced version increases the patient population to include neonates along with the pediatric and adult patient covered by earlier versions of these products. The Intended Use Statement for the enhanced software is the same as the Intended Use for the substantially equivalent software of the Model 404N (reference 510(K) 844187/A). The intended use of this software is to measure: heart rate, respiration rate, invasive blood pressure, noninvasive blood pressure, cardiac output, gaseous carbon dioxide level, temperature, atrial oxygen concentration and pulse rate in neonatal patients and to detect ventilator performance and electroencephalograph waveforms. The software will produce visual and aural alarms if any of these parameters vary beyond preset limits. The Siemens 960/1260/1280 Series Neonatal Monitoring is intended to be used by Healthcare providers, i.e. Physicians, Nurses, and Technicians. The device labeling contains instructions for use which assures safe and effective use of the device. CAUTION: Federal law in the United States restricts this device to safe by, or on the order of a physician. All Siemens bedside monitors, parameter cartridges, central displays, recorders, ancillary displays, peripheral equipment, and accessories are intended for use only by qualified medical personnel. Patient monitoring equipment, however sophisticated, should never be used as a substitute for the human care, attention, and critical judgment that only trained health care professionals can provide.
Device Story
Multi-parameter bedside monitor series (960/1260/1280) utilizing enhanced software (version VH4-HXE) to enable neonatal monitoring. Inputs: physiological signals (ECG, pressure, CO2, temperature, SpO2, EEG, ventilator data). Processing: software-based parameter calculation and threshold monitoring. Outputs: real-time physiological data, visual/aural alarms for out-of-limit parameters. Used in clinical environments by physicians, nurses, and technicians. Healthcare providers use output for patient assessment and clinical decision-making. Benefits: enables continuous monitoring of neonatal patients to detect physiological instability.
Clinical Evidence
No clinical data provided. Substantial equivalence based on identical software performance specifications to the predicate device and bench testing of electrical/mechanical safety.
Technological Characteristics
Bedside monitoring system; software-based parameter processing; monochrome or color display; compatible with existing Siemens parameter cartridges and peripheral equipment. Software version VH4-HXE. No specific materials or connectivity standards (e.g., DICOM) detailed.
Indications for Use
Indicated for neonatal, pediatric, and adult patient populations requiring physiological monitoring of heart rate, respiration, blood pressure (invasive/noninvasive), cardiac output, CO2, temperature, SpO2, pulse rate, ventilator performance, and EEG waveforms.
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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SIEMENS
K952054
510 (K) Sirecust 960/961 1260/1261 1280/1281
# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING A DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The 960/961 1260/1261 and 1280/1281 Series Neonatal Monitoring is an enhanced software version of the 960/961 1260/1261 and 1280/1281 Series monitors. The enhanced software version increases the patient population to include neonatal applications. The enhanced software is substantially equivalent to the software used in the Siemens Neonatal Monitor Model 404N (reference 510(K) 844187/A). The Intended Use Statement for the enhanced software is the same as the Intended Use for the Model 404 Neonatal Monitor.
The intended use of this software is to measure: heart rate, respiration rate, invasive blood pressure, noninvasive blood pressure, cardiac output, gaseous carbon dioxide level, temperature, atrial oxygen concentration and pulse rate in neonatal patients and to detect ventilator performance and electroencephalograph waveforms. The software will produce visual and aural alarms if any of these parameters vary beyond preset limits.
Siemens Medical Systems, Inc.
Electromedical Group
16 Electronics Avenue
Danvers, MA 01923
USA
Tel: (508) 750-7500
Fax: (508) 777-3398
Telex: 511958 (Siemensm SD)
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510 (K) Sirecust 960/961 1260/1261 1280/1281
# GENERAL INFORMATION
## A. TRADE NAME
Siemens Sirecust 1200 Series Neonatal Monitoring which includes:
- 1260 Neonatal Monitoring (Monochrome Display)
- 1261 Neonatal Monitoring (Color Display)
- 1280 Neonatal Monitoring (Monochrome Display)
- 1281 Neonatal Monitoring (Color Display)
Siemens Sirecust 960 Series Monitoring (Retrofit) which includes:
- 960 Monitor (Monochrome Display)
- 961 Monitor (Color Display)
Siemens Sirecust 1200 Series Monitoring (Retrofit)
- 1260 Monitor (Monochrome Display)
- 1261 Monitor (Color Display)
- 1280 Monitor (Monochrome Display)
- 1281 Monitor (Color Display)
## B. COMMON NAME, CLASSIFICATION NUMBER, CLASS, and REGULATION NUMBER
| Monitor, Cardiac (Include. Cardiotachometer & Rate Alarm) | 74DRT | II | 870.2300 |
| --- | --- | --- | --- |
| Monitor, Cardiac Output (Thermal) | 74KFN | II | 870.1435 |
| Monitor, Breathing Frequency | 73BZQ | II | 868.2365 |
| Monitor, Indwelling Blood Pressure | 74CAA | II | 870.1110 |
| Monitor, Electrocardiograph | 74BRS | II | 870.2370 |
| Monitor, Electroencephalograph | 84BRR | II | 882.1400 |
| Monitor, Temperature | 80BWX | II | 880.2910 |
| Monitoring Spirometer | 73BZK | II | 868.1850 |
| Oximeter | 74DQA | II | 870.2700 |
| Monitor, Carbon Dioxide | 73ILKD | II | 868.4280 |
| Monitor, Noninvasive Blood Pressure | 74BXD | II | 876.1130 |
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510 (K) Sirecust 960/961 1260/1261 1280/1281
# C. ESTABLISHMENT REGISTRATION NUMBER
1220063
# D. ADDRESS OF MANUFACTURER
Siemens Medical Electronics, Inc.
