K955113 · Johnson & Johnson Medical, Inc. · DPS · Aug 15, 1996 · Cardiovascular
Device Facts
Record ID
K955113
Device Name
DINAMAP SELECT MULTI-PARAMETER SYSTEM
Applicant
Johnson & Johnson Medical, Inc.
Product Code
DPS · Cardiovascular
Decision Date
Aug 15, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.2340
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The DINAMAP Select Multi Parameter System (MPS) is a prescription device intended for use only by health care professionals. It can be used in hospital and/or outpatient surgery center settings and functions as a patient bedside multiparameter monitoring unit. It is designed for monitoring adult, pediatric and neonatal patients in acute care settings such as critical care, emergency room, radiology, labor and delivery, and operating room. Using this monitoring system, the clinician can view, record and recall clinical data derived from the user-selectable modules/monitoring parameters. This clinical data includes heart rate, ECG waveforms, oxygen saturation (SpO2), invasive pressure, noninvasive pressure (systolic, diastolic, mean), entidad carbon dioxide (CO2), respiration rate and temperature.
Device Story
Modular bedside patient monitor; mainframe accepts various parameter modules. Inputs: ECG leads, blood pressure cuffs (oscillometric), invasive pressure transducers, pulse oximetry sensors (red/IR), CO2 sensors (infrared), temperature probes. Processing: modules convert transducer signals to waveforms and numeric data; system displays, records, and stores 24 hours of data. Used in hospitals/outpatient surgery centers by clinicians. Networked capability allows remote viewing of vital signs. Output: real-time waveforms, numeric vital signs, paper strip records. Clinical decision-making: provides continuous monitoring to assist clinicians in patient assessment and intervention. Benefits: enables simultaneous multi-parameter monitoring, data recall, and centralized observation.
Clinical Evidence
Clinical studies conducted for noninvasive blood pressure (NIBP) and pulse oximetry across adult, pediatric, and neonatal populations. Bench testing performed for ECG, heart rate, respiration (impedance), continuous temperature, invasive pressure, CO2, environmental safety, and electromagnetic compatibility.
Technological Characteristics
Modular mainframe with 9 slots. Technologies: ECG (electrocardiography), Respiration (thoracic impedance/spectroscopy), NIBP (oscillometry), Invasive Pressure (strain-gauge transducer), Pulse Oximetry (red/IR spectroscopy), CO2 (infrared spectroscopy), Recorder (thermal). Connectivity: Ethernet network, remote view, central station interface. Software-driven electronic device.
Indications for Use
Indicated for monitoring vital signs in adult, pediatric, and neonatal patients in acute care settings including critical care, ER, radiology, labor and delivery, and operating rooms.
Regulatory Classification
Identification
An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.
Novametrix Model 1265 Endtidal CO2 Monitor (K910019)
JJMI DINAMAP PLUS Monitor Recorder Model 8726 (K943709, K912188)
Reference Devices
Johnson & Johnson Medical, Inc. OBSERVER* Central Station (K933404)
Submission Summary (Full Text)
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K955/13
# 510(k) Summary
AUG 15 1996
## Date
November 7, 1995
## Contact
Annette M. Hillring
Director, Regulatory Affairs
Johnson & Johnson Medical, Inc.
4110 George Road
Tampa, Florida 33634
Telephone: (813) 887-2256
Telefax: (813) 887-2263
## Device Name
DINAMAP* Select Multi-Parameter System (MPS)
## Common Names
Physiological or Vital Signs Monitor, Patient Monitor
Includes the following monitoring modules:
- Noninvasive Blood Pressure & Heart Rate Monitor
- Invasive Blood Pressure & Heart Rate Monitor
- Endtidal Carbon Dioxide & Respiration Rate Monitor
- Pulse Oximetry & Heart Rate Monitor
- Electrocardiograph (ECG), Respiration Rate, Heart Rate & Temperature Monitor
- Recorder
## Classification
The classification names, 21 Code of Federal Regulations (CFR) Part and Paragraph numbers, and classification of the DINAMAP Select MPS and its modules follow. The tier categorization based on the list (January 27, 1994) distributed by the Office of Device Evaluation is also included.
| Classification Name | 21 CFR § & Class | Tier |
| --- | --- | --- |
| Monitor, Cardiac (including cardiotachometer & rate alarm) | 870.2300 II | 2 |
| Electrocardiograph | 870.2340 II | 2 |
| Adapter, Lead Switching, Electrocardiograph | 870.2350 II | 1 |
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510(k) Summary, Continued
## Classification (continued)
| Classification Name | 21 CFR § & Class | Tier |
| --- | --- | --- |
| Analyzer, Gas, CO2, Gaseous Phase | 868.1400 II | 2 |
| Monitor, Breathing Frequency | 868.2375 II | 2 |
| System, Measurement, Blood Pressure, Noninvasive | 870.1130 II | 2 |
| Computer, Blood Pressure | 870.1110 II | 2 |
| Alarm, Blood Pressure | 870.1100 II | 2 |
| Oximeter | 870.2700 II | 2 |
| Oximeter, Ear | 870.2710 II | 2 |
| Thermometer, Clinical Electronic | 880.2910 II | 2 |
| Recorder, Paper Chart | 870.2810 II | 1 |
| Display, Cathode-Ray Tube, Medical | 870.2450 II | 1 |
## Predicate Devices
The following table summarizes the predicate devices for the MPS and its monitoring parameters/modules and 510(k) numbers:
| Select MPS | Predicate Device & Model | 510(k) Number(s) |
| --- | --- | --- |
| System | Hewlett Packard Component Monitoring System (CMS) HP M1175A & M1176A | K941811
K922058
K910490
K896030 |
| System | Hewlett Packard Omnicare™ Monitor | Unknown |
| System | Marquette Medical Tramscope™ System | K900598 |
| ECG | JJMI DINAMAP PLUS Monitor Models 8710/9710 & 8720/9720 | K943709
K912188 |
| Respiration | Hewlett Packard HP M1002A ECG/Respiration Module for the Hewlett Packard CMS | K941811 |
| Temperature | JJMI DINAMAP PLUS Monitor Models 8700/9700, 8710/9710 & 8720/9720 | K943709
K912188 |
| NIBP | JJMI DINAMAP PLUS Monitor Models 8700/9700, 8710/9710 & 8720/9720 | K943709
K912188 |
| IP | JJMI DINAMAP PLUS Monitor Model 8720/9720 | K943709
K912188 |
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510(k) Summary, Continued
## Predicate Devices (continued)
| Select MPS | Predicate Device & Model | 510(k) Number(s) |
| --- | --- | --- |
| Oximetry | Nellcor® Model N-180 Pulse Oximeter | K913695 |
| CO2 | Novametrix Model 1265 Endtidal CO2 Monitor | K910019 |
| Recorder | JJMI DINAMAP PLUS Monitor Recorder Model 8726 | K943709
K912188 |
## Device Description
The DINAMAP Select Multi Parameter System (MPS) is a prescription device intended for use only by health care professionals. It can be used in hospital and/or outpatient surgery center settings and functions as a patient bedside multiparameter monitoring unit. It is designed for monitoring adult, pediatric and neonatal patients in acute care settings such as critical care, emergency room, radiology, labor and delivery, and operating room. Using this monitoring system, the clinician can view, record and recall clinical data derived from the user-selectable modules/monitoring parameters. This clinical data includes heart rate, ECG waveforms, oxygen saturation (SpO2), invasive pressure, noninvasive pressure (systolic, diastolic, mean), entidad carbon dioxide (CO2), respiration rate and temperature.