16 Electronics Avenue
Danvers, MA 01923
Telephone: (508) 750-7500
Fax: (508) 774-8342
Contact Person: Mr. Thomas Connelly
# E. NEW OR MODIFICATION
The 960/1260/1280 Series Neonatal Monitoring is an enhanced software version of the 960/1260/1280 Series monitors. The enhanced version increases the patient population to include neonates along with the pediatric and adult patient covered by earlier versions of these products. The Intended Use Statement for the enhanced software is the same as the Intended Use for the Siemens Medical Systems’ Model 404N Neonatal Monitor.
The enhanced software (version VH4-HXE) is fully compatible with previously sold versions of these monitors. A retrofit will be offered to the owners of units with the previous revision software (version VGx-HXE and VHx-HXE) where x is the revision number.
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510 (K) Sirecust 960/961 1260/1261 1280/1281
# INTENDED USE STATEMENT
The 960/1260/1280 Series Neonatal Monitoring is an enhanced software version of the 960/1260/1280 Series monitors. The enhanced version increases the patient population to include neonates along with the pediatric and adult patient covered by earlier versions of these products. The Intended Use Statement for the enhanced software is the same as the Intended Use for the substantially equivalent software of the Model 404N (reference 510(K) 844187/A).
The intended use of this software is to measure: heart rate, respiration rate, invasive blood pressure, noninvasive blood pressure, cardiac output, gaseous carbon dioxide level, temperature, atrial oxygen concentration and pulse rate in neonatal patients and to detect ventilator performance and electroencephalograph waveforms. The software will produce visual and aural alarms if any of these parameters vary beyond preset limits.
## Intended Operator:
The Siemens 960/1260/1280 Series Neonatal Monitoring is intended to be used by Healthcare providers, i.e. Physicians, Nurses, and Technicians.
The device labeling contains instructions for use which assures safe and effective use of the device.
**CAUTION**: Federal law in the United States restricts this device to safe by, or on the order of a physician. All Siemens bedside monitors, parameter cartridges, central displays, recorders, ancillary displays, peripheral equipment, and accessories are intended for use only by qualified medical personnel. Patient monitoring equipment, however sophisticated, should never be used as a substitute for the human care, attention, and critical judgment that only trained health care professionals can provide.
## Intended Patient Populations:
The enhanced software for the Siemens 960/1260/1280 Series Neonatal Monitoring is intended to be used with Neonatal populations.
## Intended Use Environment:
The Siemens 960/1260/1280 Series Neonatal Monitoring is intended to be used in the environment where patient care is provided by Healthcare Professionals.
## Performance Standard:
None established under Section 514 or Section 358
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510 (K) Sirecust 960/961 1260/1261 1280/1281
# 510 (K) Decision Making Chart
1. Is the device compared to Marketed device? Yes, Model 404N Neonatal Monitor (K 844187/A) Manufactured by Siemens Medical Systems, Danvers, Ma.
2. Does the device have the same Indication Statement? Yes the enhanced software has the same intended use as the predicate device.
3. Does the new device have the same intended use and may be “substantially equivalent”? Yes the new device uses the same software that is used in the predicate device.
4. Does the device have the same Technological Characteristics, e.g. Design, materials, etc? Yes, the software is the same as the software used in the predicate device.
5. Are the descriptive characteristics precise enough to ensure equivalence? Yes, the specifications are identical.
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510 (K) Sirecust 960/961 1260/1261 1280/1281
## II. SAFETY AND EFFECTIVENESS INFORMATION
### ELECTRICAL:
The results of the environmental, electrical safety, and mechanical test results which were performed on the monitors are presented in Exhibit P.
### OPERATION:
The device labeling contains instructions for use which assures safe and effective use of the device.
**CAUTION:** Federal law in the United States restricts this device to sale by, or on the order of a physician. All Siemens bedside monitors, parameter cartridges, central displays, recorders, ancillary displays, peripheral equipment, and accessories are intended for use only by qualified medical personnel. Patient monitoring equipment, however sophisticated, should never be used as a substitute for the human care, attention, and critical judgment that only trained health care professionals can provide.
### DEVELOPMENT:
Medical device development is conducted in accordance with an approved Siemens Product Planning Process. Product specifications, hazards analysis, software development plan and device test plan are required parts of the device development process. Qualification test results which demonstrate that the device performs in accordance with its specification are required before product release.
## III. SUBSTANTIAL EQUIVALENCE
The Neonatal Monitors use the same hardware with enhanced software to accommodate the neonatal population of patients. The performance specifications for the neonatal applications are identical to the performance specifications of the Siemens Medical Systems Neonatal Monitor Model 404N (reference 510(K) K844187/A)
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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.