The DINAMAP Select MPS functions as a single-patient monitor or as part of an Ethernet network. Patient data may be viewed in graphical or text form and is stored for twenty-four hours. If the MPS is networked, the user may observe vital signs data from other devices by using the Remote View feature. The MPS is modular and monitors multiple parameters simultaneously. When necessary, the user can temporarily suspend all activity of the monitor while in Standby mode. The MPS consists of the mainframe, modules and monitor (display).
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510(k) Summary, Continued
## Device Description, continued
The mainframe provides a single rack with nine slots for modules. All patient connectors are on the front of the mainframe. All network and device connectors are on the back. The indicators, on the right side of the mainframe, informs the user when the battery is being charged and when the MPS is operating on AC or battery power. The mainframe provides connection for the currently marketed Johnson & Johnson Medical, Inc. (JJMI, formerly Critikon, Inc.) OBSERVER* Central Station (K933404), other monitoring devices, such as the currently marketed Johnson & Johnson Medical, Inc., DINAMAP PLUS Monitors (K943709 & K912188), a remote monitor, a full-page printer, data collection system, remote alarm and/or host information system.
Modules measure patient vital signs and patient airway gases, and provide thermal paper strip records. The MPS accepts two types of modules: parameter modules and recorder modules. Parameter modules process data from transducers to generate waveforms and numeric data on the display screen. The waveforms and parameter measurements on the screen vary according to the modules inserted into the mainframe. The user can continue to monitor a patient with any of the remaining modules while inserting or removing other modules.
Currently, the Select MPS will offer the following modules:
- ECG (3 lead)/Respiration/Heart Rate/Continuous Temperature
- ECG (6 lead)/Respiration/Heart Rate/Continuous Temperature
- Noninvasive Blood Pressure (single wide)/Heart Rate
- Noninvasive Blood Pressure (double wide)/Heart Rate
- Invasive Pressure/Heart Rate
- Pulse Oximetry (Oxygen Saturation)/Heart Rate
- Endtidal Carbon Dioxide/Respiration
- Recorder (double wide)
## Indications
The DINAMAP Select MPS is intended to monitor a single patient’s vital signs at the bedside. The patient populations include adult, pediatric and neonatal. Remote monitoring is available if a network of monitors exists.
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510(k) Summary, Continued
## Technological Characteristics
The DINAMAP Select MPS and its monitoring modules/parameters have the same technological characteristics as the predicate devices. There are no new technological characteristics. The MPS and the predicate devices are all software-driven electronic devices. The MPS monitoring parameters and predicate devices monitoring parameters utilize the following technologies:
- ECG & Heart Rate: Electrocardiography
- Respiration: Thoracic impedance (ECG) and spectroscopy (endtidal CO2)
- Noninvasive Blood Pressure & Heart Rate: Oscillometry
- Invasive Pressure & Heart Rate: Direct measurement with strain-gauge pressure transducer
- Pulse Oximetry & Heart Rate: Nellcor®, Inc., red & infrared spectroscopy
- Endtidal CO2: Novametrix Medical Systems, Inc., infrared spectroscopy
- Recorder: Thermal
## Nonclinical Tests
Several bench studies were conducted which demonstrate safety and effectiveness of the MPS and modules/monitoring parameters:
- ECG & Heart Rate
- Respiration (Impedance)
- Continuous Temperature
- Invasive Pressure
- CO2 & Respiration
- Pulse Oximetry
- Environmental
- Electromagnetic Compatibility
## Clinical Tests
Several clinical studies were conducted which demonstrate safety and effectiveness of the MPS and modules/monitoring parameters:
- Noninvasive Blood Pressure in the adult, pediatric and neonatal populations
- Pulse Oximetry
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46
# 510(k) Summary, Continued
## Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this premarket notification, Johnson & Johnson Medical concludes that the new device, the DINAMAP Select Multi-Parameter System and modules, is safe, effective and substantially equivalent to the predicate devices as described herein.
## Other Information
Johnson & Johnson Medical will update and include in this summary any other information deemed reasonably necessary by the FDA
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.
